BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1220289 · Received November 3, 2008

    Report

    Report Number
    2134265-2008-04187
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ATTEMPTED TO DIRECT STENT WITH THE 4.0 X 12 MM LIBERTE' BARE METAL STENT BUT WAS UNABLE TO CROSS THE LESION. THE LIBERTE' STENT WAS REMOVED AND THE STENT STRUTS WERE FOUND TO BE FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIBERTE' BARE METAL STENT. 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 NA 11860051

    Patients

    Seq Age Sex Outcome Treatment
    1