BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRONUS ENDOVASCULAR GUIDEWIRE

    MDR report key: 493453 · Received October 28, 2003

    Report

    Report Number
    3003778388-2003-00002
    Event Type
    Death
    Date Received
    October 28, 2003
    Date of Event
    August 1, 2003
    Report Date
    August 1, 2003
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A CORONARY ARTERY TREATMENT PROCEDURE ATTEMPTS TO CROSS THE LESION IN THE FIRST MARGINAL WITH THE STEREOTAXIS CRONUS ENDOVASCULAR GUIDEWIRE WAS UNSUCCESSFUL. THE CRONUS FLOPPY GUIDEWIRE WAS THEN INSERTED INTO THE LEFT MAIN CORONARY ARTERY, ANGIOGRAPHY REVEALED A PROXIMAL TOTAL OCCLUSION OF THE DOMINANT CIRCUMFLEX ARTERY AND A DISSECTION OF THE PROXIMAL LAD. THE STEREOTAXIS CRONUS FLOPPY WIRE WAS REMOVED AND A COMPETITOR'S WIRE INSERTED. IMMEDIATE RECANALIZATION WAS PERFORMED AND TWO STENTS IMPLANTED. THE CIRCUMFLEX ARTERY REMAINED OPEN BUT WITH A MARKED PERIPHERAL DISSECTION. A COMPETITOR'S GUIDE WIRE WAS THEN ADVANCED INTO THE PERIPHERAL LAD, AND AFTER PREDILATION, THREE STENTS WERE IMPLANTED. AT THE END OF THE PROCEDURE, THE LAD AND CIRCUMFLEX ARTERIES APPEARED OPEN, BUT WITH MARKED DISSECTIONS. AS THE HEMODYNAMIC SITUATION DETERIORATED DURING THE PROCEDURE AND COULD ONLY BE POORLY STABLIZED, IT WAS NECESSARY TO RESUSCITATE THE PATIENT. AN EMERGENT CORONARY ARTERY BYPASS OPERATION WAS PERFORMED. THE PATIENT RECEIVED TWO SAPHENOUS VEIN BYPASS GRAFTS (LAD AND CIRCUMFLEX). HOWEVER, ATTEMPTS TO WEAN THE PATIENT FROM THE EXTRACORPOREAL CIRCULATION FAILED THREE TIMES AND FINALLY THE PATIENT DIED 6 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONUS ENDOVASCULAR GUIDEWIRE CORONARY GUIDEWIRE DQX STEREOTAXIS, INC. 001-001232-4 0211-4012

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| R