BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE FILTER SYSTEM -JUGULAR

    MDR report key: 1791764 · Received August 4, 2010

    Report

    Report Number
    2020394-2010-00241
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 9, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER WAS UNKNOWN. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENA CAVA FILTER MIGRATED CAUDALLY. REPORTEDLY, THE FILTER WAS INITIALLY IMPLANTED APPROXIMATELY 1CM BELOW THE RENAL VEIN. APPROXIMATELY TWO WEEKS AFTER IMPLANT, IT WAS IDENTIFIED INCIDENTALLY ON AN IMAGE THAT THE FILTER HAD MIGRATED 4CM CAUDALLY TO THE CONFLUENCE OF THE ILIAC VEINS. THE FILTER WAS RETRIEVED THE FOLLOWING DAY AND ANOTHER FILTER WAS SUCCESSFULLY IMPLANTED. THERE WAS NO REPORT OF INJURY TO THE ASYMPTOMATIC PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE FILTER SYSTEM -JUGULAR DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention