BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1944087 · Received January 3, 2011

    Report

    Report Number
    2134265-2010-05757
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE STENT MOVED ON THE BALLOON. THE DETAILS OF THE LESION AND PATIENT'S ANATOMY ARE UNKNOWN. THE 4.00X20MM LIBERTE BARE STENT MOVED ON THE BALLOON WHILE THE DEVICE WAS BEING ADVANCED. THE DEVICE WAS REMOVED WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893820400 13659364

    Patients

    Seq Age Sex Outcome Treatment
    1 VISION