Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Class I Recall - Potential Formation of Thrombus Inside Device

[Posted 08/16/2017]

AUDIENCE: Risk Manager, Cardiology, Surgery, Patient

ISSUE: Cook Medical Inc. is recalling the Zenith Alpha Thoracic Endovascular Graft when used for the treatment of Blunt Traumatic Aortic Injury (BTAI) because blood clots (thrombus) may form inside the device after implantation. Cook Medical is also aware of reported cases where the graft became blocked or closed (occlusion) when used to treat BTAI. Thrombosis or occlusion may lead to serious adverse health consequences, including death.

• Lot or serial numbers: All lots
• Manufacturing dates: April 10, 2015 to January 3, 2017
• Distribution dates: October 29, 2015 to March 10, 2017
• Devices recalled in the U.S.: Approximately 4,500 devices will be relabeled and 500 devices (18 to 22 mm) will be removed.

BACKGROUND: The Zenith Alpha Thoracic Endovascular Graft is intended to treat isolated lesions (not including dissections) in a patient's main blood vessel that carries blood from the heart down through the chest (descending thoracic aorta) into the abdomen. The device is used in patients who have a suitable vascular anatomy for endovascular repair.

RECOMMENDATION: On March 22, 2017, Cook Medical Inc. 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 June 22, 2017, Cook Medical Inc. sent an updated "Urgent: Medical Device Correction and Removal" notification to all affected customers. This recall notification informed customers the Instructions for Use (IFU) for this device were updated to remove the indication for use in BTAI. Because of the IFU correction to remove BTAI from the indication, 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 BTAI.

Cook Medical Inc. recommends that patients already treated with the Zenith Thoracic Endovascular Graft for the BTAI indication should be followed according the current IFU and with considerations outlined in Cook Medical's March 22, 2017 Medical Device Correction notification.

A Cook Medical Sales Representative will follow-up with affected customers and provide a corrected IFU.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/16/2017 - Recall Notice - FDA]