BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8862028 · Received August 5, 2019

    Report

    Report Number
    2916596-2019-03461
    Event Type
    Death
    Date Received
    August 5, 2019
    Date of Event
    July 15, 2019
    Report Date
    October 15, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. DEVICE THROMBOSIS AND HEMOLYSIS ARE LISTED IN THE HEARTMATE II IFU AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE PATIENT CARE AND MANAGEMENT SECTION OF THE IFU OUTLINES INDICATIONS OF THROMBUS AND HOW TO RESPOND TO SUCH EVENTS. THE PATIENT CARE AND MANAGEMENT SECTION OF THE IFU ALSO DISCUSSES ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES. THE PUMP PERFORMANCE MONITORING SECTION EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING AND PROVIDES INFORMATION REGARDING THE ASSESSMENT OF PUMP FLOW. PUMP PARAMETERS, INCLUDING PUMP POWER AND FLOW, ARE DETAILED IN THE INTRODUCTION SECTION OF THE HMII IFU. THE HMII IFU STATES THAT CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. GRADUAL POWER INCREASES (OVER HOURS OR DAYS) MAY SIGNAL THROMBUS DEPOSITS INSIDE THE PUMP. DEPENDING ON THE SPEED OF THE PUMP, POWER VALUES GREATER THAN 10 TO 12 WATTS (W) ALSO CAN INDICATE THE PRESENCE OF A THROMBUS. ABRUPT CHANGES IN POWER SHOULD BE EVALUATED FOR CAUSE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE APPROXIMATE AGE OF THE DEVICE WAS 1 YEAR AND 8 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO PUMP THROMBOSIS. REPORTEDLY, HEART FAILURE SYMPTOMS HAD RETURNED ALONG WITH ELEVATED LACTATE DEHYDROGENASE (LDH) LEVELS. PUMP POWER AND FLOW WERE ALSO ELEVATED AND EJECTION FRACTION WAS 45%. THE PATIENT WAS FULLY ANTICOAGULATED WITH HEPARIN IN LATE (B)(6) DURING A RIGHT HEART CATHETERIZATION PROCEDURE AND WAS BRIDGED BACK TO COUMADIN PRIOR TO DISCHARGE. THE PATIENT WAS KEPT AT AN INTERNATIONAL NORMALIZED RATIO (INR) OF 1.8-2.2. TEN DAYS AFTER DISCHARGE THE PATIENT WAS READMITTED DUE TO THE MENTIONED HEART FAILURE SYMPTOMS AND ELEVATED LDH. THE PATIENT IMPROVED WITH DIURETIC AND THE HEALTHCARE TEAM WAS WORKING ON A PLAN TO EXCHANGE THE PUMP WHEN THE PATIENT BEGAN TO QUICKLY DECOMPENSATE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655402 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 6171030 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death