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

Catalog Number	VBH100502A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient was undergoing a procedure to reline a previously implanted stent in an av access application in the subclavian vein with a gore® viabahn® endoprosthesis.The device was attempted to be advanced within the previously implanted stent, but it was not possible to do so.The undeployed device was then withdrawn and as it was being withdrawn it became stuck on the edge of the sheath, causing it to accordion on the delivery catheter.The sheath and device were then removed.As they were removed, some vessel damage occurred which required a cut-down and some additional suturing.A new 10fr sheath was then inserted and the case was completed with a non-gore stent.The patient did well.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8162024
• Report Number: 2017233-2018-00763
• Device Sequence Number: 19364752
• Product Code: PFV
• UDI-Device Identifier: 00733132623211
• UDI-Public: 00733132623211
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2020
• Device Catalogue Number: VBH100502A
• Device Lot Number: 17578144
• 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: 12/13/2018
• 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: Hospitalization; Other; Required Intervention