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

Model Number VBJR050702A

Device Problem Activation Failure (3270)

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

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.

Event Description

The following information was reported to gore: on (b)(6) 2019 a patient was undergoing treatment of a superficial femoral artery lesion with a gore® viabahn® endoprosthesis.Following advancement to the target location, deployment was initiated.The deployment line was pulled in a slow steady manner and it was noted that only approximately 1cm of the device had expanded when the deployment line broke.The line fragment was inspected and it appeared frayed.The physican then cut the delivery catheter open, but there was no deployment line to be found.An additional sheath was inserted and advanced to the partially expanded stent.The sheath was pushed up against the stent and this caused the stent to deploy the rest of the way.

Manufacturer Narrative

H.6.Results code 2: 213: the engineering evaluation stated the following: the following observations were made: the deployment knob, deployment line and part of the delivery catheter were returned.There was approximately 143 cm of deployment line between the hub and deployment knob.The deployment line had a single fiber coming off of the end of it that measured approximately 1 cm.There was approximately 52 cm of the delivery catheter returned including the distal shaft, upon which the endoprosthesis was mounted, and the distal tip.The delivery catheter was kinked approximately 4 and 36 cm away from the cut end of the delivery catheter.The delivery catheter appeared torn approximately 30 cm from the cut end of the of the delivery catheter for about 3 cm.The remainder of the device appears unremarkable.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.

Manufacturer Narrative

Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #20799542.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9404802
• MDR Text Key: 194021489
• Report Number: 2017233-2019-01204
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132624089
• UDI-Public: 00733132624089
• 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,Followup
• Report Date: 08/05/2020

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: 05/31/2022
• Device Model Number: VBJR050702A
• Device Catalogue Number: VBJR050702A
• Device Lot Number: 20799542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/01/2020; 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1