MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TGU373715J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Occlusion (1984)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu) adverse events which may require intervention and / or conversion to open repair include, but are not limited to: branch vessel occlusions.

Event Description

The following was reported to gore: on (b)(6) 2021, the patient underwent endovascular treatment of an arch aorta aneurysm using a gore® tag® conformable thoracic stent graft with active control system.After the device was deployed right under the left subclavian artery, the arterial line pressure of the left arm decreased.It was observed that the left subclavian artery was covered by the device.The physician attempted to move the device distally using a balloon but did not succeed.A bare metal stent was placed at the origin of the left subclavian artery, and patency of the vessel was restored.The patient tolerated the procedure.

Manufacturer Narrative

H.6.A review of the manufacturing records for the device verified the lot met all pre-release specifications.

• Brand Name: CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11208648
• MDR Text Key: 228168321
• Report Number: 2017233-2021-01617
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2022
• Device Catalogue Number: TGU373715J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 70 YR