BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD 'RECOVERY' FILTER

    MDR report key: 620484 · Received July 8, 2005

    Report

    Report Number
    620484
    Event Type
    Other
    Date Received
    July 8, 2005
    Date of Event
    June 3, 2005
    Report Date
    July 8, 2005
    Manufacturer
    BARD PERIPHERAL VASCULAR INC.
    Product Code
    DTK
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH A HISTORY GLIOBLASTOMA MULTIFORME, DEEP VEIN THROMBOSIS AND MULTIPLE PULMONARY EMBOLI WHO IS STATUS POST IVC FILTER PLACEMENT AND STATUS POST CRANIOTOMY IN 2005. THE PATIENT WAS ADMITTED IN 2005 WITH TWO SYNCOPAL EPISODES, AND THE WORKUP WAS NEGATIVE FOR ANY OTHER CAUSE THAN THE RIGHT ATRIAL MASS AND FOREIGN BODY. AN ECHOCARDIOGRAM AND CHEST CT CONFIRMED THE MIGRATION OF THE IVC FILTER INTO THE RIGHT ATRIUM AND RIGHT ATRIAL-INTERNAL VENA CAVA JUNCTION. OPEN HEART SURGERY REQUIRED TO REMOVE THE FILTER AND THE MULTIPLE CLOTS LODGED WITHIN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD 'RECOVERY' FILTER IVC FILTER DTK BARD PERIPHERAL VASCULAR INC. * GFPD0617

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR