BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1162200 · Received September 16, 2008

    Report

    Report Number
    2134265-2008-02667
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    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, STENT DAMAGE OCCURRED. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS, SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ATTEMPTED TO PLACE A 3.00X12MM TAXUS EXPRESS2 DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS THE LESION. DURING THE ATTEMPT TO CROSS THE LESION, THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS REPORTED 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 3. 00X12 MM 11243238

    Patients

    Seq Age Sex Outcome Treatment
    1