A New York man has filed a lawsuit against B. Braun, the maker of his IVC filter, which broke after just 10 days following insertion, reports the Daily Hornet.
Robert Z., a man from Valhalla, New York, received a Vena Tech inferior vena cava (IVC) filter on Nov. 18, 2015. Dr. Carlos Tulla surgically implanted the device at White Plains Hospital Center in New York.
Ten days later, on Nov. 28, Robert underwent a CT scan of his chest. The results showed the Vena Tech had migrated to the right atrium of his heart. He was immediately transferred to Weill Cornell Medicine in New York City where emergency surgery was ordered to remove the filter.
“This procedure revealed that portions of the filter had become embedded within the vena cava wall and that blood clots had occluded the filter and extended it above the location of the filter,” the lawsuit states.
Robert now faces a lifetime of ongoing medical care and special monitoring as a result of his injuries related to the filter migration.
The lawsuit accuses B. Braun of failing to warn of potential complications, dangers and risks posed by the Vena Tech IVC filter, which has been known to fracture, collapse, migrate, perforate, and cause additional blood clots.
B. Braun is currently participating in an FDA-required PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study, which is the first of its kind. It is a large-scale study involving multiple specialties for the purpose of evaluating the safety and efficacy of vena cava filters in a prospective clinical research trial. The company will follow up with 300 patients who receive the Vena Tech IVC filter over the next few years.