BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1062009 · Received June 13, 2008

    Report

    Report Number
    2134265-2008-01691
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE TORTUOUS, 'TOUGH' CALCIFIED PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. THE PHYSICIAN ATTEMPTED TO PLACED THE 2.75X12MM LIBERTE BARE METAL STENT, BUT WAS UNABLE TO CROSS THE LESION. UPON REMOVAL OF THE STENT DELIVERY SYSTEM, THE SHAFT WAS FOUND TO BE BROKEN. THE PHYSICIAN USED A NON-BSC BALLOON AND THE PROCEDURE WAS NOT COMPLETED BECAUSE ANOTHER OF THE SAME LIBERTE STENT WAS NOT AVAILABLE. NO PT COMPLICATIONS WERE REPORTED. PT STATUS REPORTED AS "STABLE".

    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 9794360

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR