BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2840024 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-06989
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    July 21, 2012
    Report Date
    October 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE STENT DELIVERY SYSTEM AND STENT WITH THE STENT PROTECTOR AND PRODUCT MANDREL PARTIALLY LOADED. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE REPORTED INFORMATION AND THE PRESENCE OF CONTRAST IN THE INFLATION LUMEN AND THE POSITION OF THE STENT PROTECTOR AND PRODUCT MANDREL ALL SUGGEST THE STENT PROTECTOR AND PRODUCT MANDREL WERE REPLACED AFTER THE REPORTED ATTEMPT TO CROSS THE TARGET LESION. THE STENT HAD MOVED ON THE BALLOON 4.0MM DISTALLY FROM THE PROXIMAL MARKERBAND, AND THERE WERE STENT STRUT IMPRESSIONS PRESENT ON THE SURFACE OF THE BALLOON BETWEEN THE MARKER BANDS INDICATING THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. THERE WAS NO INDICATION THE DEVICE WAS SUBJECTED TO POSITIVE (INFLATION) PRESSURE. THERE WERE MULTIPLE STENT STRUTS THROUGHOUT THE STENT THAT WERE STRETCHED AND BENT. MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CROSSING DIFFICULTY OR THE CONFIRMED STENT DAMAGE AND STENT MOVED ON BALLOON. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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

    COMPLAINT IS REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT WOULD NOT CROSS THE LESION AND A SHAFT KINK OCCURRED. USING THE FEMORAL APPROACH, THE PROCEDURE TREATED THE 2.25X28MM, 90% STENOSED, DE NOVO AND CONCENTRIC TARGET LESION LOCATED IN THE MILDLY CALCIFIED LEFT CIRCUMFLEX ARTERY. THERE WAS A GREATER THAN 45° BUT LESS THAN 90° BEND IN THE LESION. AFTER PRE-DILATION, THE PHYSICIAN ADVANCED A 2.25X28MM TAXUS LIBERTE STENT FOR TREATMENT, BUT IT WAS NOT ABLE TO CROSS THE LESION AND THE SHAFT OF THE STENT DELIVERY SYSTEM WAS KINKED. A 2.25X28MM TAXUS LIBERTE STENT WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. HOWEVER, ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT THERE WAS STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894028220 0015116753

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR