BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 22365408 · Received June 30, 2025

    Report

    Report Number
    2916596-2025-04067
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    March 1, 2018
    Report Date
    August 28, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: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. DORTA, E.R., MEYN, R., MÜLLER, M., HOERMANDINGER, C., SCHOENRATH, F., FALK,V., MEYER NICOLAS MERKE, A., POTAPOV, E., MULZER, J., KNIERIM, J. ARTIFICIAL ORGANS. 2025;49:441¿450. RECEIVED: 16 JUNE 2024, REVISED: 18 SEPTEMBER 2024, ACCEPTED: 3 OCTOBER 2024 DOI: 10.1111/AOR.14891. DEPARTMENT OF CARDIOLOGY, ANGIOLOGY AND INTENSIVE CARE, DEUTSCHES HERZZENTRUM DER CHARITÉ (DHZC), BERLIN, GERMANY CHARITÉ ¿ UNIVERSITÄTSMEDIZIN BERLIN, CORPORATE MEMBER OF FREIE UNIVERSITÄT BERLIN UND HUMBOLDT- UNIVERSITÄT ZU BERLIN, BERLIN, GERMANY DZHK (GERMAN CENTRE FOR CARDIOVASCULAR RESEARCH), PARTNER SITE BERLIN, BERLIN, GERMANY DEPARTMENT OF CARDIOTHORACIC AND VASCULAR SURGERY, DEUTSCHES HERZZENTRUM DER CHARITÉ (DHZC), BERLIN, GERMANY DEPARTMENT OF INTERNAL MEDICINE AND CARDIOLOGY, SANA PAULINENKRANKENHAUS BERLIN, BERLIN, GERMANY DEPARTMENT OF HEALTH SCIENCES AND TECHNOLOGY, TRANSLATIONAL CARDIOVASCULAR TECHNOLOGY, EIDGENÖSSISCHE TECHNISCHE HOCHSCHULE ZÜRICH, ZURICH, SWITZERLAND. NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE RESEARCH ARTICLE ¿POTENTIAL BENEFITS OF AORTIC VALVE OPENING IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES¿ WAS RECEIVED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE HEARTMATE 3 LVAS IFU,IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 5 OF THE IFU, ¿SURGICAL PROCEDURES¿, WARNS THAT MODERATE TO SEVERE AORTIC INSUFFICIENCY MUST BE CORRECTED AT THE TIME OF DEVICE IMPLANT. IF NOT ADDRESSED, THE LVAD WILL NOT BE ABLE TO PROVIDE THE INTENDED FLOW. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿, OF THE IFU (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS, INCLUDING INOTROPES AND RIGHT VENTRICULAR ASSIST DEVICE (RVAD) PLACEMENT. THE CURRENT REVISION OF THE IFU CAN BE FOUND ON THE 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 ¿POTENTIAL BENEFITS OF AORTIC VALVE OPENING IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES¿, THAT HEARTMATE 3 MAY BE ASSOCIATED WITH VALVE INSUFFICIENCY/REGURGITATION, HEMODYNAMIC INSTABILITY, TRANSPLANT, AND DEATH. AORTIC VALVE REGURGITATION (AR) IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES (LVADS) LEADS TO RETROGRADE FLOW FROM THE LVAD'S OUTFLOW BACK INTO THE LEFT VENTRICLE (LV). THIS CAUSES SYSTEMIC HYPOPERFUSION AND INCOMPLETE UNLOADING OF THE LV. SIGNIFICANT AR NEGATIVELY IMPACTS LVAD PATIENT OUTCOMES, RESULTING IN LOWER SURVIVAL RATES AND HIGHER REHOSPITALIZATION RATES. THE INCIDENCE OF AR INCREASES WITH THE DURATION OF MECHANICAL CIRCULATORY SUPPORT (MCS). FACTORS SUCH AS AGE, GENDER, BODY MASS INDEX (BMI), AND LVAD SETTINGS INFLUENCE THE DEVELOPMENT OF AR DURING MCS. WHEN THE AORTIC VALVE (AV) FAILS TO OPEN DURING THE CARDIAC CYCLE (NON- OPENING AV, NAVO), PERSISTENT PRESSURE ON THE VALVE THROUGHOUT SYSTOLE AND DIASTOLE MAY LEAD TO AV DEGENERATION AND SUBSEQUENT AR.4 NAVO DURING MCS HAS BEEN ASSOCIATED WITH AR. AV OPENING OR NAVO IS INFLUENCED NOT ONLY BY LVAD SETTINGS BUT ALSO BY THE MYOCARDIAL AND VALVULAR FUNCTION OF THE HEART SUPPORTED BY THE LVAD. FOR INSTANCE, SEVERE MITRAL REGURGITATION MAY PREVENT AV OPENING REGARDLESS OF LVAD ADJUSTMENT. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE CLINICAL AND CARDIAC PARAMETERS ASSOCIATED WITH AORTIC VALVE OPENING IN PATIENTS WITH LVAD. IN THIS RETROSPECTIVE ANALYSIS, THE FILES OF ALL PATIENTS WITHOUT CONGENITAL HEART DISEASE WHO UNDERWENT CFLVAD IMPLANTATION BETWEEN (B)(6) 2018 AND (B)(6) 2020 WERE REVIEWED AND THE COLLECTED DATA WERE ENTERED IN A REDCAP DATABASE. THE SPEED OF THE DEVICE WAS CALIBRATED FOR OPTIMAL BLOOD CIRCULATION AND ORGAN FUNCTION AFTER IMPLANTATION, BEFORE THE PATIENT WAS DISCHARGED AND AT EACH SUBSEQUENT OUTPATIENT APPOINTMENT. RAMP TESTS AND RIGHT HEART CATHETERIZATION WERE NOT ROUTINELY PERFORMED ON ALL PATIENTS. THESE INVESTIGATIONS WERE CARRIED OUT ONLY FOR SPECIFIC REASONS, SUCH AS POTENTIALLY SIGNIFICANT AORTIC VALVE INSUFFICIENCY, PATIENTS WITH EXERTIONAL DYSPNEA, OR PATIENTS WITH RIGHT HEART FAILURE. FOR ROUTINE PATIENTS, THE DEVICE SETTINGS WERE ADJUSTED BASED ON DEVICE PARAMETERS, ECHOCARDIOGRAPHIC FINDINGS, AND CLINICAL ASSESSMENT. SEPTUM POSITION, THE SEPTUM SHOULD BE CENTRALLY POSITIONED. IF IT WAS NOT AND THERE WAS NO OBVIOUS CAUSE, SUCH AS A SEPTIC CONDITION OR VOLUME OVERLOAD, INVASIVE DIAGNOSTIC AND/OR EVALUATION IN THE RAMP TEST WERE CONDUCTED. AORTIC VALVE OPENING, INTERMITTENT OPENING OF THE AORTIC VALVE WAS CONSIDERED INDICATIVE OF GOOD LVAD SPEED ADJUSTMENT. IF THE AORTIC VALVE OPENED IN EVERY CYCLE, THE DEVICE SPEED WAS INCREASED. IF THE AORTIC VALVE DID NOT OPEN AT ALL, THE DEVICE SPEED WAS REDUCED IF POSSIBLE. THE SPEED REDUCTION WAS CARRIED OUT GRADUALLY. FROM THE 219 PATIENTS, 156 PATIENTS PRESENTED TO THE FOLLOW- UP, ALIVE AND ON THE LVAD AFTER SIX MONTHS. 56 PATIENTS DIED EARLIER, THREE WERE HEART TRANSPLANTED, ONE GOT WEANED FROM THE DEVICE, AND THREE WERE LOST TO FOLLOW- UP. IN TWO OF THE 156 REVISED ECHOCARDIOGRAMS, WE WERE NOT ABLE TO VISUALIZE THE AV. IN THE REMAINING 154, 99 SHOWED AV OPENING IN EVERY CYCLE OR INTERMITTENTLY (64%), IN CONTRAST TO THE OTHER 36% WITH CONTINUOUSLY CLOSED AV ON THE 6- MONTH FOLLOW- UP ECHOCARDIOGRAPHY. WHEN SUBDIVIDING THE PATIENTS WITH AVO BETWEEN CONTINUOUSLY VS. INTERMITTENTLY VALVE OPENING AND COM PARING THE TWO GROUPS WITH THE NAVO SUBJECTS, THE RESULTS DID NOT DIFFER SIGNIFICANTLY FROM THOSE MENTIONED. WHEN ANALYZING INDEPENDENT PREDICTORS OF AV OPENING IN THE FOLLOW- UP IN A MULTIVARIATE LOGISTIC REGRESSION A WORSE NYHA CLASS WAS ASSOCIATED WITH LESS AV OPENING (NYHA >II: OR 0.29, IC 95% 0.10¿0.83, P 0.021), AS IT DID A HIGHER TR GRADE (TR =2: 0R 0.40, IC 95% 0.17 0.95, P 0.04) FROM THE ECHOCARDIOGRAPHIC POINT OF VIEW. LARGER LEFT VENTRICULAR END- DIASTOLIC DIAMETERS (LVEDD) AND A BETTER LEFT VENTRICULAR EJECTION FRACTION (LVEF) APPEARED AS SIGNIFICANT PREDICTORS OF A REGULAR AV OPENING AT THE TIME OF FOLLOW- UP AFTER ADJUSTING FOR OTHER RISK FACTORS (LVEDD: OR 1.06, IC 95% 1.02¿1.11, P 0.006; LVEF: OR 1.06, IC 95% 1.01¿1.11, P 0.02). AMONG ALL THE RIGHT VENTRICULAR FUNCTIONAL PARAMETERS TESTED, TAPSE SHOWED THE STRONGER ASSOCIATION WITH AV OPENING, ALTHOUGH IT DID NOT REACH STATISTICAL SIGNIFICANCE (OR 1.13, IC 95% 0.99¿1.27, P 0.07). THE MEDIAN TIME FROM PRIMARY IMPLANTATION TO THE END OF THE FOLLOW- UP WAS 3.2 YEARS (IQR 2.1 YEARS). THE HEART FAILURE MEDICATION WAS MAXIMALLY OPTIMIZED IN ALL SUBJECTS, WITHOUT DIFFERENCES WHEN DIVIDING BY AV OPENING. MOST PATIENTS WERE ON BETA- BLOCKERS AND MRA (88% AND 84%, RESPECTIVELY). TWO- THIRDS OF THEM TOLERATED ARNI (66%), AND THE REST WERE HALF ON ACE- INHIBITORS (15%) AND HALF ON ARB (15%). 102 PATIENTS HAD A HEARTWARE® SYSTEM (66%) VS. 52 PATIENTS WITH A HEARTMATE 3¿ (34%). A WORSE NYHA CLASS WAS ASSOCIATED WITH LESS AV OPENING (NYHA >II: OR 0.29, IC 95% 0.10¿0.83, P 0.021), AS IT DID A HIGHER TR GRADE (TR =2: 0R 0.40, IC 95% 0.17 0.95, P 0.04) FROM THE ECHOCARDIOGRAPHIC POINT OF VIEW. LARGER LEFT VENTRICULAR END- DIASTOLIC DIAMETERS (LVEDD) AND A BETTER LEFT VENTRICULAR EJECTION FRACTION (LVEF) APPEARED AS SIGNIFICANT PREDICTORS OF A REGULAR AV OPENING AT THE TIME OF FOLLOW- UP AFTER ADJUSTING FOR OTHER RISK FACTORS (LVEDD: OR 1.06, IC 95% 1.02¿1.11, P 0.006; LVEF: OR 1.06, IC 95% 1.01¿1.11, P 0.02). AFTER A MEDIAN FOLLOW- UP OF 3.2 YEARS, 85 OF THESE 156 PATIENTS WERE STILL ALIVE AND ON THE DEVICE (55%), 39 DIED DURING FOLLOW- UP (25%), 20 UNDERWENT HEART TRANSPLANTATION (13%), 3 UNDERWENT RVAD- IMPLANTATION (2%), AND 8 UNDERWENT LVAD EXPLANTATION DUE TO MYOCARDIAL RECOVERY (5%). THE SURVIVAL RATE ONE AND THREE YEARS AFTER THE 6- MONTH FOLLOW- UP WAS 78% AND 72%, RESPECTIVELY, IN THE GROUP WHO SHOWED REGULARLY AV OPENING AT 6 MONTHS AND 88% AND 85% IN THOSE WHO DID NOT. THE DIFFERENCE OF SURVIVAL RATE BETWEEN THE TWO COHORTS WAS NOT STATISTICALLY SIGNIFICANT. IT WAS FOUND AVO TO BE ASSOCIATED WITH LOWER NYHA CLASS, BETTER RIGHT HEART FUNCTION, AND A LOWER RATE OF AR IN PATIENTS WITH CENTRIFUGAL CONTINUOUS FLOW LVAD. THE SPEED OF THE DEVICE ALONE DOES NOT SOLELY INFLUENCE AV OPENING. STRUCTURAL HEART DAMAGE, SUCH AS SEVERE MITRAL REGURGITATION OR A VERY POOR EJECTION FRACTION, MAY ALSO IMPACT LV FILLING PRESSURES AND AV OPENING. ALTHOUGH THE TWO GROUPS OF PATIENTS SHOWED NO DIFFERENCES IN TERMS OF EJECTION FRACTION, A BETTER LVEF APPEARED AS SIGNIFICANTLY ASSOCIATED WITH REGULAR AVO AT THE TIME OF FOLLOW- UP AFTER ADJUSTING FOR OTHER RISK FACTORS. THERE IS A THOUGHT THAT A HIGHER MEAN ARTERIAL PRESSURE CAN BE AN INDIRECT EXPRESSION OF BETTER LV FUNCTION. THE BETTER LEFT VENTRICULAR FUNCTION MAY LEAD TO THE OPENING OF THE AORTIC VALVE AND CONTRIBUTE TO THE GENERATION OF A HIGHER BLOOD PRESSURE. THIS STUDY FOCUSED ON STABLE PATIENTS SIX MONTHS AFTER IMPLANTATION WHO PRESENTED IN THE OUTPATIENT CLINIC. IN THESE PATIENTS, THE VASODILATOR AND HEART FAILURE DRUGS WERE RAPIDLY INCREASED UP TO THE MAXIMUM DOSE TOLERATED BY THE PATIENT WITHIN THE FIRST 6 MONTHS AFTER IMPLANTATION ACCORDING TO A STANDARDIZED PROTOCOL. A LARGE PROPORTION OF THE PATIENTS WERE ALREADY TREATED WITH BETA- BLOCKERS, MINERALOCORTICOID RECEPTOR ANTAGONISTS, AND INHIBITORS OF THE RENIN¿ANGIOTENSIN SYSTEM AT THE TIME OF THE SIX-MONTH FOLLOW- UP, WITH NO SIGNIFICANT DIFFERENCES IN MEDICAL TREATMENT REGARDING AORTIC VALVE OPENING. PATIENTS WITH NON- AORTIC VALVE OPENING (NAVO) HAD A SIGNIFICANTLY HIGHER PREVALENCE OF RELEVANT AORTIC VALVE INSUFFICIENCY. IN CONCLUSION, THE PRESENCE OF AORTIC VALVE OPENING WAS ASSOCIATED WITH ADVANTAGEOUS PARAMETERS SUCH AS BETTER RIGHT VENTRICULAR. THE PRESENCE OF AORTIC VALVE OPENING WAS ASSOCIATED WITH ADVANTAGEOUS PARAMETERS SUCH AS BETTER RIGHT VENTRICULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2484246 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O| R