BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1161305 · Received September 11, 2008

    Report

    Report Number
    2134265-2008-02611
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 SEVERELY CALCIFIED, MILDLY TORTUOUS UNK ARTERY. THE LESION WAS NOT PREDILATED. THE PHYSICIAN ATTEMPTED TO PLACE THE 3.00X16MM LIBERTE BARE METAL STENT, BUT WAS UNABLE TO CROSS THE LESION. UPON WITHDRAWAL, STENT DAMAGE WAS IDENTIFIED. 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 11479770

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR