BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 23303959 · Received October 15, 2025

    Report

    Report Number
    2916596-2025-06467
    Event Type
    Death
    Date Received
    October 15, 2025
    Date of Event
    January 1, 2018
    Report Date
    October 15, 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
    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. (B)(6) HOSPITAL CENTER, (B)(6). PRASAD, R., LORENTE ROS, M., SIMON FRANCES, B., HUSAIN, M., PINILLA, M., PAPOLOS, A., GUPTA, R., KENIGSBERG, B., KADAKKAL, A., BALSARA, K. R., SHEIKH, F. H., & LAM, P. H. (2025). CLINICAL IMPACT OF BODY MASS INDEX IN HEARTMATE 3 LVAD RECIPIENTS REQUIRING TEMPORARY RVAD FOR EARLY RIGHT VENTRICULAR FAILURE. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 85(12, SUPPL A), ABSTRACT 1009-07. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM AND THE REPORTED EVENTS 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 IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU, IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. 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, ¿CLINICAL IMPACT OF BODY MASS INDEX IN HEARTMATE 3 LVAD RECIPIENTS REQUIRING TEMPORARY RVAD FOR EARLY RIGHT VENTRICULAR FAILURE¿ THAT HEARTMATE 3 LVAD MAY HAVE BEEN ASSOCIATED WITH RIGHT VENTRICULAR FAILURE, ARRHYTHMIAS, AND OUTCOMES INCLUDING DEATH. THE RETROSPECTIVE ANALYSIS EXAMINED THE CLINICAL IMPACT OF BODY MASS INDEX (BMI) IN PATIENTS WHO UNDERWENT HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION AND REQUIRED TEMPORARY RIGHT VENTRICULAR ASSIST DEVICE (RVAD) SUPPORT FOR EARLY RIGHT VENTRICULAR FAILURE (RVF). CONDUCTED AT A SINGLE CENTER FROM JANUARY 1, 2018, TO AUGUST 31, 2023, THE STUDY INCLUDED 44 PATIENTS, WITH A MEDIAN BMI OF 26.5. MULTIVARIATE ANALYSIS REVEALED THAT PATIENTS WITH A BMI > 35 KG/M² HAD THE HIGHEST RISK OF IN-HOSPITAL MORTALITY (OR 19.1, P=0.02). ADDITIONALLY, BMI AS A CONTINUOUS VARIABLE WAS ASSOCIATED WITH INCREASED RISK OF IN-HOSPITAL MORTALITY (OR 1.2, P=0.005). THE FINDINGS HIGHLIGHT THE IMPORTANCE OF ADDRESSING OBESITY AND RELATED COMORBIDITIES PRIOR TO LVAD IMPLANTATION TO IMPROVE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2357941 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death