IVC Filter Perforation Rate “Significantly Higher” with Cook Celect

While a growing number of inferior vena cava (IVC) filter lawsuits continue to be filed by individuals who experienced severe and debilitating complications after receiving one of the retrievable blood clot filters, new research highlights the high rate of strut perforations associated with the Cook Celect filter in particular. 

IVC filters are small devices implanted into the vena cava for individuals at risk of pulmonary embolism. The spider-like devices have a number of legs or struts that extend out to “catch” blood clots and prevent them from traveling to the lungs.

Despite questionable evidence to justify the safety or efficacy of the devices, many different types of retrievable IVC filters have been implanted in recent years, which are designed to be removed once the risk of a pulmonary embolism has passed. However, a number of users have reported severe complications and perforations with IVC filters, where the devices tilt out of position, puncture the vena cava or cause other internal injuries.

In a study published recently in the Journal of Vascular and Interventional Radiology, researchers from Northwestern University and the University of Colorado compared the retrievability of two types of inferior vena cava filters, the Cook Celect and Rex Option filters.

While the retrieval rates between the two different types of IVC filters were not significantly different, researchers found that the Cook Celect IVC filter perforation rate was “significantly higher”, with a 43% incidence of strut perforation.

In May 2014, the FDA issued a warning about the importance of removing IVC filters within one or two months after the blood clot risk has passed. The recommendations came in response to adverse event reports involving ICC filter perforation, migration, fracture, embolization, and difficulty removing the device. The agency indicated that many of those events may be related to how long the filter had been implanted.

In this latest study, researchers looked at IVC filters implanted in patients over a 33-month period, with 99 Celect and 86 Option filters reviewed.

The IVC filter perforation rate for Cook Celect filters was 43%, compared to 0% for the Option filters. That comes despite researchers finding that significant tilting was seen in 16.7% of Option filters, but only 8.9% of Cook Celect filters. Doctors also had to resort to adjunctive retrieval techniques more often to remove Option IVC filters

Concerns about the safety of removable IVC filters first emerged in August 2010, when the FDA issued an alert about the risk of problems with IVC filters. At that time, the agency indicated that it had received more than 900 adverse event reports, including 328 where the IVC filter broke free and migrating through the body, 146 where components broke loose, 70 involving perforation of the inferior vena cava and 56 involved the filter fracturing.

IVC Filter Litigation

There are currently several dozen Cook IVC filter lawsuits pending throughout the federal court system, which all involve claims for individuals who experienced complications after receiving a Cook Celect or Gunther Tulip filter.

Similar claims have also been filed against C.R. Bard over two of their retrievable IVC filters, including the Bard G2 filter and Bard Recovery filter.

Since October 2014, the Cook IVC filter litigation has been centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana, as part of an MDL or multidistrict litigation. The cases are being coordinated during pretrial proceedings to reduce the risk of duplicative discovery into common issues, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) is currently considering whether to establish similar centralized proceedings for the Bard IVC filter litigation, following oral arguments presented last month that noted hundreds of additional cases are likely to be filed over the coming months.