BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 709153 · Received May 3, 2006

    Report

    Report Number
    6000089-2006-00855
    Event Type
    Death
    Date Received
    May 3, 2006
    Date of Event
    September 1, 2005
    Report Date
    April 10, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ARRIVE CLINICAL STUDY; 538 DAYS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED ONE TARGET LESION. TARGET LESION #1 WAS S DE NOVO, MILDLY STENOSED, MILDLY CALCIFIED, 99% STENOSED REGION OF THE DISTAL CIRCUMFLEX. THE LESION WAS 2.75 MM IN WIDTH, AND 40 MM IN LENGTH. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING ONE TAXUS EXPRESS2 2.5 X 16MM STENT AND ONE TAXUS EXPRESS2 2.75 X 28 MM STENT. RESIDUAL STENOSIS WAS 2% POST PROCEDURE. THE PATIENT WAS DISCHARGED 5 DAYS POST PROCEURE RECEIVING ASPIRIN AND PLAVIX. THE SITE REPORTED THAT THE PATIENT DIED ON DAY 538 FROM METASTATIC BRAIN CANCER. IN THE OPINION OF THE PHYSICIAN, THERE WAS NO RELATIONSHIP BETWEEN THE TAXUS STENT AND THE DEATH. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORPORATION 2.75 X 28 MM 6127100

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR