BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 EXPRESS FILTER SYSTEM - FEMORAL

    MDR report key: 13729218 · Received March 11, 2022

    Report

    Report Number
    2020394-2022-90121
    Event Type
    Malfunction
    Date Received
    March 11, 2022
    Report Date
    March 11, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K080668
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: A LOT HISTORY REVIEW WAS PERFORMED. THIS IS THE ONLY COMPLAINT TO DATE FOR THIS LOT NUMBER. THEREFORE, A DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. APPROXIMATELY, TWO YEARS AND ONE MONTH POST DEPLOYMENT, FILTER REMOVAL PROCEDURE WAS ATTEMPTED. FILTER DEMONSTRATED TINE PERFORATION. THE RIGHT INTERNAL JUGULAR VEIN WAS ACCESSED USING A 5 FRENCH MICROPUNCTURE KIT. A 0.035-INCH BENSON WIRE WAS THEN THREADED INTO THE INFERIOR VENA CAVA. A 10 FRENCH SHEATH WAS PLACED. THROUGH THIS, A 5 FRENCH OMNI FLUSH CATHETER AND BENSON WIRE WERE USED TO ACCESS THE INFERIOR VENA CAVA. DIGITAL SUBTRACTION VENOGRAPHY DID NOT DEMONSTRATE ANY CLOT BURDEN WITHIN THE FILTER. AS NOTED ON THE PRIOR COMPUTED TOMOGRAPHY SCAN, THE FILTER DEMONSTRATED PROMINENT RIGHTWARD TILT. MULTIPLE ATTEMPTS WITH A BARD FILTER RECOVERY, 25 MM GOOSENECK SNARE, AND A GLIDE WIRE PROVED UNSUCCESSFUL IN RETRIEVING THE G2 FILTER. THE HOOK COULD NOT BE SNARED, COMPATIBLE WITH CLOT BURDEN VERSUS ENDOTHELIALIZATION. ULTIMATELY, FILTER RETRIEVAL SUCCESS WAS MADE BY PLACING A GLIDE WIRE THROUGH THE FILTER STRUTS AND SNARING THE WIRE. THE 10 FRENCH SHEATH WAS UPSIZED TO A 14 FRENCH SHEATH. THE GLIDE WIRE THROUGH AND THROUGH SNARE WAS THEN RETRACTED AND THE FILTER PULLED INTO THE 14 FRENCH SHEATH. THE FILTER WAS REMOVED INTACT AND COMPLETE. THE 14 FRENCH SHEATH WAS REMOVED, AND HEMOSTASIS OBTAINED VIA MANUAL COMPRESSION. THE FILTER WAS REMOVED SUCCESSFULLY AND NO EXTRAVASATION POST RETRIEVAL. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR FILTER TILT, PERFORATION OF THE INFERIOR VENA CAVA (IVC) AND RETRIEVAL DIFFICULTIES. PER MEDICAL RECORDS, MULTIPLE ATTEMPTS WERE MADE TO ENGAGE THE APEX OF THE FILTER USING BARD FILTER RECOVERY, 25 MM GOOSENECK SNARE, AND A GLIDE WIRE BUT WERE UNSUCCESSFUL DUE TO FILTER TILT, AND EMBEDMENT. THIS COULD HAVE CONTRIBUTED TO THE RETRIEVAL DIFFICULTIES. HOWEVER, 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 AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT FILTER TILTED AND TINES PERFORATED INTO THE INFERIOR VENA CAVA. APPROXIMATELY AFTER TWO YEARS FROM POST FILTER DEPLOYMENT, DEVICE WAS REMOVED PERCUTANEOUSLY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1784258 G2 EXPRESS FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFSH2155

    Patients

    Seq Age Sex Outcome Treatment
    1 Male CEFAZOLIN 2 GRAMS IV| COUMADIN, OXYCONTIN| OXYCODONE, AND SENNA PLUS| ROCEPHIN 2 GRAMS IV| VANCOMYCIN 1 GRAM IV & CEFEPIME 1 GRAM IV