BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 25037601 · Received April 29, 2026

    Report

    Report Number
    2916596-2026-02355
    Event Type
    Death
    Date Received
    April 29, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 21, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 ON (B)(6) 2026 THAT A SYSTEM CONTROLLER EXCHANGE WAS PERFORMED ON (B)(6) 2026. ATYPICAL POWER CABLE DISCONNECT ALARM EVENTS WERE RECORDED, AND THE LOG FILES WERE SUBMITTED FOR REVIEW. THE PATIENT HAD TRIED TO EXCHANGE THEIR CONTROLLER ON (B)(6) 2026 FOR AN UNKNOWN ALARM, SYNCOPIZED, AND ARRESTED. IT WAS ASSUMED THAT THE PATIENT HEARD THEIR PACER AND THOUGHT IT WAS THEIR CONTROLLER. IT APPEARED THAT THE CAREGIVER CHANGED OUT THE PATIENT'S CONTROLLER. THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR COMMUNICATED THAT THE PRIMARY CONTROLLER (B)(6) SHOWED NO ALARMS ON THE CONTROLLER AND MONITOR AT 8:55, AND THE BACKUP CONTROLLER (B)(6) SHOWED NO ALARMS ON THE CONTROLLER OR THE MONITOR AT 8:50. THE EVENT LOG FILE OF THE CONTROLLER (HSC-131417) CAPTURED 2 POWER CABLE DISCONNECT EVENTS ASSOCIATED WITH REDUCTION IN RELATIVE STATE OF CHARGE (RSOC) VALUES. A DRIVELINE DISCONNECT ALARN EVENT WAS CAPTURED AT 13APR2026 16:06:53 FOR UNKNOWN REASONS AS THERE WERE NO ISSUES NOTED PRIOR TO THE DRIVELINE BEING DISCONNECTED. IT WAS STATED THAT THE PRIMARY CONTROLLER (B)(6) THAT WAS DISCONNECTED FROM THE DRIVELINE WAS OFF BY AN HOUR. THESE EVENTS MAY HAVE PRESENTED AS A BRIEF AUDIBLE/VISUAL ALARM AS THE RSOC VALUE WAS BRIEFLY REDUCED. THE MOTOR FUNCTION WAS NOT AFFECTED BY THESE EVENTS; MOTOR SPEED MAINTAINED UNTIL THE DRIVELINE WAS DISCONNECTED. DATA FROM THE LOG FILES SHOWED THAT THE CURRENT PRIMARY CONTROLLER (B)(6) INDICATED THAT THE DRIVELINE WAS CONNECTED AT (B)(6) 2026 17:35:19 WITH NOT UNUSUAL ALARMS RECORDED. IT WAS LATER COMMUNICATED THAT AS ON (B)(6) 2026 THE PRIMARY CONTROLLER WAS (B)(6) AND BACKUP CONTROLLER SERIAL NUMBER WAS (B)(6), WHICH CONFIRMED THE CONTROLLER WAS SWAPPED OUT TO THE BACKUP. THE PATIENT HAD AN IMPLANTABLE CARDIOVERTR-DEFIBRILLATOR (ICD) WITH AN ELECTIVE REPLACEMENT INDICATOR (ERI) FOR 3/9 YEARS. THE PATIENT HAD AN ELECTROPHYSIOLOGY (EP) NOTE THAT STATED THAT THE EP RECEIVED MULTIPLE ALERTS FOR VENTRICULAR FIBRILLATION (VF) ON (B)(6) 2026 BETWEEN 4:30-5PM. THE PATIENT'S SPOUSE COMMUNICATED THAT THE PATIENT HAD A SINGLE BEEP/ALARM THAT WAS UNCLEAR IF IT CAME FROM THE (VAD) AS THE PATIENT FELT FINE AND THEIR EQUIPMENT APPEARED TO BE FUNCTIONING NORMALLY. THE PATIENT HEARD A SECOND ALARM, WAS FEELING UNWELL AND DECIDED TO CHANGE THE CONTROLLER. WHILE CHANGING THE CONTROLLER, THE PATIENT STRUGGLED TO RE-INSERT THE DRIVELINE AND TOLD THEIR SPOUSE THEY WERE GOING DOWN BEFORE LOSING CONSCIOUSNESS. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED AND THE PATIENT WAS GIVEN CARDIOPULMONARY RESUSCITATION (CPR) BY THE SPOUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239873 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 10165626 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1