BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8522782 · Received April 17, 2019

    Report

    Report Number
    2916596-2019-01881
    Event Type
    Death
    Date Received
    April 17, 2019
    Date of Event
    April 11, 2019
    Report Date
    June 23, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 (SHORT TERM, CAP, OR LONG TERM) 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). MANUFACTURER¿S INVESTIGATION CONCLUSION REVIEW OF THE SUBMITTED LOG FILE DATA CONFIRMED THE REPORTED LOW FLOW ALARMS; HOWEVER, A SPECIFIC CAUSE FOR THE LOW FLOW EVENTS COULD NOT BE DETERMINED THROUGH THIS EVALUATION. MOREOVER, A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED PERICARDIAL FLUID COLLECTION/TAMPONADE AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED CONTROLLER EVENT AND PERIODIC LOG FILES CUMULATIVELY CONTAINED DATA FROM (B)(6) 2019 AND SHOWED THAT CALCULATED FLOW REMAINED STABLE IN THE RANGE OF ABOUT 4-5 LPM THROUGH (B)(6) 2019 AT 4:16 AM. AT TIMESTAMP 4:23 AM, CALCULATED FLOW SUDDENLY DROPPED BELOW THE LOW FLOW HAZARD ALARM THRESHOLD OF 2.5 LPM. FLOW REMAINED AROUND 2-3 LPM WITH INTERMITTENT LOW FLOW HAZARD ALARMS UNTIL 5:54 AM WHEN FLOW DROPPED TO 0 LPM. FLOW BRIEFLY RECOVERED TO VALUES RANGING FROM APPROXIMATELY 2-2.5 LPM AT AROUND 6:30 AM; HOWEVER, FLOW AGAIN DECREASED TO 0 LPM SHORTLY AFTERWARD. CONTINUOUS LOW FLOW HAZARD ALARMS WERE CAPTURED THROUGH THE END OF THE LOG WHEN THE POWER CABLES WERE REMOVED FROM POWER AND THE DRIVELINE WAS DISCONNECTED AT 7:20 AM. DESPITE THE LOW FLOW CONDITION, THE PUMP SPEED REMAINED ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE LOG FILE DATA. (B)(4) WAS NOT EXPLANTED FOLLOWING THE PATIENT¿S EXPIRATION AND IS NOT AVAILABLE FOR INVESTIGATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE LISTS PERICARDIAL FLUID COLLECTION AND DEATH 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.

    Description of Event or Problem · 0

    THE PATIENT PRESENTED TO THE HOSPITAL UNRESPONSIVE WITH VAD ALARMING FOR 40 MINUTES. THE SITE DETAILED THE PATIENT APPEARED TO BE IN TAMPONADE AND EXPIRED PRIOR TO ARRIVING AT THE HOSPITAL.

    Description of Event or Problem · 0

    ON (B)(6) 2019 AND (B)(6) 2019 THE PATIENT CALLED THE EMERGENCY VAD LINE WITH COMPLAINTS OF LOW FLOW ALARMS. THE PATIENT REFUSED ADMISSION OR A CLINICAL VISIT DESPITE MULTIPLE REQUEST FROM THE MECHANICAL CIRCULATORY SYSTEM (MCS) TEAM. THE PATIENT CAUSE OF DEATH WAS REPORTED TO BE PERICARDIAL FLUID COLLECTION. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 0

    RADIOGRAPHIC IMAGING REVEALED A LARGE CARDIAC TAMPONADE THAT WAS NOTED AROUND THE LEFT VENTRICULE AND ATRIUM. THE TAMPONADE IS BELIEVED TO HAVE COME FROM THE AREA AROUND THE INFLOW OF THE DEVICE AND BE DEVICE RELATED. THE LOW FLOW ALARMS THAT OCCURED WITH THE EVENT WERE DUE TO POO LEFT VENTRICULAR FILLING DUE TO COMPRESSION OF THE LEFT ATRIUM AND LEFT VENTRICULAR BY WAY OF TAMPONADE. THE REPORTED NO EXTERNAL POWER WAS DUE TO THE RAPID POWER SOURCE CHANGE BY THE FAMILY WHILE AT HOME AND DURING THE WITHDRAW OF CARE AFTER THE PATIENT WAS PRONOUNCED DEAD. NO FURTHER INFORMATION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE: 1 YEAR, 9 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 ACCOUNT REPORTED THAT NO AUTOPSY WAS PREFORMED. HOWEVER, RADIOGRAPHIC IMAGING REVEALED A LARGE CARDIAC TAMPONADE THAT APPEARED TO BE WRAPPED AROUND THE LEFT VENTRICLE AND ARTIUM HIS TAMPONADE IS BELIEVED TO HAVE COME FROM THE AREA AROUND THE INFLOW OF THE DEVICE AND BE DEVICE RELATED. THE REPORTED LOW FLOW ALARM WAS DUE TO POOR LV FILLING DUE TO COMPRESSION OF THE LEFT ATRIUM AND LEFT VENTRICLE BY WAY OF TAMPONADE. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THE PATIENT PRESENTED UNRESPONSIVE WITH LVAD ALARMING FOR 40 MINS. THE PATIENT WENT TO HAVE A BOWEL MOVEMENT, FELT POORLY AFTERWARDS AND WENT BACK TO BED. AROUND 15 MINUTES LATER, LOW FLOW ALARMS STARTED. UPON ARRIVAL, THE PATIENT'S FLOW WAS 0. THE PATIENT'S PULSE WAS UNDETECTABLE AND NO SPONTANEOUS BREATHING. TWO UNITS OF PACKED RED BLOOD CELLS (PRBC'S) AND FLUIDS WERE ADMINISTERED PRIOR TO THE CT SCAN. THE HOSPITAL REPORTED THE PATIENT APPEARED TO BE IN CARDIAC TAMPONADE AND EXPIRED BEFORE ARRIVAL TO THE HOSPITAL. LOG FILE ANALYSIS NOTED A NO EXTERNAL POWER EVENT AND A DRIVELINE DISCONNECTED EVENT. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317315 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524 6031239

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| L