BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2142457 · Received June 28, 2011

    Report

    Report Number
    2134265-2011-02433
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED THAT THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH THE STENT DISLODGED AND RESTING ON THE LUMEN 2MM DISTAL TO THE DISTAL EDGE OF THE DISTAL MARKERBAND. THE STENT WAS DAMAGED IN THE MIDDLE SECTION OF THE STENT. STENT STRUTS WERE RAISED. THE STENT LENGTH WAS 13MM. THE TIP AND BALLOON SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS USER/ USE ERROR AS AN UNEXPANDED STENT SHOULD NOT BE MOVED IN AND OUT THROUGH THE DISTAL END OF THE GUIDE CATHETER AS STENT OR COATING DAMAGE OR STENT DISLODGMENT FROM THE BALLOON MAY OCCUR. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED (B)(6) 2011. THE 90% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). PREDILATION WAS PERFORMED WITH AN UNKNOWN BALLOON. THE PHYSICIAN ATTEMPTED TO IMPLANT A 4.0X38MM TAXUS LIBERTE STENT, BUT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN RE-DILATED THE LESION, BUT WAS UNABLE TO CROSS. FINALLY, THE PHYSICIAN WITHDREW THE STENT SYSTEM INTO THE GUIDE CATHETER AND COMPLETED THE PROCEDURE WITH TWO SHORTER STENTS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS OF THE RETURNED DEVICE REVEALED STENT DISLODGMENT AND STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894038400 0013344656

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR