BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 721173 · Received May 30, 2006

    Report

    Report Number
    6000089-2006-01034
    Event Type
    Death
    Date Received
    May 30, 2006
    Date of Event
    November 9, 2005
    Report Date
    May 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CLINICAL TRIAL: IT WAS REPORTED THAT 562 DAYS POST INDEX PROCEDURE, THE PT EXPIRED. THE INDEX PROCEDURE TREATED THE MID RCA. THIS WAS A DE NOVO LESION WITH 90% STENOSIS. THE LESION WAS 2.6 MM WIDE, AND 12 MM LONG. THE PHYSICIAN PRE-DILATED THE LESION PRIOR TO PLACING A 2.5 X 16MM TAXUS EXPRESS2 STENT. REO-PRO AND CLOPIDOGREL WERE ALSO ADMINISTERED INTRAVENOUSLY DURING THE PROCEDURE. RESIDUAL STENOSIS WAS 0% POST DEPLOYMENT. THE PT WAS DISCHARGED ON PLAVIX AND LIPITOR ONE DAY LATER. ON DAY 562, THE SITE REPORTED THAT THE PT EXPIRED DUE TO CANCER. THE PT HAD PRIMARY BREAST CANCER THAT STARTED IN AUGUST OF 2005. THE CANCER METASTISIZED TO THE LIVER, CAUSING THE PT'S DEATH. IN THE OPINION OF THE PHYSICIAN, THERE IS AN UNK RELATIONSHIP BETWEEN THE TAXUS STENT AND THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 2.5 X 16MM 6215685

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death