BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1203645 · Received October 16, 2008

    Report

    Report Number
    2134265-2008-03045
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE COULD NOT PERFORM A TECHNICAL ANALYSIS. A REVIEW OF THE MFG DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS CONSIDERED OPERATIONAL CONTEXT, DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, THE PERFORMANCE OF THE DEVICE WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. THE DIFFUSE LESION WAS 90% STENOSED AND LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED BY A NON BSC BALLOON. A 3.0 X 28 MM TAXUS EXPRESS2 WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN TRIED TO CROSS THE TARGET LESION SEVERAL TIMES, BUT IT WAS THE SAME RESULT. IT WAS REMOVED FROM INSIDE THE PT AND THE PHYSICIAN NOTICED THE STENT STRUT LIFTED UP SLIGHTLY. THE LESION WAS RE-DILATED BY A NON BSC BALLOON SEVERAL TIMES A NEW TAXUS EXPRESS2 3.0 X 28 MM STENT WAS IMPLANTED. THE PROCEDURE WAS COMPLETED. THE PT STATUS IS GOOD WITH NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG ELUTING NIQ BOSTON SCIENTIFIC 3.00 X 28 MM 9723956

    Patients

    Seq Age Sex Outcome Treatment
    1 70+ LACROSSE 2.0 MM BALLOON| LACROSSE 3.0 MM BALLOON