BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRONTRUNNER

    MDR report key: 469447 · Received June 30, 2003

    Report

    Report Number
    3002912012-2003-00006
    Event Type
    Death
    Date Received
    June 30, 2003
    Date of Event
    June 9, 2003
    Report Date
    June 9, 2003
    Manufacturer
    LUMEND, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WITH LUPUS, CHRONIC STEROID USE, OBESITY, LONGSTANDING CORONARY ARTERY DISEASE (CAD), WITH A PREVIOUS CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE WAS PRESENTING WITH RE-OCCLUDED GRAFTS INCLUDING THE LEFT INTERNAL MAMMARY ARTERY (LIMA), AND AN AUTOMATIC IMPLANTABLE CARDIOVERTER DEFRIBRILLATOR (AICD) IN PLACE. PT HAD A COMPLEX LEFT ANTERIOR DESCENDING (LAD) /DIAGNONAL STENT OCCLUDED TO THE LAD. PT WAS ADMITTED FOR AN ATTEMPT AT CROSSING THE LAD IN-STENT CHRONIC TOTAL OCCLUSION (CTO) WITH FRONTRUNNER (FBS-3900), AFTER PREVIOUS UNSUCCESSFUL ATTEMPTS AT CROSSING WITH A GUIDE WIRE (GW). THE LAD WAS OCCLUDED IMMEDIATELY BEYOND THE DIAGONAL, ALL INSTENT RESTENOSIS (RS). THE PHYSICIAN USED A 7F EBU GUIDE CATHETER, THE MIRCO GUIDE CATHETER (MGC), AND THE FBS-3900. THE INITIAL ATTEMPT TO ACCESS THE LESION WITH THE FBS-3900 WAS UNSUCCESSFUL. THE PHYSICIAN MADE SEVERAL PASSES WITH THE FBS-3900 INTO THE RAMUS BRANCH AND CIRCUMFLEX (CX), ATTEMPTING TO REACH THE LAD. HE THEN DECIDED TO USE A WIRE AND THE LUMEND OBTURATOR TO POSITION THE MGC, WHICH WORKED WELL. THE PATIENT STARTED TO HAVE CHEST PAIN WITH ST ELEVATION (THOUGH THE PATIENT HAD A PACEMAKER, SO THE EKG WAS DIFFICULT TO INTERPRET). AT THIS TIME THERE WAS FLOW IN ALL VESSELS. THE FBS-3900 WAS PLACED INTO THE LAD AND INTO THE STENTED PORTION, IN WHAT APPEARED TO BE A FAVORABLE POSITION. NEXT THE PHYSICIAN OPENED THE JAWS AT THE BIFURCATION IN AN AREA WHERE THREE STENTS APPEARED TO OVERLAP. HE HAD DIFFICULTY CLOSING THE JAWS, AND FINALLY FORCEFULLY REMOVED THE DEVICE, WITH THE GUIDE CATHETER ENTERING THE LAD. THE PATIENT'S CHEST PAIN PROGRESSIVELY WORSENED WITH EKG CHANGES, AND FINALLY BLOOD PRESSURE (BP) BEGAN TO DROP, AND PT LOST CONSCIOUSNESS. WITH AN INJECTION, THEY APPEARED TO HAVE EXTENSIVE DISSECTION IN THE CX AND POSSIBLY THE LEFT MAIN (LM), AND AORTA. UPON SUBSEQUENT INJECTIONS THE DISSECTION APPEARED TO BE LIMITED TO THE CX, WITH NO FLOW. THE CX WAS CODOMINANT WITH THE LAD ALSO OCCLUDED. THE PATIENT UNDERWENT PROLONGED CPR, A BALLOON PUMP WAS INSERTED, AND THE BP INITIALLY RETURNED AFTER EPINEPHRINE INJECTION, ONLY TO FALL AGAIN WITH A FEW MINUTES. A STENT WAS PLACED IN THE CX ACROSS THE DISSECTION, BUT NO BP COULD BE RESTORED. PT WAS TAKEN TO SURGERY EMERGENTLY WITH ONGOING CPR. THE PATIENT DIED IN SURGERY, THEY WERE NEVER ABLE TO REGAIN BP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRONTRUNNER PERCUTANEOUS CATHETER DQY LUMEND, INC. FBB 45140 1175

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death