BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5413680 · Received February 5, 2016

    Report

    Report Number
    3007042319-2016-00567
    Event Type
    Death
    Date Received
    February 5, 2016
    Date of Event
    September 11, 2015
    Report Date
    January 26, 2016
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE PROCEDURE, THERAPY OR USE OF THE DEVICE. THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT OF STRANGULATED UMBILICAL HERNIA AND SUBSEQUENT SEPSIS IS RELATED TO THE DEVICE. IN ADDITION THE SITE REPORTED THAT THEY DO NOT BELIEVE THE REPORTED EVENT AND PATIENT OUTCOME TO BE RELATED TO THE DEVICE. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S OUTCOME ARE MULTIFACTORIAL AND MAY BE ATTRIBUTED TO MEDICAL TREATMENT, PROGRESSION OF DISEASE, AND PATIENT COMORBIDITIES. THERE ARE PATIENT FACTORS AND PROCEDURAL EVENTS UNRELATED TO THE DEVICE THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THIS COMPLAINT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT PER CURRENT REGULATORY GUIDELINES. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    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. DEATH AS 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED WITH STRANGULATED UMBILICAL HERNIA, WHICH WAS SURGICALLY RESECTED. SHE THEN BECAME SEPTIC WITH FREE AIR IN HER ABDOMEN. THE PATIENT AND FAMILY DISCUSSED WHETHER THEY SHOULD PURSUE FURTHER INTERVENTION AND DECIDED TO REINSTATE HER DNR/DNI STATUS AND DECLINED ANY HEROIC MEASURES. PATIENT'S MENTATION DECREASED AND COMFORT CARES WERE INITIATED. THE OFFICIAL CAUSE OF DEATH WAS BIVENTRICULAR HEART FAILURE AND POSSIBLE PERFORATED VISCUS. AUTOPSY WAS DONE AND IS IN THE PROCESS OF BEING SENT FOR FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. NO OTHER INFORMATION WAS AVAILABLE. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71352 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death