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

Catalog Number PAHR070502E

Device Problem Material Separation (1562)

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

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.

Event Description

The patient presented with a stenosis within the iliac artery which was intended to be treated with a gore® viabahn® endoprosthesis.It was reported to gore that after successful deployment of the endoprosthesis the attempt was made to remove the delivery system from the patients artery.It was stated that while the delivery system was pulled back, the distal catheter shaft broke off.Reportedly, the broken shaft was retrieved with a snare.It was stated that the patient is doing well.

Manufacturer Narrative

Our engineers have evaluated the returned device and their investigation indicated that only the delivery catheter was returned.The endoprosthesis, which was successfully implanted, the deployment knob, and deployment line were not returned.The distal tip bonded to the distal shaft, upon which the endoprosthesis was mounted, was separated from the transition and dual lumen.The transition end of the distal shaft appeared to have an interruption in the pebax material and fraying of the stainless steel braid.The distal shaft appears to be broken at the transition end and remnants of distal shaft are apparent within the transition.The transition also appears damaged at tip end.The distal shaft measured 5.4 cm.The stainless steel braid of the distal shaft appeared compressed 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: 8230218
• MDR Text Key: 132477707
• Report Number: 2017233-2019-00009
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2020
• Device Catalogue Number: PAHR070502E
• Device Lot Number: 17636470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR