CORDIS IVC FILTERS
Cordis IVC filters are medical devices placed in the inferior vena cava with the intention of catching blood clots and stopping them from traveling to the heart or lungs. Cordis sells two brands of IVC filters—CordisOptEase and CordisTrapEase—that have been linked to reported adverse events and injuries.
CORDIS OPTEASE FILTER
The FDA cleared the Cordis OptEase filter through the 510(k) process as a permanent device on October 18, 2002. It underwent an additional 510(k) clearance in march 2004 that added a retrievable sign to its label for up to 12 days after implantation. The OptEase has been the subject to several safety notices. This includes an April 3, 2013 notice, wherein Cordis warned doctors about dangerous migration events wherein the Cordis OptEase filter could dislodge and migrate to the heart causing injury or death. Cordis’s actions in response to the notice were limited to highlighting its existing Instructions for Use.
A subsequent product recall of the Cordis OptEase occurred later that same year. The following year the FDA included the OptEase in a May 2014 Safety Notice. This notice stated that the risk of device-related malfunctions with retrievable filters, including the Cordis OptEase, may increase overtime. The FDA stated that the risks of leaving in retrievable filters, such as the OptEase, outweigh its benefits 29-54 days after implantation. Because of this, the FDA recommended that doctors consider the removal of retrievable filters, including the OptEase, as soon as protection from pulmonary embolisms are no longer needed.
The FDA cleared the Cordis TrapEase IVC filter through the 510(k) process as a permanent device on July 7, 2000. Unlike the Cordis OptEase, the TrapEase does not have a retrievable sign. Since its release to market, scientific literature has questioned the safety and efficacy of the TrapEase. In particular, the design of the TrapEase may lead to an increased risk of a blood clot formation around the filter, the very injury the filter existed to prevent. Further studies raise concern about other TrapEase complications. Including the ability to remove the TrapEase once implanted and the risk for fracturing.
NATIONAL CORDIs OPTEASE AND TRAPEASE ATTORNEYS
If you or a loved one has experienced issues with the Cordis OptEase or Cordis TrapEase IVC filter, you may have a case. Take action today and make sure you hold the responsible parties accountable. To schedule a free initial consultation, call 713-520-2500 or toll free at 800-520-1749, or contact us online at https://www.perdueandkidd.com/.
Perdue & Kidd takes all personal injury cases on a contingent fee basis. We only collect attorney fees if we secure compensation for you.