BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2140280 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02540
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE 3.0X20MM LIBERTE STENT WAS ADVANCED AND WOULD NOT CROSS THE LESION. UPON REMOVAL, A FLARED STRUT ON THE DISTAL END OF THE STENT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893820300 14239487

    Patients

    Seq Age Sex Outcome Treatment
    1