BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM -PUMP

    MDR report key: 6914576 · Received October 4, 2017

    Report

    Report Number
    3007042319-2017-03538
    Event Type
    Death
    Date Received
    October 4, 2017
    Date of Event
    February 10, 2017
    Report Date
    January 3, 2018
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE EVENT WAS NOT RELATED TO THE PROCEDURE, AS PATIENT WAS IMPLANTED ALMOST THREE YEARS AGO. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED INCLUDE THE PATIENT'S PREVIOUS MEDICAL HISTORY, ANTICOAGULANT THERAPY, AND RELATED COMORBIDITIES AND THE PROGRESSION OF THE PATIENTS UNDERLYING DISEASE PROCESS. THERE IS PATIENT, PROCEDURAL AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. FROM ALL INDICATIONS, THE DEVICE OPERATED WITHIN SPECIFICATIONS AND AS INTENDED WITH NO INDICATION OF ANY DEVICE MALFUNCTION. THE ROOT CAUSE OF DEATH WAS STATED TO HAVE BEEN ATTRIBUTED TO RIGHT HEART FAILURE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    CORRECTED FIELD: THIS EVENT WAS REASSESSED AND IS BEING UPDATED AS PART OF A RETROSPECTIVE REVIEW OF EVENTS IN RESPONSE TO AN UPDATE TO THE MDR COMPLAINT SOURCES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE CLINICAL STUDY SITE THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR URINARY TRACT INFECTION (UTI) AND SPOUSE UNABLE TO CARE FOR THE SUBJECT AT HOME. THE PATIENT HAD AN  ECHOCARDIOGRAM (ECHO) PERFORMED ON (B)(6) 2017@12:04 PM THAT REVEALED LEFT VENTRICULAR EJECTION FRACTION (LVEF) THAT WAS LESS THAN (<) 20 PERCENT (%), NO PLEURAL OR PERICARDIAL EFFUSION, REDUCED LEFT VENTRICULAR FUNCTION, SEVERE GLOBAL LEFT VENTRICLE HYPO KINESIS, RIGHT VENTRICLE IS MODERATELY TO SEVERELY DILATED AND SYSTOLIC FUNCTION SEVERELY REDUCED, BOTH RIGHT & LEFT ATRIUMS ARE SEVERELY DILATED, VALVES-MILD MITRAL, AORTIC REGURGITATION WITH MILD TO MODERATE TRICUSPID & PULMONIC REGURGITATION. NO OTHER TREATMENTS FOR RIGHT HEART FAILURE WERE STARTED NOW. ON (B)(6) 2017 @ 12:23 AM, THE MEDICAL DOCTOR (MD) WAS CALLED TO THE BEDSIDE TO ASSESS THE PATIENT:  RESPIRATIONS WERE GREATER THAN (>)30, SKIN COLD, EDEMATOUS, AND DIAPHORETIC. MIXED VENOUS OXYGEN (O2) RESULTS 22%, URINE OUTPUT DECREASED.  AFTER THE STAFF, COULD OBTAIN ARTERIAL BLOOD GASSES (ABGS) ONLY WITH ULTRASOUND GUIDANCE, THEY DISCOVERED THE SUBJECT HAD A NORMAL PARTIAL PRESSURE OF OXYGEN IN ARTERIAL BLOOD (PAO2), BUT AN ELEVATED LACTATE LEVEL OF 3.  AN ARTERIAL LINE AND A TRIPLE LUMEN CATHETER WAS PLACED FOR IMPROVED HEMODYNAMIC MONITORING, BLOOD DRAWS, AND MEDICATION ADMINISTRATION. THE PATIENT ALSO WAS INTUBATED ON (B)(6) 2017. THE PATIENT REMAINED IN ATRIAL FIB WITH RAPID VENTRICULAR RESPONSE UNTIL THE INTUBATION.  DURING THE INTUBATION ON (B)(6) 2017, THE SUBJECT CONVERTED TO VENTRICULAR TACHYCARDIA (V-TACH). PER DOCTOR'S NOTE, WHILE IN V-TACH THE PATIENT'S OXYGEN (O2) SATURATION REMAINED IN THE HIGH 90'S AND THE VENTRICULAR ASSIST DEVICE (VAD) PARAMETERS REMAINED STABLE.  A CARDIOVERSION WAS PERFORMED ON (B)(6) 2017@ 16:17PM. AFTER ONE SYNCHRONIZED SHOCK ATTEMPT WITH 200 JOULES, THE PATIENT RETURNED TO THE PREVIOUS RHYTHM OF ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (RVR).  A COMPUTED TOMOGRAPHY SCAN (CT) SCAN OF THE HEAD WAS DONE DUE TO WORSENING MENTAL STATUS ON (B)(6) 2017 AT 13:57 PM THAT REVEALED A NEW INFARCT PRESENT WITHIN THE LEFT POSTERIOR SYLVAIN AND FRONTOPARIETAL REGION WITH MILD SWELLING. THE DENSITY OF THIS WOULD SUGGEST THAT IT IS MORE THAN A FEW HOURS OLD. THERE IS NO ASSOCIATED HEMORRHAGE. THIS INFARCT IN NEW SINCE (B)(6) 2017. THE BRAIN IS OTHERWISE NOT SIGNIFICANTLY CHANGED WITH FINDINGS SUGGESTIVE OF A NORMAL PRESSURE/COMMUNICATING HYDROCEPHALUS AND OLD ISCHEMIC LESIONS AND OLD INFARCTS, NOT A CRITICAL RESULT. THE 12 LEAD ELECTROCARDIOGRAM (ECG) WAS DONE AT 13:01 PM, SHOWS ATRIAL FIBRILLATION WITH VENTRICULAR RATE OF 138 BEATS PER MINUTE (BPM) WITH OCCASIONAL PACED BEATS. THE PATIENT WAS INTUBATED DUE TO POOR MENTATION AND INABILITY TO PROTECT AIRWAY ON (B)(6) 2017 AT 12:44 PM WITH 7.5 ENDOTRACHEAL TUBE (ETT) AND REMAINED ON RESPIRATORY SUPPORT.  ON (B)(6) 2017 @ 09:08 AM, THE PATIENT'S OXYGEN (O2) DEMANDS INCREASED TO 6 L/MIN FROM 3 L/MIN, URINE OUTPUT IMPROVED WITH BUMEX, REMAINS NON-RESPONSIVE, WITH FEVER OF 102 DURING THE NIGHT. PATIENT WAS ASSESSED AND ABDOMEN WAS SOFT, LUNGS DECREASED AT THE BASES WITH UPPER AIRWAY GURGLING. AN ETHICS MEETING WAS CALLED AND THE SUBJECT WAS DETERMINED TO BE UNLIKELY TO SURVIVE, THE FAMILY AND DOCTORS DECIDED TO WITHDRAW CARE, THE PATIENT WAS EXTUBATED AND LVAD WAS STOPPED. THE PATIENT REMAINED IN ATRIAL FIBRILLATION WITH RVR (ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE) UNTIL DEATH WAS PRONOUNCED ON (B)(6) 2017 AT 22:05 PM. THE OFFICIAL CAUSE OF DEATH WAS STATED TO HAVE BEEN RIGHT HEART FAILURE. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694069 HEARTWARE® VENTRICULAR ASSIST SYSTEM -PUMP CIRCULATORY ASSIST SYSTEM, DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death