BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3935814 · Received July 15, 2014

    Report

    Report Number
    3007042319-2014-00662
    Event Type
    Death
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. THE PATIENT EXPERIENCED A TOTAL PUMP-OFF TIME OF APPROXIMATELY FIVE MINUTES AND REQUIRED AN INCREASE IN CATECHOLAMINE MEDICATION. THE PATIENT SUBSEQUENTLY EXPIRED. ONE CONTROLLER AND EIGHT BATTERIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE (B)(4) WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED 'ELECTRICAL FAULT' ALARMS AND 'VAD STOP' ALARMS. THESE CONDITIONS INDICATE INTERMITTENT ELECTRICAL CONNECTIONS OF THE DRIVELINE/DRIVELINE EXTENSION CABLE TO THE CONTROLLER OR THE DRIVELINE TO THE DRIVELINE EXTENSION CABLE. FAILURE ANALYSIS OF THE BATTERIES REVEALED THAT THE DEVICES MET SPECIFICATIONS; ALL BATTERIES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THOROUGH EXTERNAL VISUAL INSPECTION OF THE CONTROLLER REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION; FUNCTIONAL TESTING REVEALED THAT THE DEVICE PERFORMED PER SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED AND RESULTS OF DEVICE TESTING, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. NO DEVICE DEFECT OR MALFUNCTION COULD BE IDENTIFIED. A POSSIBLE ROOT CAUSE OF THE REPORTED 'VAD STOP' AND 'ELECTRICAL FAULT' ALARMS MAY BE ATTRIBUTED TO INTERMITTENT ELECTRICAL CONNECTIONS. 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. DEATH IS A KNOWN POTENTIAL CLINICAL ADVERSE EVENT ASSOCIATED WITH VADS AS OUTLINED IN THE IFU. EVENTS RELATED TO DEATH ARE MULTIFACTORIAL AND MAY BE ATTRIBUTED TO FAILED MODALITY, MEDICAL TREATMENT, PROGRESSION OF DISEASE, AND PATIENT COMORBIDITIES. PER THE INSTRUCTIONS FOR USE (IFU): PATIENTS ARE INSTRUCTED TO ALWAYS KEEP A BACK-UP CONTROLLER AVAILABLE AT ALL TIMES, BEYOND THE PRIMARY CONTROLLER THAT IS CURRENTLY IN USE. PATIENTS ARE INSTRUCTED TO CONTACT THE TREATING FACILITY IF THEY RECEIVE ANY OF A LIST OF CERTAIN ALARMS. 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

    ON POST-OPERATIVE DAY ONE FOLLOWING INITIAL IMPLANT, THIS PATIENT WAS IN THE OPERATING ROOM FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PLACEMENT, WHEN A HIGH-PRIORITY ALARM OCCURRED AFTER ONE BATTERY WAS REMOVED FROM THE PRIMARY CONTROLLER. IT WAS INTENDED TO BE REPLACED WITH THE CAC ADAPTER. THE ALARM REPORTEDLY RESOLVED WHEN THE CONTROLLER WAS CONNECTED TO THE MONITOR. FOLLOWING THE PROCEDURE, WHILE BEING TRANSFERRED BACK TO THE INTENSIVE CARE UNIT, A SECOND HIGH-PRIORITY ALARM OCCURRED WITH THE DISPLAY MESSAGE "ELECTRICAL FAULT". THERE WAS ASSOCIATED LOW FLOW FROM THE ECMO MACHINE AND THE TREATING TEAM HAD THE IMPRESSION THAT THE HVAD® PUMP HAD STOPPED. CONNECTING CAC POWER DID NOT RESOLVE THE ISSUE AND SO CARDIAC COMPRESSIONS COMMENCED. ONCE THEY HAD REACHED THE INTENSIVE CARE UNIT, A CONTROLLER EXCHANGE WAS PERFORMED AND THE PUMP RESTARTED. TOTAL PUMP-OFF TIME WAS ESTIMATED TO BE APPROXIMATELY FIVE MINUTES. THE PATIENT SUBSEQUENTLY REQUIRED AN INCREASE IN CATECHOLAMINE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412697 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death