Image by Kevin MacKenzie
Thrombus
The US Food and Drug Administration (FDA) has announced that Cook Medical Inc. is recalling the Zenith Alpha Thoracic Endovascular Graft.
The company found that when the device is used for the treatment of blunt traumatic aortic injury (BTAI), thrombi can form and the device can become occluded. This can lead to serious adverse events, including death.
There have been 5 reports of thrombosis/occlusion with this product, all in patients treated for BTAI. In 1 case, a patient died.
Therefore, Cook Medical Inc. is recalling all lots of the Zenith Alpha Thoracic Endovascular Graft that were manufactured from April 10, 2015, to January 3, 2017, and distributed from October 29, 2015, to March 10, 2017.
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, the company sent an updated notification to all affected customers.
This recall notification informed customers that the instructions for use (IFU) for the Zenith Alpha Thoracic Endovascular Graft were updated to remove the indication for 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 18-22 mm) that would likely be used only for BTAI.
About 500 of these devices (18 to 22 mm) will be removed, and roughly 4500 will be relabeled. A Cook Medical sales representative will follow-up with affected customers and provide a corrected IFU.
The company recommends that patients already treated with the Zenith Thoracic Endovascular Graft for the BTAI indication be followed according the current IFU and with considerations outlined in Cook Medical’s March 22, 2017, medical device correction notification.
Customers with questions about this recall may contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.
Healthcare professionals and patients are encouraged to report adverse events related to the Zenith Thoracic Endovascular Graft to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
