BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 23975735 · Received January 6, 2026

    Report

    Report Number
    2916596-2025-08206
    Event Type
    Death
    Date Received
    January 6, 2026
    Date of Event
    February 1, 2021
    Report Date
    January 6, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS 01FEB2021 SINCE THE DATA WERE COLLECTED BETWEEN FEBRUARY 2021 AND JANUARY 2025. SECTION D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. AUTHOR INFORMATION: CIKES, M., BRUGTS, J. J., CLAGGETT, B., JORDE, U. P., MILICIC, D., PLANINC, I., RUSCHITZKA, F., URIEL, N., KULAC, I., JAKUS, N., LONCARIC, F., PUSKARIC, F., SIPUS, D., GASPAROVIC, H., RUBIS, P., VAN LAAKE, L. W., RUDEZ, I., HEGAROVA, M., SESTAN, G., & WISNIOWSKA-SMIALEK, S. (2025). ANGIOTENSIN-NEPRILYSIN INHIBITION AND LEFT VENTRICULAR ASSIST DEVICE THERAPY. JACC: HEART FAILURE, 13(11), 102657. HTTPS://DOI.ORG/10.1016/J.JCHF.2025.102657. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) DEVICES AND THE REPORTED OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LEFT VENTRICLE ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REVISION, REV. B IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION,¿ LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE REPORTED INFORMATION WAS OBTAINED THROUGH A LITERATURE REVIEW. THE HEARTMATE 3 DEVICE SERIAL NUMBERS AND OTHER SPECIFIC CASE/PATIENT INFORMATION ARE NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THOUGH ARTICLE ¿ANGIOTENSIN-NEPRILYSIN INHIBITION AND LEFT VENTRICULAR ASSIST DEVICE THERAPY¿ REPORTED THAT HEARTMATE 3 (HM3) WAS INVOLVED IN PATIENT DEATHS AND ADVERSE IMPACTS WITHIN 12 MONTHS OF MH3 IMPLANTATION. THE RETROSPECTIVE STUDY SOUGHT TO EVALUATE THE SAFETY AND TOLERABILITY OF THE ANGIOTENSIN-NEPRILYSIN INHIBITOR SACUBITRIL/VALSARTAN VS STANDARD OF CARE (SOC) FOR MANAGING BLOOD PRESSURE (BP) IN HEARTMATE 3 LVAD RECIPIENTS. THE STUDY EVALUATED 60 HM3 PATIENTS, WITH DATA COLLECTION BEGINNING IN FEBRUARY 2021, WITH THE END OF STUDY VISIT OCCURRING ON 24JAN2025. THE RESEARCH ARTICLE REPORTED 3 DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33481 HEARTMATE 3 LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death