BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 16086046 · Received January 3, 2023

    Report

    Report Number
    2916596-2022-15754
    Event Type
    Injury
    Date Received
    January 3, 2023
    Date of Event
    November 7, 2022
    Report Date
    January 25, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011170
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    117

    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 HEARTMATE II LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS 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 II LVAS INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU LISTS RIGHT HEART FAILURE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ DESCRIBES THAT RIGHT HEART FAILURE CAN OCCUR POST-IMPLANT AND PROVIDES STRATEGIES FOR TREATING PATIENTS WHO EXPERIENCE 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 WAS HOSPITALIZED FOR RIGHT HEART FAILURE FROM ON (B)(6) 2022 UNTIL ON (B)(6) 2022. THE PATIENT EXPERIENCED VOLUME OVERLOAD AND WAS TREATED WITH DIURETICS. IT WAS NOTED THAT DURING THE ADMISSION THE PATIENT EXPERIENCED LOW FLOW ALARMS THAT WERE TREATED WITH INTRAVENOUS (IV) HYDRATION. IT WAS NOTED THAT THE RIGHT HEART FAILURE DID NOT EXIST PRIOR TO LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT, AND THAT A DEVICE RELATED ISSUE WAS NOT CONSIDERED TO CAUSE/CONTRIBUTE TO THE RIGHT HEART FAILURE. THE RIGHT HEART FAILURE RESOLVED WITH THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502343 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 104911 00813024011170

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Hospitalization| R