BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1221229 · Received November 5, 2008

    Report

    Report Number
    2134265-2008-04224
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, A THROMBOSIS OCCURRED. THE LESION, LOCATED IN THE CIRCUMFLEX ARTERY, WAS PREDILATED WITH A 2.5X12MM MAVERICK BALLOON. A 3.0X16MM LIBERTE' BARE METAL STENT WAS DEPLOYED, INFLATING THE BALLOON TO 9 ATM'S FOR 20 SECONDS. THE STENT WAS POST DILATED WITH THE SAME BALLOON, INFLATED TO 13 ATM'S FOR 20 SECONDS. FIVE DAYS LATER, THE PATIENT PRESENTED WITH A SUB ACUTE STENT THROMBOSIS. THE VESSEL WAS REPORTED TO BE "FULL OF THROMBUS". A 3.0X15MM QUANTUM MAVERICK BALLOON AND AN EXPORT CATHETER WERE USED TO TREAT THE THROMBOSIS. NO FURTHER PATIENT COMPLICATIONS OCCURRED. PATIENT 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 11922979

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention