BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 23959763 · Received January 5, 2026

    Report

    Report Number
    2916596-2025-08109
    Event Type
    Death
    Date Received
    January 5, 2026
    Date of Event
    August 22, 2025
    Report Date
    January 5, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 B2: SPECIFIC DEATH DATE IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE SECTION B3: DATE OF EVENT IS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN FEBRUARY 2021 AND JUNE 2024 OR LATER. AUTHOR INFORMATION: SOKOLSKI, M., PTAK, J., MAKIELA, M., SZWAJKOWSKI, M., WALOSZCZYK, M., WISNIEWSKI, K., GONTARCZYK, J., MAKOWSKA, P., KRUPKA, D., SITKO, N., CIELECKA, M., RAKOWSKI, M., BOCHENEK, M., PRZYBYLSKI, R., & ZAKLICZYNSKI, M. (2025). COMPARATIVE ANALYSIS OF MULTI-ORGAN FAILURE TRAJECTORIES FOLLOWING HEART TRANSPLANTATION AND HEARTMATE 3 IMPLANTATION: A 1-YEAR POSTPROCEDURAL FOLLOW-UP STUDY UTILIZING THE MELD-XI SCALE. JOURNAL OF CLINICAL MEDICINE, 14(17), 5933. HTTPS://DOI.ORG/10.3390/JCM14175933. INSTITUTE OF HEART DISEASES, JAN MIKULICZ RADECKI UNIVERSITY HOSPITAL WROCLAW, 50556 WROCLAW, POLAND; CLINICAL DEPARTMENT OF HEART TRANSPLANTATION AND MECHANICAL CIRCULATORY SUPPORT, DEPARTMENT OF CARDIAC, SURGERY AND HEART TRANSPLANTATION, INSTITUTE OF HEART DISEASES, FACULTY OF MEDICINE, WROCLAW MEDICAL UNIVERSITY, 50368 WROCLAW, POLAND; INSTITUTE OF HEART DISEASES, STUDENT SCIENTIFIC CLUB OF TRANSPLANTOLOGY AND ADVANCED THERAPIES OF HEART FAILURE, FACULTY OF MEDICINE, WROCLAW MEDICAL UNIVERSITY, 50368 WROCLAW, POLAND; FACULTY OF HEALTH SCIENCES, WROCLAW MEDICAL UNIVERSITY, 50368 WROCLAW, POLAND. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE HEARTMATE 3 DEVICE SERIAL NUMBERS AND OTHER SPECIFIC CASE/PATIENT INFORMATION ARE NOT AVAILABLE AND WERE NOT REQUESTED. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION WERE NOT PROVIDED AND WERE UNABLE TO BE DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 PATIENT HANDBOOK REV. A ARE CURRENTLY AVAILABLE. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, RIGHT HEART FAILURE, INFECTION, AND SEPSIS, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OF THE IFU "PATIENT CARE AND MANAGEMENT" (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS, INCLUDING INOTROPES AND RIGHT VENTRICULAR ASSIST DEVICE (RVAD) PLACEMENT. SECTION 6 (UNDER CAUTION!) STATES: "RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LVAS DUE TO REDUCED FILLING OF THE PUMP." NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THOUGHT THE RESEARCH ARTICLE ¿COMPARATIVE ANALYSIS OF MULTI-ORGAN FAILURE TRAJECTORIES FOLLOWING HEART TRANSPLANTATION AND HEARTMATE 3 IMPLANTATION: A 1-YEAR POSTPROCEDURAL FOLLOW-UP STUDY UTILIZING THE MELD-XI SCALE¿ COMPARING HEART TRANSPLANTS (HTX) AND HEARTMATE3(MH3) IMPLANTS¿ IMPACT ON MULTI-ORGAN FAILURE(MOF) IN PATIENTS WITH ADVANCED HEART FAILURE (HF). THE RETROSPECTIVE STUDY EVALUATED 30 TOTAL HM3 PATIENTS IMPLANTED BETWEEN 25 FEBRUARY 2021 AND 15 JUNE 2023, CONDUCTING INTERMITTENT FOLLOW UPS OVER A 1-YEAR PERIOD. WITHIN THE LVAD PATIENTS, THE STUDY IDENTIFIED PATIENT DEATHS AND SERIOUS INJURIES WITHIN 6 MONTHS OF HM3 IMPLANTATION WITH UNIDENTIFIED CAUSES. IT WAS FOUND THAT 9 HM3 PATIENT'S PATIENTS PASSED AWAY, AND 8 PATIENTS HAD A HEART TRANSPLANT. HALF OF ALL DEATHS IN THE STUDY WERE DUE TO LEFT OR RIGHT HEART FAILURE, WHILE 25% WERE RELATED TO SEPSIS OR INFECTIOUS COMPLICATIONS. IN TOTAL THERE WERE 17 CASES OF RE-HOSPITALIZATION WITHIN 12 MONTHS OF LVAD IMPLANT, 1 CASE OF HEART FAILURE EXACERBATION, AND 14 INFECTIOUS COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27680 HEARTMATE 3 LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death