BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6340599 · Received February 17, 2017

    Report

    Report Number
    3007042319-2017-00477
    Event Type
    Death
    Date Received
    February 17, 2017
    Date of Event
    January 25, 2017
    Report Date
    January 25, 2017
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 03/02/2017 STATES THAT AFTER THE PATIENT RECEIVED THE TISSUE PLASMINOGEN ACTIVATOR (TPA) PROTOCOL, THE PUMP CONTINUED TO SHOW HIGH POWERS. IT WAS FURTHER REPORTED THAT THE PUMP OCCLUDED AND THE PATIENT WENT INTO CARDIAC ARREST, WHICH IS THE OFFICIAL CAUSE OF DEATH. THERE WAS NO AUTOPSY PERFORMED AND THE PUMP WOULD NOT BE RETURNED FOR EVALUATION. OF NOTE: PATIENT WAS (B)(6). HW22844 WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING RECORDS CONFIRMED THAT THE ASSOCIATED PUMP MET ALL REQUIREMENTS FOR RELEASE. LOG FILE ANALYSIS REVEALED 4 LOW FLOW ALARMS HAVE BEEN LOGGED SINCE JANUARY 23, 2017. THE 16 HIGH WATT ALARMS HAVE BEEN LOGGED SINCE JANUARY 25, 2017, CONFIRMING THE REPORTED EVENT. WAVEFORMS INDICATE A DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOW STARTING ON JANUARY 13, 2017 TO PARAMETERS BELOW NORMAL OPERATION ON JANUARY 24, 2017. THERE IS THEN A RISE IN POWER CONSUMPTION TO A PEAK OF 6.2W ON JANUARY 25, 2017 OUTSIDE OF NORMAL POWER CONSUMPTION. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED HIGH WATT ALARMS CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION. LVAD PUMP CANDIDATES OFTEN POSSESS RISK FACTORS FOR INTRAVASCULAR COAGULATION WHICH MAY INCLUDE ARTERIAL AND/OR VENOUS VASCULAR DISEASE, CHRONIC LOW FLOW STATE AND DECREASED IMMOBILITY. PHARMACOLOGICAL AND CLINICAL FACTORS RELATED TO ANTICOAGULATION THERAPY MAY ALSO HAVE CONTRIBUTED TO THE REPORTED EVENT. THOUGH THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED, THERE ARE PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    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 SYSTEM IS DESIGNED TO ASSIST A WEAKENED, POORLY FUNCTIONING LEFT VENTRICLE. THE IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. THESE SURGICAL PROCEDURES ARE ASSOCIATED WITH NUMEROUS RISKS. PUMP THROMBUS/THROMBOSIS IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS. THE FOR USE ADDRESSES SETTING PARAMETERS FOR THE HIGH POWER ALARM THRESHOLD, HOW TO RECOGNIZE HIGH WATT ALARMS AND GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES). 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 THAT THE PATIENT HAD SEVERAL HIGH WATT ALARMS. THE PATIENT WAS HOSPITALIZED AND IT WAS FOUND THAT THE PATIENT HAD AN INTERNATIONAL NORMALIZED RATION (INR) OF 4.89 AND FREE HEMOGLOBIN OF 11.2.  THE PATIENT WAS STARTED ON A TISSUE PLASMINOGEN ACTIVATOR (TPA) PROTOCOL AND DIRECT ANTICOAGULATION INJECTION INTO THE LEFT VENTRICLE. PRIOR TO THE ADMISSION, THE PATIENT WAS CONTROLLED ON THE ANTICOAGULATION AND THERE WAS NO PAST MEDICAL HISTORY OR RECENT ILLNESS THAT PUT THE PATIENT AT RISK FOR THROMBUS. THE PATIENT WAS REPORTED TO HAVE EXPIRED ON (B)(6) 2017. THE MEDICAL TEAM DOES NOT BELIEVE THE EVENT WAS DEVICE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123202 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death