| | Class 1 Device Recall Zenith Alpha Thoracic Endovascular Graft |  |
| Date Initiated by Firm | March 22, 2017 |
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| Date Posted | August 10, 2017 |
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| Recall Status1 |
Terminated 3 on February 14, 2019 |
| Recall Number | Z-2099-2017 |
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| Recall Event ID |
77099 |
| PMA Number | P140016 |
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| Product Classification |
System, endovascular graft, aortic aneurysm treatment - Product Code MIH
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| Product | Zenith Alpha Thoracic Endovascular Graft
The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy 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 thoracic lesion: " with a length of at least 20 mm, and " with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm. |
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| Code Information |
All lots. Catalog Numbers: ZTA-D-28-160-W ZTA-D-28-229-W ZTA-D-30-160-W ZTA-D-30-229-W ZTA-D-32-160-W ZTA-D-32-229-W ZTA-D-34-142-W ZTA-D-34-190-W ZTA-D-36-142-W ZTA-D-36-190-W ZTA-D-38-147-W ZTA-D-38-197-W ZTA-D-40-147-W ZTA-D-40-197-W ZTA-D-42-152-W ZTA-D-42-204-W ZTA-D-44-157-W ZTA-D-44-211-W ZTA-D-46-157-W ZTA-D-46-211-W ZTA-DE-18-104-W ZTA-DE-18-148-W ZTA-DE-20-104-W ZTA-DE-20-148-W ZTA-DE-22-104-W ZTA-DE-22-148-W ZTA-DE-24-104-W ZTA-DE-24-148-W ZTA-DE-26-104-W ZTA-DE-26-148-W ZTA-DE-28-108-W ZTA-DE-28-154-W ZTA-DE-30-108-W ZTA-DE-30-154-W ZTA-DE-32-108-W ZTA-DE-32-154-W ZTA-DE-34-112-W ZTA-DE-34-160-W ZTA-DE-36-112-W ZTA-DE-36-160-W ZTA-DE-38-141-W ZTA-DE-38-91-W ZTA-DE-40-141-W ZTA-DE-40-91-W ZTA-DE-42-146-W ZTA-DE-42-94-W ZTA-DE-44-151-W ZTA-DE-44-97-W ZTA-DE-46-151-W ZTA-DE-46-97-W ZTA-P-18-105-W ZTA-P-18-127-W ZTA-P-20-105-W ZTA-P-20-127-W ZTA-P-22-105-W ZTA-P-22-127-W ZTA-P-24-105-W ZTA-P-24-127-W ZTA-P-26-105-W ZTA-P-26-149-W ZTA-P-28-109-W ZTA-P-28-132-W ZTA-P-28-155-W ZTA-P-28-201-W ZTA-P-30-109-W ZTA-P-30-132-W ZTA-P-30-155-W ZTA-P-30-201-W ZTA-P-32-109-W ZTA-P-32-132-W ZTA-P-32-155-W ZTA-P-32-201-W ZTA-P-34-113-W ZTA-P-34-137-W ZTA-P-34-161-W ZTA-P-34-209-W ZTA-P-36-113-W ZTA-P-36-137-W ZTA-P-36-161-W ZTA-P-36-209-W ZTA-P-38-117-W ZTA-P-38-142-W ZTA-P-38-167-W ZTA-P-38-217-W ZTA-P-40-117-W ZTA-P-40-142-W ZTA-P-40-167-W ZTA-P-40-217-W ZTA-P-42-121-W ZTA-P-42-147-W ZTA-P-42-173-W ZTA-P-42-225-W ZTA-P-44-125-W ZTA-P-44-152-W ZTA-P-44-179-W ZTA-P-44-233-W ZTA-P-46-125-W ZTA-P-46-152-W ZTA-P-46-179-W ZTA-P-46-233-W ZTA-PT-22-18-105-W ZTA-PT-26-22-105-W ZTA-PT-30-26-108-W ZTA-PT-32-28-178-W ZTA-PT-32-28-201-W ZTA-PT-34-30-161-W ZTA-PT-34-30-209-W ZTA-PT-36-32-161-W ZTA-PT-36-32-209-W ZTA-PT-38-34-167-W ZTA-PT-38-34-217-W ZTA-PT-40-36-167-W ZTA-PT-40-36-217-W ZTA-PT-42-38-173-W ZTA-PT-42-38-225-W ZTA-PT-44-40-179-W ZTA-PT-44-40-233-W ZTA-PT-46-42-179-W ZTA-PT-46-42-233-W |
Recalling Firm/
Manufacturer |
Cook Medical Incorporated
400 N Daniels Way
Bloomington IN 47404-9155
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| For Additional Information Contact | april.lavender@cookmedical.com
812-339-2235 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Device Design |
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| Action | 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. |
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| Quantity in Commerce | 4916 |
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| Distribution | Nationwide Distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| PMA Database | PMAs with Product Code = MIH
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