BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT

    MDR report key: 757787 · Received September 5, 2006

    Report

    Report Number
    6000093-2006-01752
    Event Type
    Death
    Date Received
    September 5, 2006
    Date of Event
    May 16, 2005
    Report Date
    August 10, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PATIENT. THEREFORE, NO ANALYSIS COULD BE PERFORMED. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNKNOWN, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT 7 DAYS AFTER A CORONARY DRUG-ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED 1 DE NOVO TARGET LESION LOCATED IN THE MID RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED WITH AN ANGIOPLASTY BALLOON AT 13 ATMS. THE PHYSICIAN SUCCESSFULLY IMPLANTED A 3.0X20MM TAXUS EXPRESS2 DRUG-ELUTING STENT AT 20 ATMS. THE PATIENT WAS DISCHARGED 5 DAYS POST-INDEX PROCEDURE ON ASPIRIN AND PLAVIX. THE PATIENT EXPIRED 7 DAYS POST-INDEX PROCEDURE. CAUSE OF DEATH ON THE DEATH CERTIFICATE WAS INDICATED AS MYOCARDIAL INFARCTION DUE TO CONSEQUENCES OF CORONARY ARTERY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.0X20MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death