BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 11942260 · Received June 4, 2021

    Report

    Report Number
    2916596-2021-02676
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    May 10, 2021
    Report Date
    July 30, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE II LVAS IFU IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS CARDIAC ARRHYTHMIA AND HEMOLYSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, ALSO LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 1 ALSO EXPLAINS THAT WHEN THE LEFT VENTRICLE CONTRACTS, THE INCREASE IN VENTRICULAR PRESSURE CAUSES AN INCREASE IN PUMP FLOW DURING CARDIAC SYSTOLE. THE MAGNITUDE OF THESE FLOW PULSES ARE MEASURED AND AVERAGED OVER 15-SECOND INTERVALS TO PRODUCE A ¿PULSATILITY INDEX.¿ SECTION 4 STATES THAT PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. THESE EVENTS ARE ALSO REFERRED TO AS PI EVENTS, AND MAY BE INITIATED FOR REASONS OTHER THAN TRUE PI EVENTS. SOME REASONS INCLUDE SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. SECTION 6 OF THE IFU, UNDER ¿ANTICOAGULATION¿, PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. THE IFU LISTS HYPOVOLEMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A DIRECT CORRELATION BETWEEN HEARTMATE (HM) II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILE CONTAINED DATA FROM (B)(6) 2021 TO (B)(6) 2021. MULTIPLE PULSATILITY INDEX (PI) EVENTS WERE RECORDED THROUGHOUT THE LOG FILE; HOWEVER, THERE WERE NO NOTABLE EVENTS OR ALARMS CAPTURED. THE PUMP OPERATED ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE FILE. THE PUMP APPEARED TO OPERATE AS EXPECTED. THE PATIENT REMAINS ONGOING ON HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS). NO PRODUCT IS AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    CORRECTION: THE PATIENT WAS EXPERIENCING HYPOTENSION, NOT HYPERTENSION AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR A IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCK (X1), LOW POTASSIUM, PERSISTENT PI EVENTS, DEPLETED VOLUME, AND HYPERTENSION. AT TIME OF ADMISSION THEIR INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.4. THE PATIENT HISTORICALLY HAD ELEVATED LACTATE DEHYDROGENASE (LDH), AND RECENT PLASMA FREE HEMOGLOBIN 700. THE PATIENT HAD NO CHANGE IN URINE CLARITY. THE LOG FILES CAPTURED ROUTINE EVENTS, THERE WERE NO NOTABLE ALARM CONDITIONS OR PARAMETER CHANGES. TYPE OF ARRHYTHMIA WAS NOTED TO BE VENTRICULAR TACHYCARDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837156 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization