BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS

    MDR report key: 967404 · Received January 11, 2008

    Report

    Report Number
    967404
    Event Type
    Injury
    Date Received
    January 11, 2008
    Date of Event
    November 29, 2007
    Report Date
    January 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TAXUS STENT PLACED TO 1ST IN 2007. RETURNED FIVE MONTHS LATER, WITH IN-STENT RESTENOSIS-SUCCESSFULLY REOPENED WITH PTCA & CUTTING BALLOON. ON 11/29/07, TRANSFERRED TO GSH FOR PCI OF TOTALLY OCCLUDED TAXUS STENT TO OM, FOLLOWING AMI. ASA & PLAVIX HAD BEEN DC'D 7 DAYS BEFORE COLONOSCOPY - AMI WITHIN A DAY AFTER COLONOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC 8914157

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R