BEUDAMED
    FDA Adverse Event Death Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 2492670 · Received March 12, 2012

    Report

    Report Number
    3007700286-2012-00003
    Event Type
    Death
    Date Received
    March 12, 2012
    Date of Event
    January 30, 2012
    Report Date
    March 12, 2012
    Manufacturer
    SI-BONE
    Product Code
    OUR
    PMA / PMN Number
    K080398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD (LHR) REVIEW WAS PERFORMED FOR LHR# 10011, IFUSE IMPLANT 7MM X 55, PART# 7055-90, EXPIRES 2013-09. LHR# 3766-10024, IFUSE IMPLANT 7MM X 40, PART# 7040-90, EXPIRES 2014-02 AND LHR# 7663002664003, IFUSE IMPLANT 7MM X 40, PART# 7040-90, EXPIRES 2014-07. ALL INSPECTIONS PASSED. IN ADDITION, THE HAZARD ANALYSIS DOCUMENT WAS REVIEWED, NO NEW RISKS WERE IDENTIFIED. BASED UPON THE COMPLAINT INFO AND INVESTIGATION, THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS OUT OF SPEC. THE ROOT CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE PT'S HISTORY OF MORBID OBESITY, DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLISM AS WELL AS HAVING A GREENFIELD FILTER IN THE INFERIOR VENA CAVA CONTRIBUTED/INCREASED THE RISK OF A VENA CAVA RUPTURE. RUPTURE OF THE IVC RELATED TO IVC FILTERS HAS BEEN REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT RECEIVED IFUSE IMPLANTS PERFORMED BY DR (B)(6) IN ORDER TO STABILIZE THE SACROILIAC JOINT. THE CASE WENT WELL, WITH NO INTRAOPERATIVE ISSUES. IMAGING SHOWED THAT DEVICE PLACEMENT WAS AS EXPECTED. PT WAS DISCHARGED THE SAME DAY AS THE PROCEDURE. THE PT WAS DOING WELL AND ABLE TO WALK AT HOME FOR ABOUT ONE WEEK. ON (B)(6) 2012, THE PT COMPLAINED OF BILATERAL LEG PAIN. PT WAS EVALUATED AT THE HOSP EMERGENCY ROOM. DOPPLER OF THE LEGS WAS ORDERED TO RULE OUT DEEP VEIN THROMBOSIS. DOPPLER SHOWED AN INCREASE IN CLOTS. CT SCAN OF THE PELVIS LOOKED AS EXPECTED. THERE WERE NO INDICATIONS THAT THE IFUSE DEVICES WERE OUTSIDE OF THE SACRUM/ILIUM. THE PT RAPIDLY DECOMPENSATED AND ADMITTED TO THE TRAUMA CENTER AT (B)(6). MRI SHOWED RETROPERITONEAL HEMATOMA. THE PT WAS TAKEN TO SURGERY. THE VASCULAR SURGEON FOUND RUPTURE OF THE INFERIOR VENA CAVA (IVC) ABOVE THE BIFURCATION. HEMOGLOBIN LEVEL AT THE END OF THE SURGICAL PROCEDURE WAS 5.0 G/DL WHICH IS WELL BELOW THE NORMAL HEMOGLOBIN VALUES OF 12.1 TO 15.1 G/DL (MEAN 14.0 G/DL). THE PT HAD A DOWNHILL POSTOPERATIVE COURSE AND DIED OF MULTISYSTEM ORGAN FAILURE. DR (B)(6) DOES NOT KNOW THE CAUSE OF THE VENA CAVA RUPTURE. THE TIMING OF THE RUPTURE DOES NOT SUGGEST A PERIOPERATIVE INJURY FROM THE IFUSE IMPLANT PROCEDURE. THE LOCATION OF THE RUPTURE, AS DETERMINED BY THE VASCULAR SURGEON, SEEMED QUITE CEPHALAD TO THE LOCATION OF THE IFUSE PROCEDURE, MAKING INJURY TO THE VENA CAVA DURING THE IFUSE PROCEDURE UNLIKELY. RUPTURE OF THE VENA CAVA IN PTS WITH IVC FILTERS HAS BEEN REPORTED. PT DEATH MAY HAVE OCCURRED ON (B)(6), DATE COULD NOT BE OFFICIALLY CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IFUSE IMPLANT SYSTEM PLATES, SCREWS, RODS OUR SI-BONE 10011

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death