BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1181526 · Received September 25, 2008

    Report

    Report Number
    2134265-2008-02809
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. DIRECT STENTING WAS PERFORMED USING A 3.00X32MM TAXUS EXPRESS2. AS THE PHYSICIAN TRIED TO ADVANCE TO THE LESION, IT COULD NOT CROSS THE LESION. THE STENT WAS PULLED BACK OUT OF THE BODY AND FOUND THAT A STENT STRUT WAS DEFORMED. THE PHYSICIAN WENT BACK IN AND PREDILATED AND CROSSED THE LESION WITH ANOTHER OF THE SAME DEVICE SUCCESSFULLY. PT STATUS IS FINE WITH NO COMPLICATIONS REPORTED.

    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 3.00X32MM 11380798

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR