BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE MONORAIL CORONARY STENT DEL SYS

    MDR report key: 794532 · Received November 14, 2006

    Report

    Report Number
    6000089-2006-02408
    Event Type
    Malfunction
    Date Received
    November 14, 2006
    Date of Event
    September 20, 2006
    Report Date
    October 17, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE CAUSE OF THIS EVENT. A REVIEW OF THE MANUFACTURING RECORD FOR BATCH 8002803 SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF ITS RELEASE TO DISTRIBUTION. THIS DATE HAS NO ASSOCIATED COMPLAINTS TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING PROCEDURE IN THE LEFT MAIN ARTERY, THE LIBERTE MONORAIL CORONARY STENT WAS FOUND TO BE CURVED. THE STENT WAS NEVER USED ON THE PATIENT, AND THERE WERE NO COMPLICATIONS. ANOTHER DEVICE WAS USED TO FINISH THE PROCEDURE. PATIENT STATUS WAS REPORTED AS 'OKAY.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE MONORAIL CORONARY STENT DEL SYS STENT DELIVERY SYSTEM MAF BOSTON SCIENTIFIC 20MM X 4.5MM 8002803

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR