BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 25260641 · Received May 22, 2026

    Report

    Report Number
    2916596-2026-2917242
    Event Type
    Death
    Date Received
    May 22, 2026
    Date of Event
    January 1, 2025
    Report Date
    May 22, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    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 ATTACHEDARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 01JAN2025 SINCE THE DATE OF DATA COLLECTION WAS NOT PROVIDED. AUTHOR INFORMATION: COLUMBIA UNIVERSITY MEDICAL CENTER, NEW YORK, NY; COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEW YORK, NY; COLUMBIA UNIVERSITY, NEW YORK, NY; NEW YORK PRESBYTERIAN, NEW YORK, NY; NEW YORK PRESBYTERIAN HOSPITAL, NEW YORK, NY; CARDIOVASCULAR RESEARCH FOUNDATION, NEW YORK, NY ELAD, B., BARANOWSKA, J., CHUI, A., RAHMAN, S., RAIKHELKAR, J., LOTAN, D., FRIED, J., CLERKIN, K., YUNIS, A., VALLEDOR, A. F., WATS, K., OH, K., MOELLER, C., YUZEFPOLSKAYA, M., COLOMBO, P., TAKEDA, K., NAKA, Y., BURKHOFF, D., SAYER, G., & URIEL, N. (2025). MICROCIRCULATION AS A PREDICTOR OF CLINICAL OUTCOMES IN LEFT VENTRICULAR ASSIST DEVICE THERAPY. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 44, S443¿S444. MANUFACTURER¿S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, AND A DIRECT CORRELATION WITH HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) COULD NOT BE CONCLUSIVELY ESTABLISHED. NO DEVICES WERE RETURNED FOR THIS EVALUATION THE DEVICE SERIAL NUMBERS WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. D, IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING DEATH. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU PAGE OF THE ABBOTT WEBSITE. 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 LITERATURE ARTICLE ¿MICROCIRCULATION AS A PREDICTOR OF CLINICAL OUTCOMES IN LEFT VENTRICULAR ASSIST DEVICE THERAPY¿ THAT A PROSPECTIVE STUDY WAS PERFORMED ON 34 HEARTMATE 3 PATIENTS TO DETERMINE THE MICRO VESSEL DENSITY, CAPILLARY BLOOD FLOW, CAPILLARY BLOOD VOLUME (CBV), PERFUSED BOUNDARY REGION (PBR), AND OVERALL MICROVASCULAR HEALTH SCORE (MVHS). THE COMPOSITE OUTCOME INCLUDED LATE RIGHT VENTRICULAR FAILURE (RVF), HEMOCOMPATIBILITY RELATED ADVERSE EVENTS (HRAE), AND MORTALITY. 14 PATIENTS WERE FOUND TO HAVE THE COMPOSITE OUTCOME, 5 HAD LATE RVF AND 10 HAD HRAE AFTER A FOLLOW UP OF 270 DAYS. INPATIENTS WITH THE COMPOSITE OUTCOMES, MICROVASCULAR DENSITY WAS NUMERICALLY DECREASED (59.3 [42.1,75.8] VS 78.4 [55,98.4] VESSELS/MM2, P=0.18), CAPILLARY BLOOD FLOW WAS NUMERICALLY DECREASED (59 [53,93.8] VS 103.7 [68.7,125.6] 103 M3/MM2, P=0.14), AND THERE WERE NO SIGNIFICANT DIFFERENCES IN CBV (17.9 [10.8, 27.1] VS 18.9 [14.4, 28.5] 103 M3/S/MM2, P=0.66). MVHS (3 [2.3,3.7] VS 3.4 [2.2,4.7], P=0.47), OR PBR (2.5 [2.3,2.6] VS 2.4 [2.1, 2.7] M, P=0.7).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405941 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death