BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP

    MDR report key: 7097549 · Received December 7, 2017

    Report

    Report Number
    3007042319-2017-04616
    Event Type
    Death
    Date Received
    December 7, 2017
    Date of Event
    December 4, 2017
    Report Date
    May 11, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. NO DEVICE MALFUNCTION WAS REPORTED THEREFORE, THE PURPOSE OF THIS INVESTIGATION IS SOLELY TO EVALUATE THE DEVICE CONFORMANCE TO INTERNAL RELEASE REQUIREMENTS AND/OR TO IDENTIFY ANOMALIES POTENTIALLY INTRODUCED DURING USE THAT MAY HAVE PREVENTED THE PUMP FROM PERFORMING AS INTENDED. REVIEW OF LOG FILES REVEALED POWER CONSUMPTION WITHIN NORMAL OPERATING PARAMETERS FOR 14 DAYS PRIOR TO EVENT DATE OF (B)(6) 2017. 61 LOW FLOW ALARMS HAVE BEEN LOGGED SINCE (B)(6) 2017. ANALYSIS OF THE RETURNED PUMP REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION, FUNCTIONAL TESTING AND DIMENSIONAL VERIFICATION. PATHOLOGY REPORT REVEALED NO EVIDENCE OF THROMBUS WITHIN THE DEVICE. THERE IS NO EVIDENCE OF A MALFUNCTION THAT MAY HAVE PREVENTED THE PUMP FROM PERFORMING AS INTENDED. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE LOW FLOWS OBSERVED DURING LOG FILE ANALYSIS MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA, CONSTRICTION IN THE OUTFLOW GRAFT, POOR VAD FILLING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENTS. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A HEADACHE. THE PATIENT WAS TRANSFERRED TO THE WARD AND GLASGOW COMA SCALE (GCS) DECREASED. A COMPUTERIZED TOMOGRAPHY (CT) SCAN IDENTIFIED AN INTRACRANIAL BLEED. THE PATIENT WAS TAKEN SEVERAL TIMES FOR EVACUATION AND DECOMPRESSION PROCEDURE. HOWEVER, DEVASTATING STROKE AND THE PATIENT WAS MADE PALLIATIVE CARE. INTERNATIONAL NORMALIZED RATIO (INR) HAD BEEN BETWEEN 2.0-3.0. AND MEAN ATRIAL PRESSURE (MAP) 64. THE NEUROLOGICAL EVENT WAS INITIALLY A THROMBOEMBOLIC EVENT THAT ESCALATED TO A HAEMORRHAGIC EVENT AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875845 HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Death