BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 25280135 · Received May 26, 2026

    Report

    Report Number
    2916596-2026-2917044
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    December 1, 2023
    Report Date
    May 26, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013266
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS: (B)(6) 2023 AS PATIENTS WERE IMPLANTED BETWEEN NOV2014 AND DEC2023. AUTHOR INFORMATION: APONTE CAMACHO, G. M., YUZEFPOLSKAYA, M., KURLANSKY, P., ZHAO, Y., SHAH, S., COLOMBO, P., SAYER, G., NAKA, Y., BARANOWSKA, J., REINKE, H., & TAKEDA, K. (2025). GUIDELINE DIRECTED MEDICAL THERAPY ASSOCIATIONS WITH LATE RIGHT HEART FAILURE IN PATIENTS ON HEARTMATE 3 SUPPORT. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 44(4). HTTPS://DOI.ORG/10.1016/J.HEALUN.2025.02.977 COLUMBIA UNIVERSITY VAGELOS COLLEGE OF PHYSICIANS AND SURGEONS, NEW YORK CITY, NY COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEW YORK CITY, NY NEW YORK PRESBYERIAN HOSPITAL, NEW YORK CITY, NY MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED RIGHT HEART FAILURE COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WERE NOT REPORTED AND WERE NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU REV. D IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. 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, ¿GUIDELINE DIRECTED MEDICAL THERAPY ASSOCIATIONS WITH LATE RIGHT HEART FAILURE IN PATIENTS ON HEARTMATE 3 SUPPORT.¿ A RETROSPECTIVE, SINGLE CENTER STUDY EVALUATING ASSOCIATIONS BETWEEN GUIDELINE DIRECTED MEDICAL THERAPY (GDMT) AND LATE RIGHT HEART FAILURE (L RHF) IN PATIENTS SUPPORTED WITH THE HEARTMATE 3 (HM3) LVAD. THIS STUDY EVALUATED LATE RIGHT HEART FAILURE (L RHF) IN 314 PATIENTS SUPPORTED WITH THE HEARTMATE 3 LVAD AND ASSESSED ASSOCIATIONS WITH GUIDELINE DIRECTED MEDICAL THERAPY. L RHF OCCURRED IN (B)(4) % OF PATIENTS AND WAS ASSOCIATED WITH LOWER INCIDENCE OF L-RHF IN HM3 SUPPORTED PATIENTS; USE OF BETA BLOCKERS, RAAS INHIBITORS, AND SGLT2 INHIBITORS WAS PROTECTIVE, WHILE NEED FOR AMIODARONE, DIURETICS, HYDRALAZINE, OR PDE 5 INHIBITORS WAS ASSOCIATED WITH HIGHER RISK. FIVE-YEAR SURVIVAL WAS REDUCED FOR L-RHF PATIENT VS NO RHF PATIENTS, 51.9% VS 78.5%, P< 0.01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126454 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013266

    Patients

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