BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 EXPRESS FILTER SYSTEM - FEMORAL

    MDR report key: 11162845 · Received January 13, 2021

    Report

    Report Number
    2020394-2020-06545
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    October 9, 2009
    Report Date
    January 13, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K080668
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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, SIX MONTHS OF POST-DEPLOYMENT, RETRIEVAL OF THE G2 EXPRESS FILTER WAS PERFORMED. ACCESS WAS GAINED VIA THE RIGHT INTERNAL JUGULAR VEIN. AN 18-GAUGE TROCAR NEEDLE INTO THE INTERNAL JUGULAR VEIN, UNDER DIRECT ULTRASOUND GUIDANCE ONCE IN, AN 035 BENSON WIRE INTO THE INFERIOR VENA CAVA, JUST BELOW THE FILTER, UNDER FLUOROSCOPIC GUIDANCE. A 9-FRENCH DILATOR AND THEN PLACED AN 8-FRENCH 55 CM RAABE SHEATH JUST BELOW THE FILTER, CAREFULLY NOT TO DISLODGE THE FILTER OR ANY POTENTIAL THROMBUS IN IT. INFERIOR VENA CAVOGRAM SHOWED FILTER WAS THERE IN THE PROPER POSITION, BELOW THE RENAL VEINS, AND THERE WAS NO THROMBUS. THEN USED THE LARGE ENSNARE AND HOOKED THE HOOK OF THE G2 EXPRESS FILTER. THEN CINCHED UP THE 5-FRENCH SHEATH WITH THE ENSNARE AND THEN ADVANCED THE B-FRENCH SHEATH TO COLLAPSE THE FILTER. ONCE IT GOT CLOSE TO THE PRONGS OF THE FILTER IT WAS PULLED THE FILTER INTO THE SHEATH. THEN REMOVED THE ENTIRE APPARATUS AND PUT PRESSURE ON THE NECK. A SPOT FILM WAS DONE TO PROVE THE FILTER WAS OUT. THE FILTER CAME OUT EASILY. IT WAS TILTED SLIGHTLY, BUT THE CAVA WAS SOMEWHAT CATAWAMPUS ITSELF. THERE WERE NO DEVICE DEFICIENCIES IDENTIFIED WITHIN THE MEDICAL RECORDS. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE FILTER. 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 · 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 AND PREVENTIVE MEASURES DUE TO COLON CANCER. THE DEVICE WAS REMOVED PERCUTANEOUSLY. THE PATIENT EXPERIENCED OCCASIONAL ABDOMINAL PAIN LOCATED AROUND WHERE FILTER WAS IMPLANTED/REMOVED; HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55670 G2 EXPRESS FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other ARIXTRA| ASPIRIN, TYLENOL, COMBIVENT,| FOLIC ACID, METOPROLOL, FLOMAX, COUMADIN| VASOTEC, FLOVENT INHALER