BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1761110 · Received July 19, 2010

    Report

    Report Number
    2134265-2010-02518
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    February 7, 2006
    Report Date
    February 7, 2006
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DEVICE WAS NOT RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    (B)(4). IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING PROCEDURE INCOMPLETE EXPANSION OF THE STENT OCCURRED. THE PROCEDURE TREATED THREE LESIONS WITHIN TWO VESSELS. TARGET LESION ONE WAS A 2.2X26MM, 84% STENOSED LESION OF THE CIRCUMFLEX ARTERY. A 2.75X32MM LIBERTE STENT WAS PLACED RESULTING IN 0% RESIDUAL STENOSIS. TARGET LESION TWO WAS A 2.2X14MM, 67% STENOSED LESION OF THE CIRCUMFLEX. A 2.75X16MM LIBERTE STENT WAS PLACED RESULTING IN 0% RESIDUAL STENOSIS. TARGET LESION THREE WAS A 3.2X12MM, 66% STENOSIS OF THE LAD (LEFT ANTERIOR DESCENDING). A 3.5X16MM LIBERTE STENT WAS PLACED RESULTING IN 0% RESIDUAL STENOSIS. IT WAS NOTED THAT THE 3.5X16MM LIBERTE STENT WAS UNDER EXPANDED; HOWEVER, NO ADDITIONAL PROCEDURE WAS REQUIRED. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASA AND CLOPIDOGREL WITH NO FURTHER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY UNK208

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR SPRINTER BALLOON