BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1012506 · Received March 12, 2008

    Report

    Report Number
    2134265-2008-00746
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE COMPLAINT DEVICE WAS NOT RETURNED, THEREFORE, PRODUCT ANALYSIS WAS NOT POSSIBLE. THE MFG RECORDS FOR THIS BATCH WERE REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS PRIOR TO SHIPMENT. THE ROOT CAUSE WILL BE DOCUMENTED AS UNDETERMINABLE BECAUSE IT CAN NOT BE DETERMINED WHAT LED TO STENT COMING OFF FROM THE DELIVERY SYSTEM PRIOR TO USE IN THE PT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CORONARY STENTING TREATMENT PROCEDURE, THE 3.50X12MM LIBERTE BARE METAL STENT CAME OFF OF THE BALLOON. THERE WAS NO PT CONTACT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME SIZE DEVICE. THERE WERE NO PT COMPLICATIONS 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 CORPORATION NA 9369084

    Patients

    Seq Age Sex Outcome Treatment
    1