Pharmaceutical

Pieces of fractured IVC filter remain in woman’s body

IVC filter 294x210 Pieces of fractured IVC filter remain in womans bodyTonya Brand was 44 in March 2009 when she was implanted with the Gunther Tulip IVC filter made by Cook Medical prior to back surgery. The metal, cage-like device, called an IVC filter, was placed inside the inferior vena cava – a large vein that caries deoxygenated blood to the heart – in order to capture blood clots before they travel to the heart or lungs. Brand was a candidate for the filter because two years prior she had developed deep vein thrombosis, or a blood clot in the deep veins in her legs.

In June 2011, a foreign body was discovered in Brand’s right thigh during a venous ultrasound. Four days later, she noticed an object protruding through her right thigh and pulled out a piece of metal. Diagnostic imaging later determined that two of the legs on her IVC filter had fractured and the piece of metal Brand had pulled out of her leg was one of the fragmented legs. Another leg was found lodged in her spine.

In July 2011, doctors attempted to remove the filter through the jugular vein, but the hook at the apex of the filter had become embedded in the wall of her vena cava. After several unsuccessful attempts to remove the device, doctors finally gave up.

In October 2015, doctors performed an open surgery for another attempt to remove the filter. At that time, three struts were penetrating the wall of her vena cava, and at least one strut was perforating into her aorta, the main artery of the body supplying oxygenated blood to the circulatory system. This time, doctors were able to remove the filter, but the fractured pieces could not be recovered and remain in her body, lodged in her spine.

Brand is one of several people suing Cook Medical over claims that the company did not adequately warn about the dangers of its IVC filters. The cases have been consolidated into a multidistrict litigation in U.S. District Court in the Southern District of Indiana in Indianapolis. Brand’s case has been selected to serve as a bellwether.

Source: U.S. District Court