BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1081522 · Received July 25, 2008

    Report

    Report Number
    2134265-2008-02085
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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 MANUFACTURING 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 OPERATIONAL CONTEXT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH LIMITED THE DEVICE PERFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. THERE WAS AN ATTEMPT TO OVERLAP THE STENT WHICH FAILED AND THE TAXUS EXPRESS2 WAS REMOVED. UPON REMOVAL IT WAS NOTED THAT THE STENT STRUTS WERE BENT. THE LESION WAS PREDILATED WITH A MAVERICK BALLOON AND CROSSED WITH A 3.0X32MM TAXUS EXPRESS2 STENT. THE PATIENT STATUS IS LISTED AS OK WITH NO COMPLICATIONS REPORTED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    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 3.00X28MM 9761743

    Patients

    Seq Age Sex Outcome Treatment
    1