BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 25258013 · Received May 22, 2026

    Report

    Report Number
    2916596-2026-2916752
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, B 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. DATE OF EVENT HAS BEEN ENTERED AS 01APRIL2025, SAME AS PUBLISHED DATE SINCE THE DATE OF DATA COLLECTION WAS NOT PROVIDED. ELAD, B., CHUI, A., BARANOWSKA, J., STANTON, L., RAHMAN, S., LABARRE, B., RAIKHELKAR, J., FRIED, J., CLERKIN, K., LOTAN, D., YUNIS, A., WATS, K., RUBINSTEIN, G., BAE, D., OH, K., YUZEFPOLSKAYA, M., COLOMBO, P., TAKEDA, K., NAKA, Y., BURKHOFF, D., SAYER, G., URIEL, N. (2025). TRICUSPID VALVE REGURGITATION PROGRESSION POST HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 44(4), S951 DOI: HTTPS://DOI.ORG/10.1016/J.HEALUN.2025.02.960. COLUMBIA UNIVERSITY MEDICAL CENTER, NEW YORK, NY WEILL CORNELL UNIVERSITY MEDICAL CENTER, NEW YORK, NY CARDIOVASCULAR RESEARCH FOUNDATION, NEW YORK, NY MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE HM 3 DEVICE SERIAL NUMBER, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE CURRENT REVISION OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), DOCUMENT REV. D, IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 5 OF THE IFU, ¿SURGICAL PROCEDURES¿, EXPLAINS THAT MODERATE TO SEVERE AORTIC INSUFFICIENCY MUST BE CORRECTED AT THE TIME OF DEVICE IMPLANT. THIS SECTION ALSO STATES THAT IF THE AORTIC INSUFFICIENCY IS NOT ADDRESSED, THE DEVICE WILL NOT BE ABLE TO PROVIDE THE INTENDED FLOW. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿, OF THE IFU (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. 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 TITLED ¿TRICUSPID VALVE REGURGITATION PROGRESSION POST HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION¿ IDENTIFYING THAT HEARTMATE 3 MAY BE RELATED TO TRICUSPID VALVE REGURGITATION PROGRESSION POST LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION. THIS IS A COHORT STUDY, 168 PATIENTS, WITH THE GOAL OF UNDERSTANDING THE RELATIONSHIP BETWEEN TRICUSPID REGURGITATION (TR) AND RIGHT VENTRICULAR (RV) FUNCTION PRE AND POST LVAD IMPLANT. TR SEVERITY WAS GRADED FROM 0 (NORMAL) TO 3 (SEVERE), WITH SIGNIFICANT TR (STR) DEFINED AS MODERATE OR GREATER, AND POOR RV HEMODYNAMICS INDICATED BY A RIGHT ATRIAL (RA) TO PULMONARY WEDGE (PW) PRESSURE RATIO GREATER THAN 0.6. THE FINDINGS SHOWED THAT 18% OF THE PATIENTS HAD STR PRE LVAD IMPLANT AND 17% HAD POOR RV HEMODYNAMICS (RA/PW>0.6). AT 1 YEAR POST LVAD, THOSE WITH PRE LVAD STR HAD HIGHER RATES OF STR (51.7% VS 9.2%, P<0.001), WITH SIMILAR RATES OF POOR RV HEMODYNAMICS (68% VS 52%, P=0.22) COMPARED TO THOSE WITHOUT STR PRE LVAD. AT 1 YEAR POST LVAD, 48.6% OF THE PATIENTS WITHOUT STR REMAINED WITHOUT STR AND HAD GOOD RV HEMODYNAMICS. OUT OF THE 168 PATIENTS, 44.6% DEVELOPED EITHER STR OR POOR RV HEMODYNAMICS, AND 6.8% HAD BOTH STR AND POOR RV HEMODYNAMICS. AMONG PATIENTS WITH BASELINE STR, 22.2% HAD GOOD RV HEMODYNAMICS WITHOUT STR, 33.3% HAD EITHER STR OR POOR RV HEMODYNAMICS, AND 44.4% HAD BOTH STR AND POOR RV HEMODYNAMICS. IN TOTAL, 1 YEAR AFTER LVAD IMPLANT 13 PATIENT HAD SIGNIFICANT TR AND POOR RV HEMODYNAMICS. 38 PATIENT'S HAD ONLY POOR HEMODYNAMICS, AND 1 PATIENT HAD ONLY SIGNIFICANT TR. PRE LVAD TR SEVERITY WAS CONSIDERED TO BE ASSOCIATED WITH POST LVAD TR SEVERITY, ALTHOUGH IT WAS CONTRADICTORY WITH RV FAILURE DEFINED BY INVASIVE HEMODYNAMICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130432 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening