MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number	VBJR071002A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ctag device is being reported separately.Results: a review of the manufacturing records indicated the lot met pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2016, the patient underwent treatment of a thoracoabdominal aortic aneurysm whereby conformable gore® tag® thoracic endoprostheses and gore® viabahn® endoprostheses with heparin bioactive surface were implanted.On (b)(6) 2018 the patient exhibited a gutter leak around the left renal artery.On (b)(6) 2018 the patient's left renal artery was stented and a left renal artery branch in the gutter space was embolized.The patient tolerated the procedure.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7715982
• Report Number: 2017233-2018-00429
• Device Sequence Number: 1121373
• Product Code: PFV
• UDI-Device Identifier: 00733132623778
• UDI-Public: 00733132623778
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2018

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: 10/28/2018
• Device Catalogue Number: VBJR071002A
• Device Lot Number: 14662746
• 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: 07/24/2018
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 93