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

Catalog Number VBJR062502A

Device Problem Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2018

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) 2018, a patient was undergoing of a superficial femoral artery occlusion with a gore® viabahn® endoprosthesis.The lesion was predilated.The device was being advanced over a v18 wire through a 6fr pinnacle sheath.At some point the device separated from the delivery system.No device expansion had occurred.The device and sheath were removed as a unit.Wire access was lost.The case was completed with two new viabahn devices.The outcome was successful.

Manufacturer Narrative

Results code 2: 213: the engineering evaluation stated the following: the entire deice was returned.There was a kink in distal shaft, upon which the endoprosthesis is mounted, near the transition.There was approximately 1 cm of distal shaft exposed near tip.The knob doesn¿t appear to have been pulled from hub since the deployment line is taut within the hub.There were no separations in the delivery catheter.There was no deployment of the endoprosthesis noted.Engineering evaluation conclusion is inconclusive as it relates to the event description.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: 7948521
• MDR Text Key: 123941892
• Report Number: 2017233-2018-00604
• 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: 11/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2021
• Device Catalogue Number: VBJR062502A
• Device Lot Number: 18004442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1