BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1022304 · Received March 26, 2008

    Report

    Report Number
    2134265-2008-00870
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE PHYSICIAN WAS UNABLE TO CROSS THE LESION AND WHEN THE STENT WAS REMOVED THERE WAS STENT DAMAGE. THE LESION BEING TREATED WAS A 90% STENOSED PORTION OF THE LEFT CIRCUMFLEX. THE PHYSICIAN WAS UNABLE TO CROSS THE LESION AND WHEN THE DEVICE WAS REMOVED, THE PROXIMAL EDGE OF THE STENT WAS LIFTED. ADD'L INFO HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. THERE WERE NO PT COMPLICATIONS REPORTED. PT STATUS WAS REPORTED AS "GOOD". THE PHYSICIAN COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC 3.50X20MM 11195060

    Patients

    Seq Age Sex Outcome Treatment
    1