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

Catalog Number PAJR051002B

Device Problem Activation Failure (3270)

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

Event Date 09/06/2019

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 right distal popliteal lesion with a gore® viabahn® endoprosthesis with propaten bioactive surface.The lesion was predilated by means of angioplasty.The device was advanced to the target location and positioned.The deployment knob was unscrewed and the deployment line was pulled.The endoprosthesis started to deploy a few millimeters, however resistance was felt, so pulling on the line was stopped.This device was removed from the patient through the sheath.

Manufacturer Narrative

H.6.Results code 2: 213: the engineering evaluation stated the following: the entire device was returned.There was approximately 31.5cm of deployment line between the hub and deployment knob.Approximately 2.5cm of the distal shaft, upon which the endoprosthesis is mounted, was exposed at the transition.Approximately 1.5cm of the endoprosthesis was expanded.The remainder of the endoprosthesis was constrained by the inner braided constraining line.The endoprosthesis was longitudinally compressed towards the tip end of the device with the expanded portion of the endoprosthesis covering the distal tip.The endoprosthesis appeared to be damaged with outwardly flared struts throughout the expanded portion.Additionally, the wire stent appeared to be delaminating from the graft.The rest of the device appeared unremarkable.Deployment was able to be continued with traction on the deployment line at the endoprosthesis.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.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9107005
• MDR Text Key: 160411939
• Report Number: 2017233-2019-00884
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2022
• Device Catalogue Number: PAJR051002B
• Device Lot Number: 20619440
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR