BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 15524111 · Received October 1, 2022

    Report

    Report Number
    2916596-2022-13983
    Event Type
    Death
    Date Received
    October 1, 2022
    Date of Event
    September 13, 2022
    Report Date
    October 4, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    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 RIGHT HEART FAILURE (RHF) COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE ACCOUNT COMMUNICATED THAT THE DEVICE WOULD NOT BE RETURNED FOR 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 IMPLANT KIT WAS SHIPPED ON 24MAR2014. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) (REV. B) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU LISTS RIGHT HEART FAILURE AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6, UNDER "POSTOPERATIVE PATIENT CARE", CAUTIONS: "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 LEFT VENTRICULAR ASSIST SYSTEM DUE TO REDUCED FILLING OF THE PUMP." SECTION 6 (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE DURING USE OF THE HEARTMATE II LVAS AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. 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 ON (B)(6) 2022 DUE TO RIGHT HEART FAILURE. THE PATIENT'S RIGHT HEART FAILURE WAS NOT PREEXISTING PRIOR TO THEIR LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT, BUT THE RIGHT HEART FAILURE WAS NOT DEVICE RELATED. THE DEVICE OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336021 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 105306

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Life Threatening| D