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

Catalog Number	TGU454515
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use, 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 repair of a descending thoracic aortic aneurysm using two conformable gore® tag® thoracic endoprostheses.On (b)(6) 2017, a proximal type i endoleak was identified.On the same day, a procedure to treat the proximal type i endoleak was performed.Details of the treatment was not reported to gore.During the procedure, a distal type i endoleak was also discovered.On (b)(6) 2018, an intervention was performed to treat the distal type i endoleak, whereby endoanchors were placed.

• 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: 8636886
• Report Number: 2017233-2019-00369
• Device Sequence Number: 13975901
• Product Code: MIH
• UDI-Device Identifier: 00733132618200
• UDI-Public: 00733132618200
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

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: 06/30/2017
• Device Catalogue Number: TGU454515
• Device Lot Number: 12815933
• 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: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(6) 2015: TGU454520/13253027
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 87