BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 11096059 · Received December 30, 2020

    Report

    Report Number
    2916596-2020-06438
    Event Type
    Injury
    Date Received
    December 30, 2020
    Date of Event
    December 11, 2020
    Report Date
    March 12, 2021
    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
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: POWER ELEVATIONS WERE CONFIRMED THROUGH THE ANALYSIS OF THE SUBMITTED LOG FILES. HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS AND THE REPORTED ELEVATED LDH (LACTATE DEHYDROGENASE), AS WELL AS A DIRECT CORRELATION TO HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), COULD NOT CONCLUSIVELY BE DETERMINED. THE SUBMITTED LOG FILES CONTAINED OVERLAPPING DATA FROM (B)(6) 2020 THROUGH (B)(6) 2020. NO TREND IN PUMP POWER, CALCULATED FLOW, OR AVERAGE PULSATILITY INDEX (PI) WAS OBSERVED THROUGHOUT THE LOG FILE DATA; HOWEVER, MULTIPLE TRANSIENT ELEVATIONS IN PUMP POWER WERE NOTED THROUGHOUT THE LOG FILES. CORRESPONDING ELEVATIONS IN CALCULATED FLOW WERE RECORDED DURING POWER ELEVATION EVENTS. OF NOTE, THE LOG FILE CAPTURED 244 PI EVENTS AND ALL POWER/FLOW ELEVATIONS OCCURRED DURING PI EVENTS. THE ACTUAL SPEED REMAINED ABOVE THE LOW SPEED LIMIT THROUGHOUT THE LOG FILES AND THE PUMP APPEARED TO BE FUNCTIONING AS INTENDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6). NO PRODUCT IS AVAILABLE FOR INVESTIGATION. NO FURTHER COMPLAINTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT WAS SHIPPED ON 13NOV2018. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. THIS IFU LISTS HEMOLYSIS AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM IN SECTION 1, ¿INTRODUCTION¿. THIS IFU ALSO OUTLINES THE RECOMMENDED ANTICOAGULATION THERAPY AND INR (INTERNATIONAL NORMALIZED RATION) RANGE AS WELL AS POSSIBLE MODIFICATIONS IN SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿, UNDER ¿ANTICOAGULATION¿. PUMP SPEED, POWER, FLOW, AND PI ARE ADDRESSED IN SECTION 1, ¿INTRODUCTION¿, OF THE HEARTMATE II LVAS IFU. THIS SECTION EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT; THEREFORE, CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. THIS DOCUMENT ALSO DESCRIBES HOW PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. THE HEARTMATE II LVAS IFU SECTION 1, ¿INTRODUCTION¿, STATES THAT, ¿THE PI CALCULATION REPRESENTS CARDIAC PULSATILITY. PI VALUES TYPICALLY RANGE FROM 1 TO 10. IN GENERAL, THE MAGNITUDE OF THE PI VALUES IS RELATED TO THE AMOUNT OF ASSISTANCE THAT IS PROVIDED BY THE PUMP. HIGHER VALUES INDICATE MORE VENTRICULAR FILLING AND HIGHER PULSATILITY (IE, THE PUMP IS PROVIDING LESS SUPPORT TO THE LEFT VENTRICLE). LOWER VALUES INDICATE LESS VENTRICULAR FILLING AND LOWER PULSATILITY (IE, THE PUMP IS PROVIDING GREATER SUPPORT AND FURTHER UNLOADING THE VENTRICLE).¿ ALSO IN THIS SECTION, THE IFU STATES, ¿DURING A SUCTION EVENT, DEVICE SPEED DROPS TO THE ¿LOW SPEED LIMIT¿ AND THEN RAMPS UP TO THE FIXED SPEED UNLESS ANOTHER PULSATILITY INDEX (PI) EVENT IS DETECTED, AT WHICH POINT THE DEVICE DROPS TO THE ¿LOW SPEED LIMIT¿ AGAIN AND THEN RAMPS BACK UP. THIS CYCLE REPEATS AS LONG AS PI EVENTS ARE DETECTED.¿ THE HEARTMATE II IFU SECTION 4, ¿SYSTEM MONITOR¿, 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. THESE TYPES OF PI EVENTS ARE MORE LIKELY TO BE TRIGGERED IN CASES OF LOW PULSATILITY." ALTHOUGH THE REPORTED EVENT INFORMATION INDICATED THAT THE ACCOUNT WAS CONCERNED FOR STROKE DUE TO POWER ELEVATION EVENTS, STROKE WAS NOT ABLE TO BE CONFIRMED THROUGH THIS EVALUATION AND NO ADDITIONAL INFORMATION WAS PROVIDED. HOWEVER, THE HEARTMATE LVAS IFU ALSO LISTS STROKE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM IN SECTION 1, ¿INTRODUCTION¿. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PREVIOUS PUMP EXCHANGE WAS REPORTED IN MFR# (B)(4). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    RELATED MFR #: (B)(4). IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2020 WITH AN ELEVATED LACTATE DEHYDROGENASE LEVEL GREATER THAN 900 U/L. THE LOG FILES CAPTURED A FEW NO EXTERNAL POWER EVENTS ON (B)(6) 2020 THAT APPEARED TO BE THE RESULT OF THE PATIENT SIMULTANEOUSLY DISCONNECTING POWER FROM BOTH CONTROLLER LEADS. IN ADDITION, THE LOG NOTED A SINGLE POWER/FLOW ELEVATION ON (B)(6) 2020 THAT WAS NOT SUSTAINED. POWER AND FLOW ALSO APPEAR TO BE TRENDING SLIGHTLY UPWARD. THE PATIENT HAD RECENTLY UNDERGONE A PUMP EXCHANGE ON (B)(6) 2020. ON (B)(6) 2020, THE SITE REPORTED A CONCERN FOR A POSSIBLE STROKE DUE TO A POWER SPIKE. FROM THE LOG FILES, THE PUMP POWER/FLOW AND PULSATILITY INDEX APPEARED ON A SLIGHTLY ELEVATED TREND. THE LOG ALSO CONTAINED SOME UNSUSTAINED POWER ELEVATIONS HAS HIGH AS 11.4WATTS. TECHNICAL SERVICES WAS UNABLE TO CONFIRM IF THE DATA IN THE LOG WAS ASSOCIATED WITH THE PATIENT'S CURRENT CONDITION. CONTINUED MONITORING OF THE PATIENTS LABS AND PUMP PARAMETERS WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558640 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 6706671 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization HEARTMATE II SYSTEM CONTROLLER