Cook Medical, Inc. is recalling certain Zenith Alpha thoracic endovascular grafts, following reports that blood clots and occlusions had formed inside some of the devices when they were used to treat patients with blunt traumatic aortic injury (BTAI).
The U.S. Food & Drug Administration (FDA) has designated this action Class I, the most serious medical device recall category, which indicates that the affected Zenith Alpha endo grafts may cause serious injury or death.
The Zenith Alpha thoracic endovascular graft is designed to treat isolated lesions in main blood vessels that carry blood from the heart through the chest into the abdomen. The grafts are intended to be used in patients who have suitable vascular anatomy for endovascular repair.
Blood clots or occlusion may lead to serious adverse health consequences, including death. Cook Medical has received 5 reports of blood clots or occlusion in patients who received a Zenith Alpha endo graft for BTAI. One patient died, while three others required intervention.
Cook Medical his issued two “Urgent: Medical Device Correction and Removal notifications to its customers. The first was sent in March, and included a description of the problem and reason for the recall, as well as a list of affected Zenith Endo grafts and customer actions to be taken in response to the recall notification. An updated notification issue in June informed customers that the devices’ “Instructions for Use” had been updated to remove BTAI as an indication for use.
The Zenith Alpha endo graft recall affects about 4,500 devices which will be relabeled. Cook Medical said it will be removing another 500 grafts (proximal or distal diameter of 18-22mm) that would likely only be used in patients with BTAI.
The Zenith Alpha endo grafts included in this recall were manufactured between April 10, 2015 and Jan. 3, 2017 and distributed between Oct. 29, 2015 and March 10, 2017. A complete list of lot numbers can be found HERE.
Patients who were implanted with a Zenith Alpha Thoracic Endovascular Graft to treat BTAI should be followed as detailed in the current “Instructions for Use”.
Customers with questions about this recall may contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.
Health care professionals and consumers can report adverse reactions or quality related to a Zenith Alpha Endo Graft to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.