MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; ENDOVASCULAR GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Catalog Number VBH080502W

Device Problem Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.The device was implanted in patient.The imaging was waiting to return for evaluating.

Event Description

The following was reported to gore: on (b)(6) 2020, the patient was implanted with a 8mm x 5cm gore® viabahn® endoprosthesis with heparin bioactive surface to treat iliac artery stenosis.After using 6x40 balloon pre-dilating, the viabahn device was advanced via sheath to target lesion.The physician pulled out the deployment line, the 4cm of viabahn device successfully expanded.However the remaining 1cm of viabahn device got stuck and couldn't be deployed.The viabahn device successfully expanded with many attempts.However, the deployment line was left in the patient.The physician decided to cut the deployment line and use another bare metal stent to fix the deployment line on the vessel.The patient did not experience any adverse consequences.

Manufacturer Narrative

H6-3221: no device was returned, therefore no physical evaluation of the device can be performed.Images were returned but they do not allow for evaluation.No anomalies were found following an engineering evaluation that could potentially be related to the reported event.The process fmea indicates that the final device may have a potential impact on the alleged complaint.However, there was no evidence to support that the final device was out of specification.The following information was evaluated: dhr lot review for the final device and braided constraining line using the master process sheets for rejects related to the aforementioned reported event.Machine files for the loaders and braiders near the time of manufacturing of the device and braided constraining line were evaluated for non-routine maintenance that could potentially contribute to failure to deploy fully.No anomalies and/or occurrences of non-routine maintenance were identified that could be attributed to the device malfunction allegation reported in this event.Based on the evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.The images received cannot be used to perform a full imaging evaluation.The extent and accuracy of the observations and findings may be limited due to the completeness, format and / or quality of the available images provided for review.Gore cannot make conclusions or guarantee the images provided are accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.The images received do not have any patient identifiers.The images provided are 4.Jpg¿s and 3 video files.There doesn't appear to be images that show the device constrained.Images provided do not allow for an evaluation in relationship to this event.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: ENDOVASCULAR GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10342679
• MDR Text Key: 201683768
• Report Number: 2017233-2020-01065
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2022
• Device Catalogue Number: VBH080502W
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 68