Cordis manufactures the OptEase vena cava filter, which is designed to be removed when it is no longer necessary. The longer it remains implanted, the higher the risk of complications like fracture, migration, and organ damage.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently evaluating IVC filter cases in all 50 states, regardless of whether you have been injured or not. If you or somebody you know was implanted with an IVC filter, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Overview
OptEase is a retrievable wire device that is implanted in the inferior vena cava (IVC) to catch blood clots before they can cause a pulmonary embolism.
Approval Based on Controversial Implants
OptEase was approved in 2003 with a 510(k) application, which allows new devices on the market without new clinical trials so long as they are “equivalent” to devices already on the market. The equivalent devices included C.R. Bard’s Recovery filter, which was withdrawn from the market in 2005 after being linked to a high rate of fracture. It also included Cook Medical’s Günther Tulip filter. Cook is now facing hundreds of lawsuits from people who were injured by their vena cava filters.
Cordis OptEase Recall
In March 2013, Cordis initiated a recall for about 33,000 OptEase vena cava filters sold from 2010-2013. The problem is a labeling error (an arrow pointing in the wrong direction on a storage tube) that could result in the filter being implanted backwards. If this occurs, the fixation barbs will point in the wrong direction and there would be nothing to stop the filter from migrating to a patient’s heart.
Cordis Studying Risks of OptEase Filter
The PRESERVE clinical trial is the first large-scale study of vena cava filter safety. From 2015-2020, researchers will track outcomes for about 2,100 people, including at least 300 implanted with the Cordis OptEase or TrapEase.
What is the problem?
The longer a retrievable vena cava filter remains implanted, the higher the risk of complications. In August 2010, the FDA issued a Safety Communication to warn that 921 people had been seriously injured by vena cava filters over the last five years. Many injuries were associated with temporary filters that were never retrieved. The FDA now recommends removing vena cava filters between 29 and 54 days after implantation, as long as the patient is no longer at risk of a pulmonary embolism.
Side Effects of Vena Cava Filters
- Fracture
- Embolization of broken filter pieces in the bloodstream
- Migration or tilt
- Vena cava perforation
- Organ damage (heart, lungs, kidneys, etc.)
- Bleeding or hematoma
- Irregular heart rhythm
- Blood clots (deep vein thrombosis)
- Recurrent pulmonary embolism
- Filter becomes clogged with clots and obstructs circulation
- Surgery may not be able to remove filter
- And more
Do I have an IVC Filter Lawsuit?
The Schmidt Firm, PLLC is evaluating IVC filter cases in all 50 states, regardless of whether you were injured or not. If you or someone you know received an IVC filter implant, please contact our lawyers immediately for a free case consultation. You may be entitled to compensation by filing a lawsuit.
Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.
The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.
