BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 9519543 · Received December 26, 2019

    Report

    Report Number
    2916596-2019-06089
    Event Type
    Death
    Date Received
    December 26, 2019
    Date of Event
    December 3, 2019
    Report Date
    July 14, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011170
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) LISTS DEVICE THROMBOSIS, VARIOUS TYPES OF ORGAN DYSFUNCTION, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE IFU OUTLINES THE INDICATIONS OF THROMBUS AND HOW TO RESPOND TO SUCH EVENTS. THE SECTION OF THIS DOCUMENT ENTITLED ¿ANTICOAGULATION THERAPY¿ PROVIDES DETAILS REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INTERNATIONAL NORMALIZED RANGE (INR) RANGE. THE IFU 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. DURING A PI EVENT, THE PUMP SPEED AUTOMATICALLY DROPS TO THE LOW-SPEED LIMIT. PULSATILITY INDEX (PI) EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHERE THERE IS A SUDDEN AND SUBSTANTIAL CHANGE IN PI. SOME REASONS FOR SUDDEN PI CHANGES INCLUDE SUDDEN CHANGES IN THE PATIENT'S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. THE REPORT OF SUSPECTED THROMBUS COULD NOT BE CONFIRMED. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), (B)(6), AND THE REPORTED MULTIPLE ORGAN DYSFUNCTION SYNDROME (MODS) AND FAILURE TO THRIVE COULD NOT BE DETERMINED. ANALYSIS OF THE LOG FILE PROVIDED BY THE ACCOUNT CONFIRMED TWO TRANSIENT ELEVATIONS IN PUMP POWER AND ESTIMATED FLOW; HOWEVER A SPECIFIC CAUSE COULD NOT BE DETERMINED THROUGH THIS EVALUATION. NO ATYPICAL ALARMS WERE CAPTURED AND THE PUMP OPERATED ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE FILE. THE LOG FILE APPEARED TO SHOW THE SYSTEM OPERATING AS INTENDED. DEVICE THROMBOSIS, VARIOUS TYPES OF ORGAN FAILURE, AND DEATH ARE LISTED IN THE HEARTMATE II LVAS INSTRUCTIONS FOR USE (IFU) AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LVAS. THE IFU ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURES INVESTIGATION CONCLUSION: THE DEVICE WAS NOT EXPLANTED AND WILL NOT BE RETURNED FOR EVALUATION. A CORRELATION BETWEEN THE DEVICE AND THE SUSPECTED THROMBUS COULD NOT BE CONFIRMED. ADDITIONALLY, A DIRECT CORRELATION BETWEEN THE DEVICE, AND THE REPORTED ACUTE KIDNEY INJURY (AKI) COULD NOT BE DETERMINED. ANALYSIS OF THE LOG FILE PROVIDED BY THE ACCOUNT CONFIRMED TWO TRANSIENT ELEVATIONS IN PUMP POWER AND ESTIMATED FLOW; HOWEVER, A SPECIFIC CAUSE COULD NOT BE DETERMINED THROUGH THIS EVALUATION. NO ATYPICAL ALARMS WERE CAPTURED, AND THE PUMP OPERATED ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE LOG FILES. THE LOG FILE APPEARED TO SHOW THE SYSTEM OPERATING AS INTENDED. DEVICE THROMBOSIS RENAL FAILURE, AND DEATH ARE LISTED AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM AND INFORMATION REGARDING HOW TO MONITOR AND RESPOND TO SUCH EVENTS CAN BE FOUND IN THE HEARTMATE II INSTRUCTION FOR USE (IFU). THE IFU ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. THE HMII LVAS IFU 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION H6: HEALTH EFFECT CLINICAL CODE: MULTIPLE ORGAN DYSFUNCTION SYNDROME. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REPORTED THAT THE DATE OF ADMISSION FOR THE REPORTED THROMBOSIS WAS (B)(6) 2019. IT WAS UNDETERMINED IF CHANGES TO THE PATIENT CONDITION OR ANTICOAGULATION STATUS THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO CHANGES WERE MANUALLY MADE TO PUMP PARAMETERS; HOWEVER, FLOW AND POWER WERE NOTED TO HAVE SLIGHTLY DECREASED OVER THE COURSE OF THE LOG FILE. THE PATIENT REFUSED ALL TESTS AND TREATMENT AND REQUESTED COMFORT CARE AS THE PATIENT HAD COOL EXTREMITIES AND WORSENING ACUTE KIDNEY INJURY (AKI). THE PATIENT EXPIRED ON (B)(6) 2019. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ELECTED FOR COMFORT MEASURES AND ULTIMATELY PASSED AWAY DUE TO PUMP THROMBOSIS, FAILURE TO THRIVE, AND MULTIPLE ORGAN DYSFUNCTION SYNDROME (MODS).

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING WITH THE LVAD DEVICE. 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 LOG FILE WAS SUBMITTED FOR REVIEW DUE TO SUSPECTED PUMP THROMBUS. THE OVERALL PUMP POWER AND PULSITILE INDEX (PI) SHOW A DOWNWARD TREND OVER THE COURSE OF THE LOG FILE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313241 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 104911 00813024011170

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention| D