BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1203632 · Received October 16, 2008

    Report

    Report Number
    2134265-2008-03048
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 WAS PRE-DILATED WITH A QUANTUM MAVERICK 4.0X12MM BALLOON. THE PHYSICIAN ATTEMPTED TO PLACE A LIBERTE' 3.5X12MM BARE METAL STENT TO THE 75% IN-STENT RESTENOSED NON BSC STENTED LESION LOCATED IN THE NON-CALCIFIED AND SEVERELY TORTUOUS, PROXIMAL RIGHT CORONARY ARTERY (RCA), BUT WAS UNABLE TO CROSS THE LESION. UPON REMOVAL OF THE STENT DELIVERY SYSTEM (SDS), IT WAS NOTED THAT THE TIP OF THE STENT WAS LIFTED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS POST PROCEDURE IS NOTED 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 11736999

    Patients

    Seq Age Sex Outcome Treatment
    1 MACH1 GUIDE CATHETER| ZEON INTRODUCER| FIELDER GUIDEWIRE