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	TGMR313110
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing evaluation results will be provided once they are completed.At this time it is unknown if the devices will be returned.
Event or Problem Description
On (b)(6) 2021 the patient underwent surgery for an aneurysm repair using a gore® tag® conformable thoracic stent graft with active control system.On (b)(6) 2021 during a follow up appointment a ct scan was performed and an infection was found within the device.At this time it is undetermined if the patient had a prior infection or if it is due to the graft.The graft will be explanted, but at this time the date and location is unknown.Investigation is ongoing.
Additional Manufacturer Narrative
H.6.Investigation findings 1: code 213 ¿ the review of the manufacturing paperwork verified that the lot met all pre-release specifications.Patient has been lost to follow-up, therefore no further information could be gathered.

• 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: sara collum ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12845032
• Report Number: 2017233-2021-02551
• Device Sequence Number: 4351917
• Product Code: MIH
• UDI-Device Identifier: 00733132646777
• UDI-Public: 00733132646777
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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: 01/28/2024
• Device Model Number: TGMR313110
• Device Catalogue Number: TGMR313110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male