BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS 2 MONORAIL 2.5 X 16 MM

    MDR report key: 539380 · Received August 4, 2004

    Report

    Report Number
    539380
    Event Type
    Injury
    Date Received
    August 4, 2004
    Date of Event
    July 4, 2004
    Report Date
    August 4, 2004
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GRO
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT HAD A TAXUS 2.5 X 16 MM DRUG-ELUTING STENT PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY WHICH HAD BEEN FOUND TO BE 100% OCCLUDED AT ITS ORIGIN. A FEW MONTHS LATER THE PATIENT EXPERIENCED RECURRENT LEFT CHEST AND ARM DISCOMFORT AND CAME BACK TO THE EMERGENCY DEPARTMENT. RELIEF WAS OBTAINED BY MEDICATION BUT PAIN RETURNED WITH IN A FEW HOURS. PATIENT WAS TAKEN FOR AN EMERGENCY CARDIAC CATH. THE PATIENT WAS FOUND TO HAVE A COMPLETELY OCCLUDED LAD, LEFT ANTERIOR DESCENDING, THROUGH THE BYPASS GRAFT. INTRACORONARY ULTRASOUND REVEALED SIGNIFICANT OBSTRUCTION PROXIMAL TO THE STENTED REGION WITH SIGNIFICANT SOFT PLAQUE THROUGHOUT THE STENTED REGION THAT WAS EXTENSIVE. DISTAL TO THE STENTED REGION THERE WAS DIFFUSE, SIGNIFICANT DISEASE THROUGHOUT THE DURATION TO THE APICAL REGION OF THE LEFT ANTERIOR DESCENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS 2 MONORAIL 2.5 X 16 MM DRUG-ELUTING CORONARY ARTERY STENT NIQ BOSTON SCIENTIFIC - MAPLE GRO * 6301100

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R CARDIAC DRUGS