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

Model Number VBCR060202A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Aneurysm (1708)

Event Date 01/06/2020

Event Type  Death  

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 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.

Manufacturer Narrative

Corrected data: g5.Combination product.

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
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9622705
• MDR Text Key: 176079919
• Report Number: 2017233-2020-00050
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623365
• UDI-Public: 00733132623365
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR