BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 12488766 · Received September 17, 2021

    Report

    Report Number
    2916596-2021-04951
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    August 3, 2021
    Report Date
    October 28, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A CORRELATION BETWEEN THE DEVICE AND THE REPORTED VENTRICULAR TACHYCARDIA (VT) COULD NOT BE CONCLUSIVELY DETERMINED DURING THIS EVALUATION. A CAUSE FOR THE VT COULD ALSO NOT BE DETERMINED. THE SUBMITTED LOG FILE CONTAINED DATA FROM (B)(6) 2021 THAT SHOWED NINE PI EVENTS. AN UNSUSTAINED POWER ELEVATION WAS CAPTURED DURING A PI EVENT, REPORTEDLY WHEN THE PATIENT WAS IN VT. LABS AND VITALS WERE REPORTED TO BE FINE. NO OTHER NOTABLE FINDINGS WERE IDENTIFIED, AND THE PUMP APPEARED TO OPERATE AS INTENDED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, SERIAL NUMBER (B)(6). NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE II LVAS IFU LISTS THE ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, INCLUDING ARRHYTHMIA. THIS DOCUMENT ALSO LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. THE IFU ALSO EXPLAINS THAT THE PI IS A CALCULATION THAT REPRESENTS CARDIAC PULSATILITY, AND DESCRIBES THAT PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED AUTOMATICALLY DROPS TO THE LOW SPEED LIMIT AND SLOWLY RAMPS BACK UP AT A RATE OF 100 RPM PER SECOND TO THE FIXED SPEED SETPOINT. THESE EVENTS MAY BE INITIATED FOR REASONS OTHER THAN TRUE PI EVENTS, SUCH AS SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. 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 (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU OF THIS IFU LISTS THE ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, INCLUDING ARRHYTHMIA. SECTION 4 ¿SYSTEM MONITOR¿ EXPLAINS THAT PULSATILITY INDEX (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. SOME REASONS INCLUDE SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED AUTOMATICALLY DROPS TO THE LOW SPEED LIMIT AND SLOWLY RAMPS BACK UP AT A RATE OF 100 RPM PER SECOND TO THE FIXED SPEED SETPOINT. SECTION 6 "PATIENT CARE AND MANAGEMENT" LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. 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 ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE PULSATILITY INDEX (PI) EVENTS AND FORGOT TO SWITCH OVER BEFORE BATTERIES RUN DOWN AT NIGHT. THE LOG FILE NOTED A SINGLE UNSUSTAINED POWER/FLOW ELEVATION ON (B)(6) 2021. THE PATIENT WAS IN VT (VENTRICULAR TACHYCARDIA) AT THE TIME, AND LABS AND VITALS WERE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389425 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other