BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 3053093 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02360
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    September 8, 2012
    Report Date
    March 14, 2013
    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

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) AND NO STENT WITH NO OTHER DEVICES. THERE WAS CONTRAST IN THE INFLATION LUMEN. 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. THE BALLOON WAS TIGHTLY FOLDED WHICH IS CONSISTENT OF HAVING NO POSITIVE PRESSURE APPLIED. THERE WAS DISTAL TIP DAMAGE. MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CROSSING DIFFICULTY OR THE STENT DETACHMENT AND TIP DAMAGE. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY STENTING TREATMENT PROCEDURE A STENT WAS UNABLE TO CROSS THE LESION, AND A SHAFT KINK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 70% STENOSED <=45 BENT 2.25 X 16MM CONCENTRIC DE NOVO LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE LESION WAS PREDILATED WITH A NON BSC BALLOON. THE 2.25 X 16MM TAXUS LIBERTE MR STENT DELIVERY SYSTEM WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION AND THE SHAFT KINKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED STENT DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156894 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894016220 15148481

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR