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

Catalog Number VBH060502H

Device Problem Complete Blockage (1094)

Patient Problem Ischemia (1942)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: endurant system (aaa), solaris stent (right renal artery chimney).A review of the manufacturing records for the device verified the lot met all pre-release specifications.The exact date of event is unknown therefore 2/20/2020, the date gore became aware of the incident is being used as the date of event.

Event Description

The following information was reported to gore: on (b)(6) 2019 a patient was undergoing a chimney procedure.The left renal artery was treated with a gore® viabahn® endoprosthesis.On an unknown date, the stent was found to be thrombosed with subsequent left kidney necrosis.

Manufacturer Narrative

Initial reporter name and address: updated.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9818788
• MDR Text Key: 189867827
• Report Number: 2017233-2020-00173
• Device Sequence Number: 1
• Product Code: PFV
• 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
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: VBH060502H
• Device Lot Number: 20054665
• 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): Hospitalization; Other
• Patient Age: 83 YR