BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 15313698 · Received August 29, 2022

    Report

    Report Number
    2916596-2022-12827
    Event Type
    Injury
    Date Received
    August 29, 2022
    Date of Event
    May 1, 2022
    Report Date
    August 29, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED ARTICLE TITLE: CONTINUOUS FLOW VENTRICULAR ASSIST DEVICES IN CHILDREN - HOW TO BRIDGE THE GAP THE HVAD LEFT BEHIND? FÜRNISS, H.E., ET AL. PERFUSION 37.1 SUPPL: 84-85. SAGE PUBLICATIONS INC. (MAY 2022) . (B)(6). MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE LVAD DEVICES AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RESEARCH ABSTRACT TITLED ¿CONTINUOUS FLOW VENTRICULAR ASSIST DEVICES IN CHILDREN - HOW TO BRIDGE THE GAP THE HVAD LEFT BEHIND?¿ REPORTED THE FOLLOWING INFORMATION: THE PURPOSE OF THIS STUDY WAS TO PROVIDE INSIGHTS INTO EXPERIENCES WITH THE HEARTMATE 3 (HM3) IN CHILDREN BELOW 50 KG WHO WERE PREVIOUSLY TREATED WITH AN HVAD, SINCE THE HVAD WAS DISCONTINUED DUE TO INCREASED NEUROLOGICAL EVENTS AND MORTALITY IN ADULTS. DATA WAS COLLECTED ON THE CASE OF A 13 YEAR OLD BOY WITH SEVERE ANTHRACYCLIN INDUCED CARDIOMYOPATHY AFTER OSTEOSARCOMA TREATMENT. THE PATIENT EXPERIENCED A PROBLEMATIC COURSE AS THE RIGHT VENTRICLE (RV) WAS UNABLE TO PUMP THE MINIMUM 2.5 L/MIN CARDIAC OUTPUT REQUIRED FOR THE HM3. ALTHOUGH THIS RELATIVE RV IMPAIRMENT WAS IN ITSELF NOT CLINICALLY EVIDENT, THE CONCOMITANT HM3 DIFFICULTIES WITH CONTINUOUS, DISTRESSING HM3 ALARMS SIGNIFICANTLY HAMPERED CLINICAL PROGRESS, LEADING TO IMPLANTATION OF A TEMPORARY RVAD AND NUMEROUS COMPLICATIONS. AFTER 3.5 MONTHS THE PATIENT WAS DISCHARGED HOME WITH THE HM3. PATIENT 1 DID NOT EXPERIENCE ADVERSE NEUROLOGICAL EVENTS. FINALLY, PATIENT 1 RECEIVED A HEART TRANSPLANTATION 21 MONTHS AFTER HM3 IMPLANTATION. THE STUDY CONCLUDED THAT UNDER THE PREREQUISITE OF SUFFICIENT RV FUNCTION, THE HM3 IS A SATISFACTORY ALTERNATIVE TO HVAD IN CHILDREN AND YOUNG ADOLESCENTS. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION,¿ LISTS RIGHT HEART FAILURE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE "CONTINUOUS FLOW VENTRICULAR ASSIST DEVICES IN CHILDREN - HOW TO BRIDGE THE GAP THE HVAD LEFT BEHIND?" THAT AFTER HEARTMATE 3 (HM3) IMPLANT THE PATIENT EXPERIENCED A PROBLEMATIC COURSE, AS THE RIGHT VENTRICLE (RV) WAS UNABLE TO PUMP THE MINIMUM 2.5 L/MIN CARDIAC OUTPUT REQUIRED FOR HM3. ALTHOUGH THIS RELATIVE RV IMPAIRMENT WAS IN ITSELF NOT CLINICALLY EVIDENT, THE CONCOMITANT HM3 DIFFICULTIES WITH CONTINUOUS, DISTRESSING HM3 ALARMS SIGNIFICANTLY HAMPERED CLINICAL PROGRESS, LEADING TO IMPLANTATION OF A TEMPORARY RVAD AND NUMEROUS COMPLICATIONS. AFTER 3.5 MONTHS THE PATIENT WAS DISCHARGED HOME WITH THE HM3. THE PATIENT DID NOT EXPERIENCE ADVERSE NEUROLOGICAL EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318446 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male Required Intervention| L