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

Catalog Number JHJR061502J

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 07/03/2020

Event Type  Injury  

Manufacturer Narrative

The device is undergoing an evaluation but has not yet been completed.Manufacturing evaluation results will be provided once they are completed.

Event Description

Following was reported to gore: on (b)(6) 2020, a patient underwent endovascular treatment of an in-stent occlusion in the right superficial femoral artery using gore® viabahn® endoprosthesis with heparin bioactive surface(viabahn).It was approached from left side, and a pull-through guidewire was created.After pre-ballooning, the first viabahn was advanced on a 0.018 guidewire and placed distally with no issue.Upon initiation deployment of the second viabahn, the deployment line became stuck when approximately 3 cm of the endprosthesis expanded.Attempts to deploy the remainder of the viabahn were made but were unsuccessful.While attempting to remove the delivery catheter from the patient, the delivery catheter broke and the stent graft and deployment line remained in the patient.Attempts were made to remove the remaining part using snare and/or forceps but did not succeed.A cut down at popliteal artery was performed and remaining part was removed.The procedure was completed placing an identical viabahn without any issue.The patient tolerated the procedure.Reportedly, the deployment line might have been stuck on the bare metal stent or viabahn stent.

Manufacturer Narrative

Engineering evaluation: engineering evaluation conclusion is inconclusive as it relates to the event description.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.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

Following was reported to gore: on (b)(6) 2020, a patient underwent endovascular treatment of an in-stent occlusion in the right superficial femoral artery using gore® viabahn® endoprosthesis with heparin bioactive surface(viabahn).It was approached from left side, and a pull-through guidewire was created.After pre-ballooning, the first viabahn was advanced on a 0.018 guidewire and placed distally with no issue.Upon initiation deployment of the second viabahn, the deployment line became stuck when approximately 3 cm of the endprosthesis expanded.Attempts to deploy the remainder of the viabahn were made but were unsuccessful.While attempting to remove the delivery catheter from the patient, the delivery catheter broke and the stent graft and deployment line remained in the patient.Attempts were made to remove the remaining part using snare and/or forceps but did not succeed.A cut down at popliteal artery was performed and remaining part was removed.The procedure was completed placing an identical viabahn without any issue.The patient tolerated the procedure.

• 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
• MDR Report Key: 10330348
• MDR Text Key: 200629058
• Report Number: 2017233-2020-01057
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2021
• Device Catalogue Number: JHJR061502J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Manufacturer Received: 07/03/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 07/03/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 DA
• Patient Weight: 40