MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGU343420
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Aneurysm (1708); Loss of consciousness (2418)
Date of Event	12/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications; according to the gore¿ tag¿ conformable thoracic stent graft with active control system instructions for use, adverse events with may occur and/or require intervention including, but not limited to, aneurysm enlargement this event also includes device 14185640/ 00733132617760.
Event or Problem Description
The following information was reported to gore through the global registry for endovascular aortic treatment (great 10-11): on (b)(6) 2016 the patient underwent endovascular repair of an descending thoracic aortic aneurysm using conformable gore¿ tag¿ thoracic endoprostheses.The patient tolerated the procedure.Follow up computed tomography angiography (cta) examination on (b)(6) 2016 showed the aneurysm measured 55.0 mm.Follow up cta examination on (b)(6) 2016 showed the aneurysm measured 49.0 mm.Follow up cta examination on (b)(6) 2016 showed the aneurysm measured 49.9 mm.Follow up cta examination on (b)(6) 2019 showed the aneurysm measured 66.0 mm.On (b)(6) 2019, the patient was hospitalized for transient loss of consciousness.

• Brand Name: CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
• 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: 12460210
• Report Number: 2017233-2021-02367
• Device Sequence Number: 11743513
• Product Code: MIH
• UDI-Device Identifier: 00733132618170
• UDI-Public: 00733132618170
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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: Health Professional
• Device Expiration Date: 10/28/2018
• Device Model Number: TGU343420
• Device Catalogue Number: TGU343420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 09/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 84