BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1203639 · Received October 16, 2008

    Report

    Report Number
    2134265-2008-03050
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 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 DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE MODERATELY TORTUOUS TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE 3.50X24MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION, BUT WAS UNABLE TO CROSS AND IT WAS NOTICED THAT THE NON BSC GUIDE CATHETER WAS FREED FROM THE ENGAGED POSITION. THE PHYSICIAN THEN DECIDED TO REMOVE THE TAXUS EXPRESS2 DES AND A SLIGHT RESISTANCE WAS ENCOUNTERED AT THE DISTAL PART OF THE GUIDE CATHETER. WHEN THE TAXUS EXPRESS2 DEVICE WAS REMOVED, IT WAS NOTICED THAT THE PROXIMAL SIDE OF THE STENT WAS LIFTED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PT COMPLICATIONS REPORTED. THE PT'S CURRENT CONDITION IS 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 3.50X24MM 0011590087

    Patients

    Seq Age Sex Outcome Treatment
    1