BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET

    MDR report key: 2483592 · Received February 22, 2012

    Report

    Report Number
    3002808486-2012-00006
    Event Type
    Injury
    Date Received
    February 22, 2012
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION CONCLUSION: SINCE NO PRODUCT OR IMAGES ARE AVAILABLE, THE INVESTIGATION IS BASED ONLY ON THE VERY LIMITED INFORMATION PROVIDED. IMPLANT PERIOD UNKNOWN, BUT PT DISCHARGED SEVEN DAYS POSTOPERATIVE. PT PRESENTED AFTER GUNSHOT WOUND TO RIGHT LEG. NO REPORTED TREATMENT, WHICH COULD HAVE EXPOSED THE FILTER TO MANIPULATION DURING THE IMPLANT PERIOD. DIFFICULT TO COMMENT ON FILTER PERFORATION AND/OR PERSISTENT ABDOMINAL PAIN. FILTER PERFORATION OF THE VENA CAVA WALL IS A WELL KNOWN RISK. NOTHING FURTHER IS INITIATED SINCE THE DESCRIPTION DOES NOT INDICATE PRESENCE OF DEVICE FAILURE.

    Description of Event or Problem · 1

    A (B)(6) MAN PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF INTERMITTENT ABDOMINAL AND BACK PAIN FOLLOWING PLACEMENT OF AN IVC FILTER APPROXIMATELY 10 MONTHS EARLIER. HE DESCRIBED NEW COMPLAINTS OF NAUSEA AND VOMITING WITH STREAKS OF BLOOD, AND INCREASING EPIGASTRIC PAIN WORSENED BY EATING AND CHANGES IN POSITION. DUE TO NONCOMPLIANCE WITH ANTICOAGULATION THERAPY (WARFARIN), THE PT UNDERWENT PLACEMENT OF A CELECT IVC FILTER (COOK MEDICAL, USA). FOLLOWING DISCHARGE, THE PT EXPERIENCED PERSISTENT ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A PERFORATION OF THE IVC BY ONE OF THE FILTER'S PRONGS 2.5 CM INTO THE DUODENUM. ON PRESENTATION, HIS VITAL SIGNS WERE STABLE AND EXAMINATION WAS POSITIVE FOR DIFFUSE MILD ABDOMINAL TENDERNESS WITHOUT REBOUND, GUARDING OR OTHER PERITONEAL SIGNS. THE PT WAS TAKEN TO THE OPERATING ROOM FOR EXPLORATORY LAPAROTOMY. AN EXTENSIVE KOCHER MANOEUVRE WAS PERFORMED. AN AREA ADJACENT TO THE DUODENUM WAS FIRM AND HARD WITH EXTENSIVE SCAR TISSUE. THE IVC WAS DISSECTED FREE, REVEALING THE FILTER PRONG PROTRUDING FROM THE VENA CAVA COMPLETELY TRAVERSING THE POSTERIOR TO THE ANTERIOR DUODENUM , WHERE THE INFLAMMATORY TISSUE WAS SEEN, CLEARLY IDENTIFYING THE DUODENOCAVAL FISTULA. A PURSE STRING SUTURE WAS PLACED AROUND THE IVC PUNCTURE SITE AND THE PRONG WAS DIVIDED WITH WIRE CUTTERS. THE DUODENUM WAS REPAIRED PRIMARILY WITH VICRYL (ETHICON INC, USA) AND SILK SUTURES IN A LEMBERT FASHION. FURTHER INSPECTION OF THE ANTERIOR DUODENUM REVEALED CHRONIC INFLAMMATION IN THE MESENTERY, WHICH WAS DISSECTED FREE OF THE DUODENUM. NO PURULENT OR BILIOUS MATERIAL WAS PRESENT. THE DUODENAL REPAIR WAS TESTED WITH METHYLENE BLUE VIA THE NASOGASTRIC TUBE WITHOUT SIGNS OF EXTRAVASATION. AN OMENTAL FLAP WAS THEN FREED FROM THE TRANSVERSE COLON AND PLACED BETWEEN THE DUODENUM AND IVC. THE ABDOMEN WAS THEN CLOSED IN THE USUAL FASHION. POSTOPERATIVELY, THE PT'S HOSPITAL COURSE WAS UNREMARKABLE AND HE WAS DISCHARGED ON POSTOPERATIVE DAY 7. PT IS CURRENTLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention