BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYS

    MDR report key: 789838 · Received November 20, 2006

    Report

    Report Number
    6000089-2006-02458
    Event Type
    Malfunction
    Date Received
    November 20, 2006
    Date of Event
    July 10, 2006
    Report Date
    October 23, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED DEVICE ANALYSIS FOUND THAT THE SHAFT OF THIS DEVICE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH AND A CENTER STRUT OF THE STENT WAS RAISED AND BENT BACK DISTALLY. A REVIEW OF THE MANUFACTURING RECORD FOR THIS BATCH 8003924 SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE ROOT CAUSE OF THE COMPLAINT INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    DETERMINED TO BE REPORTABLE BASED ON ANALYSIS APPROVED ON 23 OCTOBER 2006. IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE OF AN UNSPECIFIED VESSEL, DIFFICULTY CROSSING THE LESION OCCURRED. ACCORDING TO THE CUSTOMER "STENT STRUT NOT CLOSE TO BALLOON IN THE UNEXPANDED STATE, STENT DELIVERY IN THE LESION NOT POSSIBLE BECAUSE NO CHANCE TO CROSS THE LESION WITH STENT DELIVERY SYSTEM." ADDITIONAL INFORMATION WAS REQUESTED ON THIS EVENT, HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE. RETURNED PRODUCT ANALYSIS CONFIRMED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYS MAF STENT, CORONARY MAF BOSTON SCIENTIFIC 16MM X 4.00 8003924

    Patients

    Seq Age Sex Outcome Treatment
    1 *