BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIGILEO MONITOR

    MDR report key: 2840803 · Received November 20, 2012

    Report

    Report Number
    2015691-2012-18679
    Event Type
    Death
    Date Received
    November 20, 2012
    Date of Event
    August 1, 2012
    Report Date
    October 27, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K043065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS WERE RETURNED FOR EVALUATION AFTER REVIEW OF THE INFORMATION, THE CAUSE OF THE COMPLAINT CANNOT BE DETERMINE WITH ANY CERTAINTY WITHOUT THE OPPORTUNITY TO EXAMINE THE DEVICES, IT IS NOT POSSIBLE TO DETERMINE IF ANY DAMAGES OR DEFECTS WERE PRESENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE, THE FLOTRAC/VIGILEO FAILED TO TRACK RAPID HEMODYNAMIC CHANGES IN AN UNSTABLE CARDIAC SURGICAL PATIENT; "THE PATIENT WAS SCHEDULED TO UNDERGO MECHANICAL PROSTHETIC AORTIC VALVE REPLACEMENT FOR SEVERE AORTIC STENOSIS. HIS PREOPERATIVE TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) WAS PERTINENT FOR AN AORTIC VALVE AREA=0.8 CM2, MEAN AND PEAK PRESSURE GRADIENTS ACROSS THE AORTIC VALVE OF 60 MM HG AND 106 MM HG, RESPECTIVELY, AND PRESERVED LEFT VENTRICULAR EJECTION FRACTION (>60%) " INDUCTION OF GENERAL ANESTHESIA AND INTUBATION WERE UNEVENTFUL; THE PATIENT WAS MONITORED USING STANDARD MONITORS IN COMBINATION WITH A LEFT RADIAL ARTERIAL LINE CATHETER, A CENTRAL VENOUS CATHETER, AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). TEE CONFIRMED A RELATIVELY SMALL AORTIC ANNULUS (1.9 CM) TO BODY SURFACE AREA (BSA) (2.35 M2), NORMAL RIGHT VENTRICULAR FUNCTION AND SIZE, MILD TRICUSPID REGURGITATION, AND MILD DIASTOLIC DYSFUNCTION. WHILE TECHNICALLY DIFFICULT, A MECHANICAL AORTIC PROSTHESIS (ST. JUDE SIZE #21) WAS SUCCESSFULLY IMPLANTED IN THE AORTIC POSITION. INTRAOPERATIVE TEE DEMONSTRATED A WELL-SEATED VALVE AND NORMAL LEFT VENTRICULAR FUNCTION AFTER UNEVENTFUL WEANING FROM CARDIOPULMONARY BYPASS. THE MEAN PRESSURE GRADIENT ACROSS THE AORTIC PROSTHESIS WAS 20 MMHG; FOLLOWING INTRAOPERATIVE MANAGEMENT, THE PATIENT WAS TRANSFERRED TO THE CARDIAC SURGICAL ICU ON A DEXMEDETOMIDINE INFUSION IN PREPARATION FOR FAST-TRACK EXTUBATION. THE PATIENT WAS SUPPORTED ON A LOW DOSE NOREPINEPHRINE INFUSION (0.03 MCG/KG/MIN). UPON ARRIVAL TO THE ICU, THE FLOTRAC / VIGILEO (3.01) MONITOR WAS APPLIED (NOTE: THE DEVICE WAS NOT USED IN THE OPERATING ROOM). NINETY MINUTES AFTER ARRIVAL TO THE ICU, A SPONTANEOUS BREATHING TRIAL (CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP OF 5 CM H2O) WAS INITIATED IN PREPARATION FOR EXTUBATION. READINGS ON THE FLOTRAC/VIGILEO DENOTED NORMAL CARDIAC FUNCTION THROUGHOUT THE SPONTANEOUS BREATHING TRIAL. DESPITE THE NORMAL READINGS ON THE FLOTRAC/VIGILEO, ARTERIAL BLOOD PRESSURE RECORDINGS SHOWED A GRADUAL DECLINE IN THE SYSTOLIC, DIASTOLIC AND MEAN ARTERIAL PRESSURES. APPROXIMATELY ONE HOUR LATER, AND WHILE STILL INTUBATED AND BREATHING SPONTANEOUSLY, THE PATIENT WAS NOTED TO BE UNRESPONSIVE AND DEVELOPED PULSELESS VENTRICULAR TACHYCARDIA. CARDIOPULMONARY RESUSCITATION WAS EMPLOYED INTERMITTENTLY FOR APPROXIMATELY 1 HOUR (A TOTAL OF INTRAVENOUS BOLUSES OF EPINEPHRINE 1 MG, AMIODARONE 300 MG WERE ADMINISTERED COMBINED WITH CHEST COMPRESSIONS). FOLLOWING THIS PERIOD, AN EKG REVEALED ACUTE RIGHT VENTRICULAR INFARCTION. CONCOMITANT TEE REVEALED RIGHT VENTRICULAR DILATATION, GLOBAL RIGHT VENTRICULAR WALL AKINESIS, MILD TRICUSPID REGURGITATION AND LEFTWARD BOWING OF THE INTERVENTRICULAR SEPTUM. PHYSIOLOGIC DATA POINTS FOR CARDIAC OUTPUT PER THE FLOTRAC/VIGILEO WERE REPORTED AS NORMAL LIMITS THROUGHOUT THE EPISODE OF CARDIAC ARREST. THE PATIENT WAS RUSHED INTO THE CARDIAC ANGIOGRAPHY SUITE AND FOUND TO HAVE TOTAL RIGHT CORONARY ARTERY OCCLUSION NOT AMENABLE TO STENTING. THE PATIENT WAS SUBSEQUENTLY TAKEN BACK TO THE OPERATING ROOM FOR EMERGENT RIGHT CORONARY BYPASS GRAFTING. ENSUING SEVERE GLOBAL RIGHT VENTRICULAR AKINESIS AND RECALCITRANT HEMODYNAMIC INSTABILITY REQUIRED USE OF THE TANDEMHEART RIGHT VENTRICULAR ASSIST DEVICE (RVAD). THE PATIENT WAS TRANSFERRED TO THE CARDIAC ICU IN CRITICAL-SEVERE CONDITION. HIS POSTOPERATIVE COURSE WAS COMPLICATED BY PERSISTENT CARDIOGENIC SHOCK UNRESPONSIVE TO HIGH DOSES OF IONOTROPIC AGENTS. HE WAS NOT AMENABLE TO WEANING FROM RVAD, AND RAPIDLY DEVELOPED MULTI-ORGAN FAILURE REQUIRING THE INSTITUTION OF CONTINUOUS VENOVENOUS HEMODIAFILTRATION (CVVHDF). FOUR DAYS LATER HIS CARE WAS DEEMED FUTILE AND THE FAMILY ELECTED TO WITHDRAW LIFE SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIGILEO MONITOR COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES MHM1

    Patients

    Seq Age Sex Outcome Treatment
    1 53 Death MECHANICAL AORTIC PROSTHESIS (ST. JUDE SIZE #21),