BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE ' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1181528 · Received September 25, 2008

    Report

    Report Number
    2134265-2008-02811
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    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 INFORMATION 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, STENT DAMAGE OCCURRED. THE 30% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND NON TORTUOUS LEFT CIRCUMFLEX (LCX). THE 3.00X16MM LIBERTE BARE MONORAIL CORONARY STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION BUT WAS UNABLE TO CROSS. WHEN THE SDS WAS REMOVED FROM THE PATIENT, IT WAS NOTICED THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS LISTED AS "STABLE".

    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 0011116606

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR