BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL - ELUTING STENT

    MDR report key: 705336 · Received April 26, 2006

    Report

    Report Number
    6000089-2006-00721
    Event Type
    Death
    Date Received
    April 26, 2006
    Date of Event
    August 14, 2005
    Report Date
    March 27, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINICAL STUDY 037-036 SAME CASE AS MDR 600089-2006-00761. FOUR HUNDRED AN EIGHTY DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, A DEATH EVENT OCCURRED. INDEX GRAFT PROCEDURE PERFORMED ON LESION 1 PROX CX, DESCRIBED AS 3.75 IN DIAMETER, 80% STENOSED AND 20 MM LENGTH TREATED WITH A 3.0 X 24 MM TAXUS EXPRESS 2 ELUTING STENT. LESION 2 WAS LOCATED IN PROX CX, 2.5 MM IN DIAMETER 90% STENOSED. 12MM IN LENGTH MILD CALCIFICATION MODERATE TORTUOSITY AND TREATED WITH A 2.5 X 16MM TAXUS EXPRESS 2 ELUTING STENT. PATIENT WAS HOSPITALIZED FOR 30 DAYS PRESCRIBED ASA MEDICATION UPON DISCHARGED. THIS WAS CONSIDERED AN URGENT OR EMERGENT PROCEDURE. PATIENT WITH NEWLY DIAGNOSED METASTATIC COLON CANCER DURING INDEX HOSPITALIZATION. PATIENT ENROLLED IN THE HOSPICE PROGRAM UNTIL DEATH. DEATH DISCOVERED THROUGH SOCIAL SECURITY DEATH REGISTRY. DEVICE RELATIONSHIP IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL - ELUTING STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 2.50X16MM 6215685

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death