BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 2033099 · Received February 28, 2011

    Report

    Report Number
    2017233-2011-00089
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 28, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD-A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET.

    Description of Event or Problem · 1

    A 7X15 VIABAHN DEVICE WAS ADVANCED THROUGH AN 8 FR COOK FLEXOR INTRODUCER SHEATH OVER A 0.035 INCH GLIDEWIRE AND POSITIONED DEEP INSIDE THE RIGHT RENAL ARTERY. THE PHYSICIAN PULLED ON THE DEPLOYMENT LINE, WHEN SUDDENLY, THE DEPLOYMENT PROCESS HALTED. THE LINE WAS STUCK. APPROXIMATELY 1 CM OF THE DEVICE DEPLOYED. THE DEVICE WAS PULLED BACK AND REMOVED THROUGH THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED IMPLANTING ANOTHER 7X15 VIABAHN DEVICE WITHOUT ANY ADVERSE OUTCOME FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOPROSTHESIS NIP/STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES,INC WLG335 8053576

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR