BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 7064563 · Received November 28, 2017

    Report

    Report Number
    2916596-2017-02951
    Event Type
    Death
    Date Received
    November 28, 2017
    Date of Event
    November 7, 2017
    Report Date
    March 16, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S WEIGHT AND DATE OF BIRTH WERE NOT PROVIDED. THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# (B)(4) . FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON (B)(6) 2017. THE SAME DEVICE IS USED COMMERCIALLY AND IN THE ONGOING MOMENTUM 3 TRIAL. (B)(4). APPROXIMATE AGE OF DEVICE- 19 DAYS. THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED, THEREFORE THE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER''S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORT OF LOW FLOW EVENTS CAN BE CONFIRMED BASED ON THE SUBMITTED SYSTEM CONTROLLER LOG FILES. THE SYSTEM CONTROLLER LOG FILE WAS SUBMITTED TO AND REVIEWED. THE LOG FILE CONTAINED APPROXIMATELY 3 DAYS OF DATA, SPANNING FROM (B)(6) 2017 14:49:51 TO (B)(6) 2017 05:25:49, WHICH CAPTURED NUMEROUS LOW FLOW EVENTS AS LOW AS 0 LPM. PER DESIGN, WHEN THE FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LPM, A LOW FLOW STATUS IS POSTED TO THE LOG FILE. A 10-SECOND DELAY IS IMPOSED BETWEEN THE DETECTION OF THE LOW FLOW STATUS AND THE ACTIVATION OF THE ASSOCIATED AUDIO AND VISUAL INDICATORS ON THE SYSTEM CONTROLLER. ONE OF THE EVENTS LASTED OVER 10 SECONDS, AND LOW FLOW ALARM WAS FLAGGED. BESIDES THESE EVENTS, THE DEVICE APPEARED TO BE OPERATING AS EXPECTED AT THE SET SPEED OF 5300 RPMS. SIMILAR EVENTS WERE CAPTURED IN THE SYSTEM CONTROLLER PERIODIC LOG FILE AND IN BOTH THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) EVENT AND PERIODIC LOG FILES. A SPECIFIC CAUSE FOR THE LOW FLOW EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    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 LOW FLOW ALARMS OCCURRED ON (B)(6) 2017. ACCORDING TO THE PATIENT¿S FAMILY, THE ALARMS LASTED FOR APPROXIMATELY 15 TO 20 MINUTES BEFORE THE PATIENT PASSED OUT. LOCAL VOLUNTEERS PERFORMED CPR PRIOR TO THE ARRIVAL OF EMERGENCY MEDICAL SERVICES (EMS). EMX INITIATED A CHEMICAL CODE UPON ARRIVAL AND REPORTED THAT THE PATIENT HAD FIXED DILATED PUPILS AND BRADYCARDIA. WHEN THE PATIENT ARRIVED AT THE EMERGENCY ROOM, PATIENT HAD NO CARDIAC RHYTHM BUT THE PUMP CONTINUED TO RUN. THE PATIENT WAS PRONOUNCED DEAD. THE MANUFACTURER''S TECHNICAL SERVICES REPRESENTATIVE REVIEWED THE SUBMITTED LOG FILES FROM (B)(6) 2017 TO (B)(6) 2017 AND CONFIRMED LOW FLOW ALARMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843959 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 106524

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death