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	TGM343410
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/09/2021
Type of Reportable Event	Death
Event or Problem Description
Information reported: on (b)(6) 2021, the patient was implanted with a gore® tag® conformable thoracic stent graft with active control system.It is unknown what the patient was being treated for.It was reported that on (b)(6) 2021, the patient expired.It is unknown what the cause of death is.
Additional Manufacturer Narrative
According to the gore® tag® conformable thoracic stent graft active control system instructions for use, potential adverse events may include, but are not limited to, death.H6: added component code 515.H6: updated investigation findings to code 213.H6: updated investigation conclusions to code 22.H10: added statement "according to the gore® tag® conformable thoracic stent graft active control system instructions for use, potential adverse events may include, but are not limited to, death.".
Additional Manufacturer Narrative
H6: health effect- impact and clinical codes added.Component code updated per ps.

• 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: 12722303
• Report Number: 2017233-2021-02502
• Device Sequence Number: 14479104
• Product Code: MIH
• UDI-Device Identifier: 00733132646951
• UDI-Public: 00733132646951
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2022

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: 01/21/2024
• Device Model Number: TGM343410
• Device Catalogue Number: TGM343410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 01/06/2022; 08/02/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 01/06/2022; 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Death
• Patient Age: 78 YR
• Patient Sex: Female