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

Catalog Number VBJR051502A

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2019

Event Type  malfunction  

Event Description

The following information was reported to gore: on (b)(6) 2019 a patient was undergoing treatment of a superficial femoral artery in-stent stenosis.The intent was to reline the stent with a gore® viabahn® endoprosthesis.When the device was advanced to the target location, deployment was attempted, but after the device was deployed half way, the deployment line broke.The delivery catheter was then cut to try to expose the remaining deployment line.The delivery catheter was peeled open and the deployment line was exposed.The deployment line was pulled, and deployment was completed.Upon removal of the delivery system it was noted the deployment line was knotted.A second device was deployed to complete the treatment and the patient outcome was good.

Manufacturer Narrative

H.6.Results code 2: 213: the engineering evaluation stated the following: part of the deployment line attached to the deployment knob, and two sections of the delivery catheters were returned.The deployment line appeared to be broken.It measured 149cm with a 7.5cm single fiber coming from the end.There were two knots in the deployment line approximately 50.5cm and 55cm from the deployment knob.The delivery catheter appeared to be cut and resulted in 2 pieces.The pieces measured 32cm and 93cm.Approximately 39cm of the section of delivery catheter that included the distal tip was cut down the middle.Engineering evaluation conclusion(s) are: deployment line broken.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8880306
• MDR Text Key: 154304722
• Report Number: 2017233-2019-00607
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623921
• UDI-Public: 00733132623921
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2020
• Device Catalogue Number: VBJR051502A
• Device Lot Number: 17459604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1