BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 18981775 · Received March 26, 2024

    Report

    Report Number
    2916596-2024-01519
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    March 6, 2024
    Report Date
    May 13, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE (HM) II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. REVIEW OF THE SUBMITTED LOG FILE CONFIRMED SLIGHT ELEVATIONS IN PUMP POWER AND FLOW; HOWEVER, A SPECIFIC CAUSE FOR THESE FINDINGS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINED ONGOING ON HMII LVAS, SERIAL NUMBER (B)(6)UNTIL THEY WERE ULTIMATELY TRANSPLANTED ON (B)(6) 2024. 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 LEFT VENTRICULAR ASSIST SYSTEM (HMII LVAS) INSTRUCTIONS FOR USE (IFU), REV. B, AND HMII LVAS PATIENT HANDBOOK, REV. D, ARE CURRENTLY AVAILABLE. THE IFU LISTS CARDIAC ARRHYTHMIA AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LVAS. THE IFU ALSO LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. THE IFU ALSO PROVIDES AN EXPLANATION OF ALL PUMP PARAMETERS, INCLUDING PUMP POWER, FLOW, AND PULSATILITY INDEX (PI). THIS DOCUMENT 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. IN ADDITION, DEVICE FLOW AND POWER GENERALLY RETAIN A LINEAR RELATIONSHIP AT A GIVEN SPEED. IT IS ALSO NOTED THAT ANY INCREASE IN POWER NOT RELATED TO INCREASED FLOW CAUSES ERRONEOUSLY HIGH FLOW READINGS. IN REFERENCE TO PI, THIS DOCUMENT STATES THAT PI CALCULATION REPRESENTS CARDIAC PULSATILITY AND PI VALUES TYPICALLY RANGE FROM 1 TO 10. IN GENERAL, THE MAGNITUDE OF THE PI VALUE IS RELATED TO THE AMOUNT OF ASSISTANCE PROVIDED BY THE PUMP. HIGHER VALUES INDICATE MORE VENTRICULAR FILLING AND HIGHER PULSATILITY (I.E. THE PUMP IS PROVIDING LESS SUPPORT TO THE LEFT VENTRICLE). LOWER VALUES INDICATE LESS VENTRICULAR FILLING AND LOWER PULSATILITY (I.E. THE PUMP IS PROVIDING GREATER SUPPORT AND FURTHER UNLOADING THE VENTRICLE). THE IFU ALSO STATES THAT PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. THESE EVENTS MAY BE INITIATED FOR REASONS OTHER THAN TRUE PI EVENTS, INCLUDING SUDDEN CHANGES IN THE PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. FURTHERMORE, THE IFU ALSO EXPLAINS THAT 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FELT UNWELL AT 22:30 TO 23:20 ON (B)(6) 2024. AT THAT TIME, PULSATILITY INDEX (PI) VALUE WAS 2 AND PUMP POWER WAS 9, WHICH WAS ELEVATED COMPARED TO PAST PARAMETERS. IT WAS NOTED THAT BECAUSE THIS PATIENT'S LEFT VENTRICLE WAS SMALL, IT WAS POSSIBLE THAT THE INFLOW CANNULA HIT THE INSIDE OF THE VENTRICLE, CAUSING ARRHYTHMIA. LOG FILE REVIEW WAS REQUESTED. THE LOG FILE DISPLAYED SLIGHT ELEVATIONS IN POWER & FLOW ASSOCIATED WITH PI EVENTS DURING THE ROUGHLY 4-DAY LENGTH OF THE LOG FILE HISTORY. IT WAS COMMUNICATED ON 25MAR2024 THAT THE HOSPITAL WOULD NOT PROVIDE ANY ADDITIONAL INFORMATION RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 5896360 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Life Threatening| O