BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECOVERY G2 FILTER SYSTEM - FEMORAL

    MDR report key: 1501514 · Received September 15, 2009

    Report

    Report Number
    2020394-2009-00347
    Event Type
    Malfunction
    Date Received
    September 15, 2009
    Date of Event
    August 10, 2009
    Report Date
    August 20, 2009
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES 510(K) - K062887. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS MFG LOT NUMBER. THE DEVICE REMAINS IMPLANTED; THEREFORE, NOT AVAILABLE FOR EVALUATION. FOUR IMAGES WERE RECEIVED AND EVALUATED. THE IMAGES DO NOT CONTAIN DATES OF WHEN THEY WERE TAKEN. THE FIRST IMAGE IS A VENACAVAGRAM OF THE G2 FILTER DEPLOYMENT THROUGH THE RIGHT FEMORAL. THE FILTER APPEARS TO BE DEPLOYED IN A PROPER CONFIGURATION. THE NEXT 3 IMAGES ARE CTS. THE FIRST IMAGE IS A CT TAKEN IN THE SUPINE DIRECTION. THE IMAGES APPEAR TO SHOW AN ARM AND A LEG PERFORATION. THE LAST 2 IMAGES ARE CROSS SECTIONAL CTS IMAGES. THE IMAGES APPEAR TO SHOW THE FILTER SLIGHTLY TILTED WITH 3 LIMBS POTENTIALLY PERFORATING THE CAVA. BASED ON THE IMAGE REVIEW, THE COMPLAINT IS CONFIRMED FOR PERFORATION. THE ROOT CAUSE IS UNK. THE CURRENT IFU (INSTRUCTIONS FOR USE) FOR THIS DEVICE STATES: COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POTENTIAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAYS POST FILTER PLACEMENT, A CT SCAN IDENTIFIED THAT THE IVC FILTER LEGS HAD PERFORATED THE VENA CAVA AND APPEARED TO HAVE PENETRATED THE AORTA. REPORTEDLY, THE FILTER WAS SUCCESSFULLY IMPLANTED, AND IMAGES SHOWED THAT THE FILTER WAS WELL POSITIONED WITHIN THE CAVA, 1 MM BELOW THE LOWEST RENAL VEIN. TWO DAYS LATER, A CT SCAN SHOWED THE IVC FILTER LEGS HAD PERFORATED THE VENA CAVA WALL AND SEEMED TO BE LODGED IN THE AORTA. THE FILTER REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECOVERY G2 FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFTE2368

    Patients

    Seq Age Sex Outcome Treatment
    1