BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6088917 · Received November 9, 2016

    Report

    Report Number
    3007042319-2016-04061
    Event Type
    Death
    Date Received
    November 9, 2016
    Date of Event
    August 23, 2016
    Report Date
    October 31, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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 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, INFECTION AND SEPSIS ARE KNOWN POTENTIAL COMPLICATIONS THAT MAY BE ASSOCIATED WITH USE OF THIS PRODUCT AND IN PATIENTS WITH HEART FAILURE. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES OF THE DEVICE THAT WOULD IMPACT THE REPORTED EVENT. THERE IS ALSO NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S OUTCOME CAN BE MULTIFACTORIAL AND MAY BE ATTRIBUTED TO MEDICAL TREATMENT, PROGRESSION OF DISEASE, THE RECURRENT NATURE OF DRIVELINE INFECTION AND THE PATIENT'S RELATED COMORBIDITIES. THERE ARE PATIENT FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. 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 FROM THE CLINICAL DATABASE THAT A PATIENT WITH PREVIOUS SEPSIS AND RECURRENT DRIVELINE EXIT SITE AND STERNAL WOUND INFECTION COMPLETED HIS FIVE YEAR STUDY VISIT ON MAY 18TH 2016. AT THAT TIME THE PATIENT WAS NOTED TO BE ON CONTINUED ZOSYN AND LEVAQUIN. HE WAS RE-ADMITTED TO HOSPITAL ON (B)(6) 2016 FEELING UNWELL WITH HYPOTENSION AND ACUTE KIDNEY INJURY. BLOOD CULTURES WERE FOUND TO BE POSITIVE FOR CANDIDA PARAPSILOSIS. ON (B)(6) 2016, THE PATIENT'S TEMPERATURE WAS RECORDED AS 99.1 F AND HE WAS NOTED TO HAVE LEUKOCYTOSIS. THE PATIENT EXPIRED ON (B)(6) 2016 AFTER HIS FAMILY HAD OPTED TO WITHDRAW TREATMENT. THE CAUSE OF DEATH WAS REPORTED TO BE FUNGAL SEPSIS WITH ONGOING PSEUDOMONAS DRIVELINE AND STERNAL INFECTIONS. THE PRIMARY INVESTIGATOR REPORTED THAT THE EVENT WAS RELATED TO THE HVAD SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740905 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death