BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6041460 · Received October 19, 2016

    Report

    Report Number
    3007042319-2016-03634
    Event Type
    Death
    Date Received
    October 19, 2016
    Date of Event
    July 26, 2016
    Report Date
    October 6, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 COMORBIDIES 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. MULTI SYSTEM FAILURE AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE IMPLANTATION OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE. RIGHT HEART FAILURE IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE IMPLANTATION OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). ALTHOUGH THE ETIOLOGY OF THE RIGHT HEART FAILURE AND RELATIONSHIP TO THE DEVICE AND PROCEDURE CANNOT BE DETERMINED, IT MAY BE A PROGRESSION OF CHRONIC HEART DISEASE, CORONARY ARTERY DISEASE OR RIGHT VENTRICULAR INFARCTION. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT. 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 FROM THE SITE BY THE VAD COORDINATOR THAT THE PATIENT DID NOT THRIVE POST-IMPLANT OF LVAD AND CENTRIMAG (C-MAG). IT WAS ALSO STATED THAT THE PATIENT HAD SEVERAL GASTROINTESTINAL (GI) BLEEDS WHILE IN HOSPITAL WITH MULTIPLE GI INTERVENTIONS. IT WAS FURTHER STATED THAT THE PATIENT CONTINUED TO DECLINE IN STATUS ESCALATING TO MULTI SYSTEM ORGAN FAILURE REQUIRING RE-INTUBATION AND DIALYSIS SUPPORT AND CONTINUED C-MAG SUPPORT. PALLIATIVE CARE CONSULTED ON (B)(6) 2016 AND FAMILY DECIDED TO WITHDRAW CARE ON (B)(6) 2016. PATIENT EXPIRED ON (B)(6) 2016. IT WAS STATED THAT THERE WOULD BE NO AUTOPSY PERFORMED AND THAT THE PUMP WOULD REMAIN IMPLANTED. IT WAS STATED THAT ALL PERIPHERALS WERE DISPOSED OF BY THE SITE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CAUSE OF DEATH IS ATTRIBUTED TO MULTISYSTEM ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693406 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death