BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1003417 · Received February 21, 2008

    Report

    Report Number
    2134265-2008-00523
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS #2134265-2008-00524. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STENT MOVED ON THE BALLOON. THE LESION WAS LOCATED IN A VERY CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY. THE PHYSICIAN ATTEMPTED TO ADVANCE A 3.5 X 20 MM LIBERTE STENT, HOWEVER, IT BECAME "LOOSE" AFTER HITTING SOME CALCIUM. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE STENT HAD MOVED SLIGHTLY OFF THE BALLOON. THE PHYSICIAN WAS THEN GIVEN ANOTHER 3.5 X 20MM LIBERTE STENT AND NOTICED THAT THE DISTAL TIP OF THE STENT STRUTS WERE FLARED OUT. THIS SECOND STENT NEVER ENTERED THE PT. THE PHYSICIAN WENT ON TO TRY TO PLACE A 3.5 X 16MM LIBERTE BARE METAL STENT AND ANOTHER MFR'S STENT BUT NEITHER WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH THE USE OF A CUTTING BALLOON AND A LIBERTE STENT WAS SUCCESSFULLY DEPLOYED. NO PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC CORPORATION NA 11349473

    Patients

    Seq Age Sex Outcome Treatment
    1