BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDIS MEDICATED STENT

    MDR report key: 1193646 · Received October 8, 2008

    Report

    Report Number
    MW5008591
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    July 23, 2008
    Report Date
    October 8, 2008
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A CORDIS MEDICATED STENT IN 2005... DURING A SCHEDULED CATHETERIZATION. I HAVE HAD A MILD HEART ATTACK WHERE THE STENT WAS BLOCKED IN 2008 AND ANOTHER ONE TWO MONTHS LATER. THE ATTENDING CARDIOLOGIST STATED THAT THE MEDICATED STENT WAS BLOCKED AND THE SURROUNDING ARTERY WALLS HAS EXPANDED AWAY FROM THE STENT. DATES OF USE: 2005 - 2008. DIAGNOSIS OR REASON OF USE: LAD 70% BLOCKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS MEDICATED STENT NONE NIQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L