BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1022190 · Received March 26, 2008

    Report

    Report Number
    2134265-2008-00883
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Report Date
    March 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE COMPLAINANT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, BALLOON DEFLATION AND WITHDRAWAL DIFFICULTIES OCCURRED. A 3.50X20MM LIBERTE BARE METAL STENT WAS IMPLANTED IN AN UNSPECIFIED LOCATION. THE PHYSICIAN REPORTED THAT THE STENT BALLOON WAS SLOW TO DEFLATE. THE PHYSICIAN WAS ABLE TO WITHDRAW THE BALLOON WITHOUT COMPLICATION TO THE PT, BUT COMMENTED THAT "STRONG RESISTANCE WAS MET DURING WITHDRAWAL" DUE TO THE SLOW BALLOON DEFLATION. THE STENT WAS FULLY DEPLOYED AND WELL APPOSED AND WAS FULLY INFLATED WITHOUT WAIST. THE PHYSICIAN DIALED UP AND DIALED DOWN AND PULLED HARD IN RESPONSE TO THE DEFLATION DIFFICULTIES. THE STENT REMAINED IMPLANTED AND THE PT CONDITION IS LISTED AS GOOD. NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC CORPORATION NA 9123903

    Patients

    Seq Age Sex Outcome Treatment
    1