BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1220285 · Received November 3, 2008

    Report

    Report Number
    2134265-2008-04186
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 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, A TECHNICAL ANALYSIS WAS UNABLE TO BE CONFIRMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD OF ANATOMICAL, AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED WITH A 3.0X15MM NON-BSC BALLOON. THE TAXUS EXPRESS2 3.5X12MM DRUG ELUTING STENT WAS ADVANCED TO THE LESION, BUT WAS UNABLE TO CROSS THE LESION. THE LESION WAS DILATED AGAIN, HOWEVER, THE DEVICE WAS STILL UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PT AND THE DISTAL EDGE OF THE STENT WAS FOUND TO BE LIFTED UP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. 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 3.5X12MM 0011523366

    Patients

    Seq Age Sex Outcome Treatment
    1 3.0X15MM RYUJIN PLUS BALLOON