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

Model Number	TGU373715
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications; (b)(4).According to the gore® tag® conformable thoracic stent graft instructions for use, adverse events with may occur and/or require intervention including, but not limited to, endoleak.
Event or Problem Description
On (b)(6) 2015, the patient was treated for a thoracic aortic aneurysm.The physician implanted a conformable gore® tag® thoracic endoprosthesis, and the patient tolerated the procedure.On (b)(6) 2020, the patient was treated for a type ia endoleak.A gore® tag® conformable thoracic stent graft with active control system was implanted, and the endoleak was resolved.The physician had no opinion regarding the cause of the endoleak.

• 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: 10667019
• Report Number: 2017233-2020-01345
• Device Sequence Number: 16930515
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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: 04/01/2018
• Device Model Number: TGU373715
• Device Catalogue Number: TGU373715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR