BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1000603 · Received February 15, 2008

    Report

    Report Number
    2134265-2008-00441
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 14, 2008
    Report Date
    January 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED THROUGH THE RADIAL ARTERY. THE 100% STENOSED LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED RIGHT CORONARY ARTERY. THE PHYSICIAN ATTEMPTED TO ADVANCE A TAXUS EXPRESS2 4.5X12MM DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS WITHDRAWN FROM THE PT, AND IT WAS NOTED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.5X12MM TAXUS EXPRESS2 STENT. NO PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    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 4.5X12MM 9577813

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR