BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1162201 · Received September 16, 2008

    Report

    Report Number
    2134265-2008-02668
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 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 PREPARATION FOR A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PHYSICIAN NOTICED THE STENT STRUT OF THE 3.50X24MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS LIFTED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS REPORTED AS "SATISFACTORY/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. 50X24MM 11489954

    Patients

    Seq Age Sex Outcome Treatment
    1