BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5103850 · Received September 25, 2015

    Report

    Report Number
    3007042319-2015-02292
    Event Type
    Death
    Date Received
    September 25, 2015
    Date of Event
    August 9, 2015
    Report Date
    August 28, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    {ON (B)(6) 2015 PATIENT DEVELOPED SEVERE DYSPHAGIA ALSO DEPRESSION AND ANXIETY DISORDER. ON (B)(6) 2015 "SUSPECTED LUNG ASPIRATION." ON (B)(6) 2015 THERE WAS AN "OCCLUSION OF LEFT MEDIAL CEREBRAL ARTERY DIAGNOSED, NEURORADIOLOGIC INTERVENTION, BLEEDING IN TO LEFT BRAIN VENTRICLE." AND ON (B)(6) 2015 THERE WAS AN "OCCLUSION OF ANTERIOR CEREBRAL ARTERY IN CT-SCAN DIAGNOSED." IT WAS STATED BY THE PHYSICIAN THAT THE "PATIENT WAS ON THERAPEUTIC ANTICOAGULATION WITH LOW MOLECULAR HEPARIN, WHICH WAS AN INTERDISCIPLINARY DECISION BETWEEN NEURO SURGERY AND VAD SURGERY, BLEEDING CONTRA EMBOLISM. SECONDARY EMBOLISM DUE TO NOT OPTIMAL ANTICOAGULATION." ON "(B)(6) 2015: PATIENT HAD SUB-THERAPEUTIC INR (1.8 - 2.0) AND RECEIVED LOW MOLECULAR HEPARIN (LMH) FOR BRIDGING. THE DAY BEFORE AND AT THE DAY OF THE EVENT PATIENT DID NOT INJECT LMH. IT WAS FURTHER STATED BY PHYSICIAN THAT THIS EVENT WAS NOT CAUSED BY A DEVICE MALFUNCTION. THERAPY WAS DISCONTINUED ON (B)(6) 2015. THE OFFICIAL CAUSE OF DEATH ((B)(6) 2015), WAS STATED TO BE: HEMODYNAMIC INSTABILITY DUE TO CNS DYSREGULATION CAUSED BY OCCLUSION OF MEDIAL CEREBRAL ARTERY. PHYSICIAN IS STATING THAT THE EVENTS ARE CAUSED BY INCOMPLIANCE OF PATIENT REGARDING ANTICOAGULATION, RESULTING IN HCVA AND ITS CONSEQUENCES IN CONSIDERING THE RISKS FOR ANTICOAGULATION.} SERIOUS AND LIFE THREATENING ADVERSE EVENTS HAVE BEEN ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDING NEUROLOGICAL DYSFUNCTION, STROKE AND BLEEDING 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 WITH A WARNING TO MAINTAIN ANTICOAGULATION WITHIN THE RECOMMENDED INR RANGE OF 2.0-3.0. HEMORRHAGIC TRANSFORMATION IS A KNOWN MULTIFACTORIAL PHENOMENON IN WHICH ISCHEMIC BRAIN TISSUE CONVERTS INTO A HEMORRHAGIC LESION DUE TO LOSS OF MICROVASCULAR INTEGRITY WITH BLOOD-VESSEL LEAKAGE, EXTRAVASATION AND FURTHER BRAIN INJURY. AS REPORTED BY THE PHYSICIAN THE EVENT WAS NOT CAUSED BY A DEVICE MALFUNCTION WITH THE OFFICIAL CAUSE OF DEATH STATED TO BE: HEMODYNAMIC INSTABILITY DUE TO CNS DYSREGULATION CAUSED BY OCCLUSION OF MEDIAL CEREBRAL ARTERY. IT WAS FURTHER REPORTED BY THE PHYSICIAN TO BE CAUSED BY "INCOMPLIANCE OF PATIENT REGARDING ANTICOAGULATION, RESULTING IN HCVA". WITH REVIEW OF THE AVAILABLE INFORMATION AND AS REPORTED, CLINICAL STATUS, COMORBIDITIES, PHARMACOLOGICAL FACTORS AND THIS PATIENT'S SUB-THERAPEUTIC INR AND NONCOMPLIANCE ARE IDENTIFIED CONTRIBUTING FACTORS. THERE IS NO INDICATION OF ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    LOG FILE ANALYSIS REVIEW DATE: 08/10/2015; LOG DATES THROUGH (B)(6) 2015: NORMAL POWER CONSUMPTION. ADDITIONAL NOTES: NO ALARMS HAVE BEEN LOGGED IN THE LAST 14 DAYS OF AVAILABLE DATA. LOG FILE ANALYSIS REVIEW DATE: 08/19/2015; LOG DATES THROUGH (B)(6) 2015: NORMAL POWER CONSUMPTION. ADDITIONAL NOTES: WAVEFORMS INDICATE A SLIGHT DECREASE IN POWER CONSUMPTION STARTING ON (B)(6) 2015. 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. PER THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL: OUTLINES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING MEDICAL MANAGEMENT AND THERAPEUTIC ANTICOAGULATION GUIDELINES WITH A WARNING TO MAINTAIN ANTICOAGULATION WITHIN THE RECOMMENDED INR RANGE OF 2.0-3.0. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE CONCLUSION CANNOT BE MADE REGARDING FACTORS POTENTIALLY CONTRIBUTING TO THE REPORTED EVENT HOWEVER, IN ADDITION TO REQUIRED ADEQUATE ANTICOAGULATION, LVAD PUMP CANDIDATES OFTEN POSSESS SEVERAL RISK FACTORS FOR INTRAVASCULAR COAGULATION WHICH MAY INCLUDE ARTERIAL AND/OR VENOUS VASCULAR DISEASE, CHRONIC LOW FLOW STATE AND DECREASED MOBILITY. STROKE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS. THE INSTRUCTIONS FOR USE (IFU) ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES). ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE VAD INCLUDE WARNING OF SERIOUS AND LIFE THREATENING ADVERSE EVENTS, SUCH AS NEUROLOGIC DYSFUNCTION AND MYOCARDIAL INFARCT. 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 (B)(6) THAT THE "PATIENT WAS SUBMITTED TO THE HOSPITAL ON (B)(6) 2015 WITH INTRACRANIAL VASCULAR ACCIDENT (ICVA) AND LEFT SIDED HEMIPARESIS." "DIAGNOSIS, ISCHEMIA IN AREA OF MEDIAL CEREBRAL ARTERY DUE TO OCCLUSION OF RIGHT INTERNAL CAROTID ARTERY, THERAPY PTA WITH THROMBECTOMY" WAS PERFORMED. "POSTOPERATIVELY A LARGE RIGHT SIDED INTRACRANIAL BLEEDING OCCURRED, REQUIRING HEMICRANECTOMY ON (B)(6) 2015." ON (B)(6) 2015 PATIENT HAD A "COMPLICATED POSTERIOR WALL INFARCTION" OCCUR AND ON (B)(6) 2015 PATIENT SUFFERED A "SUBARACHNOID BLEEDING." NO ADDITIONAL INFORMATION PROVIDED. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634127 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death| H| L| R