The Crux Vena Cava Filter (VCF) is used for the prevention of pulmonary embolism (PE) in patients at risk for blood clots who are unable to take anticoagulant medications. The device consists of a self-expanding Nitinol filter that is inserted into the vena cava (a large vein that transports deoxygenated blood from the lower body) to catch blood clots before they reach the heart and lungs. The Crux filter is made by the Volcano Corporation, and was approved by the U.S. Food & Drug Administration (FDA) in November 2013.
What’s the Problem?
In May 2014, FDA issued updated safety warnings regarding the use of retrievable IVC filters. The agency warned that the devices should be removed from patients between 29 and 54 days after implantation if the blood clot risk has passed. Filters left in place too long can result in adverse patient outcomes, according to the FDA.
Between 2005 and 2010, the agency received at least 921 injury reports associated with vena cava filters, which included:
- 328 device migrations
- 146 embolizations (detachment of device components)
- 70 perforations of the inferior vena cava
- 56 filter fractures
IVC Filter Complications
- Deep Vein Thrombosis (DVT)
- Chest pain
- Filter fracture
- Filter migration
- Embolization of filter fragments
- IVC perforation
- Perforation of the heart
- Organ damage
- Cardiac tamponade
- Hemorrhagic pericardial effusion
- Pulmonary embolism
- Emergency surgery
- Parts of IVC filter permanently embedded in body
Study Finds Problems with IVC Filter Retrieval
A 2013 study published in the Journal of the American Medical Association (JAMA) looked at the management and outcomes of 952 patients implanted with vena cava filters. About 680 of these patients received retrievable filters designed for temporary use; however, doctors were only able to successfully remove 58 of these.
Doctors made 13 unsuccessful removal attempts, 11 of which occurred in patients whose filters had been implanted for over 85 days. Of the 13 unsuccessful attempts:
- 8 filters couldn’t be removed because the devices were embedded in the vena cava
- 3 filters had punctured a blood vessel
- 2 filters migrated from the implant site to an abnormal position which made retrieval impossible
- 1 patient had a blood clot trapped in the IVC filter
Do I Have a Crux Vena Cava Filter Class Action Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Crux IVC filter lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a lawsuit against the manufacturer and our lawyers can help.