BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECLIPSE FILTER SYSTEM - JUGULAR

    MDR report key: 11901086 · Received May 28, 2021

    Report

    Report Number
    2020394-2021-01129
    Event Type
    Death
    Date Received
    May 28, 2021
    Date of Event
    August 17, 2018
    Report Date
    May 19, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED AS UNKNOWN. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. APPROXIMATELY SIX YEARS AND FOUR MONTHS LATER, THE PATIENT REPORTEDLY EXPIRED BECAUSE OF CARDIAC ARREST, PULMONARY EMBOLISM, AND DEEP VEIN THROMBOSIS. THEREFORE THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED FAILURE AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE FILTER. ADDITIONALLY, IT CAN BE CONFIRMED THAT THE PATIENT EXPERIENCED PULMONARY EMBOLISM POST DEPLOYMENT. HOWEVER, THE RELATIONSHIP TO THE FILTER IS UNKNOWN. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: THE REVIEW OF THE INSTRUCTIONS FOR USE, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, AND CONTRAINDICATIONS SHOWED THAT THE PRODUCT LABELING IS ADEQUATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM. AT SOME TIME, POST FILTER DEPLOYMENT, THE PATIENT EXPIRED DUE TO PULMONARY EMBOLISM. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE PATIENT REPORTEDLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797077 ECLIPSE FILTER SYSTEM - JUGULAR VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death| L