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

Catalog Number	TGU454520
Medical Device Problem Codes	Collapse (1099); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/31/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® tag® thoracic endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to renal failure or other renal complications, and death.
Event or Problem Description
On (b)(6) 2019 the patient had a thoracic endovascular repair using conformable gore® tag® thoracic endoprostheses.It was reported that the patient had very torturous anatomy and the second device deployed was compressed immediately after deployment.They physician ballooned the device and while the device was slightly compressed due to the patient's anatomy, blood flow was normal.On (b)(6) 2019 the patient presented with renal failure and an aortobifemoral bypass was performed.It was reported that device previously compressed and ballooned had collapsed causing the renal failure.It was reported that the thoracic aorta was s shaped and the lumen size was variable based on how the tortuosity was kinking the aorta.On (b)(6) 2019 the patient expired.
Additional Manufacturer Narrative
Correction date of event is (b)(6) 2019.

• 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: 8700695
• Report Number: 2017233-2019-00425
• Device Sequence Number: 1942107
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup,Followup
• Report Date (Section B): 08/02/2019

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: 01/23/2022
• Device Catalogue Number: TGU454520
• Device Lot Number: 20408515
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 08/02/2019; 08/02/2019
• 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: 78 YR