BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1172141 · Received September 18, 2008

    Report

    Report Number
    2134265-2008-02705
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERLY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS ABLATED WITH A 1.5MM ROTABLATOR AND THEN THE 2.75X32MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS ADVANCED TO THE LESION, BUT THE DEVICE WAS UNABLE TO CROSS. THE PHYSICIAN PUSHED THE DEVICE SEVERAL TIMES, AND THEN THE SHAFT OF THE DEVICE BROKE ON THE PORTION THAT WAS OUTSIDE OF THE PATIENT. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED 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 2.75X32MM 11734385

    Patients

    Seq Age Sex Outcome Treatment
    1