BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE FILTER SYSTEM - FEMORAL

    MDR report key: 1935515 · Received December 16, 2010

    Report

    Report Number
    2020394-2010-00364
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS NOT KNOWN. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE FILTER REMAINS IMPLANTED AND THE DELIVERY SYSTEM WAS DISCARDED BY THE USER FACILITY. THEREFORE, A DEVICE EVAL COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAYS POST FILTER IMPLANT, THE PT EXPERIENCED ABDOMINAL DISTENTION AND IMAGING DEMONSTRATED THAT THE FILTER WAS WITHIN THE RIGHT ILIAC VEIN. THE FILTER WAS INITIALLY IMPLANTED AT THE LEVEL OF L2 AND THERE WERE NO ANOMALIES NOTED DURING DEPLOYMENT OF THE FILTER. REPORTEDLY, THE CAUDAL MOVEMENT OF THE FILTER MAY HAVE OCCURRED DURING WITHDRAWAL OF THE DELIVERY SYSTEM; HOWEVER, THIS COULD NOT BE CONFIRMED. ADDITIONAL IMAGING WAS PERFORMED AND IT WAS OBSERVED THAT ONE OF THE FILTER LIMBS WAS POINTING IN A CEPHALAD DIRECTION. A RETRIEVAL ATTEMPT HAS NOT BEEN PERFORMED. THE PT IS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1