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

Catalog Number	VBJR062502A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8139794
• Report Number: 2017233-2018-00748
• Device Sequence Number: 19224821
• Product Code: PFV
• UDI-Device Identifier: 00733132623976
• UDI-Public: 00733132623976
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1