BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 18387237 · Received December 22, 2023

    Report

    Report Number
    2916596-2023-08810
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    December 7, 2023
    Report Date
    March 12, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HEALTH EFFECT - CLINICAL CODE: APPROPRIATE TERM / CODE NOT AVAILABLE FOR PROTEIN-LOSING ENTEROPATHY (PLE). MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILE CONTAINED EVENTS FROM (B)(6) 2023 THROUGH (B)(6) 2023. ALARMS CONSISTENT WITH THE REPORTED TAVI PROCEDURE WERE OBSERVED ON (B)(6) 2023. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED, AND THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE FIXED 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 INSTRUCTIONS FOR USE (IFU), REV. C, AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. D, ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING CARDIAC ARRHYTHMIA, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS SECTION ALSO ADDRESSES ALL PUMP PARAMETERS. SECTION 4 OF THE IFU, ¿SYSTEM MONITOR¿, STATES THAT A RAMPED SPEED STUDY USING ECHOCARDIOGRAPHY IS THE MOST DIRECT METHOD FOR DETERMINING THE OPTIMAL FIXED SPEED THAT WILL PROVIDE THE PREFERRED LEVEL OF CARDIAC SUPPORT FOR EACH PATIENT. THE STEPS TO FIND THE OPTIMAL FIXED SPEED FOR THE PATIENT ARE ALSO INCLUDED. THIS SECTION FURTHER EXPLAINS THAT THE FIXED SPEED IS BASED ON CHANGES IN VENTRICULAR SHAPE AND FUNCTION, AND THE PATIENT'S PHYSIOLOGICAL RESPONSE TO CHANGING PUMP SPEEDS. THE FINAL DECISION IS ULTIMATELY DEPENDENT ON THE PHYSICIAN'S CLINICAL JUDGEMENT AND WILL VARY FROM PATIENT TO PATIENT. SECTION 4 OF THE IFU OUTLINES SITUATIONS THAT CAN RESULT IN LOW FLOW ALARMS. THIS SECTION ALSO EXPLAINS THAT A LOW-SPEED ADVISORY ALARM WILL BECOME ACTIVE WHEN THE FIXED SPEED IS SET 200 RPM OR MORE BELOW THE LOW SPEED LIMIT. SECTION 5 OF THE IFU, ¿SURGICAL PROCEDURES¿, WARNS THAT MODERATE TO SEVERE AORTIC INSUFFICIENCY MUST BE CORRECTED AT THE TIME OF DEVICE IMPLANT. IF NOT ADDRESSED, THE LVAD WILL NOT BE ABLE TO PROVIDE THE INTENDED FLOW. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, PROVIDE INFORMATION ON THE SYSTEM ADVISORY AND HAZARD ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AORTIC INSUFFICIENCY (AI) THAT WORSENED OVER TIME FOLLOWING LVAS IMPLANT. THE PATIENT WAS ADMITTED AFTER COMPLETING A TRANSPLANT WORKUP DUE TO WORSENING SYMPTOMS, INCLUDING WORSENING OF FONTAN FAILURE, INTRA-ATRIAL REENTRANT TACHYCARDIA (IART)/ARRHYTHMIA, PROTEIN-LOSING ENTEROPATHY (PLE), AND DESATURATION BELOW BASELINE. THE PATIENT¿S AORTIC VALVE WAS INCOMPETENT, AND THE PATIENT SHOWED WORSENING REGURGITATION, WITH INCOMPLETE EMPTYING OF THE SYSTEMIC VENTRICLE AT THE CURRENT PUMP SPEED. THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE IN THE CATHETERIZATION LABORATORY. DURING THE PROCEDURE, THE PUMP SPEED WAS DECREASED TO 3000 REVOLUTIONS PER MINUTE (RPM) WHEN THE VALVE WAS BEING DEPLOYED, TO PREVENT THE VALVE FROM BEING SUCKED INTO THE PUMP AND TO ALLOT TIME FOR THE VALVE TO EXPAND. IT WAS REPORTED THE PATIENT WAS IN SHOCK THROUGHOUT THE PROCEDURE AND EXPERIENCED IART UNTIL THE VALVE WAS IN PLACE. ONCE THE VALVE WAS IN PLACE, THE PUMP SPEED WAS INCREASED SLOWLY, UNTIL OPTIMAL HEMODYNAMICS WERE ACHIEVED. IT WAS LATER REPORTED THAT THE PATIENT REMAINED HOSPITALIZED AND ON INOTROPIC SUPPORT UNTIL ULTIMATELY RECEIVING A HEART TRANSPLANT ON (B)(6) 2024. THE DEVICE HAD OPERATED AS EXPECTED AND FUNCTIONED WITH NO ISSUES. IT WAS REPORTED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LOG FILES FOR PATIENT JM CONTAINED VARIOUS SET SPEED CHANGED BELOW THE LOW LIMIT. LOW SPEED ADVISORY AS WELL AS LOW FLOW HAZARD ALARMS WERE TRIGGERED AS A RESULT. THE ALARMS RESOLVED ONCE THE SET SPEED WAS ADJUSTED ABOVE THE LOW LIMIT. NO OTHER ABNORMAL SYSTEM CONTROLLER ALARMS OR PUMP FAULTS WERE SEEN IN THE LOG FILES. THE SPEED CHANGES AND THE LOW FLOWS OCCURRED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE TO REPAIR THE PATIENTS AORTIC VALVE. THE SPEED WAS SET BELOW THE LOW LIMIT AT AROUND 3000 ROTATIONS PER MINUTE TO PROTECT THE VALVE AND WAS RETURNED TO NORMAL AFTER THE PROCEDURE WAS COMPLETED. IT WAS NOTED THE PATIENT WAS IN CARDIOGENIC SHOCK AND INTRA-ARTERIAL TACHYCARDIA THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296995 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8122548 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Life Threatening| R| H