BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20433403 · Received October 11, 2024

    Report

    Report Number
    2916596-2024-06640
    Event Type
    Death
    Date Received
    October 11, 2024
    Date of Event
    September 26, 2024
    Report Date
    July 7, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    QNR
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION: MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED RIGHT HEART FAILURE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, THE REPORTED LOW FLOW ALARMS COULD NOT BE CONFIRMED AS NO LOG FILES WERE SUBMITTED BY THE ACCOUNT FOR REVIEW. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. THIS DOCUMENT ALSO STATES THAT PATIENTS MAY DEVELOP RIGHT VENTRICULAR FAILURE DURING OR SHORTLY AFTER IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. THE IFU ADDRESSES PUMP PARAMETERS, AND OUTLINES SITUATIONS THAT CAN RESULT IN LOW FLOW, INCLUDING CHANGES IN PATIENT CONDITION. ADDITIONALLY, THE IFU AND PATIENT HANDBOOK DESCRIBE ADVISORY AND HAZARD ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 1 ALSO PROVIDES AN EXPLANATION OF PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 4 OF THE IFU, ¿SYSTEM MONITOR¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LITERS PER MINUTE (LPM), A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. SECTION 4 ALSO EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 6, UNDER ¿RIGHT HEART FAILURE¿, ALSO STATES THAT PATIENTS MAY DEVELOP RIGHT VENTRICULAR FAILURE DURING OR SHORTLY AFTER IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING", OUTLINE SYSTEM CONTROLLER ALARMS, INCLUDING THE LOW FLOW HAZARD ALARM, AND PROVIDES INFORMATION REGARDING HOW TO RESPOND TO AND TROUBLESHOOT THE ALARMS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED RIGHT HEART FAILURE, CARDIAC ARRHYTHMIA, AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, THE REPORTED LOW FLOW ALARMS COULD NOT BE CONFIRMED AS NO LOG FILES WERE SUBMITTED BY THE ACCOUNT FOR REVIEW. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE, CARDIAC ARRHYTHMIA, AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 1 ALSO PROVIDES AN EXPLANATION OF PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 4 OF THE IFU, ¿SYSTEM MONITOR¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LITERS PER MINUTE (LPM), A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. SECTION 4 ALSO EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 6, UNDER ¿RIGHT HEART FAILURE¿, ALSO STATES THAT PATIENTS MAY DEVELOP RIGHT VENTRICULAR FAILURE DURING OR SHORTLY AFTER IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING", OUTLINE SYSTEM CONTROLLER ALARMS, INCLUDING THE LOW FLOW HAZARD ALARM, AND PROVIDES INFORMATION REGARDING HOW TO RESPOND TO AND TROUBLESHOOT THE ALARMS. 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 RECEIVED A CENTRIMAG POST LEFT VENTRICULAR ASSIST DEVICE (LVAD) PLACEMENT. THE PATIENT WAS IMPLANTED WITH THE LVAD ON (B)(6) 2024. IT WAS REPORTED THAT THE LVAD WAS FUNCTIONING AS INTENDED AND THAT THE CENTRIMAG WAS PLACED DUE TO ACUTE POST-OPERATIVE RIGHT HEART FAILURE (RHF) WITH VASOPLEGIA. THE DAY BEFORE THE PATIENT HAD AN IMPELLA RP FLEX INSERTED WITH A SLIGHT INCREASE ON FLOWS. IT WAS DECIDED TO TRANSITION THE PATIENT TO A CENTRIMAG ON 26SEP2024. AFTER UPGRADE TO RVAD CENTRIMAG SUPPORT THE PATIENTS, LOW FLOWS IMPROVED. IT WAS NOTED THAT THE PATIENT WAS STABLE.

    Description of Event or Problem · 0

    IT WAS NOTED THAT THE PATIENT HAD MILD-MODERATELY REDUCED RV FUNCTION PRIOR TO IMPLANT SEEN IN A PREVAD ECHOCARDIOGRAM (ECHO). THERE WERE NO DEVICE RELATED ISSUES. THE DEVICE WAS NOT THOUGH TO HAVE CONTRIBUTED TO THE RIGHT HEART FAILURE. LOG FILES WERE UNAVAILABLE.

    Description of Event or Problem · 0

    THE PATIENT DEVELOPED MULTIFOCAL PNEUMONIA REQUIRING REINTUBATION ON (B)(6) 2024. THE PATIENT ALSO EXPERIENCED VENTRICULAR FIBRILLATION WITH 1 SHOCK ON (B)(6) 2024. THE FAMILY OF THE PATIENT DID NOT FEEL ONGOING CARE WAS CONSISTENT WITH PATIENTS WISHES AND DEVICE SUPPORT WAS DISCONTINUED ON (B)(6) 2024. THE PATIENT PASSED AWAY (B)(6) 2024. THE DEVICE WAS REPORTEDLY OPERATING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343347 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS QNR THORATEC CORPORATION 106524US L00000732 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| L| D