BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 25006152 · Received April 27, 2026

    Report

    Report Number
    2916596-2026-02385
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    December 31, 2023
    Report Date
    May 26, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN 2014 AND 2023. SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DATE OF EVENT IS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN 2014 AND 2023. COLUMBIA UNIVERSITY MEDICAL CENTER, NEW YORK, NY. COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEW YORK, NY. CARDIOVASCULAR RESEARCH FOUNDATION, NEW YORK, NY. ELAD, B., LABARRE, B., CHUI, A., BARANOWSKA, J., STANTON, L., RAHMAN, S., HERTZ, A., LOTAN, D., YUNIS, A., FRIED, J., RAIKHELKAR, J., CLERKIN, K., WA, K., OH, K., BAE, D., DEFILIPPIS, E., NAKA, Y., COLOMBO, P., YUZEFPOLSKAYA, M.,¿ SAYER, G. (2025). DOES PACEMAKER MODE AFFECT OUTCOMES IN PATIENTS WITH HEARTMATE 3 LVAD? THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 44(4). HTTPS://DOI.ORG/10.1016/J.HEALUN.2025.02.235

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE RESEARCH ARTICLE "DOES PACEMAKER MODE AFFECT OUTCOMES IN PATIENTS WITH HEARTMATE3 LVAD" THAT THE HEARTMATE 3 MAY BE LINKED TO RIGHT HEART FAILURE, HEMOCOMPATIBILITY RELATED ADVERSE EVENTS (HRAE) AND DEATH. 152 PATIENTS WERE INCLUDED IN THE RETROSPECTIVE STUDY WHICH ANALYZED HEARTMATE 3 PATIENTS IMPLANTED AT THEIR CENTER BETWEEN 2014-2023. THE MEAN AGE WAS 59 YEARS, 83% WERE MEN AND 48% HAD AN ISCHEMIC CARDIOMYOPATHY. 36 (24%) HAD BIVENTRICULAR PACING (BIV), 11 (7%) HAD RIGHT VENTRICULAR (RV) PACING AND 105 (69%) HAD NO PACING. AGE (57, 69, 66 YEARS, P < 0.001), ATRIAL FIBRILLATION (58%, 9%, 36%, P=0.001), AND KIDNEY FUNCTION (EGFR: 65, 53, 54 ML/MIN/1.73 M², P=0.02) VARIED BY PACING MODE (NO PACING, RV, AND BIV PACING). TWO YEARS OVERALL SURVIVAL (NO PACING: 94.6%, RV: 90.9%, BIV: 83.2%,P=0.02), AND SURVIVAL FREE OF LATE RVF AND HRAE (NO PACING: 59.2%,RV:38.2%, BIV:39.6%, P=0.03), WERE DIFFERENT ACCORDING TO THE PACING MODES, WHILE FOR SURVIVAL FREE OF LATE RVF (NO PACING: 80.1%, RV: 58.4%, BIV:72.8%, P=0.08) A NONSIGNIFICANT DIFFERENT WAS NOTED. AFTER ADJUSTING FOR MULTIPLE COFOUNDERS, THE NO PACING MODE HAD LOWER RATES OF COMBINED END POINT OF DEATH AND RVF AND TREND OF OVERALL SURVIVAL. THE COMBINED OUTCOME OF HRAE, RVF AND DEATH DID NOT DIFFER SIGNIFICANTLY BETWEEN THE PACING MODES. IT WAS CONCLUDED THAT PACEMAKER MODE MAY IMPACT OUTCOMES IN LVAD SUPPORTED PATIENTS, HOWEVER LARGER STUDIES WOULD BE NEEDED TO VALIDATE THESE FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319703 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other