BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2810297 · Received October 31, 2012

    Report

    Report Number
    2134265-2012-06899
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    July 17, 2012
    Report Date
    October 22, 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 A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: VISUAL EXAMINATION SHOWED THERE WAS CONTRAST IN THE INFLATION LUMEN. THE REPORTED INFORMATION, THE PRESENCE OF CONTRAST IN THE INFLATION LUMEN, AND THE POSITION OF THE STENT PROTECTOR AND PRODUCT MANDREL SUGGEST THE STENT PROTECTOR AND PRODUCT MANDREL WERE REPLACED AFTER THE REPORTED FAILED ATTEMPT TO CROSS THE TARGET LESION. THE STENT HAD MOVED ON THE BALLOON 1 MM 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. MULTIPLE STENT STRUTS IN ROWS THREE AND FOUR ON THE PROXIMAL END OF THE STENT 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 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) 2012. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE, A SHAFT KINK AND DIFFICULTY CROSSING THE LESION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, 3.0 MM X 12 MM, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE LESION CONTAINED A >45 AND <90 DEGREE BEND. THE LESION WAS PREDILATED WITH AN UNSPECIFIED DEVICE. THE TAXUS LIBERTE (MR) OUS - 12 X 3.00 MM WAS UNABLE TO CROSS THE LESION AND THE SHAFT BECAME KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. DEVICE ANALYSIS REVEALED STENT MOVEMENT ON THE BALLOON AND 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 H7493894012300 0015066098

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR