BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1040397 · Received May 7, 2008

    Report

    Report Number
    2134265-2008-01326
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Removal / Correction Number
    NA
    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 75% STENOSED LESION BEING TREATED WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.5X20MM BALLOON, MANUFACTURER UNK. THE PHYSICIAN ATTEMPTED TO PLACE A 2.75 X 32MM LIBERTE BARE METAL STENT, BUT WAS UNABLE TO CROSS THE LESION. UPON REMOVAL THE PHYSICIAN NOTICED THAT THE STENT EDGE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A 2.5X30 NON-BSC STENT. NO PT COMPLICATIONS WERE REPORTED. PT STATUS REPORTED 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 11147738

    Patients

    Seq Age Sex Outcome Treatment
    1