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	TGM343420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2022, the patient reported emergently with a penetrating ulcer of the aorta with an intramural hematoma that extended to the bowel.There was a discussion of the risks of implanting endografts in the deteriorating aortic arch, but the physician decided to proceed with surgery.The physician implanted two gore® tag® conformable thoracic stent graft with active control system.The patient tolerated the procedure.On (b)(6) 2022, the patient returned to the hospital.It was found that the aortic arch had continued to deteriorate.A retrograde type a dissection was observed distal to the gore® tag® conformable thoracic stent graft with active control system.The physician decided to do an open surgery, and a dacron graft was sewn to the distal end of the endograft to repair the dissection.The patient tolerated the procedure.The event was caused by the poor condition of the patient's aorta, and was unrelated to the gore devices.Images were returned for evaluation.The images were obtained of the patient anatomy prior to the index procedure, prior to device implantation, and therefore, not relevant to the event.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13585193
• Report Number: 2017233-2022-02759
• Device Sequence Number: 4673730
• Product Code: MIH
• UDI-Device Identifier: 00733132646975
• UDI-Public: 00733132646975
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

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: 08/21/2024
• Device Model Number: TGM343420
• Device Catalogue Number: TGM343420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2022
• Initial Report FDA Received Date: 02/23/2022
• Date Device Manufactured: 08/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female