BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3891119 · Received June 24, 2014

    Report

    Report Number
    2134265-2014-03550
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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: A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND THE STENT WAS DAMAGED. THE STENT STRUTS AT THE PROXIMAL END OF THE STENT WERE BUNCHED AND DISTORTED. A SNAP GAUGE WAS USED TO MEASURE THE CRIMPED STENT OD AT THE DISTAL END. THE SPECIFIED STENT PROTECTOR WAS NOT TOO TIGHT ON THE CRIMPED STENT PROVIDED THE CORRECT REMOVAL OF THE STENT PROTECTOR WAS USED. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE AND THE SHAFT POLYMER EXTRUSION FOUND NO ISSUES WITH THE PROFILE. 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 APPROVED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. A 12 X 2.25MM TAXUS¿ LIBERTÉ¿ STENT WAS SELECTED TO TREAT THE LESION; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE TARGET LESION. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367240 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894012220 16120549

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR