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

Catalog Number TGU454520

Device Problems Collapse (1099); Patient-Device Incompatibility (2682)

Patient Problem Death (1802)

Event Date 05/31/2019

Event Type  Death  

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 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.

Manufacturer Narrative

Correction date of event is (b)(6) 2019.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8700695
• MDR Text Key: 148055584
• Report Number: 2017233-2019-00425
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/02/2019; 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR