BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24930483 · Received April 20, 2026

    Report

    Report Number
    2916596-2026-01970
    Event Type
    Death
    Date Received
    April 20, 2026
    Date of Event
    February 1, 2025
    Report Date
    April 20, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: DEVICE SERIAL 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. SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT IS LISTED AT THE PUBLICATION DATE (01FEB2025) AS THE DATE OF COLLECTION WAS NOT PROVIDED. AUTHOR INFORMATION: FRENCH, B. N., NAKIRIKANTI, A. S., KUSHER, I., WITTERSHEIM, K., VEGA, J. D., DANESHMAND, M., & GUPTA, D. (2025). LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION IN ADVANCED KIDNEY DISEASE. JHLT OPEN, 11, 100422. HTTPS://DOI.ORG/10.1016/J.JHLTO.2025.100422. EMORY UNIVERSITY SCHOOL OF MEDICINE, ATLANTA, GA EMORY UNIVERSITY DEPARTMENT OF CARDIOLOGY, ATLANTA, GA EMORY UNIVERSITY DIVISION OF CARDIOTHORACIC SURGERY, ATLANTA, GA CORRESPONDING AUTHOR: BENJAMIN N. FRENCH, MD, EMORY UNIVERSITY SCHOOL OF MEDICINE, ATLANTA, GA. E-MAIL ADDRESS: [email protected]. MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED PATIENT OUTCOMES OF EXPIRATION COULD NOT BE CONCLUSIVELY DETERMINED, AND A DIRECT CORRELATION WITH HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO DEVICES WERE RETURNED FOR EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), IS CURRENTLY AVAILABLE. ALTHOUGH NO DEVICE RELATED ISSUES WERE REPORTED BY THE ACCOUNT, SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING DEATH. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. DEVICE SERIAL NUMBERS WERE NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED IN "LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION IN ADVANCED KIDNEY DISEASE" THAT HEARTMATE 3 PATIENTS WERE INVOLVED IN EVENTS INVOLVING HEART TRANSPLANT, RENAL FAILURE, AND DEATH. THE RETROSPECTIVE STUDY REVIEWED 193 PATIENTS WHO UNDERWENT HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION AT A TERTIARY CARE ACADEMIC MEDICAL CENTER BETWEEN JUL2016 AND JUL2023. 39 PATIENTS HAD PRE-EXISTING ADVANCED KIDNEY DISEASE AND DEMONSTRATED RENAL FAILURE OR NEAR-FAILURE ON TOP OF THEIR SO-EXISTING HEART FAILURE, WITH SEVERAL REQUIRING DIALYSIS IN THE DAYS LEADING TO IMPLANTATION. THE AVERAGE INTERMACS PROFILE WAS 2.2. NEED FOR RENAL REPLACEMENT WAS DEFINED BY THE USE OF RENAL REPLACEMENT THERAPY (RRT). 38 PATIENTS REQUIRED RRT AFTER IMPLANTATION. OF THE 38, 11 RECOVERED RENAL FUNCTION, AND 7 TRANSITIONED TO LONG TERM DIALYSIS, AND 20 PASSED AWAY WHILE ON CONTINUOUS RENAL REPLACEMENT THERAPY. OVER THE 2 YEAR FOLLOW UP PERIOD, 42 PATIENTS PASSED AWAY. 8 PATIENTS UNDERWENT HEART TRANSPLANT AND WERE CENSORED FROM THE STUDY AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988272 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death