BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 19181918 · Received April 25, 2024

    Report

    Report Number
    2916596-2024-02294
    Event Type
    Death
    Date Received
    April 25, 2024
    Date of Event
    April 9, 2024
    Report Date
    April 25, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS SERIAL NUMBER (B)(6), AND THE REPORTED PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED 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 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C, IS CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS RIGHT HEART FAILURE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 "PATIENT CARE AND MANAGEMENT" (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS, INCLUDING INOTROPES AND RIGHT VENTRICULAR ASSIST DEVICE (RVAD) PLACEMENT. SECTION 6 (UNDER CAUTION!) STATES: "RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LVAS DUE TO REDUCED FILLING OF THE PUMP." 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 DUE TO RIGHT HEART FAILURE AND WITHDRAWAL OF SUPPORT ON COMFORT CARE. IT WAS UNKNOWN IF RIGHT HEART FAILURE WAS PRE-EXISTING BUT IT WAS NOT THOUGHT TO BE DEVICE RELATED. SYMPTOMS OF SHORTNESS OF BREATH AND EDEMA WERE NOTED. THE DEATH WAS NOT DEVICE RELATED AND THE DEVICE OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659448 HEARTMATE 3 LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 6930336 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death