BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21426509 · Received February 20, 2025

    Report

    Report Number
    2916596-2025-00853
    Event Type
    Death
    Date Received
    February 20, 2025
    Date of Event
    November 29, 2024
    Report Date
    March 20, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011712
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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

    SECTION H6: HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT - IMPACT CODE, AND MEDICAL DEVICE PROBLEM CODE CORRECTED. MANUFACTURER¿S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED LOW FLOW ALARMS. A SPECIFIC CAUSE WAS NOT ABLE TO BE DETERMINED THROUGH THIS EVALUATION; HOWEVER, THE ACCOUNT COMMUNICATED THE LOW FLOW ALARMS WERE CAUSED BY PUMP THROMBOSIS. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS AND PATIENT¿S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED CONTROLLER EVENT LOG FILES COLLECTIVELY CONTAINED EVENTS FROM 11JAN2025 THROUGH 28JAN2025. LOW FLOW HAZARD ALARMS WERE CAPTURED ON 18JAN2025, 22JAN2025, 26JAN2025, AND 27JAN2025. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE SET SPEED. 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 LVAS IFU, REV. C, AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. B, ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEVICE THROMBOSIS, STROKE, MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION (RESPIRATORY FAILURE, RIGHT HEART FAILURE, RENAL FAILURE, HEPATIC DYSFUNCTION) AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. ADDITIONALLY, IT ADDRESSES 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 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 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. THIS SECTION, UNDER ¿ANTICOAGULATION¿, PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. 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 PROVIDE 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 LOG FILES WERE SUBMITTED FOR REVIEW AND CONTAINED LOW FLOW ESTIMATES AS WELL AS SUSTAINED LOW FLOW HAZARD EVENTS BETWEEN (B)(6) 2025 6:37AM AND (B)(6) 2025 7:04PM. THE LOW FLOW EVENTS APPEARED TO HAVE RESOLVED FOLLOWING THIS TIME FRAME. THE LOW FLOW READINGS DID NOT APPEAR TO BE THE RESULT OF ANY EXTERNAL EQUIPMENT MALFUNCTION. NO PATIENT SYMPTOMS WERE OBSERVED. THE PATIENT WAS ON VENTILATOR AND SEDATED. THE CAUSE OF LOW FLOWS WAS THOUGHT TO BE DUE TO PUMP THROMBOSIS. LOW FLOWS RESOLVED AFTER CARDIOPULMONARY RESUSCITATION (CPR) AND DRUG/FLUID RESUS. THE PATIENT PASSED AWAY ON (B)(6) 2025. IT WAS NOTED THAT THE PATIENT WAS READMITTED ON (B)(6) 2024 WITH SUPERIMPOSED BACTERIAL HOSPITAL-ACQUIRED PNEUMONIA (HAP). THIS RESULTED IN PROLONGED VENTILATION AND ESCALATION OF INOTROPIC SUPPORT. THE PATIENT ALSO DEVELOPED MULTIPLE STROKES THAT WERE LIKELY CARDIOEMBOLIC EVENTS. THE PATIENT EXPERIENCED GENERAL DECLINE SINCE (B)(6) 2025 PRESUMPTIVE ISCHEMIC BOWEL WITH PROGRESSIVE MULTIORGAN FAILURE, REQUIRING RENAL DIALYSIS. PATIENT HAD AN EPISODE OF CARDIOVASCULAR COLLAPSE ON (B)(6) 2025, REQUIRING CPR AND MAXIMAL INOTROPIC SUPPORT. PATIENT PROGRESSIVELY DECLINED AND DEMISED ON (B)(6) 2025 AS NON-CORONER'S CASE. CAUSE OF DEATH WAS ISCHEMIC BOWEL BLOOD GLUCOSE (B/G) AND HEART FAILURE.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD SOME LOW FLOW EVENTS WHILE HEMODYNAMICALLY STABLE ON (B)(6) 2025 AND AGAIN ON (B)(6) 2025. OMISSIONS OF ANTICOAGULANT INFRAVESICAL OBSTRUCTION (IVO) LED TO HEMORRHAGIC CONVERSION OF THE PATIENT'S PREVIOUS CEREBRAL INFARCT WHICH MAY HAVE CONTRIBUTED TO THE PUMP THROMBOSIS. CAUSE OF DEATH WAS ISCHEMIC BOWEL WITH BACKGROUND OF ADVANCED HEART FAILURE AND ILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424154 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 10223056 00813024011712

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Death