BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2833201 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-06991
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    August 6, 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 EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) AND STENT WITH THE STENT PROTECTOR AND PRODUCT MANDREL PARTIALLY LOADED. 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 HYPOTUBE WAS DETACHED/SEPARATED 22 CM FROM THE STRAIN RELIEF. THE FRACTURE FACES WERE OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION, AND THE MATERIAL WAS JAGGED AND STRETCHED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE STENT WAS CENTERED BETWEEN THE MARKERBANDS ON THE TIGHTLY FOLDED BALLOON; THERE WAS NO INDICATION THE DEVICE WAS SUBJECTED TO POSITIVE (INFLATION) PRESSURE. THERE WAS DISTAL TIP DAMAGE. MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED SHAFT KINK AND CROSSING DIFFICULTY OR THE CONFIRMED HYPOTUBE 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) 2012. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL 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 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS AND SIGNIFICANT BEND OF >45 AND <90 DEGREES 2.25 X 16 MM LEFT CIRCUMFLEX ARTERY. THE 2.25 X 16 MM TAXUS LIBERTE MR STENT DELIVERY SYSTEM WAS ADVANCED WITH RESISTANCE, BUT WAS UNABLE TO CROSS THE LESION, AND A KINK OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894016220 0015148481

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR