BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1031991 · Received April 21, 2008

    Report

    Report Number
    2134265-2008-01143
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 23, 2008
    Report Date
    March 24, 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 DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN A CALCIFIED AND SEVERELY TORTUOUS DISTAL RIGHT CORONARY ARTERY. THE 3.56 X 16 MM LIBERTE' BARE METAL STENT WAS UNABLE TO CROSS THE LESION AND A STENT STRUT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S STENT. NO PT COMPLICATIONS OCCURRED. PATIENT 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 11190620

    Patients

    Seq Age Sex Outcome Treatment
    1 DRIVER STENT