BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 10375878 · Received August 6, 2020

    Report

    Report Number
    2017233-2020-01095
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 13, 2020
    Report Date
    February 24, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PFV
    UDI-DI
    00733132623501
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING OBSERVATIONS WERE MADE: THE DELIVERY CATHETER WAS RETURNED NOT THE DEVICE. THE DUAL LUMEN WAS KINKED 14.5 AND 65 CM FROM THE HUB. THE REMAINDER OF THE DELIVERY CATHETER WAS UNREMARKABLE. BASED ON THE DEVICE EXAMINATION PERFORMED, NO MANUFACTURING ANOMALIES WERE IDENTIFIED TO WHICH THE EVENT COULD BE DEFINITIVELY ATTRIBUTED.

    Additional Manufacturer Narrative · 0

    G4 - UPDATED WITH PMA/510(K) NUMBER (P040037). C1, CORRECTION - IN MANUFACTURER REPORT NUMBER, 2017233-2020-01095, THE DEVICE IS IDENTIFIED AS A CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM APL, WHICH IN COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY/NON-ELUTING. THIS DEVICE IN NOT COATED WITH A HEPARIN BIOACTIVE SURFACE.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A GORE® VIABAHN® ENDOPROSTHESIS (VSX) WAS TO BE PLACED FOR TREATMENT OF A FAILED FISTULA IN THE BRACHIAL ARTERY. HOWEVER, WHEN THE PHYSICIAN WAS DEPLOYING THE DEVICE IT PARTIALLY EXPANDED THEN STOPPED. THE PHYSICIAN WAS NOT ABLE TO FULLY DEPLOY THE DEVICE AND REMOVED THE DEVICE AND SHEATH IN TANDEM. AN ADDITIONAL VSX WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841152 GORE VIABAHN ENDOPROSTHESIS PFV / NIP PFV W. L. GORE & ASSOCIATES, INC. VBCR080501A 00733132623501

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR