BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21191089 · Received January 20, 2025

    Report

    Report Number
    2916596-2025-00331
    Event Type
    Death
    Date Received
    January 20, 2025
    Date of Event
    July 1, 2021
    Report Date
    January 20, 2025
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: 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 01JUL2021 AS DATA WAS COLLECTED BETWEEN OCT2012 AND JUL2021. AUTHOR INFORMATION: STAPÓR, M., ET AL. (2024). RIGHT VENTRICULAR-PULMONARY ARTERIAL COUPLING IN PATIENTS WITH IMPLANTED LEFT VENTRICULAR ASSIST DEVICES. HELLENIC JOURNAL OF CARDIOLOGY: HJC = HELLENIKE KARDIOLOGIKE EPITHEORESE, 77, 44¿53. HTTPS://DOI.ORG/10.1016/J.HJC.2023.06.002. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING DEATH. THIS DOCUMENT ALSO WARNS THE USER THAT MODERATE TO SEVERE AORTIC INSUFFICIENCY MUST BE CORRECTED AT THE TIME OF DEVICE IMPLANT. 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 ¿RIGHT VENTRICULAR¿PULMONARY ARTERIAL COUPLING IN PATIENTS WITH IMPLANTED LEFT VENTRICULAR ASSIST DEVICES¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH RIGHT VENTRICULAR FAILURE, STROKE, ANEMIA, ATRIAL FIBRILLATION/FLUTTER, MITRAL/TRICUSPID/AORTIC REGURGITATION AND DEATH. BASIC CLINICAL, ECHOCARDIOGRAPHIC, AND RIGHT HEART CATHETERIZATION CHARACTERISTICS WERE REVIEWED IN THE SCREENED PATIENTS, AND THE INFORMATION INCLUDED PREVIOUS STROKE, ANEMIA, AF/FLUTTER, MR, AR, TR. ADDITIONALLY, EARLY POST-IMPLANT RHF OCCURRED IN 11 SUBJECTS, AND LATE IN 17. THE GOAL OF THE STUDY WAS TO DETERMINE THE PROGNOSTIC IMPACT OF RIGHT VENTRICULAR (RV)- PULMONARY ARTERIAL (PA) COUPLING IN 72 PATIENTS IMPLANTED BETWEEN OCT2015 AND JUL2021 WITH LEFT VENTRICULAR ASSIST DEVICE¿S (LVAD). THE STUDY CLAIMED THAT THE ADDITIONAL VOLUME LOAD SUPPLIED BY A LVAD PUMP AFFECTS RV CONTRACTILITY THROUGH LEFT VENTRICULAR REMODELING, PULMONARY VASCULAR REMODELING, POSTCAPILLARY PULMONARY HYPERTENSION, AND INCREASED RV AFTERLOAD. RV-PA IS BASED ON INDEXING RV PERFORMANCE TO RV AFTERLOAD. WHEN RV ¿ PA COUPLING IS INTACT, THE MECHANICAL STROKE WORK IS TRANSFERRED TO THE PULMONARY CIRCUIT, MEANING THAT AN INCREASE IN RV AFTERLOAD WILL MAKE THEE CONTRACTIBILITY OF RV INCREASE. IN RV ¿ PA UNCOUPLING, RV IS NOT ABLE TO MAINTAIN ADEQUATE FLOW ACROSS THE PULMONARY VASCULATURE FOR THE AMOUNT OF RV AFTERLOAD. AS A RESULT, RV - PA UNCOUPLING MAY BE ASSOCIATED WITH ADVERSE OUTCOMES IN PATIENTS WITH IMPLANTED LVAD¿S. THE RV-PA COUPLING WAS ASSESSED PREOPERATIVELY BY THE RATIO OF RV FREE WALL STRAIN (RVFWS) DERIVED FROM SPECKLE-TRACKING ECHOCARDIOGRAPHY AND NONINVASIVELY MEASURED PEAK RV SYSTOLIC PRESSURE (RVSP). ONLY PATIENTS WITH POOR RV MYOCARDIAL IMAGING WERE EXCLUDED FROM THE STUDY. THE MEDIAN AGE OF THE STUDY GROUP WAS 57 YEARS. (P=0.399) THE STUDY FOUND THAT 19 PATIENTS HAD RV-PA UNCOUPLING. WHEN COMPARING OUTCOMES AFTER 12 MONTHS, 47.37% OF PATIENTS (9 PATIENTS) WITH RV-PA UNCOUPLING PASSED AWAY, WHILE 13.21% OF PATIENTS (7 PATIENTS) WHERE RV-PA REMAINED COUPLED ALSO PASSED AWAY, P=0.003. FURTHERMORE AFTER 12 MONTHS, 89.47% OF PATIENTS (17 PATIENTS) WITH RV-PA UNCOUPLING EITHER PASSED AWAY OR WERE HOSPITALIZED FOR RIGHT HEART FAILURE (RHF), WHILE 30.19% OF PATIENTS (16 PATIENTS) WHERE RV-PA REMAINED COUPLED EITHER PASSED AWAY OR WERE HOSPITALIZED FOR RHF, P<0.001. IN TOTAL 16 PATIENTS PASSED AWAY AND 17 PATIENTS WERE HOSPITALIZED FOR RHF BUT DID NOT DIE IN THE 12-MONTH STUDY PERIOD. THE PAPER CONCLUDED THAT EVALUATION OF THE RV FUNCTION BY INDEXING RV PERFORMANCE TO PA AFTERLOAD MAY PROVIDE OPTIMAL PROGNOSTIC INFORMATION FOR PATIENTS CONSIDERED FOR LVAD SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644963 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death