BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1161314 · Received September 11, 2008

    Report

    Report Number
    2134265-2008-02618
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). THERE WAS DIFFICULTY ADVANCING THE 4.00X12MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) TO THE TARGET LESION AND THE SHAFT OF THE DEVICE BROKE. THE BROKEN PORTION OF THE SHAFT WAS CONTAINED IN THE GUIDE CATHETER, AND THE PHYSICIAN WAS ABLE TO SUCCESSFULLY RETRIEVE THE TAXUS EXPRESS2 DEVICE ALONG WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PT COMPLICATIONS REPORTED. THE PT'S CURRENT CONDITION IS LISTED AS "STABLE".

    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 4.00X12MM 11271299

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR