BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 546863 · Received September 30, 2004

    Report

    Report Number
    6000089-2004-00806
    Event Type
    Death
    Date Received
    September 30, 2004
    Date of Event
    May 14, 2004
    Report Date
    June 14, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS MFR # 6000093-2004-00659 AND 6000089-02004-00660. THE PT HAD RECURRENT CHEST PAIN AND WAS ENROLLED IN PROGRAM IN 2004. TARGET LESION 1 WAS IDENTIFIED IN THE MID LAD WITH 80% STENOSIS AND A 3.0 MM REFERENCE VESSEL DIAMETER. TARGET LESION 1 WAS TREATED WITH PREDILATATION AND PLACEMENT OF TWO OVERLAPPING 2.5 X 24 MM TAXUS STENTS. A 2.75 X 32 MM TAXUS STENT WAS THEN ADVANCED IN THE PROXIMAL SEGMENT OF THE MID LAD OVERLAPPING ONE OF THE PREVIOUSLY PLACED TAXUS STENTS. RESIDUAL STENOSIS WAS 0% AFTER POST-DILATATION. NEXT, ANGIOPLASTY WAS PERFORMED TO THE LATERAL SEGMENT OF THE SECOND OBTUSE MARGINAL BRANCH. A 2.25 X 23 MM PIXEL STENT WAS ADVANCED ACROSS THE LESION BUT UPON FURTHER INSPECTION, IT WAS DECIDED NOT TO STENT THE VESSEL DUE TO ITS SMALL CALIBER. THE PIXEL STENT WAS REMOVED AND RESIDUAL STENOSIS WAS 30-40%. THE PT WAS DISHCARGED TO OTHER FACILITY 2 DAYS LATER ON PLAVIX AND ASA. THE PT EXPIRED IN 2004 (23 DAYS POST IMPLANT PROCEDURE) WITH END STAGE RENAL DISEASE AS THE CAUSE OF DEATH. AN AUTOPSY WAS NOT PERFORMED.

    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 CORP. TAXUS EXPRESS2 8.8% 2.50 X 24MM 6176962

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death