BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19843620 · Received July 26, 2024

    Report

    Report Number
    2916596-2024-04730
    Event Type
    Death
    Date Received
    July 26, 2024
    Date of Event
    July 11, 2024
    Report Date
    October 11, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6: HEALTH EFFECT - IMPACT CODE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED OUTFLOW GRAFT OBSTRUCTION AND REPORTEDLY RELATED CLOT WERE UNABLE TO BE CONFIRMED AS NO IMAGES OR PRODUCT WERE SUBMITTED FOR EVALUATION. A SPECIFIC CAUSE FOR THE REPORTED OUTFLOW GRAFT OBSTRUCTION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, AND A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED. REVIEW OF THE SUBMITTED LOG FILES CONFIRMED LOW FLOW ALARMS ON (B)(6) 2024. THE END OF THE LOG FILE CAPTURED A PERSISTENT LOW FLOW ALARM, LASTING OVER 5 HOURS. A GRADUAL DECREASE IN FLOW WAS NOTED OVER THE APPROXIMATELY 12 DAYS LEADING UP TO (B)(6) 2024. IT WAS REPORTED THAT THE LOW FLOW WAS DUE TO OUTFLOW GRAFT OBSTRUCTION. THE SYSTEM OTHERWISE APPEARED TO BE OPERATING AS INTENDED AT THE SET SPEED, AND THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILES. IT WAS REPORTED THAT HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), WOULD NOT BE RETURNED FOR EVALUATION. 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) REV. C IS CURRENTLY AVAILABLE. SECTION 1 "INTRODUCTION" PROVIDES AN EXPLANATION OF ALL PUMP PARAMETERS, INCLUDING PUMP FLOW AND POWER. THIS SECTION EXPLAINS THAT DEVICE FLOW AND POWER GENERALLY RETAIN A LINEAR RELATIONSHIP AT A GIVEN SPEED. HOWEVER, WHILE POWER IS DIRECTLY MEASURED BY THE SYSTEM CONTROLLER, THE REPORTED FLOW IS ESTIMATED, BASED ON POWER. AN OCCLUSION OF THE FLOW PATH DECREASES FLOW AND CAUSES A CORRESPONDING DECREASE IN POWER. PUMP OUTPUT SHOULD BE ASSESSED IN THIS SITUATION. SECTION 4 ¿SYSTEM MONITOR¿ PROVIDES INFORMATION ABOUT THE PUMP FLOW DISPLAY AND THE LOW FLOW HAZARD ALARM CONDITION. THIS SECTION STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW IS LESS THAN 2.5 LPM (LITERS PER MINUTE) AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ DESCRIBES ALARM CONDITIONS, INCLUDING THE LOW FLOW HAZARD, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. SECTION 1 OF THE IFU LISTS PUMP THROMBOSIS, STROKE, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 5, "SURGICAL PROCEDURES" (UNDER ¿PREPARING THE VENTRICULAR APEX SITE¿), INSTRUCTS TO INSPECT THE VENTRICULAR CHAMBER FOR MURAL THROMBI AND CROSSING TRABECULAE FOLLOWING REMOVAL OF THE CORE AND TO ADDRESS ONE OR BOTH, AS NEEDED. FURTHERMORE, SECTION 5, UNDER ¿IMPLANT PROCEDURES¿, WARNS TO INSPECT THE VENTRICLE AND REMOVE ANY PREVIOUSLY FORMED CLOTS THAT MAY CAUSE EMBOLISM OR ANY TRABECULAE THAT MAY IMPEDE FLOW. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ ALSO CONTAINS INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR (INTERNATIONAL NORMALIZED RATIO) RANGE. SECTION 5 OF THE IFU CONTAINS INFORMATION ON "PREPARING THE SEALED OUTFLOW GRAFT." SECTION 5 ALSO CONTAINS A SUB-SECTION ON "ATTACHING THE SEALED OUTFLOW GRAFT TO THE AORTA", WHICH INSTRUCTS THE USER TO STRETCH THE GRAFT COMPLETELY AND THEN MEASURE AND CUT THE SEALED OUTFLOW GRAFT TO THE APPROPRIATE LENGTH. SECTION 5 INSTRUCTS THE USER TO VERIFY THAT THE GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. THE HEARTMATE 3 LVAS PATIENT HANDBOOK REV. D, IS CURRENTLY AVAILABLE. SECTION 5 "ALARMS AND TROUBLESHOOTING" OUTLINES SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THIS DOCUMENT INSTRUCTS THE USER THAT IN THE EVENT OF A LOW FLOW HAZARD ALARM, CALL YOUR HOSPITAL CONTACT IMMEDIATELY FOR DIAGNOSIS AND INSTRUCTIONS. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. 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

    IT WAS ADDITIONALLY REPORTED THAT THE OUTFLOW GRAFT OBSTRUCTION (OGO) WAS CONFIRMED WITH IMAGING ON (B)(6) 2024. THE TYPE OF STROKE DIAGNOSED WAS AN ISCHEMIC THROMBOTIC STROKE. THE PATIENT HAD FAILED WARFARIN THERAPY WITH NO MEASURABLE TIME IN THE THERAPEUTIC RANGE AND THE PATIENT WAS TRIALED ON APIXABAN (ELIQUIS) HOWEVER THE PATIENT'S COMPLIANCE WITH ANTICOAGULATION COULD NOT BE MEASURED. THE PATIENT EXPERIENCED SHOCK AND LOW FLOWS. IT WAS NOTED THAT THE OGO WAS THE CAUSE OF THE CLOT AND LOW FLOWS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD PROGRESSED WITH AN OUTFLOW GRAFT OBSTRUCTION (OFGO) AND A CTA WAS BEING PLANNED. IT WAS NOTED THAT THE PATIENT WAS NONCOMPLIANT WITH MEDICATIONS AND FOLLOW-UPS. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED CONTINUOUS LOW FLOW ALARMS ON (B)(6) 2024. THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2024 FOR AN OUTFLOW GRAFT REVISION. THE PATIENT HAD A STROKE AND EXPIRED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933453 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7385785 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Death