BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 12165985 · Received July 14, 2021

    Report

    Report Number
    2017233-2021-02163
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 17, 2021
    Report Date
    March 21, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PFV
    UDI-DI
    00733132646029
    PMA / PMN Number
    P130006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED COMPONENT CODE TO SECTION H6 CORRECTED PMA 510(K) NUMBER TO P130006 IN SECTION G4.

    Additional Manufacturer Narrative · 1

    CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A PATIENT PRESENTED WITH STENOSIS IN THE LEFT BASILIC VEIN AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THE PHYSICIAN WAS ABLE TO ADVANCE THE DEVICE TO THE TARGET LESION WITHOUT ISSUE USING AN 8FR SHEATH AND 0.035" GUIDEWIRE. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE, THE CENTER OF THE DEVICE WOULD NOT FULLY EXPAND. THE PHYSICIAN ATTEMPTED TO EXPAND THE DEVICE USING POST DEPLOYMENT BALLOONING, BUT WAS UNSUCCESSFUL. BLOOD FLOW WAS CONFIRMED THROUGH THE DEVICE. THE DEVICE REMAINS IMPLANTED AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065958 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT PFV W. L. GORE & ASSOCIATES, INC. VBHR100502A 00733132646029

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male