BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1860737 · Received October 7, 2010

    Report

    Report Number
    2134265-2010-04460
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 IN PREPARATION FOR A STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.5X28MM LIBERTE' BARE METAL STENT WAS BEING PREPPED FOR USE WHEN THE DEVICE BROKE OUTSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893828350 13148673

    Patients

    Seq Age Sex Outcome Treatment
    1