BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 25284282 · Received May 26, 2026

    Report

    Report Number
    2916596-2026-2917114
    Event Type
    Death
    Date Received
    May 26, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 26, 2026
    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

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), IS CURRENTLY AVAILABLE. THE CURRENT REVISION OF THE IFU CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. SECTION 1 OF THE IFU, "INTRODUCTION," LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LVAS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN AS THE PATIENT WAS FOUND AFTER A WELLNESS CHECK. THE LENGTH OF DEATH BEFORE BEING FOUND COULD NOT BE DETERMINED. THE PATIENT POSSIBLY HAD PUMP STOPS IN THE PAST AND DRIVELINE REPAIR. THE PATIENT WAS ON THE ORANGE CABLE AND WAS AT RISK OF FUTURE PUMP STOPS (2916596-2024-05262).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334801 THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) Ventricular (assist) bypass DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Death