BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1040396 · Received May 7, 2008

    Report

    Report Number
    2134265-2008-01327
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 9, 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, THEREFORE, A TECHNICAL ANALYSIS WAS UNABLE TO BE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS PARTICULAR BATCH FOUND THAT THE DEVICE MET MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS OPERATIONAL CONTEXT 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 90% STENOSED LESION WAS LOCATED IN A SEVERELY TORTUOUS DISTAL CIRCUMFLEX ARTERY. A TAXUS EXPRESS2 2.5X20MM DRUG ELUTING STENT WAS ADVANCED TO THE LESION BUT WAS UNABLE TO CROSS. UPON REMOVAL, IT WAS NOTED THAT THE EDGE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    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 2.5X20MM 11096945

    Patients

    Seq Age Sex Outcome Treatment
    1