Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular

FDA device recall Z-2099-2017 · posted 2017-08-10 · Terminated

Recall details

Recalling firm

Cook Medical Incorporated

Reason for recall

There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention.

Action taken

The firm, Cook Medical, sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 22, 2017 to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. On 6/22/2017, updated "URGENT: MEDICAL DEVICE CORRECTION AND REMOVAL" notifications were sent to the affected consignees via courier. The update included removal of the indication for use in BTAI, as follows: The Zenith Alpha Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair including: " Iliac/femoral anatomy that is suitable for access with the required introduction systems " Nonaneurysmal aortic segments (fixation sites) proximal and distal to the aneurysm or ulcer: o with a length of at least 20 mm, and o with a diameter measured outer-wall-to-outer-wall of no greater than 42 mm and no less than 20 mm. Additionally, the following warning has been added to describe the thrombus risk that has been observed when the device is used to treat BTAI: " Risk of in-graft thrombus has been observed when the Zenith Alpha Thoracic Endovascular Graft has been used to treat 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 18 22 mm) that would likely be used only for BTAI. This notice must be shared with appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred. Should you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.

Root cause

Device Design

Status

Terminated

Product code

MIH

Quantity affected

4916

Distribution

Nationwide Distribution.

Date initiated

2017-03-22

Date posted

2017-08-10

Date terminated

2019-02-14

Location

Bloomington, IN