BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1061991 · Received June 13, 2008

    Report

    Report Number
    2134265-2008-01689
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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 THE NON-CALCIFIED, NON-TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN ATTEMPTED TO PLACE A 3.50X16 LIBERTE BARE METAL STENT, BUT WAS UNABLE TO CROSS THE LESION. WHEN REMOVING THE STENT DELIVERY SYSTEM THE PHYSICIAN "FELT THE STENT WAS SOMEHOW FAULTY ON THE BALLOON". WHEN THE DEVICE WAS REMOVED, IT APPEARED AS IF A SPIDERWEB WAS ON THE END. THE PROCEDURE WAS COMPLETED WITH A 3.50X24MM LIBERTE STENT. NO PT COMPLICATIONS WERE REPORTED. PT STATUS REPORTED AS "OK".

    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 11490416

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR