BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' OTW CORONARY STENT DELIVERY SYSTEM

    MDR report key: 793578 · Received November 28, 2006

    Report

    Report Number
    6000093-2006-02459
    Event Type
    Malfunction
    Date Received
    November 28, 2006
    Date of Event
    October 28, 2006
    Report Date
    October 30, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    p040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS VERIFIED THE STENT DAMAGE AS STATED IN THE COMPLAINT. THE DELIVERY DEVICE WITH THE STENT ON THE BALLOON WAS RECEIVED AND STENT DAMAGE WAS OBSERVED. VISUAL EXAMINATION OF THE STENT REVEALED A PROXIMAL STENT STRUT WAS BENT. THE BALLOON WAS VISUALLY AND MICROSCOPICALLY EXAMINED. NO VISUAL DEFECTS WERE OBSERVED UNDER MAGNIFICATION. THE BALLOON WAS TIGHTLY WRAPPED AND DID NOT APPEAR TO HAVE BEEN SUBJECTED TO ANY POSITIVE PRESSURE. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 8973818 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF THE STENT DAMAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PTCA PROCEDURE, THE STENT WAS FOUND WITH A FLARED STRUT. THIS DEVICE WAS NEVER USED ON THE PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' OTW CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC NA 8973818

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR