BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1161570 · Received September 15, 2008

    Report

    Report Number
    2134265-2008-02646
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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 LESION BEING TREATED WAS LOCATED IN THE 100% STENOSED, CALCIFIED, AND EXTREMELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD). AFTER PERFORMING PLAIN OLD BALLOON ANGIOPLASTY, THE PHYSICIAN PLACED A GUIDEWIRE AND ATTEMPTED TO DELIVER THE 3.50X8MM TAXUS EXPRESS2 DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS THE LESION. IT SEEMED TO BE RELATED TO THE GUIDEWIRE, SO THE PHYSICIAN CHANGED TO GUIDEWIRE. HOWEVER, THE PHYSICIAN WAS STILL UNABLE TO CROSS THE LESION, AND THE TAXUS STENT WAS WITHDRAWN. IT WAS NOTICED THAT THE TAXUS STENT WAS LIFTED UP AND IT WAS CHANGED TO ANOTHER STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT 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 CORPORATION 3.50X8MM

    Patients

    Seq Age Sex Outcome Treatment
    1 RENATO| FIELDER| GUIDE CATHETER: LAUNCHER| GUIDE WIRE: EXTREME