BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5055074 · Received September 3, 2015

    Report

    Report Number
    3007042319-2015-02070
    Event Type
    Death
    Date Received
    September 3, 2015
    Date of Event
    July 24, 2015
    Report Date
    August 5, 2015
    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

    THE HEARTWARE VAD 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, INCLUDING TRANSPORTATION. IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, A MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. THESE SURGICAL PROCEDURES AND THE USE OF THE DEVICE ARE ASSOCIATED WITH NUMEROUS RISKS. RIGHT HEART FAILURE AND RESPIRATORY DYSFUNCTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE IMPLANTATION OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). IT USUALLY DEVELOPS WITHIN THE FIRST 24 HOURS AFTER LVAD IMPLANTATION. ALTHOUGH UNUSUAL, IT MAY OCCUR AT LONGER POST IMPLANT INTERVALS, WHICH MAY BE DUE TO PROGRESSION OF CHRONIC HEART DISEASE OR RIGHT VENTRICULAR INFARCTION. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT BOTH PRE AND POST OPERATIVELY INCLUDING TREATMENT RELATED TO RIGHT HEART FAILURE. CLINICAL AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE EVENTS. WITH REVIEW OF THE AVAILABLE INFORMATION AND AS REPORTED, THERE IS NO EVIDENCE TO SUGGEST A RELATIONSHIP TO ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES TO THE EVENTS. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, A MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. THESE SURGICAL PROCEDURES AND THE USE OF THE DEVICE ARE ASSOCIATED WITH NUMEROUS RISKS. RIGHT HEART FAILURE AND RESPIRATORY DYSFUNCTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE IMPLANTATION OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). IT USUALLY DEVELOPS WITHIN THE FIRST 24 HOURS AFTER LVAD IMPLANTATION. ALTHOUGH UNUSUAL, IT MAY OCCUR AT LONGER POST IMPLANT INTERVALS, WHICH MAY BE DUE TO PROGRESSION OF CHRONIC HEART DISEASE OR RIGHT VENTRICULAR INFARCTION. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT BOTH PRE AND POST OPERATIVELY INCLUDING TREATMENT RELATED TO RIGHT HEART FAILURE. CLINICAL AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE EVENTS. WITH REVIEW OF THE AVAILABLE INFORMATION AND AS REPORTED, THERE IS NO EVIDENCE TO SUGGEST A RELATIONSHIP TO ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES TO THE EVENTS. 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

    THE PERFUSIONIST AT THE HOSPITAL REPORTED THAT THE PATIENT DEVELOPED RIGHT VENTRICULAR FAILURE FOLLOWING LEFT VENTRICULAR (LVAD) IMPLANT REQUIRING EXTENDED USE OF INOTROPIC THERAPY. THE PATIENT DEVELOPED ADULT RESPIRATORY DISTRESS SYNDROME (ARDS) POST-OP AS WELL AND WAS NEVER EXTUBATED. THE SITE DESCRIBED PATIENT AS "FAILURE TO THRIVE." A FAMILY MEETING HELD AND CARE WAS WITHDRAWN ON (B)(6) 2015. THE PATIENT EXPIRED LATER THAT DAY. NO AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT'S DEATH IS NOT RELATED TO DEVICE MALFUNCTION AND THEREFORE, NO EQUIPMENT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583909 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death