BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24942356 · Received April 21, 2026

    Report

    Report Number
    2916596-2026-02321
    Event Type
    Death
    Date Received
    April 21, 2026
    Date of Event
    January 1, 2023
    Report Date
    April 21, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    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 ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B2: SPECIFIC DEATH DATE IS DOCUMENTED AS UNKNOWN. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 01JAN2023 AS THE PATIENTS WERE IMPLANTED BETWEEN 2015 AND 2023. AUTHOR INFORMATION: ELAD, B., OH, K., OREN, D., RAHMAN, S., LABARRE, B., FRIED, J., LOTAN, D., CLERKIN, K., RAIKHELKAR, J., YUNIS, A., MOELLER, C., NAKA, Y., FERNANDEZ VALLEDOR, A., TAKEDA, K., BARANOWSKA, J., HERTZ, A., YUZEFPOLSKAYA, M., COLOMBO, P., BURKHOFF, D., SAYER, G., URIEL, N. (2025). IMPACT OF IMPELLA SUPPORT ON THE PROGRESSION OF AORTIC INSUFFICIENCY FOLLOWING LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 44(4), S173. DOI: HTTPS://DOI.ORG/10.1016/J.HEALUN.2025.02.351. COLUMBIA UNIVERSITY MEDICAL CENTER, NEW YORK, NY, NEW YORK PRESBYTERIAN, COLUMBIA UNIVERSITY, NEW YORK, NY, COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEW YORK, NY, COLUMBIA UNIVERSITY, NEW YORK, NY, WEILL CORNELL UNIVERSITY MEDICAL CENTER, NEW YORK, NY, NEW YORK PRESBYTERIAN, NEW YORK, NY, CARDIOVASCULAR RESEARCH FOUNDATION, NEW YORK, NY. 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 REPORTED INFORMATION WAS OBTAINED THROUGH A LITERATURE REVIEW. THE HEARTMATE 3 DEVICE SERIAL NUMBERS AND OTHER SPECIFIC CASE/PATIENT INFORMATION ARE NOT AVAILABLE. 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) REV. D 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. 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 ¿IMPACT OF IMPELLA SUPPORT ON THE PROGRESSION OF AORTIC INSUFFICIENCY FOLLOWING LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION¿ IDENTIFYING THAT HEARTMATE 3 MAY BE RELATED TO SIGNIFICANT AORTIC INSUFFICIENCY. THIS IS A COHORT STUDY WITH 270 HEARTMATE 3 PATIENTS WHO WERE IMPLANTED BETWEEN 2015 AND 2023, WHILE INVESTIGATING THE RELATIONSHIP BETWEEN PRE-LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPELLA SUPPORT AND AORTIC INSUFFICIENCY (AI) PROGRESSION. PATIENTS WHO UNDERWENT AORTIC VALVE (AV) INTERVENTION DURING LVAD IMPLANT WERE EXCLUDED. THE FINDINGS SHOWED THAT 35 (13.2%) PATIENTS HAD AN IMPELLA PRIOR TO LVAD. PRIOR TO LVAD, THE RATE OF SIGNIFICANT AI (SAI) WAS 0% IN THE NON-IMPELLA COMPARED TO 3.7% FOR THE IMPELLA. ONE YEAR POST LVAD IMPLANT, SAI INCREASED TO 3.3% IN THE NON-IMPELLA COMPARED TO 37% IN THE IMPELLA. IN THE PROPENSITY MATCHED ANALYSIS, 22 WITH IMPELLA AND 22 WITHOUT WERE COMPARED. PRE LVAD, SAI WAS 0% IN THE NON-IMPELLA AND 4.5% IN THE IMPELLA (P=1). AT 6 MONTHS POST IMPLANT, SAI WAS 0% FOR NON-IMPELLA AND 22.7% FOR IMPELLA (P=0.049). AT 12 MONTHS, SAI WAS 13.6% FOR NON-IMPELLA AND 40.9% FOR IMPELLA (P=0.09). SURVIVAL FREE OF RIGHT HEART FAILURE AND HEMOCOMPATIBILITY RELATED ADVERSE EVENTS AT 12 MONTHS WAS 82% IN THE NON-IMPELLA VS 64% IN THE IMPELLA (P=0.18).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998876 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown