Susie Allen was only 49 years old when she was implanted with a Cook Celect IVC filter, a tiny, cage-like device placed inside the inferior vena cava (IVC) – a large vein that delivers deoxygenated blood from the lower extremities – designed to catch blood clots before they reach the heart. But something went horribly wrong.
In January 2012, nearly four years after receiving the IVC filter, doctors discovered that the device had fractured inside her body. In July 2013, doctors discovered that one of the fractured legs of the filter had perforated her aortic wall – the main artery in the body. Allen was rushed into surgery where doctors attempted to remove the strut through her jugular vein. That attempt failed.
Four days later, doctors tried again. This time they entered through the abdomen and conducted an endovascular aortic repair. The struts of the filter had perforated the vena cava as well, and had progressed to penetrate the aorta and into the vertebral body. Doctors were finally able to remove all four struts, but the filter, along with the retrieval hook, remain imbedded in her inferior vena cava wall.
Allen is one of several people suing Cook Medical as part of a multidistrict litigation accusing the device makers for failing to warn about serious risks involving its Cook Celect IVC filter. Those risks include deep vein thrombosis, filter fracture, filter migration, filter embolization and IVC perforation. Another multidistrict involving IVC filter risks targets medical device company Bard.
Source: US District Court Southern District of Indiana