BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1983897 · Received February 10, 2011

    Report

    Report Number
    2134265-2011-00226
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). 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. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL / PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.75X8.0MM VERIFLEX STENT WAS ADVANCED TO TREAT THE TARGET LESION, BUT WAS UNABLE TO CROSS THE LESION. UPON REMOVAL OF THE DEVICE STENT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A NON BSC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H749389358270 11428920

    Patients

    Seq Age Sex Outcome Treatment
    1