In November 2012, when Donna Newsome was 48, she was implanted with a tiny, cage-like device designed to capture blood clots that may arise following back surgery before they reach the heart. The device, called an IVC filter, specifically called a Cook Celect IVC filter, was implanted in her inferior vena cava, a large vein that carries deoxygenated blood to the heart. It was intended to be a short-term remedy.
One month after being implanted with the device, Donna suffered a pulmonary embolism, or blood clot in her lung. It was found within the right lower lobe of her pulmonary artery. She was scheduled the retrieval of her filter in December 2012.
However, doctors discovered that the cranial hook and apex of the filter in her body were embedded in the wall of her posterior vena cava, and they were unable to remove it.
In January 2014, two years after her doctor’s failed attempt at retrieving the wayward IVC filter inside her, Donna underwent a venacavagram, which showed that the two posterior wires of the filter were perforating extensively through the vena cava walls. Doctors scheduled an open removal of the device in August 2014, at which time her doctor discovered that the struts of the filter were existing through the walls of the vena cava with several of the filter struts perforating the serosa of the duodenum, the first part of the small intestine immediately beyond the stomach.
Doctors freed the proximal portion of the filter, and cut the twisted struts with wire cutters. The remainder of the filter was removed.
Donna is one of several people suing Cook Medical, maker of the Cook Celect IVC filter, as part of a multidistrict litigation in the U.S. District Court Southern District of Indiana. Cook Medical is accused of failing to warn patients or doctors about the filter’s dangerous risks. IVC filters have been linked to deep vein thrombosis, filter fracture, filter migration, filter embolization, and IVC filter perforation.
Medical company Bard, another manufacturer of IVC filters, is also named in a multidistrict litigation.
Source: U.S. District Court Southern District of Indiana