BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1031453 · Received April 18, 2008

    Report

    Report Number
    2134265-2008-01134
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 26, 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 2.50X24MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS ADVANCED TO THE UNSPECIFIED TARGET LESION. THE DES WAS UNABLE TO CROSS THE LESION AND IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT WAS LIFTED UP. THE DES WAS SUCCESSFULLY REMOVED FROM THE PT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED WITH THE PATIENT'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 2.50X24MM 9574004

    Patients

    Seq Age Sex Outcome Treatment
    1