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

Catalog Number VBJR051502A

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); Activation Failure (3270)

Patient Problems Occlusion (1984); No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2019

Event Type  malfunction  

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.All information has been placed on file for use in tracking and trending.

Event Description

The following was reported to gore by the doctor: the patient presented with total occlusion of the sfa.According to the doctor, the deployment line broke after the gore® viabahn® endoprosthesis (viabahn) was 80 percent deployed.The physician then performed a popliteal stick and access.This allowed access for a guide wire and pta balloon to be placed in the partially deployed viabahn.The pta balloon was inflated within the viabahn, successfully deploying the viabahn.It was reported that the patient is doing well.

Manufacturer Narrative

A2 - patient's dob was entered.A3 - patients sex entered.A4 - patient's weight was entered.B7 - updated preexisting medical conditions.G5 - otc product - selected 'no'.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8895455
• MDR Text Key: 154537007
• Report Number: 2017233-2019-00647
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623921
• UDI-Public: 00733132623921
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2022
• Device Catalogue Number: VBJR051502A
• Device Lot Number: 20739389
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 104