BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRONTRUNNER

    MDR report key: 469456 · Received June 30, 2003

    Report

    Report Number
    3002912012-2003-00007
    Event Type
    Death
    Date Received
    June 30, 2003
    Date of Event
    May 15, 2003
    Report Date
    June 10, 2003
    Manufacturer
    LUMEND, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS WITH A CHRONIC TOTAL OCCLUSION (CTO) IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD), WITH COLLATERALS FROM THE RIGHT CORONARY ARTERY (RCA), AS WELL AS CALCIFIC AORTIC DISEASE. THE PATIENT WAS NOT A GOOD SURGICAL CANDIDATE AND THE PHYSICIAN WANTED TO ATTEMPT TO OPEN THE CTO WITH THE FRONTRUNNER (FBS-3900). THE LAD HAD TWO CTOS, ONE PROXIMAL AND THE SECOND MORE DISTAL IN THE MID-LAD WITH MILD TORTUOSITY. THE PATIENT ALSO HAD TORTUOUS ILIACS AND WAS ON CHRONIC STEROID USE. THE PHYSICIAN ATTEMPTED TO CROSS THE LAD CTO WITH THE FBS-3900. THE PHYSICIAN STATED IT WAS A DIFFICULT CASE WITH SEVERE CALCIFICATION. DUE TO THE TORTUOUS ILIAC ARTERY, THE PHYSICIAN TRIED MULTIPLE GUIDES AND SETTLED FOR AN 8F LEFT GUIDE. THERE WAS CALCIFICATION AT THE OCCLUSION SITE AND THE PHYSICIAN WAS UNABLE TO DO SIMULTANEOUS INJECTIONS BECAUSE THE OPPOSITE ILIAC WAS OCCLUDED. THE PHYSICIAN ADVANCED THROUGH THE FIRST OCCLUSION WITH AN FBS-3900 AND STARTED ON THE SECOND CTO. THE JAWS WERE ACTUATED AND THE PHYSICIAN NOTICED A "SUDDEN GIVE TO THE DEVICE", IT SEEMED TO JUMP FORWARD, BUT DID NOT SEEM TO BE STUCK. IT LOOKED LIKE IT WENT INTO A BRANCH AND WHEN THE PHYSICIAN TOOK A SHOT WITH FLUORO, HE NOTICED A PERFORATION WITH FLOW INTO THE PERICARDIAL SPACE. THE PATIENT'S BLOOD PRESSURE DECREASED FROM ABOUT 110 TO 80. THE PHYSICIAN PLACED A PERICARDIAL DRAIN AND THE PATIENT'S PRESSURE STABILIZED OVER 100. THE VESSEL WAS DILATED TWICE AND STILL HAD FLOW TO DYE INTO THE PERICARDIAL SPACE. THE PHYSICIAN LEFT THE BALLOON INFLATED AND TRANSFERRED THE PATIENT TO THE OPERATING ROOM. THE PATIENT WAS HEMODYNAMICALLY STABLE WHEN TAKEN FOR SURGERY. THE BYPASS SURGERY WAS PROLONGED DUE TO COMPLICATIONS. THE DISEASED AORTA DISSECTED WHEN IT WAS CLAMPED AND THE PATIENT CONTINUED TO HAVE BLEEDING PROBLEMS WITH A PROLONGED PUMP RUN. POST OPERATIVELY, THE PATIENT CAME OFF INOTROPIC DRIP AND THEN WENT INTO DIFFUSE INTRAVASCULAR COAGULATION (DIC) AND NEVER IMPROVED. THE PATIENT SUBSEQUENTLY DIED 3 DAYS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRONTRUNNER PERCUTANEOUS CATHETER DQY LUMEND, INC. FBB 45140 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death