An Idaho man has filed a lawsuit against Cook Medical over an IVC filter that he claims is defective and led to his injuries. Jacob B. was implanted with a retrievable Celect inferior vena cava (IVC) filter on April 27, 2010, at Kootenai Medical Center in Coeur D’ Alene, Idaho. Dr. Nicole Burbank inserted the filter to catch blood clots in his bloodstream, preventing a potential pulmonary embolism (PE).
According to The Daily Hornet, the Celect filter has an extremely high rate of vein perforation, more so than other IVC filters available. The Celect has been accused of defective design as far back as 2007, when multiple studies concluded that the design was inefficient and dangerous.
The Celect is constructed with four main “legs” or struts intended to keep the filter anchored in place inside the vena cava, the largest vein in the body. The anchoring is to prevent tilting, which could lead to one of the struts puncturing through the vein.
In one particular study, 43 percent of Celect filters were found to have perforated the vein within two months after insertion. The Celect filters proved to have a high rate of vein perforation within 71 days after insertion, according to a separate study. In yet another study, many of the filters couldn’t be removed because of “technical failure” that forced doctors to leave the filter in the patients’ bodies.
When the legs of the filter perforate the vein, the patient is at increased risk of having a nearby organ punctured, as well.
Because of retrievable IVC filters’ high rates of failure, the FDA has issued an official recommendation to have the device removed as soon as the risk of PE has passed, within 29 to 54 days after insertion.