BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1190621 · Received October 6, 2008

    Report

    Report Number
    2134265-2008-02920
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 CALCIFIED LESION LOCATED IN THE EXTREMELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ATTEMPTED TO IMPLANT A TAXUS EXPRESS2 3.50X12MM DRUG ELUTING STENT, HOWEVER, THE STENT WAS LIFTED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THE PATIENT STATUS AFTER THE PROCEDURE WAS 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 CORPORATION 3.50X12MM 11519592

    Patients

    Seq Age Sex Outcome Treatment
    1