BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1203355 · Received October 15, 2008

    Report

    Report Number
    2134265-2008-03014
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN A SAPHENOUS VEIN GRAFT (SVG) TO THE OBTUSE MARGINAL. THE PHYSICIAN WAS UNABLE TO DEPLOY THE 3.50X16MM LIBERTE BARE METAL STENT. WHEN THE STENT WAS REMOVED FROM THE PATIENT, A STENT STRUT WAS FOUND TO BE RAISED. ANOTHER LIBERTE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC NA 11826920

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR