Daniel Shafer was 54 when, in October 2011, he was implanted with Cook Medical’s blood clot capturing device prior to back surgery. Shafer had a history of deep vein thrombosis and had difficulty staying in therapeutic levels with his blood thinner, warfarin.
The clot catcher Shafer was implanted with was the Cook Celect IVC filter. The tiny, cage-like device is implanted into the inferior vena cava, or IVC, a large vein in the body that carries deoxygenated blood to the heart. The device is designed to catch blood clots traveling from the lower limbs before they reach the heart or lungs.
But Shafer never had the back surgery. That’s because his legs started swelling and his right leg began to hurt less than two weeks after he received the Cook Celect IVC filter. A CT scan indicated his iliac veins and IVC were distended up to the level of the filter. There was also mild inflammation surrounding the IVC with multiple small para-aortic and juxta caval lymph node present.
His doctors raised concerns of IVC acute thrombophlebitis. He discharged with a diagnosis of IVC thrombosis with IVC filter in place and deep vein thrombosis in his right lower leg.
The following year, another CT scan was performed. The scan showed chronic occlusion from Shafer’s right groin to the IVC. He was diagnosed with post-thrombotic syndrome emanating from his IVC filter, a painful condition.
Shafer is one of dozens of people who have been implanted with an IVC filter and claim they suffered serious injuries. The lawsuits claim that Cook Medical, as well as other IVC filter manufacturers failed to warn doctors or patients that the filters were associated with adverse events including device migration, filter perforations, filter fractions and embolizations, or movement of the entire filter or fragments of the filter to the heart or lungs.
Source: U.S. District Court of Indiana