BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 4102584 · Received September 16, 2014

    Report

    Report Number
    1820334-2014-00493
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    July 3, 2014
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO ARTICLE "INFERIOR VENA CAVA FILTER RETRIEVAL: EFFECTIVENESS AND COMPLICATIONS OF ROUTINE AND ADVANCED TECHNIQUES." THE ONLY COMPLICATION ASSOCIATED WITH ROUTINE TECHNIQUE WAS AN IVC INTUSSUSCEPTION. THE HOOK OF THE FILTER WAS SNARED WITHOUT DIFFICULTY, BUT THE SHEATH COULD NOT BE FULLY ADVANCED OVER THE FILTER DESPITE A LARGE AMOUNT OF TENSION. WHEN TENSION WAS RELEASED, THE FILTER LEGS WERE COAPTED, RESULTING IN SEVERE IVC STENOSIS, WHICH WAS TREATED WITH INTERFILTER ANGIOPLASTY, RESULTING IN MODERATE IVC STENOSIS (SIR MAJOR COMPLICATION, GRADE C).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572064 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R