BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE VIABAHN® ENDOPROSTHESIS

    MDR report key: 4100404 · Received September 18, 2014

    Report

    Report Number
    2017233-2014-00487
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    July 24, 2014
    Report Date
    August 26, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CODE 77-PER THE INSTRUCTIONS FOR USE (IFU) OF THE GORE® VIABAHN® ENDOPROSTHESIS, WARNINGS ASSOCIATED WITH THE USE OF THE GORE® VIABAHN® ENDOPROSTHESIS HESIS MAY INCLUDE BUT ARE NOT LIMITED, DO NOT WITHDRAW BACK INTO THE INTRODUCER SHEATH ONCE THE ENDOPROSTHESIS IS FULLY INTRODUCED. WITHDRAWING THE ENDOPROSTHESIS BACK INTO THE SHEATH CAN CAUSE PREMATURE DEPLOYMENT. IF REMOVAL PRIOR TO DEPLOYMENT IS NECESSARY, WITHDRAW THE ENDOPROSTHESIS TO A POSITION CLOSE TO BUT NOT INTO THE INTRODUCER SHEATH. BOTH THE GORE® VIABAHN® ENDOPROSTHESIS AND INTRODUCER SHEATH CAN THEN BE REMOVED IN TANDEM.

    Description of Event or Problem · 1

    RECEIVED COMPLAINT BY E-MAIL ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT WAS BEING IMPLANTED WITH A GORE® VIABAHN® ENDOPROSTHESIS (ITEM#: VBC100502, LOT#: 10608537) FOR TREATMENT OF STENOSIS AT THE RIGHT HYPOGASTRIC ARTERY, USING "CROSSES SHEATH" TECHNIQUE FROM THE LEFT FEMORAL ARTERY. DURING INSERTION, IT WAS REPORTED THAT THE DEVICE WAS SUCCESSFULLY AND FULLY INTRODUCED INTO THE RIGHT COMMON ILIAC ARTERY BUT CANNOT REACH THE RIGHT HYPOGASTRIC ARTERY, THE PHYSICIAN REMOVED THE DEVICE AND REPLACED IT WITH ANOTHER VIABAHN THE SAME SIZE TO COMPLETE THE PROCEDURE. THERE REPORTEDLY WAS NO INJURY TO THE PATIENT. THE REMOVED VIABAHN WAS REPORTEDLY FOUND THE DEPLOYMENT LINE BEING LOOSENED AND THE STENT PARTIALLY DEPLOYED AT THE DISTAL END OF DEVICE EVEN THE DEPLOYMENT KNOB WAS NOT PULLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579902 GORE VIABAHN® ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES 10608537

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR