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

Model Number	VBCR060202A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/06/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.The gore viabahn® endoprosthesis instructions for use, warnings section state the following: do not cut the endoprosthesis.The endoprosthesis should only be placed and deployed using the supplied catheter system.
Event or Problem Description
The following was reported to gore: the patient presented for aortic aneurysm repair.The doctor cut the viabahn and sewed a little section onto the exterior of the cook zenith® fenestrated aaa endovascular graft on the back table.The doctor reported to gore that there was difficulty in accessing the renal artery with the fenestration.The procedure lasted approximately 12 hours.The doctor reported the patient died as a result of heart issues.
Additional Manufacturer Narrative
Corrected data: g5.Combination product.
Additional Manufacturer Narrative
Type of reportable event.Additional received information determined that this event is not reportable to the fda and therefore the medwatch (and supplemental) will be retracted.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9622705
• Report Number: 2017233-2020-00050
• Device Sequence Number: 585270
• Product Code: PFV
• UDI-Device Identifier: 00733132623365
• UDI-Public: 00733132623365
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2020

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: 10/01/2021
• Device Model Number: VBCR060202A
• Device Catalogue Number: VBCR060202A
• Device Lot Number: 21367018
• 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: 01/23/2020
• Supplement Report FDA Received Date: 02/03/2020; 03/31/2020
• 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: 72 YR