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

Catalog Number JHJR052502J

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 12/05/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, this patient underwent endovascular treatment using gore® viabahn® endoprosthesis with heparin bioactive for chronic total occlusion in the left superficial femoral artery.It was reported during deployment of the viabahn, the deployment line broke and came out from the lumen of the hub.The physician completed the deployment by pulling the remaining deployment line in the hub.It was reported the device was fully opened.When the guide wire was removed, a part of the deployment line came out with the guide wire.The deployment line was reportedly ¿twined¿ around the guide wire.Angiography was performed and blood flow to the foot was reportedly confirmed.The physician stated that he felt a minimal amount resistance during deployment.It was reported the patient undergoes dialysis, and the anatomy being treated was heavily calcified.Reportedly, it is suspected the deployment line may have been caught on the calcium.The patient tolerated the procedure.No adverse event was reported.

Manufacturer Narrative

H6: code 213 ¿ the review of the manufacturing paperwork verified that the lot met all pre-release specifications.The engineering evaluation stated the following: the device was returned to w.L.Gore & associates for investigation.The following observations were made: the deployment knob, deployment line, and delivery catheter were returned.The deployment line was returned in three sections.One section was attached to the deployment knob and measured 185cm including two single fibers on the end measuring 0.5cm and 7.3cm.Approximately 46.8cm from the deployment knob, there was a knot in this section of deployment line.Another section of deployment line measured 150.8cm including two single fibers measuring 0.5cm in length on one end and two single fibers measuring 0.5cm and 105cm on the other end.The other section of deployment line measured 126.5cm including two 0.5cm length single fibers on one end and two single fibers measuring 1cm and 63cm on the other end.The remainder of the device appeared unremarkable.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9496392
• MDR Text Key: 194021038
• Report Number: 2017233-2019-01256
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: JHJR052502J
• Device Lot Number: 20818569
• 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