BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21550512 · Received March 7, 2025

    Report

    Report Number
    2916596-2025-01507
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    November 1, 2024
    Report Date
    March 27, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - REPORTER ESTABLISHMENT NAME: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 DEVICES AND THE REPORTED PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SERIAL NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING MYOCARDIAL INFARCTION, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS DEPLOYED AT TIME OF EVENT. HOUGH, R., DUNN, J. L., & HEPBURN, L. (2024). RE-IMAGINING THE FUTURE STATE OF THE VENTRICULAR ASSIST DEVICE CONTROLLER INTERFACE THROUGH HUMAN-CENTERED DESIGN. ARTIFICIAL ORGANS, 48(11), 1313-1345. DOI: HTTP://DX.DOI.ORG/10.1111/AOR.14817. SCHOOL OF ARCHITECTURE, DESIGN AND PLANNING, UNIVERSITY OF SYDNEY, SYDNEY, NSW, AUSTRALIA. 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 THROUGH THE LITERATURE ARTICLE ¿RE-IMAGINING THE FUTURE STATE OF THE VENTRICULAR ASSIST DEVICE CONTROLLER INTERFACE THROUGH HUMAN-CENTERED DESIGN¿ THAT THE HEARTMATE 3 (HM3) PUMP MAY BE ASSOCIATED WITH HEART ATTACKS, AND THE HM3 SYSTEM CONTROLLER MAY BE ASSOCIATED WITH OVERHEATING. IT WAS ALSO REPORTED THAT THE HM3 SYSTEM CONTROLLER MAY NEGATIVELY IMPACT PATIENTS¿ QUALITY OF LIFE, AS IT¿S FUNCTIONALITY CAN BE ASSOCIATED WITH PSYCHOLOGICAL SYMPTOMS. VENTRICULAR ASSIST DEVICE (VAD) PATIENTS (N = 21), CAREGIVERS (N = 4) AND HEALTHCARE PRACTITIONERS (N = 24) WERE INTERVIEWED TO UNCOVER DESIGN OPPORTUNITIES. FROM THIS, A SERIES OF REALISTIC SCENARIOS TO DESIGN FOR EMERGED. AN ADDITIONAL 15 PATIENTS AND 2 CAREGIVERS WERE ENGAGED TO EXPLORE CURRENT VAD SYSTEM CONTROLLER EXPERIENCES AND EVALUATE THE FUTURE-STATE CONCEPTS. AN ONLINE QUESTIONNAIRE ON THE PATIENT EXPERIENCE OF VAD WEARABLE EQUIPMENT WAS CONDUCTED WITH PARTICIPANTS RECRUITED FROM 15 ONLINE COMMUNITIES FOR VAD USERS WITH GLOBAL REACH, AND 65 VAD PATIENTS WHO HAD PARTICIPATED IN THE ONLINE QUESTIONNAIRE AND CONSENTED TO FOLLOW-UP RESEARCH WERE INVITED BY EMAIL TO STAGE 2 INTERVIEWS. IN THE INTERVIEWS, THERE WERE 17 PARTICIPANTS FROM UNITED STATES (N = 13), THE NETHERLANDS (N = 3), AND THE UNITED KINGDOM (UK) (N = 1). OF THIS GROUP, 14 PARTICIPANTS WERE CURRENT VAD PATIENTS (NINE MALES, FIVE FEMALES), ONE PARTICIPANT WAS A FORMER VAD PATIENT (ONE FEMALE POST-HEART TRANSPLANTATION FROM HEARTMATE II), AND TWO PARTICIPANTS WERE CURRENT CAREGIVERS TO A VAD PATIENT WHO WERE PRESENT IN THE INTERVIEWS WITH VAD PATIENTS (ONE MALE, ONE FEMALE). FOUR PATIENTS HAD BEEN IMPLANTED WITH A HEARTMATE II DEVICE, EIGHT PATIENTS HAD A HEARTMATE 3 DEVICE, AND THREE HAD RECEIVED A HEARTWARE HVAD. WHEN ASKED ABOUT THEIR EMOTIONAL EXPERIENCE, ONE PATIENT STATED THAT THE SYSTEM CONTROLLER WAS ¿TOO WARM, I MEAN, IT RADIATES HEAT YOU KNOW, 24/7. THAT'S BOTHERSOME.¿ ONE PATIENT EXPLAINED THAT THEY WANTED EMERGENCY CONTACTS TO BE NOTIFIED WITH CRITICAL OR NON-CRITICAL ALERTS BECAUSE THEY HAD ¿I'D DONE A HAT-TRICK WITH MY HEART ATTACKS. BECAUSE I'VE HAD A COUPLE.¿ THE FOLLOWING WERE REPORTED RELATED TO THE CURRENT STATE OF THE VAD PATIENT¿S EMOTIONS: PANIC (N = 7), IRRITATION (N = 3), OVERWHELMED (N = 3), ANXIETY (N = 4), CONCERN (N = 6), WORRY (N = 6), HATE (N = 3), AND MILD IRRITATION (N = 5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098855 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention