BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1080642 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-02026
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 18, 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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE THE PHYSICIAN NOTICED THAT THE STENT WAS FAULTY. THE 75% STENOTIC LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. DURING ADVANCEMENT OF THE 2.5X24MM LIBERTE BARE STENT AN "OPPOSITION" WAS FELT, SO THE PHYSICIAN PULLED BACK THE STENT AND NOTICED THAT THE STENT WAS "FAULTY". THERE WERE NO PT COMPLICATIONS. THE PHYSICIAN THEN SUCCESSFULLY COMPLETED THE PROCEDURE BY PREDILATING THE LESION WITH A 2.75X15MM MAVERICK2 BALLOON AND DEPLOYING A 2.75X 24MM LIBERTE BARE STENT. PT STATUS IS REPORTED AS "NO PROBLEM IN HEALTH".

    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 11507749

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR