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

Model Number	TGU454520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, this patient was implanted with conformable gore® tag® thoracic endoprosthesis.The pathology of the treatment is not known.On (b)(6) 2020, the patient presented with a thoracic aortic dissection.The location of the dissection and the cause of the dissection was not reported to gore.On the same day, two additional conformable gore® tag® thoracic endoprostheses were implanted to treat the dissection.

• 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: 11229276
• Report Number: 2017233-2021-01625
• Device Sequence Number: 4018168
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• 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: 2017
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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: 10/31/2017
• Device Model Number: TGU454520
• Device Catalogue Number: TGU454520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR