BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6134805 · Received November 30, 2016

    Report

    Report Number
    3007042319-2016-04227
    Event Type
    Death
    Date Received
    November 30, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 24, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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, INCLUDING TRANSPORTATION. THE SYSTEM IS INDICATED FOR USE UNDER THE DIRECT SUPERVISION OF A LICENSED PRACTITIONER OR BY PERSONNEL TRAINED IN ITS' PROPER USE. THESE PROFESSIONALS SHOULD BE AWARE OF THE PHYSICAL AND PSYCHOLOGICAL NEEDS OF PATIENTS UNDERGOING LVAD SUPPORT. 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. DEATH, SEPSIS AND MULTI-ORGAN FAILURE ARE POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. THE INSTRUCTIONS FOR USE (IFU) PROVIDES GUIDELINES TO REDUCE THE OCCURRENCE AND SEVERITY OF INFECTION. THOSE WITH COMPROMISED IMMUNE SYSTEMS AND/OR TREATED WITH MULTIPLE ANTIBIOTICS ARE MORE SUSCEPTIBLE TO THESE TYPES OF INFECTIONS. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT WAS STILL HOSPITALIZED POST VENTRICULAR ASSIST DEVICE (VAD) IMPLANTATION AND HAD NOT BEEN EXTUBATED AT THE TIME OF THE EVENT. THE SITE FURTHER REPORTED THAT THE PATIENT HAD BEEN RESPONSIVE AT TIMES POST-OPERATIVELY BUT HAD BEEN LIGHTLY SEDATED FOR ENDOTRACHEAL TUBE TOLERANCE. THE PATIENT'S MEDICAL TEAM REPORTED THAT THE SUSPECTED SOURCE OF THE PATIENT'S SEPSIS WAS THE INFECTED CENTRAL VENOUS CATHETER. THE CAUSE OF DEATH WAS REPORTED TO BE UNKNOWN AND NO AUTOPSY WAS PERFORMED. THE PATIENT'S PHYSICIAN DOES NOT BELIEVE THAT THE EVENT WAS RELATED TO THE VENTRICULAR ASSIST DEVICE SYSTEM OR THE IMPLANT PROCEDURE. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE THE PATIENT'S PAST MEDICAL HISTORY AND RELATED COMORBIDITIES. THOUGH THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED; THERE ARE PATIENT FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. HVAD PUMP (B)(4) WAS NOT RETURNED TO HEARTWARE FOR EVALUATION. THIS COMPLAINT IS ASSOCIATED WITH A CLINICAL ADVERSE EVENT, NO DEVICE MALFUNCTION WAS REPORTED AGAINST (B)(4); THEREFORE, THE PURPOSE OF THIS INVESTIGATION IS SOLELY TO EVALUATE THE DEVICE CONFORMANCE TO INTERNAL RELEASE REQUIREMENTS AND/OR TO IDENTIFY ANOMALIES POTENTIALLY INTRODUCED DURING USE THAT MAY HAVE PREVENTED THE PUMP FROM PERFORMING AS INTENDED. REVIEW OF THE MANUFACTURING DOCUMENTATION AND STERILITY CERTIFICATE CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. LOG FILE ANALYSIS REVEALED 127 LOW FLOW ALARMS HAVE BEEN LOGGED SINCE (B)(6) 2016. 1 HIGH WATT ALARM WAS LOGGED ON (B)(6) 2016 AT 18:07:34. WAVEFORMS INDICATE A SLIGHT DECREASE IN POWER CONSUMPTION OF APPROXIMATELY 0.5W ON (B)(6) 2016. PARAMETERS RETURNED TO BASELINE POWER CONSUMPTION ON (B)(6) 2016. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WHO HAD UNDERGONE HVAD IMPLANTATION ON (B)(6) 2016, DEVELOPED FLUCTUATING LEUKOCYTOSIS POST-OPERATIVELY WHICH REQUIRED PERSISTENT INOTROPIC SUPPORT.  A CULTURE OF THE PATIENT'S NOSE AND THROAT ON (B)(6) 2016 WAS POSITIVE FOR PICORNAVIRUS.  HE WAS TREATED WITH LINEZOLID, FLUCONAZOLE, CEFEPIME, MEROPENUM, VANCOMYCIN, TAZOCIN AND CASPOFUNGIN THROUGHOUT HIS POST-OPERATIVE COURSE.  A CULTURE OF THE PATIENT'S CENTRAL VENOUS CATHETER (CVC) ON (B)(6) 2016 WAS POSITIVE FOR ENTEROCOCCUS FAECIUM VAN A.  IN ADDITION, THE PATIENT DEVELOPED DECREASED HVAD FLOWS AND LOSS OF PULSATILITY ON (B)(6) 2016.  THE PATIENT WAS INITIALLY TREATED WITH AN INCREASE IN HIS NORADRENALINE INFUSION.  AT THE TIME OF THE EVENT, THE PATIENT WAS ON AN INTRAVENOUS (IV) INFUSION OF HEPARIN.  LABORATORY FINDINGS INCLUDED A THERAPEUTIC PARTIAL THROMBOPLASTIN TIME (PTT) AND NORMAL HEMOGLOBIN (HGB).  A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED A LARGE PERICARDIAL EFFUSION.  THE PATIENT WAS THEN FURTHER TREATED WITH SURGICAL DRAINAGE OF THE EFFUSION WITH THE SUBSEQUENT IMPROVEMENT IN HIS HVAD FLOWS AND PULSATILITY.  ON NOVEMBER 21ST 2016, THE PATIENT'S SPUTUM CULTURE WAS POSITIVE FOR YEAST.  DESPITE THE PATIENT'S TREATMENT WITH MULTIPLE IV ANTIBIOTICS, HIS LEUKOCYTOSIS CONTINUED TO RISE ALONG WITH HIS LACTATE LEVELS.  HE REQUIRED INCREASING DOSES OF NORADRENALINE AND MILRINONE WITH HIS PROGRESSIVE MULTI-ORGAN FAILURE (MOF).  A DECISION WAS MADE TO PALLIATE THE PATIENT'S CONDITION AND HE EXPIRED ON (B)(6) 2016 WITH THE CAUSE OF DEATH THOUGHT TO BE SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786712 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death