BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8984301 · Received September 10, 2019

    Report

    Report Number
    2916596-2019-04193
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    August 23, 2019
    Report Date
    September 12, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF ALTERED MENTAL STATUS AND NEUROLOGIC DYSFUNCTION. THEIR SPOUSE REPORTED THAT AROUND 5:30 IN THE MORNING, THE PATIENT WOKE UP AND WAS UNABLE TO SPEAK AND WAS JUST STARING AHEAD. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT BY EMS. THE PATIENT'S SYSTEM CONTROLLER LOG FILE WAS SUBMITTED WHICH CONTAINED APPROXIMATELY 36 HOURS OF DATA, SPANNING FROM TO (B)(6) 201922:16:46 TO (B)(6) 201910:45:15. SEVERAL LOW FLOW EVENTS WERE CAPTURED ON (B)(6) 2019, WHERE THE CALCULATED AVERAGE FLOW WAS CAPTURED AT 2.4 LPM OR LOWER. 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. NONE OF THE LOW FLOW EVENTS LASTED 10 SECONDS AND LOW FLOW ALARMS WERE NOT TRIGGERED. BESIDES THESE EVENTS, THE DEVICE APPEARED TO BE OPERATING AS EXPECTED AT THE SET SPEEDS OF 5000 RPMS. A SPECIFIC CAUSE FOR THE LOW FLOW EVENTS AND A CORRELATION TO THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED. THE CONTROLLER PERIODIC AND LVAD EVENT AND PERIODIC LOG FILES APPEARED TO CAPTURE THE PUMP OPERATING AS INTENDED. A STAT CTA WAS PERFORMED WHICH REVEALED LEFT M1 OCCLUSIONS AND EMERGENT LARGE VESSEL OCCLUSION (ELVO) WAS ACTIVATED. THE PATIENT THEN UNDERWENT A LEFT M1-M2 THROMBECTOMY. THE ISSUE REPORTEDLY RESOLVED ON (B)(6) 2019. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE SENT TO THE CUSTOMER. THE PATIENT REMAINS ONGOING ON VAD SUPPORT. NO PRODUCT AVAILABLE FOR INVESTIGATION. THE HEARTMATE 3 LVAS IFU LISTS STROKE AND NEUROLOGIC DYSFUNCTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE HEARTMATE 3 LVAS IFU DESCRIBES THE PUMP FLOW DISPLAY, PULSATILITY INDEX, AND THE HAZARD ALARMS. THIS DOCUMENT STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THE ALARMS AND TROUBLESHOOTING SECTION DESCRIBES THE ACTIONS TO TAKE IN THE EVENT OF A LOW FLOW ALARM. THE HEARTMATE 3 LVAS PATIENT HANDBOOK DESCRIBES THE ACTIONS TO TAKE IN THE EVENT OF A LOW FLOW ALARM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE (B)(6) CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). 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. LOG FILE ANALYSIS REPORTED A POWER ELEVATION ON (B)(6) 2019. THE PUMP MAINTAINED THE SET SPEED OF 5000 ROTATIONS PER MINUTE DURING THIS TIME. THE FLOW DID DECREASE THIS SEQUENCE OF EVENTS OCCURRED OVER AN 26 SECOND TIME FRAME. THE CAUSE OF THIS EVENT DOES NOT APPEAR TO BE ANY TYPE OF ISSUE WITH THE PUMP. THIS APPEARS TO BE HEMODYNAMICALLY RELATED. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (B)(6) 2019 WITH COMPLAINTS OF ALTERED MENTAL STATUS PER FAMILY MEMBER. WIFE REPORTED THAT AROUND 5:30 AM THE PATIENT WOKE UP AND WAS UNABLE TO SPEAK AND THAT HE WAS "JUST STARING AHEAD." PATIENT WAS TRANSPORTED BY EMERGENCY MEDICAL SERVICES TO THE EMERGENCY DEPARTMENT. A STAT COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED LEFT M1 MIDDLE CEREBRAL ARTERY OCCLUSIONS AND EMERGENT LARGE VESSEL OCCLUSION WAS ACTIVATED. PATIENT HAD A LEFT M1-M2 THROMBECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777403 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 6226025

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R