BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 681634 · Received March 1, 2006

    Report

    Report Number
    6000089-2006-00323
    Event Type
    Death
    Date Received
    March 1, 2006
    Date of Event
    November 15, 2005
    Report Date
    February 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINICAL STUDY: SAME CASE AS 6000089-2006-00324. IT WAS REPORTED THAT 21 MONTHS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, THE PATIENT EXPIRED. LESION 1 SAS A 4.0MM, 90% STENOSED PORTION OF THE MID RIGHT CORONARY ARTERY (MID RCA). THE PHYSICIAN TREATED THE LESION WITH PEDILATATION AND SUCCESSFUL PLACEMENT OF A TAXUS EXPRESS2 8.8% 3.50X16MM DRUG ELUTING STENT IN THE TARGET LESION. LESION 2 WAS A 2.5MM BIFURCATED 100% STENOSED PORTION OF THE DISTAL CIRCUMFLEX (DIST CX). THE PHYSICIAN TREATED THE LESION WITH PREDILATATION AND SUCCESSFUL PLACEMENT OF A TAXUS EXPRESS2 8.8% 2.50X16MM DRUG ELUTING STENT. THERE WERE NO REPORTED COMPLICATIONS, THE PATIENT WAS DISCHARGED 14 DAYS LATR ON PLAVIS AND ASPIRIN. 21 MONTHS AFTR THE INITIAL PROCEDURE THE PATIENT EXPIRED. THERE WAS NO AUTOPSY. IN THE OPINION OF THE PHYSICIAN THE CAUSE OF DEATH WAS BRAIN CANCER AND THE TARGET VESSEL WAS NOT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC 3.50X16 6068277

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death