BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1062047 · Received June 13, 2008

    Report

    Report Number
    2134265-2008-01678
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 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 ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 75-90% STENOSED UNSPECIFIED TARGET LESION WAS MILDLY TORTUOUS AND CALCIFIED. THE LESION WAS PREDILATED AND THEN THE 2.50X20MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION BUT WAS UNABLE TO CROSS. IT WAS NOTICED UPON REMOVAL THAT THE STENT STRUT WAS LIFTED UP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED WITH THE PT'S CURRENT CONDITION 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 2.50X20MM 11453913

    Patients

    Seq Age Sex Outcome Treatment
    1