BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1213671 · Received October 23, 2008

    Report

    Report Number
    2134265-2008-03116
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CORONARY STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. WHEN THE PHYSICIAN REMOVED THE STYLET AND THE PROTECTIVE COVER FROM THE LIBERTE' 3.0X16 MM BARE METAL STENT, IT WAS NOTED THAT THERE WAS NOT A STENT ON THE STENT DELIVERY SYSTEM. THE STENT WAS FOUND ON THE STYLET, JAMMED INTO IT. THE PROCEDURE WAS COMPLETED USING ANOTHER LIBERTE' 3.0X16 MM STENT. NO PT INJURIES OR COMPLICATIONS WERE REPORTED.

    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 0011858567

    Patients

    Seq Age Sex Outcome Treatment
    1