BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6186969 · Received December 19, 2016

    Report

    Report Number
    3007042319-2016-04462
    Event Type
    Death
    Date Received
    December 19, 2016
    Date of Event
    April 13, 2016
    Report Date
    December 7, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. 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. THE SYSTEM IS DESIGNED TO ASSIST A WEAKENED, POORLY FUNCTIONING LEFT VENTRICLE. THE IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. THESE SURGICAL PROCEDURES ARE ASSOCIATED WITH NUMEROUS RISKS. STROKE/NEUROLOGICAL DYSFUNCTION IS A KNOWN POTENTIAL CLINICAL ADVERSE EVENT ASSOCIATED WITH VADS AS OUTLINED IN THE IFU. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL CONTAINS STROKE AND NEUROLOGIC DYSFUNCTION AS POTENTIAL EVENTS THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. THE IFU PROVIDES ANTICOAGULATION GUIDELINES TO REDUCE THE OCCURRENCE AND SEVERITY OF STROKES. THE SYSTEM IS CONTRAINDICATED IN PATIENTS WHO CANNOT TOLERATE ANTICOAGULATION THERAPY TO REDUCE THE POSSIBILITY OF STROKE. MOREOVER, THE IFU FURTHER EDUCATES THE USER ON PUMP OPERATION AND FLOW GUIDELINES IN ORDER TO DECREASE THE RISK OF A STROKE. DEATH IS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. CLINICAL RESULTS AND COMMERCIAL EXPERIENCE DEMONSTRATE THAT THE PLACEMENT OF A VAD IN CHRONIC NYHA CLASS IV PATIENTS IMPROVES SURVIVAL AND QUALITY OF LIFE WHEN COMPARED TO A SIMILAR PATIENT POPULATION RECEIVING CONVENTIONAL THERAPY. FURTHERMORE, THESE BENEFITS APPLY TO PATIENTS BEING BRIDGED TO HEART TRANSPLANT, PATIENTS RECEIVING PERMANENT SUPPORT (DESTINATION THERAPY), AND THOSE BEING SUPPORTED WITH THE EXPECTATION FOR MYOCARDIAL RECOVERY. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE EVENT. THERE IS ALSO NO CLINICAL EVIDENCE TO SUGGEST THAT A MALFUNCTION OF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT OF (ENCEPHALOPATHY) AND PATIENT OUTCOME ARE MULTIFACTORIAL AND MAY BE ATTRIBUTED TO THE PATIENT'S CLINICAL CONDITION PRIOR TO IMPLANT, THE IMPLANT PROCEDURE, AND COMPLICATIONS EXPERIENCED DURING THE POST-OPERATIVE PERIOD FOLLOWING LVAD IMPLANT PROCEDURE. THERE ARE PATIENT AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICAL STUDY THAT THIS PATIENT EXPERIENCED MULTIPLE COMPLICATIONS DURING THE POST-OPERATIVE PERIOD AFTER LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT PROCEDURE VIA THORACOTOMY APPROACH.  IN THE DAYS FOLLOWING IMPLANT, THE PATIENT EXPERIENCED OUTFLOW-AORTA ANASTOMOSIS BLEEDING REQUIRING FIVE UNITS OF PACKED RED BLOOD CELLS (PRBC'S) REOPERATION, SUSTAINED VENTRICULAR ARRHYTHMIA REQUIRING DEFIBRILLATION/CARDIOVERSION, RIGHT HEART FAILURE REQUIRING RIGHT VENTRICULAR ASSIST DEVICE (RVAD), AND RENAL DYSFUNCTION REQUIRING HEMODIALYSIS.  DESPITE HAVING THE RVAD FOR ADDITIONAL CIRCULATORY SUPPORT, THE PATIENT DEVELOPED MEAN ARTERIAL PRESSURES (MAPS) IN THE 60S AND 50S. THE DECISION WAS MADE TO SWITCH FROM RVAD TO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) TO INCREASE OXYGENATION.  THE RVAD WAS DECOMMISSIONED ON (B)(6) 2016.  THE PATIENT SUBSEQUENTLY EXPERIENCED ANOXIC ENCEPHALOPATHY AND WAS INTUBATED.  HE EXPIRED 2 DAYS LATER, ON (B)(6) 2016.  THE CAUSE OF DEATH WAS DETERMINED TO BE CIRCULATORY: ISCHEMIC CARDIOMYOPATHY.  THE DEVICE REMAINED IMPLANTED POST-MORTEM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837565 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death