Texas IVC Filter Lawsuit Filed

A Texas man hasCook IVC Filter Attorney filed an IVC Filter Lawsuit in Houston’s Harris County courthouse.  Jeffrey Alan Pavlock has filed a case naming the implanting doctor and Cook Incorporated, a/k/a Cook Medical, LLC.

State Jurisdiction

Cook Medical is headquartered in Indiana, but the implanting doctor practices in Texas; so Mr. Pavlock has exercised his right to demand a jury trial in Harris County. The plaintiff’s claims in the action were also brought solely under state law. The petition states that the “Plaintiff does not herein bring, assert, or allege, either expressly or impliedly, any causes of action arising under any federal law, statute, regulation, or provision.  Thus,” it argues, “there is no federal jurisdiction in this action on the basis of a federal question under 28 U.S.C. section 1331.”

Mr. Pavlock, 33, was surgically implanted with an IVC filter on or about March 3, 2015, by Dr. Adrian A. Wong, a specialist in Interventional Radiology. Dr. Wong implanted a Cook Celect Inferior Vena Cava Filter in Mr. Pavlock.

Failed Removal Attempts
Seven weeks later, on or about April 23, 2015, surgeons attempted to remove the Celect IVC filter but were unable to remove it. According to the petition, the filter had tilted and imbedded into the wall of Mr. Pavlock’s vena cava.  Another removal attempt was made June 2015, but was also unsuccessful. A leg or strut of the IVC filter had protruded through the man’s vena cava wall and lodged in a position adjacent to his aorta, according to the petition.

Mr. Pavlock, by trade a professional firefighter and first-responder, is now at risk for future migrations, perforations, and/or fractures from the irremovable filter, charges the petition. He also faces numerous health risks from the retained filter, including increased risk of blood clots and the risk of death. He will require ongoing medical care and monitoring for the rest of his life and may ultimately require more surgery in further attempts to remove the filter.

The Doctor’s Responsibility Alleged
The petition further alleges that the doctor knew or should have known, inter alia, that only certain patients were proper candidates for an IVC filter, and the doctor also should have known that:

  • the longer a Celect IVC remains in the body, the higher the risk of device fracture or failure
  • the Celect IVC filter is not effective to prevent clots and/or increases the risks of clots
  • safer alternatives to the Celect IVC filter existed
  • Celect filters frequently tilt, migrate, perforate, fracture, and thus involve a high increasing degree of risk to a patient implanted

Lack of Clinical Testing, Contraindications

The petition further claims Cook failed to conduct any clinical testing, such as animal studies; that Cook knew or should have known the Celect filter had a high rate of fracture, migration, and excessive tilting and perforation of the vena cava wall once implanted. It further claims that Cook knew or should have known such failures exposed patients to serious injuries that include death, hemorrhage, cardiac/pericardial tamponade, cardiac arrhythmia, and other symptoms similar to myocardial infarction – severe and persistent pain, perforations of tissue, vessels, and organs; and inability to remove the device. Cook also knew or should have known certain conditions or post-implant procedures such as morbid obesity or open abdominal procedure could affect the safety and integrity of the Celect IVC Filter.

The petition also claims Cook should have known these risks for the Celect were and are substantially higher than other similar devices. The petition also alleges that Cook failed to issue a recall of the Celect Filter and failed to notify customers that a safer device was available.

Texas IVC Filter Case Filed

The case is No. 201703885 in Harris County District Court, Jeffrey Alan Pavlock v. Adrian A. Wong, M.D.; Cook Incorporated; a/k/a Cook Medical, (LLC).  Attorney David Matthews of Matthews & Associates Law Firm represents the plaintiff.

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Indiana IVC Filter Case Filed

Patricia and IVC FilterKenneth Ashcraft of Indiana  have filed an IVC filter case against Indiana-based Cook Medical, Inc., a/k/a Cook Medical Group. The Ashcrafts’ petition was filed July 27, 2016 in Marion County Superior Court.

IVC Filter Perforation
The lawsuit petition states that plaintiff Patricia Ashcraft was implanted with a Cook IVC filter on or about April 5, 2005. In May 2016, doctors discovered the Cook filter had perforated her IVC. The lawsuit further alleges that Mrs. Ashcraft is now at risk for future Cook filter fractures, migrations, perforations and tilting. It charges that she faces numerous health risks, including the risk of death. Further, for the rest of her life, she will require ongoing medical monitoring as well as anti-coagulants.

IVC Filters
IVC filters are designed to filter blood clots (called “thrombi”) that would otherwise travel from the lower portions of the body to the heart and lungs. IVC filters may be designed to be implanted either temporarily or permanently within the vena cava.

The inferior vena cava is a vein that returns blood to the heart from the lower portion of the body. In certain people thrombi travel from vessels in the legs and pelvis through the vena cava into the lungs. These thrombi often develop in the deep leg veins, causing “deep vein thrombosis” or DVT.  An IVC filter such as the Cook filter is designed to prevent thromboembolic events by filtering or preventing blood clots/thrombi from traveling to the heart and/or lungs.

The Indiana lawsuit petition says the Cook filter has caused Mrs. Ashcraft to undergo medical treatment as a result of the device’s failure.

The petition reads: “Plaintiff has incurred significant medical expenses and has endured physical pain and suffering, mental anguish, loss of enjoyment of life, and other losses, some of which are permanent in nature. As a result of the failure of the Cook Filter, Plaintiff has become impaired and will remain so in the future. The defective Cook Filter remains in Plaintiff’s body.”

Lawsuit Counts
The lawsuit counts are Negligence, Strict Product Liability – Failure to Warn, Strict Product Liability – Defective Design, Breach of Express & Implied Warranty, Negligent Misrepresentation, Medical Monitoring, Punitive Damages, Loss of Consortium.

Medical Monitoring Case
The petition also makes a medical monitoring claim that intermittent imaging studies are needed to determine whether the Cook Filter has failed. Such imaging studies typically include computed tomography scan (CT Scan) to visualize the filter. CT Scan imaging produces an image of the filter to show whether it has fractured or migrated.

The petition also says that patients requiring medical monitoring are recommended to undergo regular and frequent imaging studies of the device or portions of it at least once or twice annually.  It charges that the potential for future device failure exists as long as the device, or portions of it, remains within the patient’s body.  Consequently, IVC filter patients require regular and frequent medical monitoring for the duration of the device’s life inside them.

Indiana IVC Filter Case Filed

Attorney David Matthews of Matthews & Associates represents the plaintiffs.  The case is Patricia Ashcraft and Kenneth Ashcraft v. Cook Incocporated, Inc., Cook Incorporated, Inc. a/k/a et. al in Marion County Superior Court, cause no. 49D101607CT026764.

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IVC Filter Lawsuit filed in Illinois

A Cook IVC gunther-tulipfilter lawsuit was filed in Illinois’ Cook County Sept. 12, 2016. Marian Incavo filed the case against Loyola University Health System and Cook Medical Inc., an Indiana corporation. The case specifically concerns Cook’s Günther Tulip IVC filter.

Causes of Action
Causes of Action claimed in the petition are Negligence, Medical Negligence, Strict Product Liability – Failure to Warn, Defective Design, Manufacturing Defect, Breach of Express & Implied Warranty, Negligent Misrepresentation, Wrongful Death, Loss of Consortium.

Death of Plaintiff
Noel Francis Incavo died at age 78 on Sept. 10, 2014. He had been implanted with a Cook IVC filter on or about April 21, 2009. According to the petition, Mr. Incavo received the implant prior to a spinal procedure at Loyola University Medical Center in Cook County, Illinois.

IVC Filter Failure
IVC filters are advertised to prevent deep vein thrombosis. The petition says autopsy performed at the Autopsy Center of Chicago revealed “massive bilateral acute pulmonary embolism; deep venous thrombosis and complete occlusion of the left iliac vein; and a recent pre-mortem thrombus within the IVC filter.”

IVC Filter Problems Known
The petition states that “Defendants knew or should have known of the dangerous propensities of the IVC filter (to) cause injury and subsequent death, similar to the injuries sustained by the Decedent [Mr. Incavo].”

“Further,” the petition states, “several published clinical studies showed IVC filter lacked efficacy, were inferior to anticoagulation therapy, and were associated with higher rates of DVT, including one of the only randomized controlled trials ever performed on IVC filters PREPIC.”

The petition also charges that Cook continued to promote its Günther Tulip filter as safe and effective even though clinical trials did not support its long or short term efficacy.

IVC Filter Lawsuit filed in Illinois

The case is No. 2016L009027 Marian Invaco, et al. Vs. Loyola University Health System, Cook Inc. et al. in the Circuit Court of Cook County, Illinois Dept., Law Division. David P. Matthews of Matthews & Associates represents Mrs. Invaco.

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Technology runs Amok

TechnologyPhone Spy runs amok today. Most people seem to accept that the “latest” technology, whatever it is, should be embraced and celebrated. Each new apple product or so-called “Smart phone”or appliance is trotted out with a public relations blitzkrieg that seamlessly blends “news” with advertising. Many of us and our friends and relatives become salespeople ourselves, promoting the latest gadgets to one another.

Machines Ascend as Humanity Descends

Mahatma Gandhi was still alive as the industrial revolution began to alter the values of the world. Technology began to make human beings less important in the means of production, as in Henry Ford’s assembly lines. Machines were made to seem increasingly indispensable, human beings less and less so.

Machines replace and delimit Humanity

Human survival becomes more and more dependent upon our ability to run machines, while increasingly the machines run us. More and more jobs are replaced by machines. People become secondary. Human labor is needed primarily to keep the machines going, while liquid capital from labor is used to pay for “new and improved” or “upgraded” machines: smart phones (not so smart for us), televisions, automobiles, dishwashers and other so-called “Smart” appliances and “Smart” meters, which are not smart at all. Meanwhile, credit cards replace cash so that everything is cleverly calibrated to track our every move, purchase, emotion, to corral us for advertisers who want to understand and manipulate us in order to sell us more machines.

Hate Not The Machines

Mahatma Gandhi said, “I hate not the machines, but this growing passion for machines. I hate the passion for the machines which work upon diminishing man power. (I) want the wealth to be accumulated not just in a few hands but for all the people in the world.”

The Worship of Technology

Gandhi was not against technology. He was against worshiping technology as a means of salvation. He thought salvation could not come from outside; it could only be attained internally. Gandhi thought that technology encouraged the soul to be led astray by greed.

Machines Triumph
The dishwasher, the leaf blower, the so-called “Smart” TV, cell phone or computer – we quickly buy whatever new technology is thrown at us. Most hold a decided prejudice that whatever is newer must necessarily be better. Old bad, new good, seems to be the prevailing “wisdom” with all new technologies. Those who aren’t using the latest whatever are seen as fools or losers. Why wouldn’t one want to “take advantage” of the latest gadget?

Medical Device Technology runs Amok

In the world of medicine, there may be no better example of technology run amok than with IVC blood clot filters. Thousands of IVC filter lawsuits have been filed because any risk-benefit analysis shows they are clearly not worth their risks. Anyone taking a few minutes to handle and examine one of the flimsy IVC filter devices could readily see that the notion of jamming one into a human being’s vena cava is a terrible idea.

Studies show IVC filters fail to improve anticoagulant therapy, while studies also show they are not being retrieved in timely fashion. The longer they remain in the body, the more difficult they are to remove. In addition, the longer they remain implanted, the more likely they are to cause problems, including life-threatening complications.

Morcellator Lawsuits are being filed because power morcellators were sold as less invasive for hysterectomy or uterine fibroid removal than prior methods of surgery for women; however, power morcellators can spread undetected cancer that can kill the woman who has been unwittingly talked into having one used on her.

Plastic mesh was sold to gynecologists primarily as a money-making scheme. Johnson & Johnson, Bard, AMS, and other mesh makers used very well-funded advertising blitzes to convince doctors that this product was a good idea. It was easier to put plastic mesh into a woman to treat pelvic organ prolapse or stress urinary incontinence than it was to find a surgeon with the surgical chops to do the job the way it had been successfully done for more than 100 years.

Metal on metal hip implants were, at one time, the latest, greatest thing. The problem was and is that they grind against each other and eventually cause tiny shards of metal to enter the bloodstream. Cobalt and other metal poisoning results, in addition to enormous pain as the metal on metal hip replacements fail.

Technology runs Amok

Here’s a short list of technological “advances” trotted out as advances that are questionable at best, and nothing of the sort if one looks closely at them, and what their real cost is to human beings.

•  IVC Filters
•  Power Morcellators
•  Transvaginal (Plastic Mesh)
•  GMO / Monsanto “Foods”
  Leaf Blowers
•  Smart Meters

Each of these fails a risk-benefit test. Each was meant to replace something that already worked just fine. Each of these cost more than the thing it was meant to replace. Each causes at least as many problems as it solves. Each nullifies or belittles the human element, the man power of which Gandhi spoke. Each takes more from us than it gives. Would that we could turn them all off, or stop using them, and take back some of the humanity that we’ve allowed their makers to steal from us.

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New Laser Technique removes IVC Filters

Despite thereIVC Filter Graphic being no evidence blood clot filters help the overall population, or that they increase mortality for trauma patients, some 250,000 IVC filters are implanted in people yearly. Even more concerning, many of these devices are not removed as soon as they should be. Research has meanwhile shown that the longer IVC filters remain in the body, the more likely they are to cause problems.  Fortunately, help may be on the way.

New Technology could save Lives

New technology is showing some promise, paving the way for the possible safe removal of IVC filters. New technology and methods could potentially save thousands of lives.

FDA recommends Quick IVC Filter Removal
Studies estimate that only 8% of IVC filters are removed from patients within 3.8 years of their being implanted. The FDA, meanwhile, recommends IVC filters be removed 24 to 59 days after being implanted.

The problem is that IVC filters aren’t always easy to remove, even within the recommended window; and the longer they remain implanted, the more difficult they can be to remove. IVC filters like those made by C.R. Bard, Cook Medical, and Cordis Corporation, have been named in blood clot filter lawsuits which allege they are prone to perforating the inferior vena cava wall. They can also migrate throughout the body and fracture, causing their parts to embed into vital organs. One client at Matthews & Associates Law Firm, which represents people who have filed IVC filter lawsuits, has an IVC filter embedded in a kidney. The entire kidney will likely need to be removed to safeguard the person’s life.

When an IVC filter fails within a person’s body, it can be extremely difficult to remove the device. Besides the kidneys, pieces can lodge in the heart or lungs,  and devices that have perforated the vena cava wall often can’t be removed without causing further damage.

Serious, Life-threatening Complications

IVC filters left inside one’s body can cause serious, life-threatening complications, including internal bleeding or strokes. Patients left with the defective devices may live in constant fear that the wrong movement could jar a jagged piece loose and cause fatal damage. Into this fearful scenario comes this hopeful news.

Five-Year Study shows Promise for Filter Removal

A five-year study examined the safety and efficacy of using advanced laser technology to remove previously irretrievable IVC filters. Endovascular laser-assisted retrieval has been applied to successfully remove several different types of IVC filters. Researchers who worked in the study believe that nearly all defective IVC filters can be removed using this laser technology.

New Laser Technique removes IVC Filters

More clinical studies need to be performed using this procedure, which for now appears able to give many thousands of people hope for a better, healthier future unencumbered by IVC filter fears.

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IVC Filters Poor Choice for Trauma Victims

IVC filters are IVC Filter Graphica poor choice for trauma victims. Patients implanted with IVC filters were no more likely to survive more than 24 hours after injury than those who received no filter, according to a study published in JAMA September 28, 2016. The research examined 451 trauma patients given an IVC filter, against a control group of 1,343 not given a filter. The study also referenced several other points which give cause to question whether the benefits of IVC filters are worth their risks.

No Significant Difference

The research study concluded there was “no significant difference” in survival for trauma patients with or without an IVC filter, whether or not they had venous thrombosis.

Death Risks rise with IVC Filter Dwell Time

The authors’ conclusions called for a reexamination of the use of filters in the trauma population, especially given the fact that removal rates are low “and there is increased risk of morbidity in patients with filters that remain in place.”  The longer the filter remains in place, the more likely it is to cause problems.

Venous Thromboembolism (VTE)
VTE is a significant cause of morbidity and mortality in the U.S., with some 900,000 patients a year developing VTE or pulmonary embolism (PE). Blood thinners are typically used for VTE prophylaxis in hospitalized patients or for treatment of acute venous thromobosis. Blood clot filters are often implanted in patients for whom blood thinners are contraindicated, as they often are for trauma patients.

IVC Filter Use Increases despite Lack of Evidence

Study authors Shayna Sarosiek, MD; Denis Rybin, PhD; Janice Weinberg, ScD; and others point out that despite a “lack of high-quality evidence” to prove the safety and effectiveness of IVC filter placement, IVC filter use has increased in the trauma population. The authors set out to “delineate the long-term mortality risk associated with IVC filter placement in trauma patients with and without a VTE. They performed a retrospective cohort study of trauma patients at Boston Medical Center at Boston University School of Medicine.

IVC Filters –No Benefit

Once the trauma patients survived the initial injury for 24 hours, there was no significant difference in mortality between those who received an IVC filter and those who did not. The data the researchers saw showed no benefit or decrement in long-term mortality for trauma patients with IVC filter insertion, whether or not patients had DVT or PE. Most filters were placed in those without VTE, with 91.6% (413/451) not removed. That indicates long-term IVC filter placement did not increase survival through prevention of future PE or decrease survival because of IVC filter complications (embolism, ruptured viscera, filter fracture).

IVC Filters Need Removal
The authors also noted that most IVC filters are not retrieved in a timely fashion and no clear protocol has been set for a timetable to retrieve them. But the authors said that their study was designed to examine mortality only, “and any nonlethal morbidity attributed to filter insertion would not be evident in these data.

Study Conclusion
The authors concluded that their data indicate IVC filters “should not be placed in trauma patients in an effort to decrease all-cause mortality.”  They also noted that “given the expected morbidity of long-term IVC filter use, filters should be removed as soon as a patient’s contraindication to anticoagulation resolves.”

IVC Filter Lawsuits

The failure of IVC filter manufacturers to inform implanting surgeons of the need to closely monitor IVC filter implantees, and to remove their filters as soon as anticoagulation resolves, is just one factor which leaves IVC filter makers vulnerable to IVC filter lawsuits.

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Law Firm Filing IVC Filter Lawsuits

Matthews & Associates Law FirmIVC Filter is handling IVC filter lawsuits nationwide against all the major makers of IVC – Inferior Vena Cava – blood clot filters. The firm, with offices in Houston and New York, is engaged in litigation against Bard, Cook, Cordis, and Rex, the major IVC filter manufacturers.

IVC Filter Injury Research

Matthews & Associates attorneys have reviewed thousands of internal documents and dozens of published medical studies. They have also consulted with several leading experts in the field. These reviews and consultations have found, unfortunately, that mounting evidence indicates most IVC filters will eventually fail. In addition, many temporary filters are not being retrieved in a timely fashion, and many IVC filter implantees are unaware they have a filter implanted.

Several different injuries may constitute a potential IVC filter case. The firm is investigating cases in which one of the following IVC filter injuries obtain:

1) any part of the IVC filter fractured or broke off;
2) the IVC filter or a part of the IVC filter moved or migrated from its original location;
3) the filter perforated the inferior vena cava or other organ;
4) the filter is embedded or tilted;
5) a doctor tried to remove the filter without success;
6) a doctor recommended removal but felt the procedure was too risky;
7) a doctor diagnosed someone, AFTER the filter was implanted, with one of the following medical conditions, which could be associated with the IVC filter:
a. caval thrombosis;
b. pulmonary embolism;
c. DVT /post-thrombotic syndrome; or
d. thrombosis/embolism.

Filter Failure more likely over time

Virtually all of the medical evidence that our attorneys have reviewed indicates that the longer an IVC filter remains in the body, the more likely it is to fail. In addition, the medical literature we have reviewed indicates that damage caused by the filter tends to be progressive.

For these reasons, people with an IVC filter in place might be wise to get screened even if they have had a prior test which showed that the filter was intact and in place.

Statutes of Limitations Issues

If upon testing and screening by a doctor, someone is diagnosed with one of the seven conditions listed above, that person might may want to contact an attorney to consider an IVC filter lawsuit. Anyone who has had complications arising from the removal or attempted removal of an IVC filter, or has been diagnosed by a doctor with any of the conditions above, or who has experienced a failed attempted removal of the filter, could trigger a deadline to file a lawsuit in court. That person might be wise to contact an attorney if they do not already have legal representation. Lawsuits have strict time limits for filing, and IVC filter lawsuits are no different.

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Cook must produce IVC Filter FDA Reports

Virtually every IVC Filterlawsuit involves a judge’s issuing key rulings that impact the outcome. A judge’s decisions for the court can hinder plaintiffs  – such as the recent judge in the Mirena birth control cases who ruled to exclude all the plaintiffs’ experts, which challenges the hopes of women who have alleged Mirena injury. On the other hand, a judge’s rulings can also help plaintiffs.  A recent judge’s ruling in the Cook IVC filter multidistrict litigation has allowed plaintiffs to continue building their cases.

“Discovery” Allowed in Cook’s Reports to FDA

In May 2016 in the Cook IVC filter multidistrict litigation set in Indiana, a federal judge refused to bar Discovery involving plaintiffs’ allegations that Cook failed to file reports to the FDA that showed bad results with some Cook IVC filters.

Adverse Device Events allowed in IVC Filter Cases

Plaintiffs in the Cook IVC filter cases requested Discovery relating to information Cook Medical delivered to the FDA regarding the outcomes of patients implanted with Cook IVC filters. The plaintiffs’ group believes Cook underreported IVC filter device problems to the FDA. The group wants access (Discovery) to all information regarding whatever Cook shared or possibly failed to share with FDA.

Cook Medical requests Protective Order to Conceal Reports

Cook Medical responded by filing a motion for “protective order,” which would have effectively barred Discovery of reports Cook made to FDA. Cook argued that it had no duty to produce this information to the plaintiffs, based on some recent court decisions.

Cook IVC Filter MDL Magistrate Judge Tim Baker disagreed with Cook’s attorneys. Judge Baker ruled that this information requested by plaintiffs is potentially relevant to the claims in the case. He ruled that Cook has an obligation under the Rules of Civil Procedure to produce this information. Since Judge Baker denied Cook’s motion, the company is now required to produce this FDA reporting information to attorney David Matthews and other lawyers representing plaintiffs in the MDL.

Discovery

Once a lawsuit is filed, defendants have a chance to “answer” or enter a plea to the complaint, either by admitting the complaint is true or by denying its veracity. Following the filing of these “pleadings,” the battling parties engage in formal discovery. Discovery in civil litigation is the exchange of documents and information between the parties. The Rules of Civil Procedure require Discovery. This occurs when one side writes questions (Interrogatories) or requests for documents (Requests for Production of Documents). Unless there is a compelling reason to withhold the information, the other side must then prepare written answers and make all requested documents available to the requesting party. The parties then use that information to build their cases for trial.

Discovery Decision Impacts IVC Filter Cases

The court’s decision allows the plaintiffs to “discover” information Cook sent to FDA regarding Cook IVC filters and adverse events. Plaintiffs’ cases may be aided if those Cook reports to FDA are false, misleading or incomplete. Plaintiffs’ petitions now charge that Cook misrepresented IVC filter efficacy and safety, and that Cook failed to adequately warn of the risks.

IVC Filter Problems Underreported?

If it turns out that Cook underreported problems with the Cook IVC filter, the defense of the learned intermediary doctrine could be stripped from the case. The learned intermediary doctrine means that a medical device manufacturer cannot be liable for negligence if it provides all necessary information to a “learned intermediary” such as the doctor or implanting surgeon. It is that learned intermediary’s responsibility to inform the patient of the risk-benefit analysis, the benefits and risks of using the medical device. Medical device makers typically argue to the court that they notified the doctor (and therefore the patient) about the risks involved; it is the doctor’s responsibility to explain those risks to the patient.

However, if the IVC filter (or other device) maker underreported problems to the FDA, the learned intermediary doctrine becomes meaningless. The physician could not have informed the patient of the real risk-benefit profile if only limited information were available, especially if that information were withheld. Consequently, if Cook Medical can be shown to have underreported or misreported IVC filter problems to FDA, its defense could be substantially weakened.

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FDA Reporting Regulations:

Medical device makers must report to FDA (1) within 30 calendar days of learning information that reasonably suggests one of their devices may have caused or contributed to a death, serious injury, or malfunction and (2) within 5 working days if an event requires action other than routine maintenance or service to prevent a public health problem.

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Gunther Tulip IVC Filters Troubling Studies

IVC blood clot IVC Filter Graphicfilters have a troubled history when one looks closely at their safety and efficacy studies. The general safety profile of IVC filters makes them difficult to justify using for the general population.

Gunther Tulip IVC Filter Tilt 91%

Several researchers – including Alan Sag, BS; Joseph M. Stavas, MD; Charles T. Burke, MD; and several others – analyzed a retrospective review of 175 patients with the Gunther Tulip IVC filter implanted from 2003-2007. They reviewed each patient’s medical records and cavagrams, and published their conclusions in the Journal of Vascular and Interventional Radiology in 2008. Ninety-one percent (91%), 159/175 patients had tilt in their filters upon the first retrieval attempt. They found that the tilt “resulted in decreased clot-trapping abilities, increased complications, thrombosis, and difficulty in removing.”

IVC Filters increase DVTs

An American Heart Association study published in March 2005 by the PREPIC Study Group concluded that, at eight years, vena cava filters reduced the risk of PE, but increased the risk of DVT’s, and had no effect on patient survival. The authors’ conclusion was that although IVC filter use “may be beneficial in patients at high risk for pulmonary embolism, systematic use in the general population with venous thrombotic embolism (DVT and PE) is not recommended.” (emphasis ours)

IVC Filter Role Unproven

A clinical investigation by the International Society of Endovascular Specialists in 2007 looked at the retrievability of Cook’s Gunther Tulip Vena Cava Filter after dwell times longer than 180 days for multiple trauma patients. Thirty three (33) of 115 filters could not be retrieved. The investigation concluded that the role of IVC filters is unproven, and that retrieval should be done as soon as clinically indicated.

IVC Filters Difficult Removal

A Journal of Medical Imaging and Radiation Oncology article published in 2008 looked at the retrievable Gunther Tulip inferior vena cava filter in 317 patients. The authors reported that reported retrieval periods for the Gunther Tulip filter have continued to lengthen despite recommendations to remove them at 14 days, which later became at the doctor’s discretion.

The authors concluded: “Our data suggest (that) the extended filter dwell times may compromise successful retrieval.”

IVC Filters Not Retrieved

A Journal of Vascular and Interventional Radiology article published in 2008 examined 188 patients with attempted filter removal, with a mean dwell time of 63 days. Even at just two months, 12% were retrieval failures. The authors concluded that 90 percent of filters not retrieved perforated the IVC, the connection between perforation and inability to remove. Just as disconcerting, they concluded that increased dwell time was a significant factor in determining retrieval success.

Gunther Tulip worsens over time

Another Journal of Vascular and Interventional Radiology article, this one published in 2013, found the Gunther Tulip Filter troubling when left in a person over time. The authors concluded: “Although the Gunther Tulip and Option filters exhibit caval penetration on CT imaging, only the GTF (Cook) exhibits progressive penetration over time.

Gunther Tulip IVC Filters Troubling Studies

A 2007 study published in The Journal of Trauma and Acute Care Surgery found that despite IVC filters being generally accepted to reduce the risk of fatal PE, “this has not been proven, particularly when used for prophylactic indications.”

Further troubling, the study found that most IVC filters are not retrieved when placed for trauma patients. That information comes in addition to the fact that IVC filters have not been proven to increase trauma patients mortality.

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IVC Filters Risk Serious Complications – Health Canada

IVC filters riskHealtha Canada serious complications, said Health Canada this week. Serious IVC filter complications, including death, have been reported in patients implanted with an IVC filter.  IVC filters can result in caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, and/or cardiac tamponade. Many of these serious complications occurred with long-term filter implantation – greater than 30 days. Health Canada said these complications have also been reported internationally.

Dear Doctor Letter for IVC Filter Use

On July 25, 2016, Health Canada sent a “Dear Healthcare Professional Letter” (a ‘Dear Doctor letter’ in American parlance) to warn doctors and other medical professionals about the dangers of IVC filters. The IVC Filters named in the letter include those made by Bard, Cook Medical, B. Braun and Cordis.

The letter said its intended audience was physicians who request or implant Inferior Vena Cava (IVC) filters and clinicians responsible for follow-up care:  radiologists, cardiologists, vascular surgeons, thrombosis specialists, internists, emergency physicians, bariatric surgeons, orthopaedic surgeons, primary care physicians.

It also asked these professionals to distribute the letter to “relevant departments and appropriate personnel who use IVC filters.”

Limited Indications for IVC Filters

Healthcare professionals were cautioned in the letter that they should carefully consider the indications for IVC filters. Health Canada said the IVC filter should be considered only for patients with acute proximal deep vein thrombosis (DVT) of the leg, and those with acute pulmonary embolism (PE) IF those patients also have a contraindication to anticoagulation (blood thinner medication such as cumadin).

Retrievable IVC Filters short-term only

The letter further cautioned that retrievable IVC filters are intended only for short-term placement. When possible, they should be removed when anticoagulation therapy can be started or if a patient’s PE risk subsides.

Health Canada encourages each hospital to identify all patients who have a retrievable IVC filter placed and to develop a formal strategy to assess these patients for filter removal.
Health Canada said it had received 121 reports of serious complications associated with IVC filters as of June 6, 2016. Serious complications such as caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, cardiac tamponade, and death have been reported in patients who have been implanted with IVC filters. Many of these complications occurred with long-term (greater than 30 days) filter implantation. These complications have also been reported internationally.

Health Canada named six IVC filter manufacturers and twelve (12) different IVC blood clot filter products in the letter:

Filter & Maker:

ALN:

•  ALN Vena Cava Filter   (Retrievable)

Bard:   

•  Denali Vena Cava Filter (Retrievable)

•  G2 Filter System            (Retrievable)

•  Simon Nitinol Vena Cava Filter  (Permanent)

B. Braun Medical:

•  VenaTech LP Vena Cava Filter (Permanent)

Cordis Cashel:

•  Optease Vena Cava Filter       (Retrievable)

•  Trapease Permanent Vena Cava Filter

William Cook, Europe APS And Cook, Inc.:

•  Cook Celect Platinum Vena Cava Filter (Retrievable)

•  Cook Celect Vena Cava Filter (Retrievable)

•  Gianturco-Roehm Birds Nest Vena Cava Filter (Permanent)

•  Gunther Tulip Vena Cava MREye Filter Set (Retrievable)

 REX Medical, LP

•  Option Retrievable Vena Cava Filter System  (Retrievable)

Randomized Control Trials show IVC Filters fail efficacy

Randomized control trials are the gold standard for testing medical device safety. Health Canada said there have been several clinical studies of IVC filters, but only two randomized controlled trials (RCTs). Results from those two RCTs fail to support IVC filter use in patients who can be treated with anticoagulation. In addition, those RCTs failed to show reductions in VTE and mortality.

IVC Filters Risk Serious Complications – Health Canada

Health Canada also noted that it is working with IVC filter makers to monitor post-market safety and effectiveness of IVC filters in Canada and worldwide. Health Canada has required IVC filter makers to put post-market evaluations in place that could include Canadian registries. The agency said it wants to “further understand appropriate patient populations that should be treated with IVC filters.” Health Canada said it is also sharing this important IVC filter safety information with healthcare professionals via fax, in addition to publication on Healthy Canadians Web site, as well as MedEffect.

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