BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 22456690 · Received July 9, 2025

    Report

    Report Number
    2916596-2025-04278
    Event Type
    Death
    Date Received
    July 9, 2025
    Date of Event
    May 8, 2025
    Report Date
    July 9, 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, SERIAL NUMBER (B)(6), AND THE REPORTED EVENT AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. 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 3 LVAS IFU, REV. C IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS BLEEDING AND DEATH AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO RANGE, AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. 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 SUFFERED A SUBARACHNOID BLEEDING (SAB) AFTER FALLING DOWN THE STAIRS. A COMPUTED TOMOGRAPHY (CT) SCAN WAS DONE. THIS SCAN CONFIRMED THE BLEEDING. THE BLEEDING WAS TREATED CONSERVATIVELY. THE FALL AS NOT DUE TO LVAD THERAPY. THE PATIENT PASSED AWAY DUE TO THE SAB. THE DEATH WAS NOT CONSIDERED DEVICE OR THERAPY RELATED. THE DEVICE OPERATED AS EXPECTED. AN AUTOPSY WAS NOT PERFORMED. THE DEVICE WAS NOT EXPLANTED AND WOULD NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577284 HEARTMATE 3 LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524INT 6067843 00813024011712

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Death