BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE FILTER SYSTEM - FEMORAL

    MDR report key: 3833396 · Received May 19, 2014

    Report

    Report Number
    2020394-2014-00224
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    March 23, 2014
    Report Date
    October 2, 2019
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWO YEARS AFTER IMPLANTATION OF A VENA CAVA FILTER DURING THE SCHEDULED RETRIEVAL, A DETACHED FILTER LIMB WAS DISCOVERED IN THE LEFT VENTRICLE. NO ATTEMPT WAS MADE TO RETRIEVE THE FILTER OR THE DETACHED FILTER LIMB. THE PATIENT IS REPORTED TO BE ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295769 ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFWC1095

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Life Threatening| O ALENDRONATE, EXEMESTANE, IRBESARTAN, OMEPRAZOLE| CARVEDILOL| ONDANSETRON, ACETAMINOPHEN, DOCUSATE SODIUM| SUCRALFATE, FERROUS SULFATE, PANTOPRAZOLE| XAGVIA, FUROSEMIDE, BENZONATATE, LOVENOX