BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1841814 · Received September 22, 2010

    Report

    Report Number
    2134265-2010-04186
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 3, 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) - 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED MULTIPLE TIMES WITH AN UNKNOWN BALLOON. A 4.0X16MM LIBERTE' BARE METAL STENT WAS ADVANCED TO THE LESION, BUT COULD NOT CROSS. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, STENT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIBERTE' STENT. NO PATIENT INJURIES OCCURRED. PATIENT STATUS IS LISTED AS GOOD. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893816400 13383138

    Patients

    Seq Age Sex Outcome Treatment
    1