BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1101732 · Received August 7, 2008

    Report

    Report Number
    2134265-2008-02225
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE STENT REMAINS IMPLANTED. THE COMPLAINANT INDICATED THAT THE DELIVERY 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

    SAME CASE AS MFR#2134265-2008-02226, 2134265-2008-02227. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE PHYSICIAN IMPLANTED THREE LIBERTE BARE METAL STENTS IN THE RIGHT CORONARY ARTERY (RCA), SIZES 4.00X20MM, 4.00X12MM, AND 4.00X8MM. LESS THAN TWO HOURS LATER, THE PT SUFFERED A THROMBOSIS IN THE RCA. THE PHYSICIAN ADVANCED AN ASPIRATION CATHETER TO THE LESION AND ASPIRATED THE THROMBOSIS. THE PHYSICIAN THEN ADVANCED A 4.00X15MM NON-BSC BALLOON TO THE LESION WHERE IT WAS INFLATED FOR 14 SECONDS AT 8 ATMS, 16 SECONDS AT 12 ATMS, 10 SECONDS AT 12 ATMS, AND 15 SECONDS AT 8 ATMS. VENTRICULAR FIBRILLATION OCCURRED AND THE PT WAS DEFIBRILLATED. THE PHYSICIAN PLACED AN INTRA AORTIC BALLOON PUMP (IABP) AND CONFIRMED THAT IT WAS FUNCTIONING PROPERLY. THE PT WAS TRANSFERRED FOR FURTHER FOLLOW UP. THE PHYSICIAN FEELS THAT THE EVENT IS NOT RELATED TO THE STENTS, BUT IS INSTEAD RELATED TO THE PT'S EXISTING ILLNESS. FURTHER INFO HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    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 4.00X20MM

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention