BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6088784 · Received November 9, 2016

    Report

    Report Number
    3007042319-2016-04039
    Event Type
    Death
    Date Received
    November 9, 2016
    Date of Event
    August 4, 2016
    Report Date
    August 8, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 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. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUEL ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT. DEATH IS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. CLINICAL RESULTS AND COMMERCIAL EXPERIENCE DEMONSTRATE THAT THE PLACEMENT OF A VAD IN CHRONIC NYHA CLASS IV PATIENTS IMPROVES SURVIVAL AND QUALITY OF LIFE WHEN COMPARED TO A SIMILAR PATIENT POPULATION RECEIVING CONVENTIONAL THERAPY. FURTHERMORE, THESE BENEFITS APPLY TO PATIENTS BEING BRIDGED TO HEART TRANSPLANT, PATIENTS RECEIVING PERMANENT SUPPORT (DESTINATION THERAPY), AND THOSE BEING SUPPORTED WITH THE EXPECTATION FOR MYOCARDIAL RECOVERY. CARDIAC ARRYTHMIAS ARE 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. CATALOG # : 1650 SERIAL #: UNKNOWN BATTERY. (B)(4). METHOD: ACTUAL DEVICE NOT EVALUATED (B)(4). RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (B)(4). CONCLUSION: DEVICE NOT RETURNED (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) WAS RETURNED TO HEARTWARE FOR EVALUATION; A BATTERY WITH AN UNKNOWN SERIAL NUMBER WAS NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED A CONTROLLER POWER UP AND MOTOR START EVENT WAS RECORDED ON (B)(6) 2016 AT 09:58:41 INDICATING A LOSS OF POWER TO THE CONTROLLER. THE LAST DATA POINT RECORDED BEFORE THE LOSS OF POWER WAS AT 09:47:36 LEAVING AN APPROXIMATE PUMP OFF TIME OF 11 MINUTES. THE LAST DATA POINT BEFORE THE LOSS OF POWER DEMONSTRATED TWO BATTERIES WERE CONNECTED TO THE CONTROLLER WITH CHARGES OF 98% AND 91%. TWO MORE CONTROLLER POWER UP AND MOTOR START EVENTS WERE RECORDED AT 09:59:34 AND 10:26:45 LEAVING AN APPROXIMATE PUMP OFF TIME BETWEEN 12-27 MINUTES. THE NEXT DATA POINT RECORDED AFTER THE CONTROLLER POWER UP AND MOTOR START EVENTS WAS AT 10:41:46. A BATTERY WITH 65% WAS CONNECTED TO POWER SOURCE PORT 1 AND NO POWER SOURCE WAS CONNECTED TO PORT 2. ONE LAST CONTROLLER POWER UP AND MOTOR START EVENT WAS RECORDED AT 11:00:52. THE LAST DATA POINT RECORDED BEFORE THE LAST LOSS OF POWER WAS AT 10:56:47 LEAVING A MAXIMUM PUMP OFF TIME OF 4 MINUTES. THE LAST DATA POINT BEFORE THE LAST LOSS OF POWER DEMONSTRATED A BATTERY WITH 63% CHARGE CONNECTED TO POWER SOURCE PORT 1 AND NO POWER SOURCE CONNECTED TO POWER SOURCE PORT 2. 21 LOW FLOW ALARMS WERE RECORDED STARTING ON (B)(6) 2016 AT 10:37:19 AND WERE OBSERVED THROUGH (B)(6) 2016. ANALYSIS OF THE PUMP REVEALED THAT THE DEVICE MET SPECIFICATIONS; THE PUMP PASSED VISUAL INSPECTION, DIMENSIONAL VERIFICATION, AND FUNCTIONAL TESTING. INDEPENDENT PATHOLOGICAL EVALUATION DID NOT REVEAL ANY EVIDENCE OF THROMBUS FORMATION. 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 EVENT CAN BE ATTRIBUTED TO A DOUBLE DISCONNECT OF THE POWER SOURCES FROM THE CONTROLLER. 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 CLINICAL STUDY DATABASE THAT THIS PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) OF AN OUTSIDE HOSPITAL IN CARDIAC ARREST. THE PATIENT WAS UNRESPONSIVE WITH PUPILS FIXED AND DILATED. TIME OF COLLAPSE AT THE TIME OF ADMISSION WAS UNKNOWN; HOWEVER, THE MEDICAL TEAM REPORTED THAT THE PATIENT HAD A LOW BATTERY ALARM UPON ARRIVAL TO THE EMERGENCY DEPARTMENT. THE PATIENT'S FAMILY WENT HOME AND RETRIEVED A NEW BATTERY TO EXCHANGE THE DEPLETED BATTERY. PRELIMINARY LOG FILE ANALYSIS PERFORMED BY THE SITE REVEALED POWER CONSUMPTION BELOW NORMAL OPERATING RANGES AND 21 "LOW FLOW" ALARMS SINCE (B)(6) 2016. THE PATIENT WAS ALSO REPORTED TO BE CONNECTED TO AC POWER AND ONE BATTERY DURING THE TIME OF THE REPORTED EVENT. THE PATIENT SUBSEQUENTLY EXPIRED. AUTOPSY RESULTS PROVIDED BY THE SITE DETERMINED THE CAUSE OF DEATH TO BE RELATED TO ANOXIC BRAIN INJURY. AUTOPSY REPORTS ALSO REVEALED "LOW FLOW" AND "REPLACE BATTERY" MESSAGES DISCOVERED AFTER THE PATIENT WAS FOUND DOWN AT HOME". THERE WAS NO EVIDENCE OF "ANTEMORTEM" THROMBOSIS OF THE INFLOW CANNULA, OUTFLOW GRAFT, OR LEFT VENTRICLE. THERE WAS ALSO NO EVIDENCE OF STRUCTURAL ABNORMALITY OF THE HEART. THE SITE REPORTED THAT THEY DID NOT BELIEVE "THE VAD WAS CAUSE FOR ISSUE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741659 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death