Cook IVC Filter
What’s the Problem with the Cook Ivc Filters?
The Cook IVC filter is intended to prevent pulmonary embolisms, which is a life-threatening condition that occurs when blood clots travel from the lower body and become trapped in the lungs. If the clots block major blood vessels, lung tissue can be severely damaged, leading to organ failure and death.
Although pulmonary embolisms are very dangerous, treating stable patients with an IVC filter may actually be even more dangerous — especially if they are implanted with a removable device that is never removed.
Retrievable IVC filters are intended for short-term protection against pulmonary embolism, but they are not always retrieved when a patient is no longer at risk of pulmonary embolism. After 3-4 months, the risk of complications increases. If the filter fractures or migrates, it may be difficult or impossible to remove. In some cases, the filter must remain in a patient’s body because the risks of removing it outweigh the risk of long-term complications.
Cook Ivc Filter Side Effects
Some of the most serious IVC filter side effects occur when temporary, retrievable IVC filters (such as the Günther Tulip and Celect) are not removed when the patient is not at risk of a pulmonary embolism. These life-threatening side effects include:
- Cardiac tamponade
- Organ damage
- Chest pain Death
Fda Warns Against Ivc Filter Usage
Patients who suffer from the threat of pulmonary embolism and are contraindicated for anticoagulation therapy may find themselves receiving an Inferior Vena Cava filter or IVC to prevent pulmonary embolism.
Since the introduction of the IVC filter in 2005, the FDA has received roughly one thousand adverse reports involving these filters. Specifically, it was reported that the IVC filters fragment and embolize in the body.
Research of these devices and the reports made by physicians and consumers has caused the FDA to urge physicians who advise their patients to use an IVC filter to consider the risk and benefits for individual patients instead of simply choosing the IVC for all patients who are ineligible for anticoagulation therapy, and to remove the device once the symptoms have diminished.
IVC filter complications are very serious and can be life threatening. Out of the 921 reported events to the FDA, there were:
- 328 device migrations
- 146 involved embolizations or detachment of the device components
- 70 IVC perforations
- 56 IVC filter fractures
Fda Warns Against Ivc Filter Usage
The Günther Tulip is an inferior vena cava (IVC) filter manufactured by Cook Medical. It has been on the market in Europe since 1992 and the United States since 2003. It is designed with twelve filter wires, including four legs that are each 44-mm in length.
It is designed to catch blood clots in the top of the filter while still allowing blood to flow through the vena cava. This helps prevent pulmonary embolism in patients with deep vein thrombosis (DVT), especially patients who cannot take a blood-thinning medication. T
The Günther Tulip is a retrievable IVC filter, which means it is only intended for short-term protection against pulmonary embolism. If it is left in a patient for more than 3-4 months, there is a higher risk of complications like filter fracture or migration. This can make it very difficult to retrieve the filter.
Embolization occurs when broken pieces of an IVC filter travel to the heart, where they are impossible to remove. This can lead to long-term complications, perforation of the heart muscle, arrhythmia (abnormal heart rhythm), bleeding, sudden heart attack, and death.
In April 2012, Cardiovascular and Interventional Radiology published a study demonstrating a high risk of vena caval perforation with longer indwelling times for the Günther Tulip filter.
After analyzing data on 50 patients who were implanted with a Cook Celect or Günther Tulip from July 2007 to March 2009, researchers found:
- All of the filters showed some degree of vena caval perforation within 71 days.
- Filter tilt was also seen in 40% of the patients.
- In 86% of patients, at least one component of the filter completely perforated the vena cava.
Cook Celect Filter Problems and Complications
Cook Medical manufactures the Celect Vena Cava Filter. It was approved in 2008 under the FDA 510(k) approval process. This allows manufacturers of new devices to avoid conducting new safety studies so long as the device is similar to another device on the market. Cook introduced the Celect as an improved version of the Günther Tulip IVC filter, which was approved in the 1990s.
The Cook Celect IVC filter is designed to stop or catch blood clots travelling through the inferior vena cava, to prevent a pulmonary embolism. They are implanted in patients at risk for a pulmonary embolism, who are unable to take a medication to reduce the risk of blood clots or if such anticoagulants have failed.
When the Cook Celect IVC filter is left in place after the risk of a pulmonary embolism has passed, the legs or struts that extend out in a spider-like fashion may fracture or break. This could allow the pieces of the filter to travel through the bloodstream and get lodged in other parts of the body, usually the heart or lungs.
In 2012, a study published in Cardiovascular and Interventional Radiologystudied 50 patients who were implanted with a Günther Tulip or Celect filter between July 2007 and May 2009. After 71 days, all of the filters had some degree of erosion into the vena caval wall. Overall, 86% perforated the vena cava and 40% tilted into the vena cava.
Symptoms of problems from a Cook Celect filter fracture or migration may result in severe and persistent chest pain and shortness of breath. This often results in emergency medical treatment to determine whether the symptoms are a heart attack or fracture of the IVC filter.
Cook Günther Tulip Filter Lawyers & Cook Celect Filter Lawyers
Despite information that indicated consumers faced an unreasonable risk of injury or death from Cook Günther Tulip and Celect IVC filters, the manufacturer failed to take adequate steps to protect consumers or warn about the risks.
Thousands of individuals have been implanted with the Cook Günther Tulip and Celect IVC filter, exposing them to a risk of serious and potentially life-threatening injury if the Cook IVC filter fracture, migrate or fail. As a result of Cook’s failure to inform or warn physicians or the public, individuals who received one of these IVC filters may be entitled to financial compensation through a Cook IVC Filter lawsuit.
The Cook Günther Tulip and Celect IVC filter attorneys at Heninger Garrison Davis LLC are providing free consultations and claim evaluations to all individuals who received an IVC filter since 2003, who suspect that they may have experienced problems from a fractured Cook Günther Tulip and Celect IVC filter. All cases are pursued on a contingency fee basis, which means that there are no fees or expenses to hire our Cook filter attorneys unless we win your case.