BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENFIELD 12FR SS VENA CAVA FILTER

    MDR report key: 249973 · Received November 17, 1999

    Report

    Report Number
    6000036-1999-00145
    Event Type
    Injury
    Date Received
    November 17, 1999
    Date of Event
    October 16, 1999
    Report Date
    October 18, 1999
    Manufacturer
    MEDI-TECH A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE FILTER DID NOT OPEN IMMEDIATELY FOLLOWING VIA A FEMORAL APPROACH. THE FILTER BEGAN TO MIGRATE TOWARDS THE RIGHT ATRIUM. THE FILTER WAS CAPTURED WITH A SNARE AND PULLED BACK DOWN INTO POSITION IN THE VENA CAVA. ANOTHER SNARE WAS ADVANCED WHICH REMOVED WHAT APPEARED TO BE A PIECE OF PLASTIC ENCAPSULATING THE FILTER; BELIEVED TO BE THE FILTER CARRIER CAPSULE. FOLLOWING REMOVAL OF THE CARRIER CAPSULE, THE FILTER OPENED UP AND WAS APPROPRIATELY PLACED WITH A SNARE. THE PT'S CONDITION IS GOOD. THE DEVICE IS CURRENTLY BEING EVALUATED BY THIS MFR. UPON COMPLETION OF THE ENGINEERING EVAL, A SUPPLEMENT WILL BE FORWARDED UNDER 6000036-1999-00145. WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE CAUSE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENFIELD 12FR SS VENA CAVA FILTER Implant VENA CAVA FILTER DTK MEDI-TECH A DIVISION OF BOSTON SCIENTIFIC CORP. NA 2498775

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention