BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6130533 · Received November 28, 2016

    Report

    Report Number
    3007042319-2016-04221
    Event Type
    Death
    Date Received
    November 28, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 17, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT COULD HAVE CONTRIBUTED TO THE PATIENT'S DEATH. THE PATIENT PRESENTED WITH POOR RIGHT HEART FUNCTION AND POOR KIDNEY FUNCTION WHICH MAY HAVE HAD AN IMPACT ON THE PATIENT'S OUTCOME. CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE THE PATIENT'S POOR CLINICAL CONDITION, COMORBIDITIES, AND PHARMACOLOGICAL FACTORS. 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED SECTIONS HAVE BEEN UPDATED ACCORDINGLY. ADDITIONAL INFORMATION, PROVIDED STATES THAT THE MEDICAL TEAM BELIEVES THAT THE RIGHT HEART WAS THE CAUSE OF THE DEATH. THE PATIENT ALREADY HAD SIGNIFICANT RIGHT HEART FOR WHICH THEY WERE UNABLE TO MANAGE WITH MEDICATIONS/SUPPORT. 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

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED ON (B)(6) 2016 WHO ALSO HAD SIGNIFICANT RIGHT HEART DYSFUNCTION, WAS BEING CONSIDERED FOR BIVENTRICULAR SUPPORT. THE PATIENT LEFT THE OPERATING ROOM WITH MILRINONE AND INTERNUCLEAR OPHTHALMOPLEGIA (INO) AND WAS ABLE TO BE STABILIZED. OVER THE NEXT FEW WEEKS, THE PATIENT REMAINED INTUBATED AND ON TAKING DIALYSIS DUE TO POOR KIDNEY FUNCTION. THERE WERE SEVERAL DISCUSSIONS ABOUT RIGHT HEART SUPPORT AND BIVAD SUPPORT BUT THE PATIENT WAS TOO SICK. THE RIGHT HEART DYSFUNCTION CONTINUED TO WORSEN AND THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) ON (B)(6) 2016. HOWEVER, A DECISION WAS MADE TO WITHDRAW SUPPORT AND THE PATIENT EXPIRED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781506 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death