BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1070149 · Received July 3, 2008

    Report

    Report Number
    2134265-2008-01890
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 23, 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, STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ATTEMPTED TO DIRECT STENT THE 2.50X16MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES), BUT THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN REMOVED THE STENT DELIVERY SYSTEM (SDS) FROM THE PATIENT AND IT WAS NOTICED THAT THE PROXIMAL SIDE OF THE STENT WAS LIFTED UP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OR THE SAME DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS 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 2.50X16MM 11198712

    Patients

    Seq Age Sex Outcome Treatment
    1