BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1220284 · Received November 3, 2008

    Report

    Report Number
    2134265-2008-04171
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, CROSSING DIFFICULTIES AND A SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND CALCIFIED BIFURCATION OF THE CIRCUMFLEX (CX) AND OBTUSE MARGINAL (OM). THE PHYSICIAN WAS USING A 7FR GUIDE CATHETER ALONG WITH A MAVERICK2 BALLOON AND THE 4.00X8MM LIBERTE BARE MONORAIL CORONARY STENT DELIVERY SYSTEM (SDS). THE MAVERICK2 BALLOON AND THE LIBERTE BARE SDS WERE ADVANCED TO THE LESION AT THE SAME TIME BUT BOTH WERE UNABLE TO CROSS THE LESION. THE PHYSICIAN ATTEMPTED TO REMOVE THE LIBERTE BARE SDS AND THE SHAFT BROKE AT THE END OF THE HYPOTUBE. THE LIBERTE BARE SDS WAS INSIDE OF THE GUIDE CATHETER WHEN THE SHAFT BROKE AND BOTH DEVICES WERE SUCCESSFULLY REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "OKAY".

    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 8712291

    Patients

    Seq Age Sex Outcome Treatment
    1