BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 20110726 · Received August 30, 2024

    Report

    Report Number
    2916596-2024-05596
    Event Type
    Death
    Date Received
    August 30, 2024
    Date of Event
    July 26, 2024
    Report Date
    October 15, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED PATIENT OUTCOME COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. REVIEW OF THE SUBMITTED LOG FILE CONFIRMED THE PULSATILITY INDEX (PI) EVENTS; HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILE CONTAINED EVENTS FROM 24JUL2024 THROUGH 26JUL2024. OF NOTE, PI EVENTS WERE CAPTURED THROUGHOUT THE FILE. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE FIXED SPEED THROUGHOUT THE FILE. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2024 DUE TO PULSELESS ELECTRICAL ACTIVITY ARREST. IT WAS COMMUNICATED THAT THE OUTCOME WAS NOT DEVICE OR THERAPY RELATED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. 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 LVAS INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LVAS. THIS SECTION ALSO ADDRESSES PUMP PARAMETERS, INCLUDING PULSATILTY INDEX (PI). SECTION 4 OF THE IFU, ¿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 MAY BE INITIATED FOR REASONS OTHER THAN TRUE PI EVENTS, INCLUDING SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. 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 COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD PASSED AWAY ON (B)(6) 2024 DUE TO AN UNKNOWN REASON. THEY EXPERIENCED PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED SOME PERIODS OF PERSISTENT PI EVENTS THROUGHOUT THE LOG BUT NOTHING UNUSUAL NOTED. THE OUTCOME WAS NOT CONSIDERED DEVICE OR THERAPY RELATED. AN AUTOPSY WAS NOT PERFORMED. THE DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522550 THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 8657323 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Death