BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 25334755 · Received May 29, 2026

    Report

    Report Number
    2916596-2026-2917096
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    August 1, 2024
    Report Date
    May 29, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 01AUG2024, SINCE THE DATE OF LVAD IMPLANT OCCURRED BETWEEN APRIL 2019 AND AUGUST 2024. AUTHOR INFORMATION: J. JOZWIAK-NOZDRZYKOWSKA, ET AL. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION 44 (2025) 44(4): S534. DOI:10.1016/J.HEALUN.2025.02.1148. CARDIOLOGY, HEART CENTER LEIPZIG AT LEIPZIG UNIVERSITY, LEIPZIG, GERMANY. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO DEVICES WERE RETURNED FOR EVALUATION. NO DEVICES WERE RETURNED FOR EVALUATION. DEVICE SERIAL NUMBERS WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING RIGHT HEART FAILURE. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿RIGHT HEART FAILURE¿) OUTLINES INDICATIONS OF RIGHT HEART FAILURE AS WELL AS POSSIBLE TREATMENTS. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. 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 ¿A STEPWISE WEANING PROTOCOL OF THE LONG-TERM PULSATILE RVAD IN PATIENTS WITH HYBRID BIVENTRICULAR ASSIST DEVICE SUPPORT¿ IDENTIFYING THAT THE HEARTMATE 3 (HM3) IS ASSOCIATED WITH RIGHT VENTRICULAR FAILURE AND TRANSPLANT. THIS IS A SINGLE-CENTER OBSERVATIONAL RETROSPECTIVE STUDY WITH THE AIM OF EVALUATING A NOVEL WEANING PROTOCOL FROM THE BERLIN HEART EXCOR PULSATILE RIGHT VENTRICULAR ASSIST DEVICE (RVAD) IN PATIENTS WITH HYBRID BIVENTRICULAR VAD (BVAD) SUPPORT. BETWEEN APR2019 AND AUG2024, 9 PATIENTS UNDERWENT SIMULTANEOUS HYBRID BVAD IMPLANTATION USING HM3 AS LEFT VENTRICULAR ASSIST DEVICE (LVAD) AND BERLIN HEART EXCOR AS RVAD. A STEP-BY-STEP WEANING PROTOCOL WAS ESTABLISHED. ALL PATIENTS WITH STABLE CLINICAL STATUS, STABLE VAD PARAMETERS AND IMPROVED RV FUNCTION UNDERWENT RIGHT HEART CATHETERIZATION WITH A SHORT-TERM WEANING PROTOCOL: THE RVAD RATE WAS GRADUALLY REDUCED BY 5-10 BPM EVERY 5 MINUTES. AT EACH STAGE, HEMODYNAMIC AND LVAD PARAMETERS WERE RECORDED, AND ECHOCARDIOGRAPHY WAS PERFORMED. THE RVAD RATE WAS REDUCED BY 10 BPM DAILY WITH CLOSE MONITORING OF CLINICAL STATUS, LAB AND LVAD PARAMETERS AND ECHOCARDIOGRAPHIC MEASUREMENTS DOWN TO 30 BPM. THE WEANING ATTEMPT WAS DISCONTINUED IN CASE OF LACTATE INCREASE, A DROP IN CENTRAL VENOUS SATURATION OR LVAD FLOW, RELEVANT ARRHYTHMIAS OR SIGNS AND SYMPTOMS OF RVF. ALL PATIENTS WERE FOLLOWED UP UNTIL OCT2024. THERE WAS NO MORTALITY UNDER BVAD IN THIS COHORT WITH SEVEN PATIENTS UNDERGOING HEART TRANSPLANTATION AFTER A MEAN OF 114 DAYS (RANGE 27-259) OF BVAD SUPPORT. IN TWO PATIENTS, RVAD COULD BE EXPLANTED AFTER 65 AND 110 DAYS OF SUPPORT, THEY ARE ALIVE AT 118 AND 231 DAYS OF FOLLOW-UP, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396230 HEARTMATE 3 LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524INT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R