BEUDAMED
    FDA Adverse Event Death Summary report: N

    G2 X FILTER SYSTEM - JUGULAR

    MDR report key: 11862046 · Received May 21, 2021

    Report

    Report Number
    2020394-2021-01088
    Event Type
    Death
    Date Received
    May 21, 2021
    Date of Event
    June 6, 2009
    Report Date
    May 6, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K082305
    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 REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE NOT PROVIDED. THERE WERE NO DEVICE DEFICIENCIES IDENTIFIED WITHIN THE MEDICAL RECORDS. THE PATIENT REPORTEDLY EXPIRED. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE 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. LABELING REVIEW: THE REVIEW OF THE INSTRUCTIONS FOR USE, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, AND CONTRAINDICATIONS SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. EXPIRY DATE: 04/2012.

    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/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE PATIENT REPORTEDLY EXPIRED DUE TO ACUTE PULMONARY EMBOLISM POST IMPLANT. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760757 G2 X FILTER SYSTEM - JUGULAR VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFTC2585

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death| L COUMADIN