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

Catalog Number VBJR062502A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

Review of device manufacturing record history confirmed device met pre-release specifications.The device remains implanted.Therefore, direct product analysis was not possible.

Event Description

The following was reported to gore: patient presented for treatment in the superficial femoral artery due to stenotic lesion.Atherectomy was performed, and a gore® viabahn® endoprosthesis was advanced and deployed at the intended treatment site.As reported, the distal tip broke off in the patient at some point.Another device (unknown manufacturer) was deployed to pin the distal tip against the vessel wall.More information was requested but was not made available.

Manufacturer Narrative

Code 706: the engineering evaluation state the endoprosthesis, deployment knob, deployment line, nor distal tip were returned to gore.The distal shaft upon which the endoprosthesis was mounted, measured approximately 25.7 cm from the transition to tip end.The expected distal shaft length is 24.6 to 27.6.The tip end of distal shaft does not appear to have melting or interruption of the pebax material.Based on the device examination performed, anomalies were identified that could potentially be attributed to manufacturing.However, there were no additional non-conforming units beyond the one investigated in this complaint.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8139794
• MDR Text Key: 130048679
• Report Number: 2017233-2018-00748
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623976
• UDI-Public: 00733132623976
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2020
• Device Catalogue Number: VBJR062502A
• Device Lot Number: 17850864
• 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