BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1023388 · Received April 2, 2008

    Report

    Report Number
    2134265-2008-00962
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY (RCA). THE VESSEL WAS PREDILATED WITH AN UNK TYPE AND SIZE BALLOON. A 3.5X24MM TAXUS STENT WAS IMPLANTED IN THE MID RCA. THE PHYSICIAN ATTEMPTED TO ADVANCED A 4.0 X 20 MM LIBERTE' BARE METAL STENT TO THE PROXIMAL RCA BUT ENCOUNTERED CROSSING DIFFICULTY AND THE STENT DISLODGED IN THE PROXIMAL RCA. A 2.5X15MM APEX BALLOON WAS USED TO DEPLOY THE DISLODGED STENT IN THE PROXIMAL RCA. NO FURTHER PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC NA 11282728

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention