BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1190811 · Received September 24, 2008

    Report

    Report Number
    2134265-2008-02795
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STENT MOVED ON THE BALLOON. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ADVANCED THE 5.00 X 12 MM LIBERTE BARE MONORAIL CORONARY STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION, BUT IT WAS UNABLE TO CROSS. THE DEVICE WAS REMOVED FROM THE PT AND IT WAS NOTICED THAT THE STENT HAD MOVED ON THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE AND NO PT COMPLICATIONS. THE PT'S CURRENT CONDITION IS LISTED 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 8161425

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR