BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 EXPRESS FILTER SYSTEM - FEMORAL

    MDR report key: 6032004 · Received October 15, 2016

    Report

    Report Number
    2020394-2016-00968
    Event Type
    Injury
    Date Received
    October 15, 2016
    Date of Event
    August 15, 2014
    Report Date
    September 10, 2020
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K080668
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: 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 FOUR MONTHS POST FILTER DEPLOYMENT, PATIENT PRESENTED WITH VENTRAL HERNIA REPAIR AND RIGHT LOWER QUADRANT ABDOMINAL PAIN. SUBSEQUENT COMPUTED TOMOGRAPHY (CT) REVEALED THAT THE FILTER WAS VISUALIZED WITHIN THE INFRARENAL INFERIOR VENA CAVA. STRUTS WERE VISUALIZED EXTRALUMINALLY, WITH APPEARANCE UNCHANGED FROM PRIOR COMPUTED TOMOGRAPHY (CT) SCAN. AROUND ONE YEAR AND FOUR MONTHS LATER, ANOTHER COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) CHEST REVEALED THAT THERE WAS STABLE FINDINGS OF CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION AS EVIDENCED BY ENLARGEMENT OF THE MAIN AND CENTRAL PULMONARY ARTERIES WITH PERIPHERAL VESSEL PRUNING, ABRUPT CUT OFF OF THE RIGHT DESCENDING INTERLOBAR PULMONARY ARTERY LIKELY RELATED TO CHRONIC THROMBUS AND MOSAIC LUNG ATTENUATION. INFRARENAL INFERIOR VENA CAVA FILTER PARTIALLY VISUALIZED WITH SPOKES APPEARED TO EXTEND BEYOND THE VENOUS LUMEN. EVENTUALLY TWO MONTHS LATER, THE PATIENT PRESENTED WITH LOWER ABDOMINAL PAIN. SUBSEQUENT COMPUTED TOMOGRAPHY (CT) REVEALED THAT THE INFERIOR VENA CAVA FILTER STRUTS EXTENDED OUT OF THE INFERIOR VENA CAVA AND INTO THE PANCREAS, UNCHANGED IN APPEARANCE. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR PERFORATION OF THE INFERIOR VENA CAVA (IVC). ADDITIONALLY, IT CAN BE CONFIRMED THAT THE PATIENT EXPERIENCED PE POST DEPLOYMENT. BASED UPON 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. APPROXIMATELY FIVE YEARS FOUR MONTHS POST FILTER DEPLOYMENT, COMPUTED TOMOGRAPHY SCAN DEMONSTRATED FILTER LIMBS EXTENDING BEYOND THE CAVAL WALL INTO THE PANCREAS. COMPUTED TOMOGRAPHY SCAN PERFORMED FOR COMPLAINT OF LOWER ABDOMINAL PAIN APPROXIMATELY SEVEN YEARS POST FILTER DEPLOYMENT DEMONSTRATED THE FILTER IN AN UNCHANGED APPEARANCE FROM THE PREVIOUS COMPUTED TOMOGRAPHY SCAN. 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.

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. VISUAL/MICROSCOPIC INSPECTION: AS THE DEVICE WAS NOT RETURNED, AN INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: AS THE DEVICE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: THE PATIENT WITH HISTORY OF BILATERAL PULMONARY EMBOLI AND TRICUSPID VEGETATION WAS SCHEDULED FOR FILTER PLACEMENT. THE LEFT COMMON FEMORAL VEIN WAS ACCESSED AND AN INFERIOR CAVAGRAM DEMONSTRATED THE LEVEL OF THE RENAL VEINS AND IVC SIZE. THE FILTER WAS SUCCESSFULLY DEPLOYED BELOW THE LOWEST RENAL VEIN. THE PATIENT TOLERATED THE PROCEDURE WELL AND HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. THE PATIENT WAS TO REMAIN INPATIENT FOR ONE MONTH OF ANTIFUNGAL MEDICATION ADMINISTRATION PRIOR TO VALVE SURGERY FOLLOWING THE RECOMMENDATION OF INFECTIOUS DISEASE. APPROXIMATELY SEVEN YEARS POST FILTER DEPLOYMENT, CT SCAN PERFORMED FOR COMPLAINT OF LOWER ABDOMINAL PAIN DEMONSTRATED IVC FILTER LIMBS EXTENDING BEYOND THE CAVAL WALL INTO THE PANCREAS WHICH WAS UNCHANGED IN APPEARANCE FROM CT SCAN PERFORMED APPROXIMATELY FIVE YEARS FOUR MONTHS POST FILTER DEPLOYMENT. IMAGE/PHOTO REVIEW: AS MEDICAL IMAGES WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE DEVICE WAS NOT RETURNED. IMAGES WERE NOT PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. A VENA CAVA FILTER WAS SUCCESSFULLY DEPLOYED BELOW THE LOWEST RENAL VEIN. SEVEN YEARS POST FILTER DEPLOYMENT, A CT SCAN DEMONSTRATED THE FILTER LIMBS TO BE EXTENDING BEYOND THE CAVAL WALL INTO THE PANCREAS. BASED ON THE MEDICAL RECORDS, THE INVESTIGATION CAN BE CONFIRMED FOR FILTER LIMB PERFORATION OF THE IVC WALL. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: POTENTIAL COMPLICATIONS: PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENA CAVA FILTER WAS DEPLOYED SUCCESSFULLY, THE REASON FOR THE FILTER DEPLOYMENT WAS NOT PROVIDED. NO ALLEGED DEFICIENCY WITH THE DEVICE WAS REPORTED. NO OTHER INFORMATION REGARDING THIS EVENT WAS RECEIVED. PATIENT STATUS WAS NOT PROVIDED. NEW INFORMATION RECEIVED: MEDICAL RECORDS WERE RECEIVED AND REVIEWED. APPROXIMATELY FIVE YEARS FOUR MONTHS POST FILTER DEPLOYMENT, CT SCAN DEMONSTRATED FILTER LIMBS EXTENDING BEYOND THE CAVAL WALL INTO THE PANCREAS. CT SCAN PERFORMED FOR COMPLAINT OF LOWER ABDOMINAL PAIN APPROXIMATELY SEVEN YEARS POST FILTER DEPLOYMENT DEMONSTRATED THE FILTER IN AN UNCHANGED APPEARANCE FROM THE PREVIOUS CT SCAN. NO ADDITIONAL INFORMATION WAS PROVIDED IN THE MEDICAL RECORDS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683788 G2 EXPRESS FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| O GUAIFENESIN, AMBIEN, AMPHOTERICIN AND COUMADIN.| GUAIFENESIN, AMBIEN.| LINEZOLID, REGULAR INSULIN, AMILORIDE.| LINEZOLID, REGULAR INSULIN, AMILORIDE.| MAGNESIUM OXIDE, ALBUTEROL, ATROVENT.| MAGNESIUM OXIDE, ALBUTEROL, ATROVENT.| PROTONIX, SILDENAFIL, ZOFRAN, VICODIN.| PROTONIX, SILDENAFIL, ZOFRAN, VICODIN.| TRIPICAMIDE, LANTUS, BENADRYL, TYLENOL.| TRIPICAMIDE, LANTUS, BENADRYL, TYLENOL.| GUAIFENESIN, AMBIEN| LINEZOLID, REGULAR INSULIN, AMILORIDE| MAGNESIUM OXIDE, ALBUTEROL, ATROVENT| PROTONIX, SILDENAFIL, ZOFRAN, VICODIN| TRIPICAMIDE, LANTUS, BENADRYL, TYLENOL