BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 14021545 · Received April 6, 2022

    Report

    Report Number
    2916596-2022-02055
    Event Type
    Death
    Date Received
    April 6, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 21, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED DISSEMINATED INTRAVASCULAR COAGULOPATHY (DIC) RESULTING IN LOW CARDIAC OUTPUT AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. (B)(6) WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA (QUALITY ASSURANCE) SPECIFICATIONS. THE HEARTMATE II LVAS INSTRUCTIONS FOR USE (IFU) (REV. B) IS CURRENTLY AVAILABLE. BLEEDING, THROMBUS, AND DEATH ARE LISTED AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LVAS. THE PATIENT CARE AND MANAGEMENT SECTION OF THE IFU DISCUSSES ANTICOAGULATION, INCLUDING RECOMMENDED INR (INTERNATIONAL NORMALIZED RATIO) VALUES. THIS SECTION ALSO OUTLINES INDICATIONS OF THROMBUS AND HOW TO RESPOND TO SUCH EVENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2022 DUE TO DISSEMINATED INTRAVASCULAR COAGULOPATHY (DIC) AND LOW CARDIAC OUTPUT. PRIOR TO THEIR LVAD IMPLANT, THE PATIENT WAS ON BIVENTRICULAR SUPPORT WITH A CENTRIMAG SINCE (B)(6) 2022. POST IMPLANT, THE CENTRIMAG WAS USED FOR RIGHT VENTRICULAR SUPPORT. OPTIMAL FLOW COULD NOT BE MAINTAINED AND DIC WAS DIAGNOSED; THE PATIENT SUBSEQUENTLY PASSED AWAY. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED AND THE DEVICE OPERATED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488261 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106016 8150868

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Death| L| R| H L06856-LA8