BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 9209821 · Received October 18, 2019

    Report

    Report Number
    2916596-2019-04906
    Event Type
    Death
    Date Received
    October 18, 2019
    Date of Event
    February 19, 2018
    Report Date
    October 21, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011170
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. IT WAS REPORTED THAT THE DEVICE WAS NOT EXPLANTED. THEREFORE, NO PRODUCT WAS AVAILABLE FOR INVESTIGATION. CARDIAC ARRHYTHMIA, BLEEDING, DRIVELINE INFECTION, LOCAL INFECTION, PUMP POCKET INFECTION, AND RIGHT HEART FAILURE ARE LISTED IN THE HMII IFU AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE PATIENT CARE AND MANAGEMENT SECTION OF THE HMII IFU LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. THE PATIENT CARE AND MANAGEMENT SECTION ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES. CARE INSTRUCTIONS REGARDING PREVENTING INFECTION ARE PROVIDED IN VARIOUS SECTIONS OF THE IFU, INCLUDING CARING FOR THE DRIVELINE EXIT SITE AND CONTROLLING INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ALTERED MENTAL STATUS AT HOME. PATIENT WAS IN VENTRICULAR TACHYCARDIA AT THE ER AND WAS TRANSFERRED TO ANOTHER MEDICAL CENTER. PATIENT WAS STARTED ON AMIODARONE DRIP. A HEAD CT WAS PERFORMED WHICH WAS NEGATIVE. THE PATIENT HAD LACTIC ACIDOSIS OF 12.6, INR OF 6.3, SODIUM OF 117 MEQ/L, BUN OF 88 MMOL/L AND CREATININE OF 3.3 MG/DL. THE PATIENT WAS NOT PRODUCING URINE. PATIENT'S WHITE BLOOD CELL (WBC) COUNT WAS 27. PATIENT HAD A NASOGASTRIC (NG) TUBE WHICH RETURNED 1 L OF DARK RED BLOOD. THE PATIENT WAS STARTED ON ANTIBIOTICS, INR WAS REVERSED, AND HE WAS BRIEFLY TRIALED DOBUTAMINE DUE TO CONCERN OF RIGHT VENTRICULAR FAILURE. PATIENT WAS ALSO INTUBATED. IN PREPARATION FOR TRANSFER, HE WENT INTO VENTRICULAR FIBRILLATION AND WAS SUCCESSFULLY CARDIOVERTED. AFTER CARDIOVERSION HIS PUPILS WERE FOUND TO BE FIXED AND DILATED. UNDER ECHO THERE WAS NO HEART MOVEMENT. PATIENT EXPIRED DUE TO CARDIAC ARREST. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004529 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 104911 00813024011170

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| H| R