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

Catalog Number	VBJR071002A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records indicated that the device met pre-release specifications.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following was reported to gore: the patient presented for sfa occlusion repair.The gore® viabahn® endoprosthesis with heparin was advanced into place and the deployment line pulled.According to the doctor, while pulling the deployment line, the deployment line and deployment stopped after approximately 1cm of expansion.The device was pulled back into the sheath and removed from the patient.The doctor reported the device was discarded at the hospital.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7846185
• Report Number: 2017233-2018-00543
• Device Sequence Number: 16472237
• Product Code: PFV
• UDI-Device Identifier: 00733132623778
• UDI-Public: 00733132623778
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

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: 03/02/2021
• Device Catalogue Number: VBJR071002A
• Device Lot Number: 18028328
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR