BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 22091175 · Received May 27, 2025

    Report

    Report Number
    2916596-2025-03208
    Event Type
    Death
    Date Received
    May 27, 2025
    Date of Event
    January 1, 2022
    Report Date
    June 3, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS IN USE WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. THE CURRENT REVISIONS OF THE IFU CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. SECTION 1, "INTRODUCTION," LISTS POTENTIAL ADVERSE EVENTS WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS, INCLUDING DEATH. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE SERIAL NUMBER 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. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF DEATH ESTIMATED AS DATE OF EVENT THE DATE OF EVENT HAS BEEN ENTERED AS 01JAN2022 AS DATA WAS COLLECTED BETWEEN JAN2015 AND JAN2022. AUTHOR INFORMATION: LAMBERT, DAVID S., ET AL. MODEL FOR END STAGE LIVER DISEASE EXCLUDING INTERNATIONAL NORMALIZED RATIO PREDICTS SEVERE RIGHT VENTRICULAR FAILURE AFTER HEARTMATE 3 IMPLANTATION IN A CONTEMPORARY COHORT. JOURNAL OF THE AMERICAN HEART ASSOCIATION VOL14, ISSUE 7 APRIL 2025. HTTP://DX.DOI.ORG/10.1161/JAHA.124.037553 STUDY SITES: DEPARTMENT OF MEDICINE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE IN ST. LOUIS SAINT LOUIS MO USA DEPARTMENT OF CARDIAC SURGERY MASSACHUSETTS GENERAL HOSPITAL BOSTON MA USA CARDIOVASCULAR DIVISION WASHINGTON UNIVERSITY SCHOOL OF MEDICINE IN ST. LOUIS SAINT LOUIS MO USA DIVISION OF CARDIOLOGY MASSACHUSETTS GENERAL HOSPITAL/HARVARD MEDICAL SCHOOL BOSTON MA USA NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE TITLED, ¿MODEL FOR END STAGE LIVER DISEASE EXCLUDING INTERNATIONAL NORMALIZED RATIO PREDICTS SEVERE RIGHT VENTRICULAR FAILURE AFTER HEARTMATE 3 IMPLANTATION IN A CONTEMPORARY COHORT¿, THAT RIGHT VENTRICULAR FAILURE (RVF) AFTER LEFT VENTRICULAR ASSIST DEVICES (LVAD) WAS ASSOCIATED WITH SIGNIFICANT MORBIDITY AND MORTALITY. THE MODEL FOR END STAGE LIVER DISEASE EXCLUDING INTERNATIONAL NORMALIZED RATIO (MELD- XI), IS A PREVIOUSLY VALIDATED MEASURE OF LIVER DYSFUNCTION DEVELOPED FOR PATIENTS WHO MAY BE ON ANTICOAGULATION, WAS CALCULATED AS 5.11×LN(BILIRUBIN)+11.76×LN(CREATININE)+9.44.14 THE EUROMACS (EUROPEAN REGISTRY FOR PATIENTS WITH MECHANICAL CIRCULATORY SUPPORT) SCORE WAS CALCULATED AS RIGHT ATRIAL PRESSURE TO PULMONARY CAPILLARY WEDGE PRESSURE RATIO (RAP/PCWP)>0.54 (2 POINTS)+HEMOGLOBIN =10 G/DL (1 POINT)+MULTIPLE INTRAVENOUS INOTROPES (2.5 POINTS)+INTERMACS (INTERAGENCY REGISTRY FOR MECHANICALLY ASSISTED CIRCULATORY SUPPORT) PROFILE 1 TO 3 (2 POINTS)+SEVERE RV DYSFUNCTION ON ECHOCARDIOGRAPHY (2 POINTS).8 THE MICHIGAN RVF RISK SCORE WAS CALCULATED AS VASOPRESSOR REQUIREMENT (4 POINTS)+ASPARTATE TRANSAMINASE =80 IU/L (2 POINTS)+BILIRUBIN =2.0 MG/DL (2.5 POINTS)+CREATININE =2.3 MG/DL (3 POINTS). THE LIVER IS THE FIRST ORGAN UPSTREAM OF THE RIGHT- SIDED HEART CHAMBERS AND IS SENSITIVE TO ELEVATED CENTRAL VENOUS PRESSURES. CONGESTIVE HEPATOPATHY IS A RECOGNIZED COMPLICATION OF HEART FAILURE (HF) THAT CAN LEAD TO HEPATIC DYSFUNCTION AND IN SOME CASES CARDIAC CIRRHOSIS. (MELD- XI) IS A MODIFICATION OF THE ORIGINAL MELD THAT WAS CREATED FOR USE IN PATIENTS REQUIRING ANTICOAGULATION, WHICH IS COMMON AMONG PATIENTS WITH HF. ELEVATED MELD- XI HAS BEEN ASSOCIATED WITH WORSE SURVIVAL IN HOSPITALIZED PATIENTS WITH HF AND LVAD RECIPIENTS AND MAY PREDICT RVF IN A NON- HM3 POPULATION. THE STUDY RETROSPECTIVELY ANALYZED ALL ADULT PATIENTS OVER THE AGE OF 18 WHO RECEIVED A HEART MATE 3 (HM3) LVAD AS INITIAL IMPLANTATION BETWEEN 2015 AND 2022 AT WASHINGTON UNIVERSITY IN ST. LOUIS AND MASSACHUSETTS GENERAL HOSPITAL. EXCLUDED WERE PATIENTS WHO UNDERWENT PUMP EXCHANGE OR HAD INSUFFICIENT CLINICAL DATA. THE PRIMARY OUTCOME WAS SEVERE RVF ACCORDING TO THE INTERMACS DEFINITION, CHARACTERIZED BY CLINICAL SYMPTOMS OF ELEVATED FILLING PRESSURES AND NEEDING RV ASSIST DEVICE IMPLANTATION, >14 DAYS OF INOTROPES, OR >48 HOURS OF PULMONARY VASODILATORS FOLLOWING HM3 IMPLANTATION. SECONDARY OUTCOMES WERE IN- HOSPITAL DEATH AND A COMPOSITE OF POST DISCHARGE DEATH OR PUMP EXCHANGE. THE STUDY INCLUDED 246 HM3 RECIPIENTS, OF WHOM 28% WERE BLACK AND 20% WERE FEMALE. IN TOTAL, 74 (30%) OF PATIENTS EXPERIENCED SEVERE RVF BY THE INTERMACS DEFINITION. WHEN COMPARING THOSE WHO DEVELOPED SEVERE RVF TO THOSE WHO DID NOT, BASELINE DEMOGRAPHICS AND MEDICAL COMORBIDITIES WERE SIMILAR. HOWEVER, AT TIME OF IMPLANTATION, PATIENTS WHO DEVELOPED SEVERE RVF WERE MORE LIKELY TO BE INTERMACS PROFILE 1 OR 2 (50% VERSUS 26%, P<0.00. ASSESSED WHETHER PREOPERATIVE MELD- XI CAN PREDICT MORTALITY AFTER HM3 IMPLANTATION. IN THE COHORT, 45 (18%) OF PATIENTS DIED WITHIN 1 YEAR OF FOLLOW- UP WITH MEDIAN TIME- TO- DEATH OF 32 DAYS. WHEN STRATIFIED BY MELD- XI =14 OR OR<14 A PRIORI, WE FOUND THAT MELD- XI =14 WAS ASSOCIATED WITH SIGNIFICANTLY WORSE IN- HOSPITAL MORTALITY AFTER LVAD IMPLANTATION (LOG- RANK P=0.002). MELD- XI DID NOT PREDICT THE RISK OF DEATH OR PUMP EXCHANGE AT 1- YEAR FOLLOW- UP AMONG PATIENTS WHO SURVIVED INDEX HOSPITALIZATION (LOG- RANK P=0.9. THE OCCURRENCE OF SEVERE RVF AFTER LVAD INCREASES THE RISK OF IN- HOSPITAL MORTALITY AS WELL AS SIGNIFICANT MORBIDITY INCLUDING THE NEED FOR RENAL REPLACEMENT THERAPY, STROKE, AND GASTROINTESTINAL BLEEDING.2¿4,27¿29 THUS, IDENTIFICATION OF PATIENTS AT INCREASED RISK OF RVF IS PARAMOUNT IN THE EVALUATION OF PATIENTS FOR LVAD CANDIDACY, SHARED DECISION- MAKING TO PROCEED WITH HM3 IMPLANTATION, AND PERIOPERATIVE PLANNING. IN THE PRESENT STUDY, IT IS SHOWN THAT HIGHER MELD- XI IS ASSOCIATED WITH AN INCREASED LIKELIHOOD OF SEVERE RVF. IN CONCLUSION, MELD- XI IS INDEPENDENTLY ASSOCIATED WITH AN INCREASED RISK OF SEVERE RVF AND IN-HOSPITAL MORTALITY AFTER HM3 IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715148 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death