BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 X FILTER SYSTEM - JUGULAR

    MDR report key: 13682220 · Received March 7, 2022

    Report

    Report Number
    2020394-2022-90112
    Event Type
    Injury
    Date Received
    March 7, 2022
    Date of Event
    July 9, 2014
    Report Date
    March 7, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K082305
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. APPROXIMATELY FIVE YEARS AND THREE MONTHS LATER POST FILTER DEPLOYMENT, ABDOMEN 2 VIEW SHOWED THAT AN INFERIOR VENA CAVA FILTER WAS AT THE L3 LEVEL UNCHANGED. SMALL METALLIC WIRE IN THE RIGHT PELVIS MOST LIKELY AN INFERIOR VENA CAVA FILTER LEG WHICH WAS IN A HYPOGASTRIC VEIN. AFTER ONE YEAR AND NINE MONTHS, ABDOMEN SINGLE VIEW WAS PERFORMED DUE TO LEFT UPPER QUADRANT ABDOMINAL PAIN AND RESULT SHOWED THAT THE INFERIOR VENA CAVA FILTER WAS AT THE L3-4 LEVEL. LINEAR METALLIC DENSITY WITHIN THE RIGHT HEMIPELVIS. ON THE NEXT DAY, PORTABLE ABDOMEN 2 VIEW SHOWED THAT INFERIOR VENA CAVA FILTER WAS AT L3-4 WAS UNCHANGED. ONE OF THE LEGS EXTENDED FAR TO THE LEFT LIKELY OUTSIDE OF THE INFERIOR VENA CAVA. THIS WAS UNCHANGED. ADDITIONAL LEG FRACTURED OVERLAY THE FILTER IN THE VENA CAVA. ADDITIONAL LEG WAS PRESENT IN THE RIGHT PELVIS POSSIBLY IN THE ILIAC VEIN AND WAS ALSO UNCHANGED. SOME OF THE INFERIOR VENA CAVA FILTER LEGS WHICH WERE MALPOSITIONED BUT UNCHANGED. AFTER FOUR DAYS, UPPER GASTROINTESTINAL SERIES WITH KIDNEY, URETER AND BLADDER SHOWED THAT AN INFERIOR VENA CAVA FILTER WAS NOTED. IT WAS GROSSLY FRACTURED WITH ONE DETACHED LEG TOWARDS THE RIGHT AND ANGULATED LEG TOWARDS THE LEFT. THE MAJORITY OF THE FILTER WAS APPROPRIATELY POSITIONED AND INTACT. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE ALLEGED FILTER DETACHMENT AND PERFORATION OF THE INFERIOR VENA CAVA. BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE.

    Description of Event or Problem · 0

    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 AND IN CONJUNCTION WITH OR BEFORE BARIATRIC PROCEDURE. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER LIMB DETACHED AND PRESENT IN RIGHT PELVIS AND FILTER LEG PERFORATED LEFT LIKELY OUTSIDE THE INFERIOR VENA CAVA. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2219871 G2 X FILTER SYSTEM - JUGULAR VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other MULTIVITAMIN, AND HYDROCODONE-ACETAMINOPHEN