BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1911938 · Received December 1, 2010

    Report

    Report Number
    2134265-2010-05181
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: 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 THE PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. WHILE PREPARING FOR A STENTING TREATMENT PROCEDURE, THE 4.0X16MM VERIFLEX STENT WAS FOUND TO BE DEFORMED WHEN IT WAS REMOVED FROM THE BOX. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 4.0X16MM VERIFLEX. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893416400 0013614790

    Patients

    Seq Age Sex Outcome Treatment
    1