The FDA issued a Class I recall for 4,916 of the Zenith Alpha Thoracic Endovascular Grafts because they can potentially become blocked with blood clots and cause death.
There have been 5 reports of graft thrombosis (blood clots) or occlusion of the patient’s aorta worldwide. One case resulted in patient death, and 3 cases required surgical re-intervention.
Cook Medical warned of a 25% rate of thrombus (blood clots) within the graft during follow-ups to an investigational clinical trial. In past studies, the rate ranged from 15% to 40%, the company said.
Patients who develop blood clots after being implanted with the device may need an emergency open-heart surgery or a bypass.
Zenith Alpha grafts are often used to treat aortic aneurysms and Blunt Thoracic Aortic Injuries (BTAI), which are often caused by car accidents and other types of severe trauma. On June 22, Cook Medical removed the indication for BTAI and permanently stopped selling Zenith Alpha grafts with diameters between 18 and 22 mm that were specifically designed for BTAI.
The first warnings about problems with the Zenith Alpha aorta grafts were issued by Cook Medical in a notice to customers on March 22, 2017.
The recall now includes all serial numbers and all lots of Cook Medical Zenith Alpha Thoracic Endovascular Grafts that were distributed between October 29, 2015 and March 10, 2017.
For more information, customers can contact Cook Medical Customer Relations by calling 800-457-4500 or 812-339-2235.