BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1171333 · Received September 17, 2008

    Report

    Report Number
    2134265-2008-02680
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    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, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS PARTICULAR TOP ASSEMBLY BATCH NUMBER 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 OPERATIONAL CONTEXT AS THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE BOSTON SCIENTIFIC CORPORATION (BSC) DESIGN AND MANUFACTURING SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE THE PERFORMANCE WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN THE CALCIFIED, SEVERELY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH AN UNKNOWN SIZE AND MANUFACTURERS BALLOON. THE PHYSICIAN ATTEMPTED SEVERAL TIMES TO PLACE A 3.50X16MM TAXUS EXPRES2 DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN NOTICED THE DISTAL PART OF THE STENT STRUT WAS SLIGHTLY LIFTED UP. THE PROCEDURE WAS COMPLETED WITH A 3.50X20MM TAXUS STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS REPORTED AS "GOOD".

    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 3.50X16 MM 0011295998

    Patients

    Seq Age Sex Outcome Treatment
    1