BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENA TECH - LGM

    MDR report key: 690723 · Received March 2, 2006

    Report

    Report Number
    MW1038182
    Event Type
    Death
    Date Received
    March 2, 2006
    Date of Event
    May 28, 2005
    Report Date
    March 2, 2006
    Manufacturer
    *
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT DEFECT DESCRIBED RELATED TO THE PT'S DEATH, BUT WAS NOT A CAUSE OF DEATH. THE PT WAS A PEDESTRIAN STRUCK BY AN AUTOMOBILE. TWO WEEKS LATER, DEVELOPED BILATERAL PULMONARY EMBOLI, WAS ANTICOAGULATED, AND A VENA TECH CAVAL FILTER WAS PLACED. THE PT DEVELOPED SHORTNESS OF BREATH, COLLAPSED AND DIED. AT AUTOPSY, A LARGE SADDLE THROMBOEMBOLUS WAS PRESENT, OCCLUDING THE PULMONARY TRUNK AND MAIN PULMONARY ARTERIES. THE VENA CAVAL FILTER WAS FOUND TO BE DISLODGED, AND LOCATED IN THE RIGHT VENTRICLE OF THE HEART. SOME OF THE THROMBOEMBOLUS WAS STILL ATTACHED TO IT. BILATERAL LOWER EXTREMITY DEEP VEIN THROMBOSES WERE PRESENT. IT APPEARED THAT THE LARGE THROMBOEMBOLUS DISLODGED THE FILTER, WHICH THEN CAME TO REST IN THE RIGHT VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENA TECH - LGM VENA CAVAL FILTER DTK * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death