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 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
Please note: as gore was unable to determine which device was responsible for the proximal endoleak and which device was responsible for the distal endoleak, this report is being sent to capture the reintervention on the distal device.The reintervention on the proximal device was reported on mfr report 2017233-2019-00369.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 (this was reported on mfr report 2017233-2019-00369).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: 8781166
• Report Number: 2017233-2019-00516
• Device Sequence Number: 19492666
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• 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: 10/31/2017
• Device Catalogue Number: TGU454520
• Device Lot Number: 13253027
• 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: 07/11/2019
• 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: ON (B)(6) 2015: TGU454515/12815933
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 87