BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4251980 · Received November 14, 2014

    Report

    Report Number
    3007042319-2014-01219
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 11, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE HAS INDICATED THAT THE PUMP REMAINS IMPLANTED, THEREFORE IT WILL NOT BE RETURNED. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VENTRICULAR ASSIST DEVICE (VAD) IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT FIFTEEN DAYS POST LVAD IMPLANTATION, THE PATIENT EXPIRED AS THE RESULT OF POST-OPERATIVE COMPLICATIONS. THE CLINICIANS REPORTED AN ABRUPT DROP IN FLOW WITH CARDIOGENIC SHOCK. ECHO REVEALED PERICARDIAL TAMPONADE ASSOCIATED WITH BLEEDING; THE PATIENT WENT ON TO DEVELOP MULTI ORGAN SYSTEM FAILURE. TESTING OF THE PUMP COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE DEVICE MET ALL REQUIREMENTS FOR RELEASE. A REVIEW OF THE CONTROLLER LOG FILES ASSOCIATED WITH THE EVENT CONFIRMED THE REPORTED DECREASE IN FLOW. LOGS INDICATE POWER CONSUMPTION AND ESTIMATED FLOW TO BE BELOW THE NORMAL OPERATING RANGE STARTING ON THE REPORTED EVENT DATE. WAVEFORM TRENDS OF THIS NATURE INDICATE OF A CHANGE IN PATIENT STATE AND CORRELATE WITH THE REPORTED INCIDENCE IF PERICARDIAL TAMPONADE AND ASSOCIATED BLEEDING. PERICARDIAL EFFUSION, TAMPONADE, AND RESPIRATORY DYSFUNCTION ARE KNOWN POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE IMPLANTATION OF THE HEARTWARE® SYSTEM AS ADDRESSED IN THE LABELING. THE ACCUMULATION OF BLOOD OR FLUID IN BLEEDING AND VOLUME OVERLOADED PATIENTS IS FREQUENTLY SEEN IN PATIENTS POST VAD IMPLANT. THESE COMPLICATIONS ARE INCLUDED IN THE (B)(6) DATABASE AND ARE OFTEN REPORTED IN CLINICAL MANUSCRIPTS. ALTHOUGH A DEFINITIVE CAUSE OF THE POST-OPERATIVE EVENTS CANNOT BE DETERMINED, THE MOST LIKELY ROOT CAUSE OF THE REPORTED LOW FLOW RATE IS DUE TO THE INCIDENCES OF GI BLEEDING AND A CARDIAC TAMPONADE EXPERIENCED BY THE PATIENT. FURTHERMORE, IT IS POSSIBLE THAT PERICARDIAL FLUID COLLECTION RESULTING IN CARDIAC TAMPONADE AND RESPIRATORY DISTRESS MAY HAVE BEEN IMPACTED BY CLINICAL FACTORS AND OPERATIONAL CONTEXT. MOREOVER, THE MOST LIKELY ROOT CAUSE OF THE CARDIAC TAMPONADE AND BLEEDING ARE DUE PATIENT COMPLICATIONS RESULTING FROM THE VAD IMPLANTATION. REVIEW OF THE REPORTED INFORMATION AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF A RELATIONSHIP TO ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES. 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. SERIOUS AND LIFE THREATENING ADVERSE EVENTS, INCLUDING DEVICE THROMBOSIS, HAVE BEEN ASSOCIATED WITH USE OF THIS DEVICE AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES OF INR BETWEEN 2.0 AND 3.0). WHILE THERE IS NO EVIDENCE BASED ON THE AVAILABLE INFORMATION, IT MAY BE POSSIBLE THAT THERE WERE SOME UNDERLYING HEALTH CONDITIONS THAT COULD HAVE PREDISPOSED THE PATIENT TO THIS EVENT. FROM ALL INDICATIONS THE DEVICE OPERATED WITHIN SPECIFICATIONS AND AS INTENDED WITH NO INDICATION OF ANY DEVICE PERFORMANCE ISSUES CONTRIBUTING TO THE EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. (B)(4).

    Description of Event or Problem · 1

    FIFTEEN DAYS POST LVAD IMPLANTATION THIS PATIENT EXPIRED AS THE RESULT OF POST-OPERATIVE COMPLICATIONS. THE CLINICIANS REPORTED AN ABRUPT DROP IN FLOW WITH CARDIOGENIC SHOCK. ECHO REVEALED PERICARDIAL TAMPONADE ASSOCIATED WITH BLEEDING. INTERVENTIONS INCLUDED CARDIOPULMONARY RESUSCITATION, ADDITIONAL SURGERY AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. THE PATIENT WENT ON TO DEVELOP MULTI ORGAN SYSTEM FAILURE. THE THERAPEUTIC TEAM DID NOT REPORT A CAUSAL RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736897 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death