BEUDAMED
    FDA Adverse Event Death Summary report: N

    GREENFIELD VENA CAVA FILTER

    MDR report key: 1328114 · Received February 26, 2009

    Report

    Report Number
    2134265-2009-00705
    Event Type
    Death
    Date Received
    February 26, 2009
    Report Date
    January 30, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTK
    PMA / PMN Number
    K955396
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE POTENTIAL BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEATH OCCURRED. A GREENFIELD VENA CAVA FILTER WAS IMPLANTED IN A PATIENT'S AORTA. EITHER DURING THE SURGERY TO REMOVE IT OR SHORTLY THEREAFTER THE PATIENT DIED. NO FURTHER INFORMATION REGARDING THIS EVENT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENFIELD VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death