BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 10308583 · Received July 22, 2020

    Report

    Report Number
    2916596-2020-03505
    Event Type
    Injury
    Date Received
    July 22, 2020
    Date of Event
    June 25, 2020
    Report Date
    August 3, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: ANALYSIS OF THE SUBMITTED LOG FILES CONFIRMED A SLIGHT INCREASE IN ESTIMATED FLOW FROM (B)(6) 2020 THROUGH (B)(6) 2020, THEN MULTIPLE LOW FLOW HAZARD ALARMS IN (B)(6) 2020. A SPECIFIC CAUSE FOR THESE LOG FILE FINDINGS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, A DIRECT CORRELATION BETWEEN THE LOG FILE FINDINGS, REPORTED EVENTS (ELEVATED LDH, VENTRICULAR FIBRILLATION, HYPOTENSION, DEHYDRATION), AND HEARTMATE II LVAS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE FIRST SUBMITTED LOG FILE CONTAINS DATA FROM (B)(6) 2020 AT 10:16AM THROUGH (B)(6) 2020 AT 12:50PM. ESTIMATED FLOW APPEARED TO INCREASE SLIGHTLY OVER THE DURATION OF THE FILE, AVERAGING APPROXIMATELY 7.4 LPM FROM THE BEGINNING OF THE FILE THROUGH (B)(6) 2020 AT 10:06AM, THEN AVERAGING APPROXIMATELY 9.5 LPM FROM (B)(6) 2020 AT 05:12PM THROUGH THE END OF THE FILE. OVERALL, POWER RANGED FROM 4.8-9.1 W, ESTIMATED FLOW RANGED FROM 4.5-12.0 LPM, AND AVERAGE PI WAS BETWEEN 4.1 AND 7.8. THE SECOND SUBMITTED LOG FILE CONTAINS DATA FROM (B)(6) 2020 AT 09:35AM THROUGH (B)(6) 2020 AT 10:33AM. MULTIPLE LOW FLOW HAZARD ALARMS WERE CAPTURED BETWEEN (B)(6) 2020 AND (B)(6) 2020, AND AGAIN BETWEEN (B)(6) 2020 AND (B)(6) 2020 (155 TOTAL). ESTIMATED FLOW RANGED FROM 2.3-2.4 LPM FOR THESE EVENTS. OVERALL, POWER RANGED FROM 3.3-6.3 W, ESTIMATED FLOW RANGED FROM 2.3-7.8 LPM, AND AVERAGE PI WAS BETWEEN 2.2 AND 11.2. AVERAGE PI DID APPEAR TO BE SLIGHTLY ELEVATED AT TIMES, REACHING A MAXIMUM OF 11.2. NO ADDITIONAL ATYPICAL ALARMS WERE CAPTURED. THE PUMP SPEED REMAINED ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE FILES. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE SENT TO THE CENTER; HOWEVER, NO FURTHER DETAILS WERE PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS AND NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED AT THIS TIME. THE HMII LVAS IFU LISTS HEMOLYSIS AND CARDIAC ARRHYTHMIA AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, AND OUTLINES THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. THE IFU EXPLAINS THAT DEVICE FLOW AND POWER GENERALLY RETAIN A LINEAR RELATIONSHIP AT A GIVEN SPEED. HOWEVER, WHILE POWER IS DIRECTLY MEASURED BY THE SYSTEM CONTROLLER, THE REPORTED FLOW IS ESTIMATED, BASED ON POWER. THE IFU EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. THIS DOCUMENT EXPLAINS THAT PHYSIOLOGICAL FACTORS THAT AFFECT THE FILLING OF THE PUMP, SUCH AS HYPOVOLEMIA OR POSTURAL HYPOTENSION, RESULT IN REDUCED PUMP FLOWS AS LONG AS THE CONDITION PERSISTS. PUMP FLOWS ARE NOT RESTORED TO NORMAL UNLESS SUCH CONDITIONS ARE TREATED. ADDITIONALLY, THE IFU ADDRESSES ALL SYSTEM CONTROLLER ALARMS (INCLUDING LOW FLOW HAZARD ALARMS) AND HOW TO RESPOND TO SUCH EVENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS CURRENTLY HOSPITALIZED SINCE (B)(6) 2020 WITH VENTRICULAR FIBRILLATION, DEHYDRATION, HYPOTENSION AND ELEVATED PULSATILITY INDEX. LACTATE DEHYDROGENASE LEVELS HAVE BEEN ELEVATED SINCE LAST MONTH. LOG FILE ANALYSIS SHOWED PERSISTENT LOW FLOW EVENTS ON (B)(6) 2020 THROUGH (B)(6) 2020 WHICH RESOLVED BUT RETURNED ON (B)(6) 2020 THROUGH (B)(6) 2020. LOW FLOWS APPEARED TO BE PATIENT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773677 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 7248621 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R