BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1052503 · Received May 22, 2008

    Report

    Report Number
    2134265-2008-01487
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. WHILE ATTEMPTING TO PLACE THE TAXUS EXPRESS2 3.0X16MM DRUG ELUTING STENT, THE STENT BECAME KINKED. THE PROCEDURE WAS COMPLETED WITH A 3.0 X 24MM TAXUS EXPRESS2 STENT. NO PATIENT COMPLICATIONS OCCURRED. PATIENT 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 3.0X16MM 11206191

    Patients

    Seq Age Sex Outcome Treatment
    1