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 CordisOptEase filter was cleared by the FDA 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 indication to its label for up to 12 days after implantation. The OptEase has been the subject to several safety notices, including an April 3, 2013 notice, wherein Cordiswarned doctors about dangerous migration events wherein the CordisOptEase filter could dislodge and migrate to the heart causing injury or death. Cordis’s actions in response to the notice was largely limited to highlighting its existing Instructions for Use. A subsequent product recall of the CordisOptEase occurred later that same year wherein unexpired CordisOptEase filters were removed from the market. The following year the OptEase was included in a May 2014 FDA Safety Notice that stated that the risk of device related malfunctions with retrievable filters, including the CordisOptEase, may increase overtime. The FDA went on to state that the risks of leaving in retrievable filters, such as the CordisOptEase,begin to outweigh its benefits 29-54 days after implantation. Because of this, the FDArecommended that doctors consider removal of retrievable filters, including the CordisOptEase, as soon as protection from pulmonary embolisms are no longer needed.
CORDIS TRAPEASE FILTER
The CordisTrapEase IVC filter was cleared by the FDA through the 510(k) process as a permanent device on July 7, 2000. Unlike the CordisOptEase, the TrapEase does not have a retrievable indication.Since its release to market, scientific literature has brought into question the safety and efficacy of the CordisTrapEase. In particular, the design of the CordisTrapEase may lead to an increased risk of blood clot formation around the filter, the very injury the filter was designed to prevent. Further studies raise concern about other CordisTrapEasecomplication including the ability to remove the CordisTrapEase once it is implanted and its propensity for fracturing.
NATIONAL CORDIS OPTEASE AND TRAPEASE ATTORNEYS
If you or a loved one has experienced issues with the CordisOptEase or CordisTrapEase IVC filter, you may have a case and you need to take action to ensure the responsible parties are held accountable. The lawyers at Perdue & Kidd are skilled and capable of ensuring that your rights are protected. To schedule a free initial consultation, call 713-520-2500 or toll free at 800-520-1749, or simply contact us online at http://www.perdueandkidd.com/.
All personal injury cases are taken on a contingent fee basis. Attorney fees are collected only if we secure compensation for you.