BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 17557885 · Received August 16, 2023

    Report

    Report Number
    2916596-2023-05742
    Event Type
    Death
    Date Received
    August 16, 2023
    Date of Event
    February 1, 2022
    Report Date
    September 26, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    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 COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO AUTOPSY WAS PERFORMED, AND THE DEVICE WAS NOT EXPLANTED 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 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS RIGHT HEART FAILURE AND DEATH AS ADVERSE EVENTS WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LVAS. SECTION 6, ¿PATIENT CARE AND MANAGEMENT," OUTLINES INDICATIONS OF RIGHT HEART FAILURE AND THE RECOMMENDED TREATMENT OPTIONS FOR PATIENTS WITH RIGHT HEART FAILURE. 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. THE PATIENT HAD DECREASED RIGHT HEART FUNCTION OVER TIME. RIGHT HEART FAILURE DID NOT EXIST PRIOR TO IMPLANT OF THE LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE DEATH WAS NOT CONSIDERED TO BE DEVICE OR THERAPY RELATED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE RIGHT HEART FAILURE DID NOT EXIST BEFORE THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT BUT THE LVAD DID NOT CAUSE OR CONTRIBUTE TO IT. THE DEVICE REPORTEDLY OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893755 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 105306

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Death