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

Catalog Number PAH070502B

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/02/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.Based on the device examination performed, manufacturing anomalies were identified that potentially could have contributed to the event.(b)(4).

Event Description

The following was reported to gore: the doctor implanted a gore® viabahn® endoprosthesis with heparin bioactive surface in the iliac of a patient.After completion angio the doctor noticed the tip of the gore® viabahn® endoprosthesis with heparin bioactive surface catheter was missing.The doctor performed a cut-down of the treated vessel looking for the tip.The nursing staff found the tip on the operating room floor.

Manufacturer Narrative

Additional manufacturer narrative: patient identifier.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7174965
• MDR Text Key: 96732954
• Report Number: 2017233-2018-00011
• 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: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2019
• Device Catalogue Number: PAH070502B
• Device Lot Number: 15107835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other