BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 545002 · Received September 20, 2004

    Report

    Report Number
    6000089-2004-01130
    Event Type
    Death
    Date Received
    September 20, 2004
    Date of Event
    September 9, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DISSECTION WAS TREATED BY PLACING A 3.00 X 24 MM, A 2.50 X 20 MM, A 2.50 X 16 MM AND A 3.00 X 16 MM TAXUS EXPRESS2 DRUG ELUTING STENT.

    Description of Event or Problem · 1

    SAME AS MFR # 60000093-2004-01113, 01114, 001131, 01132 AND 01133. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING TREATMENT PROCEDURE IN 2004, DIFFICULTY REMOVING THE BALLOON WAS ENCOUNTERED AND A DISSECTION OCCURRED. THE LESIOIN BEING TREATED WAS A MODERATELY CALCIFIED, 75% STENOTIC LESION IN A MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN SUCCESSFULLY DEPLOYED A TAXUS EXPRESS2 -3.0 X 24 MM STENT AND A 2.75 X 24 MM STENT IN THE LAD. UPON REMOVING BOTH FULLY DEFLATED BALLOONS THE PHYSICIAN FELT RESISTANCE. THE PHYSICIAN HAD TO PULL ON THE SHAFT OF THE CATHETERS TO SUCCESSFULLY REMOVE THE BALLOONS. WHILE ATTEMPTING TO FREE THE BALLOONS A DISSECTION OCCURRED. THE DISSECTION WAS REPAIRED WITH 4 OTHER TAXUS STENTS. IT IS NOTED THAT MULTIPLE VIEWS WERE TAKEN AND THE PHYSICIAN WAS SATISFIED WITH THE RESULTS. TWO DAYS LATER THE PT EXPIRED FROM UNK COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 3.00 X 24 MM 6746333

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death