BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1080647 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-02025
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ATTEMPTED TO ADVANCE THE 2.5X20MM LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION, BUT THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN DECIDED TO PULL THE SDS BACK OUT IN ORDER TO DILATE THE LESION AND WHILE THE DEVICE WAS BEING PULLED BACK THE SHAFT SECTION BROKE INSIDE OF THE CATHETER. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE DEVICE FROM THE PT. THE PROCEDURE WAS COMPLETED BY DILATING THE LESION WITH AN UNSPECIFIED BALLOON AND THEN AN UNSPECIFIED BARE METAL STENT WAS IMPLANTED. NO PT COMPLICATIONS WERE REPORTED. ADD'L INF HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED.

    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 11382409

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR