BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 14187571 · Received April 22, 2022

    Report

    Report Number
    2916596-2022-10287
    Event Type
    Death
    Date Received
    April 22, 2022
    Date of Event
    March 31, 2022
    Report Date
    July 14, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED ISCHEMIC CARDIOMYOPATHY AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, THE EXTRACTED LOG FILES FROM THE RETURNED SYSTEM CONTROLLER CONFIRMED LOW FLOW ALARMS; HOWEVER, A DIRECT CAUSE FOR THE ALARMS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE EXTRACTED CONTROLLER EVENT LOG FILE CONTAINED DATA DURING PATIENT SUPPORT FROM (B)(6) 2022. THE LOG FILE CAPTURED THE FLOW OPERATING WITHIN ITS BASELINE RANGE UNTIL (B)(6) 2022 AT 19:59:39 WHEN FLOW DECREASED. A SUSTAINED LOW FLOW ALARM WAS ULTIMATELY CAPTURED ON (B)(6) 2022 AT 20:09:52. THE FLOW WAS RECORDED AT 0 LITERS PER MINUTE (LPM) ON (B)(6) 2022 AT 06:38:54, AND REMAINED AT 0 LPM FOR THE DURATION OF THE LOG FILE UNTIL SUPPORT WAS DISCONTINUED. THE PUMP APPEARED TO OPERATE AS INTENDED AT THE SET SPEED FOR THE DURATION OF THE LOG FILE. (B)(6) WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING AND QA (QUALITY ASSURANCE) SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) (REV. G) IS CURRENTLY AVAILABLE. DEATH IS LISTED IN THE HEARTMATE 3 LVAS IFU AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE SYSTEM MONITOR SECTION DESCRIBES THE PUMP FLOW DISPLAY (B)(6)) AND THE HAZARD ALARMS ((B)(6)). THIS IFU STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5 LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW, SUCH AS HYPERTENSION. THE ALARMS AND TROUBLESHOOTING SECTION DESCRIBES THE ACTIONS TO TAKE IN THE EVENT OF A LOW FLOW ALARM (B)(6)). NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS FOUND DEAD IN THEIR HOUSE WITH THEIR LEFT VENTRICULAR ASSIST DEVICE (LVAD) STILL RUNNING ON (B)(6) 2022. WHEN THE PATIENT WAS FOUND, THE PATIENT'S SYSTEM CONTROLLER WAS DISPLAYING LOW FLOW AND LOW VOLTAGE ALARMS. THE OFFICIAL CAUSE OF DEATH WAS ISCHEMIC CARDIOMYOPATHY. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED AND THE DEVICE OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171078 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 6846958

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| D