Cook Medical is recalling the Zenith Alpha thoracic endovascular graft when used for the treatment of blunt traumatic aortic injury because thrombus may form inside the device after implantation. Cook Medical is also aware of reported cases where the graft became occluded when used to treat such injuries. The thrombosis or occlusion may lead to serious adverse health consequences, including death.
The Zenith Alpha thoracic endovascular graft is intended to treat isolated lesions (not including dissections) in the descending thoracic aorta. The device is used in patients who have a suitable vascular anatomy for endovascular repair.
On 22 March 2017, Cook Medical sent an “Urgent: Medical Device Correction and Removal” notification to all affected customers. This recall notification included a description of the problem and reason for the recall, list of affected products and customer actions to be taken in response to the recall notification.
On 22 June 2017, the company sent an updated notification to all affected customers, informing them that the instructions for use (IFU) for the Zenith Alpha device were updated to remove the indication for use in blunt trauma aortic injury. As a result, it is necessary to remove specific sizes of this device (grafts with a proximal or distal diameter of 18–22mm) that would likely be used only for the treatment of blunt trauma injury.
Cook Medical recommends that patients already treated with the Zenith thoracic endovascular graft for the blunt trauma aortic injury indication should be followed according the current IFU and with considerations outlined in Cook Medical’s March 22, 2017 “Medical Device Correction and Removal” notification.
Cook Medical says that a company sales representative will follow up with all affected customers and provide a corrected IFU