BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6087225 · Received November 8, 2016

    Report

    Report Number
    3007042319-2016-03864
    Event Type
    Death
    Date Received
    November 8, 2016
    Date of Event
    April 2, 2015
    Report Date
    April 13, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEUROLOGICAL DYSFUNCTION IS A KNOWN POTENTIAL CLINICAL ADVERSE EVENT ASSOCIATED WITH VADS AS OUTLINED IN THE IFU. EVENTS OF THESE TYPES ARE MULTIFACTORIAL AND MAY BE ATTRIBUTED TO PRE-EXISTING CONDITIONS AND PROGRESSION OF THESE DISEASES, THE HVAD SYSTEM, THE IMPLANT PROCEDURE, OR CONCOMITANT THERAPY. THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING OR PERFORMANCE ISSUES RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER NEUROLOGICAL DYSFUNCTION IS A KNOWN INHERENT RISK ASSOCIATED WITH VAD THERAPY. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. 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 STROKE, HAVE BEEN ASSOCIATED WITH USE OF THIS DEVICE. A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. NEUROLOGICAL DYSFUNCTION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING MEDICAL MANAGEMENT AND THERAPEUTIC ANTICOAGULATION GUIDELINES TO MINIMIZE THE RISKS. HEARTWARE IS SUBMITTING THIS CORRECTION TO A PREVIOUSLY SUBMITTED MDR 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SITE THAT THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2015 WITH SLURRED SPEECH AND COMPLETE LEFT-SIDED PARALYSIS. COMPUTED TOMOGRAPHY (CT) SCAN REVEALED ACUTE, AND SUBACUTE SMALL INFARCTIONS IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) TERRITORY. PATIENT WAS TRANSFERRED FROM THE EMERGENCY ROOM (ER) TO THE IMPLANTING HOSPITAL ON (B)(6) 2015. CT SCAN TAKEN ON (B)(6) 2015 SHOWED AN ACUTE RIGHT MIDDLE CEREBRAL ARTERY DISTRIBUTION INFARCTION. IT WAS STATED THAT THE PATIENT HAD AN ISCHEMIC CARDIOVASCULAR ACCIDENT (ICVA) THAT CONVERTED INTO A HEMORRHAGIC NEUROLOGICAL DYSFUNCTION. PATIENT WAS TRANSFERRED TO NEUROLOGY INTENSIVE CARE UNIT (ICU) ON (B)(6) 2015. DOBHOFF FEEDING TUBE WAS PLACED ON (B)(6) 2015. PATIENT WAS MADE A DO NOT RESUSCITATE (DNR) AND TRANSFERRED BACK TO IMPLANTING HOSPITAL ON (B)(6) 2015. THE PATIENT WAS FOLLOWED BY SPEECH, PHYSICAL THERAPY, AND OCCUPATIONAL THERAPY TEAMS WHILE IN HOSPITAL. A JEJUNOSTOMY FEEDING TUBE (J-TUBE) WAS INSERTED ON (B)(6) 2015 FOR NUTRITION. THE PATIENT WAS RESPONSIVE WITH LEFT HEMIPARESIS. PATIENT WAS DISCHARGED IN STABLE CONDITION TO A LONG-TERM ACUTE CARE FACILITY ON (B)(6) 2015. THE PATIENT WAS RE-ADMITTED FROM THE LONG-TERM ACUTE CARE FACILITY ON (B)(6) 2015 DUE TO DYSPNEA AND DISLODGEMENT OF J-TUBE. THE PATIENT WAS UNABLE TO SPEAK AND REMAINED FLACCID ON THE LEFT SIDE. AFTER LONG DISCUSSION WITH FAMILY IT WAS DECIDED J-TUBE WOULD NOT BE RE-INSERTED AND THE LVAD WOULD BE DISCONTINUED. LVAD WAS TURNED OFF ON (B)(6) 2015 AT APPROXIMATELY 13:00 AND THE PATIENT EXPIRED ON (B)(6) 2015 AT 12:05 AM. THE PRIMARY INVESTIGATOR DEEMED THE EVENT AS RELATED TO PATIENT CONDITION, POSSIBLY RELATED TO THE LVAD, AND UNRELATED TO THE LVAD PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736994 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death