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	TGMR313120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore through the pivotal study for the gore® tag® thoracic branch endoprosthesis (tbe device): on (b)(6) 2021, the patient underwent endovascular treatment of a thoracic aortic aneurysm in (zone 0) and was implanted with gore® tag® conformable thoracic stent graft with active control system.The patient tolerated the procedure.It was reported that on (b)(6) 2021, the patient had an acute ischemic stroke.The patient required prolongation of existing hospitalization and drug therapy was initiated.The patient tolerated the procedure.
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: tgmr313115/20059796 udi (b)(4).Patient medications: aspirin and clopidogrel.The gore® tag® conformable thoracic stent graft with active control system instructions for use state that may occur and/or require intervention include, but are not limited to, cerebrovascular accident.

• 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
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13098048
• Report Number: 2017233-2021-02645
• Device Sequence Number: 14519756
• Product Code: MIH
• UDI-Device Identifier: 00733132646791
• UDI-Public: 00733132646791
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/10/2022

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: 07/20/2024
• Device Model Number: TGMR313120
• Device Catalogue Number: TGMR313120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White