National Filter Registry Finds High Fracture Rates For OptEase And TrapEase IVC Filters

March 09, 2016

Kaiser Permanente recently conducted a study to answer the question of how commonly do inferior vena cava filters malfunction when left in place long-term (more than four years). This question is highly relevant today, as most medical studies regarding IVC filters have only looked at short term complications, and due to the recent FDA safety notices warning that the risk of device complications may increase the longer these devices are left implanted.

To answer the question, the authors looked at all IVC filters implanted in patients from January 2007 through December 2009 at several health care facilities around the country. They categorized the patients who had imaging of the filter done four years or more after the device was implanted. There were 96 patients who fit this category. The authors then examined the imaging to see if the IVC filter had malfunctioned.

After looking at the data, the authors determined that, after four years or more after implantation, problems with the device “are relatively common.” They also determined the Cordis OptEase and TrapEase IVC filters experienced fracture rates of 37.5% and 23.1%, respectively. Notably, this is not the first medical study to find that Cordis filters suffer extremely high fracture rates if left in long term.

In 2012, another study examined the complication rate in 20 patients implanted with Cordis TrapEase Filters for a mean time of 50 months. The authors found that 50% of the TrapEase filters had fractured. According to the study, “remarkably, 9 of the 14 filters (64%) that had been inserted for longer than 4 years revealed fractures.” The authors concluded that “patients undergoing permanent TrapEase IVCF insertion are at extremely high risk of strut fractures as early as 2 to 3 years after IVCF placement.” They further concluded that patients with Cordis filters should be monitored closely and should consider having the devices removed.

According to these medical studies, Cordis IVC filters may expose patients to a substantial risk of complications if left implanted long-term. Furthermore, both studies are consistent with recent FDA safety notices suggesting that patients should be evaluated for removal of retrievable IVC filters once the risk of pulmonary embolism has passed.

Troy Brenes, of the Brenes Law Group, is actively litigating cases on behalf of clients implanted with the Cordis TrapEase and OptEase IVC filters.

Practice Areas

Medical Devices