BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19976576 · Received August 13, 2024

    Report

    Report Number
    2916596-2024-05165
    Event Type
    Death
    Date Received
    August 13, 2024
    Date of Event
    July 16, 2024
    Report Date
    November 6, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    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

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, REVIEW OF THE LOG FILES CONFIRMED LOW FLOW ALARMS; HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED CONTROLLER EVENT LOG FILE CONTAINED RELEVANT EVENTS ON (B)(6) 2024. LOW FLOW EVENTS WERE CAPTURED BETWEEN 01:59:28 AND 03:09:54. DURING THESE LOW FLOW EVENTS, FLOW WAS CAPTURED FROM 0.3-2.4 LPM UNTIL 03:09:00, WHEN FLOW DECREASED TO 0 LPM. FLOW WAS CAPTURED AT 0 LPM FOR THE REMAINDER OF THE FILE. THE DRIVELINE WAS DISCONNECTED AT 03:09:57 AND THE CONTROLLER WAS THEN SHUT DOWN. NO OTHER NOTABLE EVENTS WERE CAPTURED. THE DEVICE APPEARED TO OPERATE AS INTENDED AT THE SET SPEED. (B)(6) WAS RETURNED ASSEMBLED WITH THE PUMP CABLE INTACT. THE MODULAR CABLE WAS NOT RETURNED. THE OUTFLOW GRAFT WAS SECURED TO THE PUMP COVER OUTLET PORT. THE OUTFLOW GRAFT BEND RELIEF WAS ATTACHED AT THE GRAFT HARDWARE. THE APICAL CUFF WAS RETURNED WITH THE CUFF LOCK FULLY ENGAGED. UPON DISASSEMBLY OF THE RETURNED PUMP, VISUAL INSPECTION OF THE BLOOD CONTACTING SURFACES DID NOT REVEAL ANY ADHERED DEPOSITIONS OR THROMBUS FORMATIONS THAT WOULD HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. (B)(6) WAS CLEANED, REBUILT, AND FUNCTIONALLY TESTED ON A MOCK CIRCULATORY LOOP. THE DEVICE OPERATED AS INTENDED AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) AND THE PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING DEATH, BLEEDING, RIGHT HEART FAILURE, AND RENAL FAILURE. THIS SECTION ALSO ADDRESSES ALL PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 4, ¿SYSTEM MONITOR¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. THE IFU STATES THAT PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 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. THIS SECTION ALSO EXPLAINS THAT CHANGES IN PATIENT CONDITION CAN RESULT IN LOW FLOW. SECTION 7 OF THE IFU, "ALARMS AND TROUBLESHOOTING", AND SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING", ADDRESS ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. FURTHERMORE, SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. 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 ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    AN AUTOPSY WAS DONE THAT CONFIRMED UPPER GIB FROM DIEULAFOY LESION WITH ESOPHAGEAL TEARS. THIS WAS AN ACUTE BLEED TREATED WITH PRESSORS. THE PATIENT WAS NOTED TO HAVE NORMAL RIGHT VENTRICLE FUNCTION PRIOR TO THE LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE DEVICE WAS SAID NOT TO CAUSE/CONTRIBUTE TO RHF. THE PATIENT HAD SYMPTOMS OF PROFOUND HYPOTENSION WITH LOW FLOW ALARMS. THE ACUTE RHF FROM CARDIOGENIC SHOCK AND GIB RESULTED IN DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY AFTER A HYPOTENSIVE EPISODE. THE LOG FILES WERE REVIEWED AND CAPTURED LOW FLOW EVENTS ON (B)(6) 2024 BETWEEN 1:59:38 AND 3:09:54. THE MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT APPEARED TO OPERATE AS INTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) FOR AN ACUTE KIDNEY INJURY (AKI) ON (B)(6) 2024. THE PATIENT PASSED AWAY AFTER A HYPOTENSIVE EPISODE ON (B)(6) 2024. IT WAS SUSPECTED THIS WAS LIKELY DUE TO GASTROINTESTINAL BLEEDING (GIB) AND RIGHT HEART FAILURE (RHF). THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED. THE DEVICE WAS PLANNED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200185 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 10208926 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Death