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	TGM262610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/20/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Code 22-per the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to death.
Event or Problem Description
Mdt form# (b)(4): on (b)(6) 2020, the patient was implanted with gore® tag® conformable thoracic stent graft with active control system.It was reported the patient expired on (b)(6) 2020.It is unknown if the device was implant or explanted.
Additional Manufacturer Narrative
Addition b2; addition g3/g4; addition h1/h2; multiple attempts were made to obtain additional information for this event.As no additional information has been received, this event will be closed with the provided information.

• 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: 10960670
• Report Number: 2017233-2020-01506
• Device Sequence Number: 3211071
• Product Code: MIH
• UDI-Device Identifier: 00733132646920
• UDI-Public: 00733132646920
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: PO40043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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: No Information
• Device Expiration Date: 10/07/2022
• Device Model Number: TGM262610
• Device Catalogue Number: TGM262610
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 02/16/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 56 YR