BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6135918 · Received November 30, 2016

    Report

    Report Number
    3007042319-2016-04264
    Event Type
    Death
    Date Received
    November 30, 2016
    Date of Event
    October 25, 2016
    Report Date
    November 23, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 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. MULTI-ORGAN FAILURE IS A KNOWN POTENTIAL CLINICAL ADVERSE EVENT ASSOCIATED WITH VADS AS OUTLINED IN THE IFU. INVESTIGATIONS OF COMPLAINTS WITH SIMILAR CIRCUMSTANCES WERE REVIEWED; EVENTS OF THESE TYPES ARE MULTIFACTORIAL AND MAY BE ASSOCIATED WITH POOR POST-OPERATIVE (IMPLANT) OUTCOMES. IN MANY CASES PATIENTS EXHIBIT SYMPTOMS OF SEVERE MULTI ORGAN FAILURE PRIOR TO DEATH; IT MAY BE UNCLEAR WHICH ONE OF THE FAILING ORGANS WAS THE PRINCIPAL CAUSE OF DEATH OR IF DEATH WAS THE RESULT OF THE INTERACTION OF THE FAILURE OF SEVERAL ORGANS. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE WERE NO DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE EVENT. THE SITE ALSO REPORTED THAT THEY BELIEVED THE REPORTED EVENT OF MULTI-ORGAN FAILURE TO BE UNRELATED TO THE DEVICE. THOUGH THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED, CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S OUTCOME RELATED TO THE EVENT ARE MULTIFACTORIAL AND MAY BE ATTRIBUTED TO MEDICAL TREATMENT, PROGRESSION OF DISEASE, AND PATIENT COMORBIDITIES. IN MANY CASES, IT MAY BE UNCLEAR WHICH ONE OF THE FAILING ORGANS WAS THE PRINCIPAL CAUSE OF DEATH OR IF DEATH WAS THE RESULT OF THE INTERACTION OF THE FAILURE OF SEVERAL ORGANS. THERE ARE PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT EXPIRED DUE TO CARDIOGENIC SHOCK AND MULTI-SYSTEM ORGAN FAILURE. THE EVENT WAS DEEMED UNRELATED TO THE DEVICE. ALL EQUIPMENT WAS DISPOSED OF BY THE SITE. NO AUTOPSY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785702 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death