BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21327528 · Received February 6, 2025

    Report

    Report Number
    2916596-2025-00604
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    March 1, 2021
    Report Date
    February 6, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. DIVISION OF CARDIOVASCULAR MEDICINE, DEPARTMENT OF INTERNAL MEDICINE, UNIVERSITY OF UTAH HEALTH AND SCHOOL OF MEDICINE, SALT LAKE CITY, UT; GEORGE E. WAHLEN DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTER, SALT LAKE CITY, UT; NORA ECCLES HARRISON CARDIOVASCULAR RESEARCH AND TRAINING INSTITUTE, UNIVERSITY OF UTAH, SALT LAKE CITY, UT; DIVISION OF CARDIOTHORACIC SURGERY, DEPARTMENT OF SURGERY, UNIVERSITY OF UTAH HEALTH AND SCHOOL OF MEDICINE, SALT LAKE CITY, UT; DEPARTMENT OF HEALTH POLICY & ORGANIZATION, SCHOOL OF PUBLIC HEALTH, THE UNIVERSITY OF ALABAMA AT BIRMINGHAM, BIRMINGHAM, AL; AND THE ARNOLD SCHOOL OF PUBLIC HEALTH, UNIVERSITY OF SOUTH CAROLINA, COLUMBIA, SC. KYRIAKOPOULOS, C. P., SELZMAN, C. H., GIANNOUCHOS, T. V., MYLAVARAPU, R., SIDERIS, K., ELMER, A., VANCE, N., HANFF, T. C., KAGAWA, H., STEHLIK, J., DRAKOS, S. G., & GOODWIN, M. L. (2024). HOSPITAL READMISSIONS IN PATIENTS SUPPORTED WITH DURABLE CENTRIFUGAL-FLOW LEFT VENTRICULAR ASSIST DEVICES. JOURNAL OF CLINICAL MEDICINE, 13(10), 2869. HTTPS://DOI.ORG/10.3390/JCM13102869 MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. CENTRIFUGAL-FLOW LEFT VENTRICULAR ASSIST DEVICES (CF-LVADS) HAVE IMPROVED MORBIDITY AND MORTALITY FOR LVAD RECIPIENTS. HOSPITAL READMISSIONS, HOWEVER, REMAIN COMMON AND AFFECT QUALITY OF LIFE AND SURVIVAL. WE SOUGHT TO IDENTIFY FACTORS ASSOCIATED WITH READMISSIONS ON LVAD SUPPORT. HOSPITAL READMISSIONS FOLLOWING LVAD IMPLANTATION REMAIN A COMMON AND VEXING CLINICAL ISSUE ADVERSELY AFFECTING PATIENT QUALITY OF LIFE AND SURVIVAL, AS WELL AS INCREASING HEALTHCARE COSTS AND RESOURCE UTILIZATION [1¿4]. IT HAS BEEN REPORTED THAT UP TO 71% OF PATIENTS ARE REHOSPITALIZED WITHIN ONE YEAR FOLLOWING LVAD IMPLANTATION. DATA WERE COLLECTED TWO TO FOUR MONTHS FOLLOWING LVAD IMPLANTATION, WITH AT LEAST TWO CONSECUTIVE WEEKS BEING REQUIRED AS A MINIMUM FOR A PATIENT TO BE CONSIDERED AS BEING ON A SPECIFIC PHARMACOLOGIC AGENT THERAPY. PATIENTS RECEIVING A CF-LVAD BETWEEN FEBRUARY 2011 AND MARCH 2021 WERE PROSPECTIVELY EVALUATED. HOSPITAL READMISSIONS WERE DICHOTOMIZED INTO HF/LVAD-RELATED OR NON-HF/LVAD-RELATED. MULTIVARIABLE LOGISTIC REGRESSION MODELS AUGMENTED USING THE LEAST ABSOLUTE SHRINKAGE AND SELECTION OPERATOR METHOD FOR VARIABLE SELECTION WERE USED TO ESTIMATE ASSOCIATIONS BETWEEN =1 HF/LVAD-RELATED READMISSIONS AND CLINICAL VARIABLES. THE PRIMARY OUTCOME OF INTEREST WAS THE INCIDENCE OF ANY HF/LVAD-RELATED READMISSION UP TO THREE YEARS POST-LVAD IMPLANTATION HOSPITAL DISCHARGE. THE SECONDARY OUTCOME WAS THE HAZARD OF HF/LVAD-RELATED READMISSIONS WHILE ON LVAD SUPPORT OVER THE THREE YEARS POST-LVAD IMPLANTATION HOSPITAL DISCHARGE. A MODEL WAS CREATED ACCURATELY IDENTIFYING PATIENTS WITH A HIGH LIKELIHOOD OF READMISSIONS AFTER LVAD IMPLANT. MOST VARIABLES ASSOCIATED WITH READMISSION CAN BE IDENTIFIED PRE-OPERATIVELY. THE FINDINGS CAN GUIDE THE IMPLEMENTATION OF THERAPEUTIC STRATEGIES TO MITIGATE READMISSION RISK AND FURTHER IMPROVE OUTCOMES. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE LISTS ADVERSE EVENTS, INCLUDING BLEEDING, INFECTION, CARDIAC ARRHYTHMIA, AND NEUROLOGICAL DYSFUNCTION (NOT STROKE RELATED), WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THE IFU LISTS ARRHYTHMIA, NEUROLOGICAL DYSFUNCTION, AND HYPOVOLEMIA AS POTENTIAL LATE POSTIMPLANT COMPLICATIONS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THE IFU PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. BOTH THE IFU AND PATIENT HANDBOOK CONTAIN VARIOUS SECTIONS REGARDING INFECTION AND HOW TO PREVENT IT. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS ADVERSE EVENTS, INCLUDING BLEEDING, INFECTION, CARDIAC ARRHYTHMIA, NEUROLOGICAL DYSFUNCTION (NOT STROKE RELATED), AND RENAL DYSFUNCTION, WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 6 ¿PATIENT CARE AND MANAGEMENT LISTS ARRHYTHMIA, NEUROLOGICAL DYSFUNCTION, AND HYPOVOLEMIA AS POTENTIAL LATE POSTIMPLANT COMPLICATIONS THAT MAY BE ASSOCIATED WITH THE USE OF 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. BOTH THE IFU AND PATIENT HANDBOOK CONTAIN VARIOUS SECTIONS REGARDING INFECTION AND HOW TO PREVENT IT. 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 "HOSPITAL READMISSIONS IN PATIENTS SUPPORTED WITH DURABLE CENTRIFUGAL-FLOW LEFT VENTRICULAR ASSIST DEVICES" THAT HEARTMATE 3 (HM3) PATIENTS WERE READMITTED IN THE HOSPITAL POST IMPLANTATION DUE TO BLEEDING, INFECTION, CARDIAC ARRHYTHMIA, AND NEUROLOGICAL DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910104 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R