MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGM454515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the patient underwent endovascular treatment of an aberrant right subclavian aneurysm using a gore® tag® conformable thoracic stent graft with active control system.It was reported that prior to implant of device there were carotid subclavian artery bypasses bilaterally.The gore® tag® conformable thoracic stent graft with active control system was deployed successfully.The patient tolerated the procedure.Reportedly within 24 hours the patient had a stroke.No further information is available.
Additional Manufacturer Narrative
Code 213 : a review of the manufacturing records indicated, the lot met pre-release specifications; code 3221 : the device remains implanted.Therefore, the device was not available for evaluation; code 22: according to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), potential adverse events or complications may include, but are not limited to: neurologic damage, local or systemic (e.G., stroke, paraplegia, paraparesis).

• Brand Name: GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11616945
• Report Number: 2017233-2021-01842
• Device Sequence Number: 11816242
• Product Code: MIH
• UDI-Device Identifier: 00733132646999
• UDI-Public: 00733132646999
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: PO40043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2023
• Device Model Number: TGM454515
• Device Catalogue Number: TGM454515
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 07/30/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 77 YR
• Patient Weight: 82