BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6056650 · Received October 26, 2016

    Report

    Report Number
    3007042319-2016-03744
    Event Type
    Death
    Date Received
    October 26, 2016
    Date of Event
    August 31, 2016
    Report Date
    October 11, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITH REVIEW OF THE AVAILABLE INFORMATION ,THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION OR PERFORMANCE ISSUES IMPACTING THE EVENT. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, CLINICAL, PHARMACOLOGICAL, AND PATIENT FACTORS INCLUDING COMORBIDITIES ARE KNOWN POSSIBLE CONTRIBUTORS TO THE EVENT. 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 IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. THESE SURGICAL PROCEDURES ARE ASSOCIATED WITH NUMEROUS RISKS. DEATH, BLEEDING, SEPSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE IMPLANTATION OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. DEVICE REMAINS WITH PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE SITE THAT THE PATIENT WAS IMPLANTED (B)(6) 2016 FOR BRIDGE TO TRANSPLANT AND WAS STATED TO HAVE DECOMPENSATED QUICKLY AND REQUIRED PLACEMENT OF 5.0 IMPELLA DUE TO RIGHT HEART FAILURE FROM (B)(6) 2016. PATIENT WAS STATED TO HAVE BEEN REMOVED FROM THE TRANSPLANT LIST DUE TO BEING TOO SICK. IT WAS STATED THAT THE PATIENT'S CONDITION WAS DETERIORATING AND FAMILY DISCUSSED WITHDRAWAL OF CARE. ON (B)(6) 2016 IT WAS STATED THAT THE PATIENT DIED AND THE OFFICIAL CAUSE OF DEATH WAS MULTI-SYSTEM ORGAN FAILURE. THE SITE STATED THAT THERE WOULD BE NO AUTOPSY DONE ON THE PATIENT AND THAT THE SITE WOULD DISPOSE OF THE PERIPHERALS. IT WAS STATED BY THE PHYSICIAN THAT THE CAUSE OF DEATH WAS NOT PUMP RELATED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708607 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death