BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1082640 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02076
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PHYSICIAN ATTEMPTED TO DIRECT STENT A LIBERTE' 5.0X20MM BARE METAL STENT BY "MINI CRASH TECHNIQUE" TO THE 80% STENOSED LESION LOCATED IN THE MODERATELY CALCIFIED, MILDLY TORTUOUS, PROXIMAL CIRCUMFLEX (CX) AND OBTUSE MARGINAL (OM) ARTERIES. "THE STENT STRUT IS BROKEN WHILE IT WAS CROSSING THE LESION IN CX DUE TO TORTUOUSITY, SO THEY DID NOT USE THE STENT FOR THE PROCEDURE." ADDITIONAL INFO REGARDING THIS EVENT HAS BEEN REQUESTED, BUT NOT 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 11435796

    Patients

    Seq Age Sex Outcome Treatment
    1