BEUDAMED
    FDA Adverse Event Other Summary report: N

    GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER

    MDR report key: 158463 · Received March 23, 1998

    Report

    Report Number
    1820334-1998-00028
    Event Type
    Other
    Date Received
    March 23, 1998
    Date of Event
    February 26, 1998
    Report Date
    February 26, 1998
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WAS RECEIVED FROM THE REPORTING PHYSICIAN. HE INDICATED THE PT HAD BEEN IN A MOTOR VEHICLE ACCIDENT SOME TIME AFTER PLACEMENT OF THE BIRD'S NEST FILTER. AS A RESULT OF THE ACCIDENT, THE PT HAD SUSTAINED TRAUMA TO THE CHEST, I.E. BROKEN RIBS. THIS TRAUMA MAY HAVE CONTRIBUTED TO THE DAMAGE SEEN WITH THE FILTER.

    Description of Event or Problem · 1

    THE FILTER WAS PLACED ON AUGUST 14, 1991. AN X-RAY NOTED BOTH THE RIGHT INFERIOR AND SUPERIOR STRUTS HAVE FRACTURED. THE FILTER WAS ALSO NOTED TO HAVE MIGRATED 5CM. NO INTERVENTION HAS BEEN ATTEMPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER Implant VENA CAVA FILTER DTK COOK, INC. NA 301949

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other