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

Model Number	TGU343420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the conformable gore® tag® thoracic endoprosthesis instructions for use, potential adverse events that may occur and/or require intervention include, but are not limited to endoleak.
Event or Problem Description
On (b)(6) 2015, this patient underwent endovascular treatment for a descending thoracic aortic aneurysm and was implanted with two conformable gore® tag® thoracic endoprostheses.The patient tolerated the procedure.On (b)(6) 2020, the patient presented with a proximal type i endoleak with no enlargement of the aneurysm.The patient underwent a re-intervention on the same day and an additional conformable gore® tag® thoracic endoprosthesis was placed proximally.The patient tolerated the procedure and the endoleak was resolved.Per the physician, the endoleak was caused by disease progression.

• Brand Name: GORE TAG CONFORMABLE THORACIC 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: 10171853
• Report Number: 2017233-2020-01002
• Device Sequence Number: 1762536
• Product Code: MIH
• UDI-Device Identifier: 00733132618170
• UDI-Public: 00733132618170
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• 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): 06/18/2020

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: 05/18/2018
• 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: 06/09/2020
• Initial Report FDA Received Date: 06/18/2020
• 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: 89 YR
• Patient Weight: 48