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

Model Number	TGU454515
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	12/12/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: tgu404015/20655652 udi: (b)(4).Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to death.The review of the manufacturing paperwork verified that these lots met all pre-release specifications.
Event or Problem Description
On (b)(6) 2019, the patient was implanted with conformable gore® tag® thoracic endoprostheses.It was reported the patient expired on (b)(6) 2019.No additional information related to this event will be made available to gore.Therefore, further investigation is not possible.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9668159
• Report Number: 2017233-2020-00072
• Device Sequence Number: 2668397
• Product Code: MIH
• UDI-Device Identifier: 00733132618200
• UDI-Public: 00733132618200
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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: 07/15/2021
• Device Model Number: TGU454515
• Device Catalogue Number: TGU454515
• Device Lot Number: 18499207
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2020
• 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: Death
• Patient Age: 74 YR