BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIABAHN ENDOPROSTHESIS

    MDR report key: 1022091 · Received March 27, 2008

    Report

    Report Number
    MW5006073
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 27, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FAILURE OF ENDOPROSTHESIS TO FULLY DEPLOY. THE ENDOPROSTHESIS DEVICE DEPLOYMENT STRING WAS BROKEN DURING THE PLACEMENT OF THE VIABAHN ENDOPROSTHESIS IN THE PATIENT'S SFA. ATTEMPTS TO THEN FIND THE DEPLOYMENT STRING AND REMOVE IT FAILED. FURTHER ATTEMPTS TO REMOVE THE DEVICE THROUGH THE INTRODUCER SHEATH ALSO FAILED. THE PATIENT WAS TRANSFERRED TO THE OR FOR SURGICAL REMOVAL OF THE DEVICE AND SUBSEQUENT FEMORAL TO ABOVE THE KNEE POPLITEAL BYPASS. DOSE OR AMOUNT: 1. FREQUENCY: 1. ROUTE: INTRA-ARTERY. DIAGNOSIS OR REASON FOR USE: OCCLUSION OF LEFT SFA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIABAHN ENDOPROSTHESIS 6MMX15CM NIP W.L. GORE & ASSOCIATES, INC. VBH061502 05613207

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| S