BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 6943986 · Received October 12, 2017

    Report

    Report Number
    2916596-2017-02347
    Event Type
    Death
    Date Received
    October 12, 2017
    Date of Event
    September 18, 2017
    Report Date
    December 27, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE SAME DEVICE IS USED COMMERCIALLY AND IN THE ONGOING MOMENTUM 3 TRIAL. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). APPROXIMATE AGE OF DEVICE ¿ 4 MONTHS.  THE PATIENT REMAINS ONGOING WITH THE DEVICE. 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¿S LACTATE DEHYDROGENASE (LDH) WAS RISING WITH NO EVIDENCE OF RISING FLOWS OR POWER. ON (B)(6) 2017, LDH WAS 886 U/L. PRIOR, THE PATIENT LDH WAS BETWEEN 400S U/L AND 500S U/L. LVAD SPEED WAS DECREASED TO 5100 RPM. PATIENT WAS PLACED ON HEPARIN AT 7 UNITS/KG/HR UNTIL (B)(6) 2017. THE PATIENT¿S LDH DECREASE, HOWEVER LDH STAYED ABOVE 600 U/L. ON (B)(6) 2017, LDH WAS 726 U/L. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT PRIOR TO LVAD IMPLANT, THE PATIENT HAD HISTORY OF VENTRICULAR TACHYCARDIA (VT). THE VT EMANATED FROM APICAL INFEROLATERAL LEFT VENTRICULAR (LV) WALL. THE MULTIPLE ABLATIONS PRODUCED SCAR FORMATION AND THINNING OF THE LV WALL. STATUS POST LVAD PLACEMENT, THE PATIENT CONTINUED TO HAVE RECURRENT REFRACTORY VT EVENTS. RECURRENT VT CONTRIBUTED TO THE DECISION TO WITHDRAW CARE AND TURN OFF LVAD. THE PATIENT SUBSEQUENTLY EXPIRED ON (B)(6) 2017. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725394 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H| R