BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 2182457 · Received July 6, 2011

    Report

    Report Number
    2182457
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 4, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    CARDIAC TRANSPLANT PATIENT WITH HISTORY OF GI BLEEDING AND RENAL INSUFFICIENCY. HAD BARD ECLIPSE FILTER PLACED FOR BILATERAL LEG DVT. SUBSEQUENT CT APPROXIMATELY 3 MONTHS AFTER FILTER PLACEMENT SHOWED CAUDAL MIGRATION OF FILTER WITH PERFORATION OF MEDIAL VENA CAVA WHICH CLINICALLY THOUGHT TO BE CAUSING ABDOMINAL PAIN. PATIENT ADMITTED THIS YEAR FOR REMOVAL OF THIS FILTER AND EXCHANGE FOR COOK CELECT FILTER. THE BARD FILTER WAS SUCCESSFULLY REMOVED AND RETAINED IN INTERVENTIONAL RADIOLOGY. THE NEW COOK CELECT FILTER WAS SUCCESSFULLY DEPLOYED. NO KNOWN HARM TO PATIENT AFTER FILTER REMOVED.======================MANUFACTURER RESPONSE FOR IVC FILTER, EC500R ECLIPSE FILTER (PER SITE REPORTER)======================WILL ASK MANUFACTURER TO SHARE INFO AFTER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BARD PERIPHERAL VASCULAR, INC. * GFU I 2692

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR