BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8734278 · Received June 26, 2019

    Report

    Report Number
    2916596-2019-02913
    Event Type
    Death
    Date Received
    June 26, 2019
    Date of Event
    May 13, 2019
    Report Date
    September 23, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSIONS: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE DETERMINED. NO PRODUCT IS AVAILABLE FOR INVESTIGATION. THE CURRENT HEARTMATE 3 LVAS IFU LISTS SEPSIS AND BLEEDING AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED AT (B)(6). APPROXIMATE AGE OF DEVICE - 1 YEAR, 7 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT WAS AT HOME WHEN THE PATIENT STARTED HAVING PAIN IN THE CHEST WHERE THE PUMP WAS SITUATED. THE LOG FILES WERE NORMAL. THE CONSULTANTS THEN DECIDED TO APPLY RADIO FREQUENCY ABLATION AND IT WAS NOTED THAT THE LVAD WAS NOT TESTED FOR THAT. THE FIRST TREATMENT WAS SUCCESSFUL AND HELPED FOR A FEW WEEKS AND THERE WAS NO CHANGE IN ANY PUMP PARAMETERS. PATIENT STILL HAD PAIN AND RADIO FREQUENCY ABLATION WAS DONE AGAIN ALTHOUGH THIS TIME THE PATIENT STARTED COUGHING BLOOD SHORTLY AFTER TREATMENT AND DECOMPENSATED WITHIN A COUPLE OF HOURS. IN THE END, IT WAS THE FAMILY'S DECISION TO SWITCH OFF THE VENTILATOR AND LET THE PATIENT GO. THE PATIENT DIED FOLLOWING A NUMBER OF INJECTIONS OF LOCAL ANESTHETIC INTO THE RIB AREA TO RESOLVE A RECURRENT PAIN. THEY BELIEVE THAT FINAL INJECTION APPARENTLY TRIGGERED A CHAIN OF EVENTS INCLUDING SEPSIS. THE HEALTHCARE PROFESSIONAL CONFIRMED THAT THE DEATH WAS NOT DEVICE RELATED AND THAT THE DEVICE WAS WORKING AS EXPECTED AT THE TIME OF DEATH. NO EQUIPMENT WILL BE SENT BACK FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529760 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524INT 6121572

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H