BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTEASE

    MDR report key: 4724161 · Received April 13, 2015

    Report

    Report Number
    MW5042195
    Event Type
    Death
    Date Received
    April 13, 2015
    Date of Event
    February 23, 2015
    Report Date
    April 13, 2015
    Manufacturer
    CORDIS
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HEMOPERICARDIUM - SMALL PIECE OF METAL FROM CORDIS OPTEASE VENA CAVA FILTER WITHIN THE SUPERIOR VENA CABA ERODING THROUGH BOTH THE SUPERIOR VENA CAVA AND THE ADJACENT ASCENDING AORTA, WITH 520 ML OF BLOOD AND BLOOD CLOT FOUND WITHIN THE PERICARDIAL SAC. DATES OF USE: (B)(6) 2005 - (B)(6) 2015. DIAGNOSIS OR REASON FOR USE: BILATERAL UPPER EXTREMITY DVTS S/P MULTITRAUMA D/T MVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244048 OPTEASE VENA CAVA FILTER DTK CORDIS 466F220A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death