MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PAJR080502E

Device Problem Activation Failure (3270)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

Please notice that additional information was received from the physician on may 19, 2022, which makes this case reportable.Please notice that patient details and patient history was not provided.Product history review: a review of the manufacturing records indicated the device met pre-release specifications.Engineering investigation: evaluation of the returned device confirms a broken deployment line.The cause of the broken deployment line could not be confirmed, but there is evidence of high force applied to the deployment line.The device was returned with the endoprosthesis partially expanded.The deployment knob was not returned the deployment knob was not returned.Deployment line: one deployment line fiber extends outward from the hub 9.1cm the deployment line is broken.The deployment line was pulled out of the catheter through the transition during evaluation: length of deployment line from device to break = 113.5cm.Single fiber length = 18cm.Distal shaft: appears unremarkable.Extra dual lumen material near the hub (12mm of webbing).This is columnar failure of the dual lumen which can appear this way due to relatively high deployment line force against an unsupported catheter.Deployment continues easily when pulling the deployment line parallel to the device.The reported device failure mode, broken deployment line, is confirmed through evaluation of the returned device.The cause of the broken deployment line could not be established because deployment continued during evaluation.In the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is stated: hazards and adverse events device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: deployment failure; device failure.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It was reported to gore a patient underwent endovascular treatment for a thrombectomy and dialysis access revision with a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn-device).It was stated the viabahn-device was advanced to the target lesion and after pulling the deployment line for deployment, the line broke.The physician was able to remove the complete system including the rest of the deployment line.Reportedly, the physician was able to implant another viabahn-device with the same size and could finish the procedure successfully.There was no report of patient harm.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14674830
• MDR Text Key: 293948638
• Report Number: 2017233-2022-03008
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2022

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: 06/12/2023
• Device Catalogue Number: PAJR080502E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1