BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5574228 · Received April 13, 2016

    Report

    Report Number
    3007042319-2016-01615
    Event Type
    Death
    Date Received
    April 13, 2016
    Date of Event
    March 4, 2016
    Report Date
    April 4, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE HEARTWARE® 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. THROMBUS IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE LABELING. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    HVAD PUMP (B)(4) WAS NOT RETURNED TO HEARTWARE FOR EVALUATION. THIS COMPLAINT IS ASSOCIATED WITH A CLINICAL ADVERSE EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF CONTROLLER LOG FILES WAS NOT POSSIBLE SINCE LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS RE-ADMITTED WITH HEMATURIA, ELEVATED HVAD FLOWS, ELEVATED LACTATE DEHYDROGENASE (LDH) LEVELS AND ACUTE KIDNEY INJURY ON (B)(6) 2016. THE PATIENT WAS GIVEN "GENTLE HYDRATION" WITH LASIX AS NEEDED TO PROTECT HIS KIDNEYS. GIVEN THE RECURRENT NATURE OF THE PATIENT'S ADMISSIONS FOR THIS ISSUE AND HIS LIMITED TREATMENT OPTIONS, A DECISION WAS MADE TO TURN THE HVAD PUMP OFF ON (B)(6) 2016. THIS MEASURE WAS ALSO REPORTED TO HAVE BEEN TO PREVENT THE COMPLICATIONS OF FURTHER PUMP THROMBOSIS. THE PATIENT DEVELOPED SYMPTOMS OF WORSENING HEART FAILURE, CARDIOGENIC SHOCK AND MULTI-ORGAN SYSTEM FAILURE (MOSF) AND WAS STARTED ON DOBUTAMINE AND LASIX FOR SUPPORT. A DECISION WAS MADE TO CHANGE THE PATIENT'S STATUS TO DO NOT RESUSCITATE/INTERVENE AND THE PATIENT EXPIRED ON (B)(6) 2016. THE PRIMARY INVESTIGATOR REPORTED THAT THE SUSPECTED THROMBUS EVENT WAS RELATED TO THE HVAD SYSTEM AND UNRELATED TO THE PATIENT'S CONDITION OR TO THE HVAD PROCEDURE AND THAT THE ACUTE RENAL FAILURE WAS RELATED TO THE HVAD SYSTEM AND TO THE PATIENT'S CONDITION AND UNRELATED TO THE HVAD PROCEDURE. THE HVAD PUMP ((B)(4) ) REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF CONTROLLER LOG FILES WAS NOT POSSIBLE SINCE LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE POSSIBLE ISSUES WITH THE MANAGEMENT OF THE PATIENT'S THERAPEUTIC ANTICOAGULATION AND ANTIPLATELET MEDICATIONS, THE RECURRENT NATURE OF THE PATIENT'S HEMOLYSIS AND THE PATIENT'S PAST MEDICAL HISTORY AND RELATED COMORBIDITIES. ALTHOUGH THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED, THERE ARE PATIENT AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THE SYSTEM IS INDICATED FOR USE UNDER THE DIRECT SUPERVISION OF A LICENSED PRACTITIONER OR BY PERSONNEL TRAINED IN ITS' PROPER USE. THESE PROFESSIONALS SHOULD BE AWARE OF THE PHYSICAL AND PSYCHOLOGICAL NEEDS OF PATIENTS UNDERGOING LVAD SUPPORT. 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. DEATH, DEVICE THROMBOSIS, HEMOLYSIS, HEPATIC DYSFUNCTION, MULTI-ORGAN FAILURE, RENAL DYSFUNCTION AND WORSENING LEFT HEART FAILURE ARE KNOWN POTENTIAL COMPLICATIONS THAT MAY BE ASSOCIATED WITH USE OF THIS PRODUCT AND IN PATIENTS WITH HEART FAILURE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE US A PATIENT COMPLAINTS OF LVAD FLOWS >10 WITH ELEVATED LDH. AFTER MULTIPLE ADMISSIONS FOR THROMBUS AND TREATMENT PROVIDED, THE TREATMENT TEAM DECIDED TO TURN THE DEVICE OFF ON (B)(6) 2016. THE PATIENT HAD SIGNS AND SYMPTOMS OF WORSENING HEART FAILURE AND WAS STARTED ON DOBUTAMINE AND LASIX. THE PATIENT WAS MADE "DNR/DNI" AND EXPIRED ON (B)(6) 2016. THE TREATMENT TEAM BELIEVE THE EVENT IS RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227950 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| H| O