BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1241060 · Received November 20, 2008

    Report

    Report Number
    2134265-2008-04408
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 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, THE STENT MIGRATED. THE 75% STENOSED LESION BEING TREATED WAS LOCATED IN THE MILDLY CALCIFIED, MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH A 3.0X15MM QUANTUM MAVERICK BALLOON, INFLATED TWICE TO 6ATM FOR 15 SECONDS. THE PHYSICIAN DEPLOYED THE 3.00X24MM LIBERTE BARE METAL STENT AT 12ATM FOR 22 SECONDS. AS THE PHYSICIAN WAS REMOVING THE BALLOON, HE FELT THE STENT MOVE PROXIMAL, 1 TO 2MM. THE PHYSICIAN THEN POST DILATED THE STENT WITH A 3.0X15MM QUANTUM BALLOON, INFLATED THREE TIMES TO 12-15ATM FOR 19-24 SECONDS. FURTHER DILATATIONS WERE MADE WITH A 3.5X8MM QUANTUM BALLOON AND A 3.0X15MM QUANTUM BALLOON. THE CASE WAS COMPLETED SUCCESSFULLY. PT STATUS REPORTED AS "FINE".

    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 9405533

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention