BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 X FILTER SYSTEM - FEMORAL

    MDR report key: 12258432 · Received August 2, 2021

    Report

    Report Number
    2020394-2021-01414
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    October 25, 2011
    Report Date
    July 20, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K082305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. APPROXIMATELY, ONE YEAR TEN MONTHS OF POST DEPLOYMENT, EVALUATION WAS REQUESTED FOR POSSIBLE FILTER REMOVAL. USING ULTRASOUND GUIDANCE, A 21-GAUGE NEEDLE WAS INTRODUCED INTO THE RIGHT INTERNAL JUGULAR VEIN. A 0.018 WIRE WAS INTRODUCED INTO THE RIGHT ATRIUM. A 5 FRENCH CO-AXIAL DILATOR WAS PLACED. A BENSON WIRE WAS INTRODUCED INTO THE INFERIOR VENA CAVA BELOW THE LEVEL OF THE FILTER. AN OMNI FLUSH CATHETER WAS INTRODUCED OVER THE BENSON WIRE INTO THE RIGHT COMMON ILIAC VEIN. THE WIRE WAS REMOVED AND A CAVAGRAM WAS PERFORMED IN MULTIPLE PROJECTIONS. VENOGRAM WHICH SHOWED NO COMMON ILIAC VEIN OR INFERIOR VENA CAVA THROMBUS. THE FILTER WAS IN GOOD POSITION. THE WIRES AND CATHETER WERE REMOVED, AND HEMOSTASIS ACHIEVED AT THE RIGHT NECK USING MANUAL COMPRESSION. THE PATIENT HAS HAD THE FILTER FOR TWO AND A HALF YEARS WHICH EXCEEDS THE ALLOWABLE WINDOW FOR FILTER RETRIEVAL. ALSO, RECENT COMPUTERIZED TOMOGRAPHY SCAN SHOWED THAT THE STRUTS OF THE FILTER WERE PROTRUDING A FEW MILLIMETERS OUTSIDE THE INFERIOR VENA CAVA WHICH WOULD MAKE REMOVAL RISKIER UNLESS THERE WAS A STRONG INDICATION TO DO IT. THEN HAD A DISCUSSION WITH THE PATIENT AND DECIDED TO LEAVE THE FILTER IN. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE PERFORATION OF THE INFERIOR VENA CAVA. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED PERFORATION COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT IN CONJUNCTION WITH OR BEFORE BARIATRIC PROCEDURE. APPROXIMATELY ONE YEARS AND TEN MONTHS POST FILTER DEPLOYMENT, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE FILTER STRUTS PERFORATED. 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
    1156291 G2 X FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other BUDESONIDE, ALBUTEROL, TIOTROPIUM BROMIDE| ENOXAPARIN, ONDANSETRON, METHADONE| KETOROLAC, TORADOL, ATIVAN| LASIX, PHENAZOPYRIDINE, SIMETHICONE| LORAZEPAM, LISINOPRIL, DILAUDID| METHADONE, NEXIUM, PHENERGAN| METOCLOPERAMIDE, PANTOPRAZOLE, DIPHENHYDRAMINE| MORPHINE, LORAZEPAM, PREGABALIN| PROAIR, SPIRIVA, CELEXA| TESSALON AND VITAMIN D2| THEOPHYLLINE ER, HYDROCORTISONE, PROTINEX