BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 19118895 · Received April 16, 2024

    Report

    Report Number
    2916596-2024-01984
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    March 28, 2024
    Report Date
    April 16, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE PATIENT'S SEPSIS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED. THE CONTROLLER EVENT LOG FILE CONTAINED EVENTS FROM 25MAR2024 THROUGH 27MAR2024. NO NOTABLE EVENTS OR ALARMS WERE CAPTURED, AND THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE FIXED SPEED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED BY THE ACCOUNT. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). NO FURTHER RELATED EVENTS 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 SPECIFICATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS, INCLUDING CARDIAC ARRHYTHMIA AND SEPSIS, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. ALTHOUGH ONLY SEPSIS WAS REPORTED BY THE ACCOUNT, THE IFU ALSO LISTS INFECTION AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, AS WELL AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SEVERAL SECTIONS OF THE IFU AND PATIENT HANDBOOK ALSO PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IN WITH RUNS OF VENTRICULAR TACHYCARDIA AND SEPSIS. LOG FILES CAPTURED SOME PERIODS OF PULSATILITY INDEX EVENTS BUT NOTHING UNUSUAL WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445895 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6827895 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other