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

Catalog Number VBH100502A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Perforation of Vessels (2135)

Event Date 12/07/2018

Event Type  Injury  

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 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to be advanced within the previously implanted stent, but it was not possible to do so.The undeployed device was then withdrawn and as it was being withdrawn it became stuck on the edge of the sheath, causing it to accordion on the delivery catheter.The sheath and device were then removed.As they were removed, some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
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: angela brown ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8162024
• MDR Text Key: 130311969
• Report Number: 2017233-2018-00763
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623211
• UDI-Public: 00733132623211
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2020
• Device Catalogue Number: VBH100502A
• Device Lot Number: 17578144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention