BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1052019 · Received May 21, 2008

    Report

    Report Number
    2134265-2008-01467
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 85% STENOSED LESION BEING TREATED WAS LOCATED IN THE NON-CALCIFIED, MILDLY TORTUOUS CIRCUMFLEX (CX) ARTERY. THE PT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. THE LESION WAS PREDILATED WITH A 2.50X15MM MAVERICK BALLOON, INFLATED TO 16 ATMS, "RESULT WAS WELL". THE PHYSICIAN POSITIONED THE 3.5X16MM LIBERTE BARE METAL STENT AND INFLATED THE STENT BALLOON TO 17 ATMS FOR 20 SECONDS, UNDER X-RAY. THE STENT WAS FULLY DEPLOYED AND WELL APPOSED. WHILE DEFLATING THE BALLOON, THE PHYSICIAN RECOGNIZED BLOOD IN THE ENCORE 26 INFLATION DEVICE, COMING FROM THE BALLOON. THE BALLOON HAD BURST. NO PIECES OF THE BALLOON REMAIN IN THE BODY. PT STATUS REPORTED AS "GOOD".

    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 11491586

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR