BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 FILTER SYSTEM - JUGULAR

    MDR report key: 6032198 · Received October 15, 2016

    Report

    Report Number
    2020394-2016-00970
    Event Type
    Injury
    Date Received
    October 15, 2016
    Date of Event
    January 16, 2014
    Report Date
    September 3, 2020
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K052578
    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 THREE YEARS AND TEN MONTHS POST FILTER DEPLOYMENT, COMPUTED TOMOGRAPHY (CT) REVEALED A TILTED INFERIOR VENA CAVA FILTER WAS NOTED WITH DISTAL MEDIAL LEGS EXTEND INTO SMALL VENOUS PARASPINAL BRANCHES OR JUST OUTSIDE THE INFERIOR VENA CAVA. EVENTUALLY ONE YEAR LATER, COMPUTED TOMOGRAPHY (CT) REVEALED AN INFERIOR VENA CAVA FILTER STRUTS HAVE PENETRATED THE MEDIAL WALL OF THE INFERIOR VENA CAVA AND ONE FILTER STRUT APPEARS TO BE EMBEDDED IN THE WALL OF THE AORTA AND AN ADDITIONAL STRUT APPEARS TO BE EMBEDDED INTO THE ACCESSORY RIGHT AORTIC RENAL VEIN. SUBSEQUENTLY THE PATIENT PRESENTED WITH ABDOMINAL PAIN. SEVEN DAYS LATER, PATIENT SCHEDULED FOR THE FILTER RETRIEVAL. THE FILTER WAS SUCCESSFULLY RETRIEVED WITHOUT DIFFICULTY. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR PERFORATION OF THE INFERIOR VENA CAVA (IVC) AND FILTER TILT. 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 AND GASTRO INTESTINAL BLEED. APPROXIMATELY FOUR YEARS POST PROPHYLACTIC VENA CAVA FILTER DEPLOYMENT, A COMPUTED TOMOGRAPHY (CT) SCAN DEMONSTRATED A TILTED FILTER WITH LIMBS EXTENDING OUTSIDE THE CONFINES OF THE IVC WALL. APPROXIMATELY FIVE YEARS POST FILTER DEPLOYMENT, THE FILTER WAS SUCCESSFULLY RETRIEVED WITHOUT DIFFICULTY WITH A CONED RETRIEVAL SYSTEM.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 VENA CAVA FILTER WAS INDICATED FOR PATIENT WITH DVT AND GASTROINTESTINAL HEMORRHAGE ON ORAL ANTICOAGULATION. THE FILTER WAS DEPLOYED IN A GOOD POSITION WITHOUT INCIDENT. APPROXIMATELY FOUR YEARS POST FILTER DEPLOYMENT, A CT SCAN DEMONSTRATED A TILTED FILTER WITH LIMBS EXTENDING OUTSIDE THE CONFINES OF THE IVC WALL. THERE WAS NO EVIDENCE OF FREE FLUID OR FREE AIR. APPROXIMATELY FIVE YEARS POST FILTER DEPLOYMENT, A CT SCAN DEMONSTRATED AGAIN MULTIPLE FILTER LIMBS EXTENDING OUTSIDE THE CONFINE OF THE IVC WALL WITH ONE LIMB APPEARING TO BE EMBEDDED IN THE WALL OF THE AORTA AND ANOTHER LIMB APPEARING TO BE EMBEDDED INTO THE ACCESSORY RIGHT AORTIC RENAL VEIN. THE PHYSICIAN FELT THAT DUE TO THE CLOSE PROXIMITY OF THE FILTER LIMBS TO THE AORTA, FILTER REMOVAL SHOULD BE CONSIDERED. SEVEN DAYS LATER, THE PATIENT WAS SCHEDULED FOR A FILTER RETRIEVAL PROCEDURE. ACCESS WAS GAINED TO THE RIGHT INTERNAL JUGULAR VEIN AND A VENACAVAGRAM WAS PERFORMED DEMONSTRATING NO THROMBUS WITHIN THE FILTER. THE FILTER WAS SUCCESSFULLY RETRIEVED WITHOUT DIFFICULTY WITH A CONED RETRIEVAL SYSTEM. A POST FILTER RETRIEVAL VENACAVAGRAM DEMONSTRATED NO EXTRAVASATION AND NO SIGNIFICANT SCARRING OR CLOT FORMATION. THERE WERE NO IMMEDIATE COMPLICATIONS. IMAGE/PHOTO REVIEW: AS MEDICAL IMAGES AND PHOTOS 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 PLACED. APPROXIMATELY FOUR YEARS POST FILTER DEPLOYMENT, A CT SCAN DEMONSTRATED A TITLED FILTER WITH LIMBS EXTENDING OUTSIDE THE IVC WALL. FIVE YEARS POST FILTER DEPLOYMENT, A CT SCAN IDENTIFIED ONCE AGAIN MULTIPLE FILTER LIMBS EXTENDING OUTSIDE THE CONFINES OF THE IVC WALL WITH ONE LIMB APPEARING TO BE EMBEDDED IN THE WALL OF THE AORTA AND ANOTHER APPEARED TO BE EMBEDDED IN THE ACCESSORY RIGHT AORTIC RENAL VEIN. BASED ON THE MEDICAL RECORDS, THE INVESTIGATION CAN BE CONFIRMED FOR FILTER TILT AND PERFORATION OF FILTER LIMBS, AS BOTH WERE IDENTIFIED THROUGH CT SCANS. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS/POTENTIAL COMPLICATIONS: MOVEMENT, MIGRATION OR TILT OF THE FILTER ARE KNOWN COMPLICATIONS OF VENA CAVA FILTERS. PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL. FILTER TILT. FILTER MALPOSITION. NOTE: IT IS POSSIBLE THAT COMPLICATIONS SUCH AS THOSE DESCRIBED IN THE "WARNINGS", "PRECAUTIONS", OR "POTENTIAL COMPLICATIONS" SECTIONS OF THIS INSTRUCTIONS FOR USE MAY AFFECT THE RECOVERABILITY OF THE DEVICE AND RESULT IN THE CLINICIAN'S DECISION TO HAVE THE DEVICE REMAIN PERMANENTLY IMPLANTED. 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 FOUR YEARS POST PROPHYLACTIC VENA CAVA FILTER DEPLOYMENT, A CT SCAN DEMONSTRATED A TILTED FILTER WITH LIMBS EXTENDING OUTSIDE THE CONFINES OF THE IVC WALL. THERE WAS NO EVIDENCE OF FREE FLUID OR FREE AIR. APPROXIMATELY FIVE YEARS POST FILTER DEPLOYMENT, THE FILTER WAS SUCCESSFULLY RETRIEVED WITHOUT DIFFICULTY WITH A CONED RETRIEVAL SYSTEM. THERE WAS NO EXTRAVASATION AND NO SIGNIFICANT SCARRING OR CLOT FORMATION IDENTIFIED. THERE WERE NO IMMEDIATE COMPLICATIONS. NO ADDITIONAL INFORMATION SURROUNDING THIS EVENT WAS PROVIDED IN THE MEDICAL RECORDS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683485 G2 FILTER SYSTEM - JUGULAR VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other