BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 22413340 · Received July 7, 2025

    Report

    Report Number
    2916596-2025-04452
    Event Type
    Death
    Date Received
    July 7, 2025
    Date of Event
    September 5, 2022
    Report Date
    August 27, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011712
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) SERIAL NUMBER (B)(6), AND THE REPORTED EVENT AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 LVAS IFU, REV. B IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION (RESPIRATORY FAILURE, RIGHT HEART FAILURE, RENAL FAILURE, HEPATIC DYSFUNCTION) AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE CURRENT REVISION OF THE IFU CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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 ADDITIONALLY REPORTED THAT MOF WAS SUSPECTED TO BE A NATURAL PROGRESSION OF THE PATIENT'S UNDERLYING DISEASE, HOWEVER AS AN AUTOPSY WAS NOT PERFORMED THIS COULD NOT BE CONFIRMED. THERE WERE NO DEVICE ISSUES AT THE TIME OF OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT SUFFERED FROM A PROGRESSIVE MULTIPLE ORGAN FAILURE (MOF). THEY PASSED AWAY DUE TO MOF. THE OUTCOME WAS NOT CONSIDERED DEVICE OR THERAPY RELATED. THE DEVICE OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052112 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 5754539 00813024011712

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Death