BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE FILTER SYSTEM

    MDR report key: 2121364 · Received June 6, 2011

    Report

    Report Number
    2020394-2011-00130
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS UNK. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE HAS BEEN RETURNED TO THE MFR FOR EVAL. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX TWO MONTHS POST IVC FILTER IMPLANT, THE PT PRESENTED WITH SEVERE CHEST PAIN. REPORTEDLY, AN ANGIOGRAM WAS PERFORMED AND DEMONSTRATED THAT ONE OF THE FILTER ARMS HAD DETACHED AND MOVED TO THE WALL OF THE RIGHT VENTRICLE, JUST BELOW THE TRICUSPID VALVE. THE FOLLOWING DAY, THE FILTER WAS RETRIEVED WITHOUT INCIDENT. TO DATE, THERE HAVE BEEN NO ATTEMPTS TO RETRIEVE THE DETACHED LIMB FROM THE HEART. CURRENT PT STATUS IS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening