BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21462410 · Received February 25, 2025

    Report

    Report Number
    2916596-2025-01110
    Event Type
    Injury
    Date Received
    February 25, 2025
    Date of Event
    April 1, 2024
    Report Date
    March 21, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. SECTION D4: DEVICE MANUFACTURE DATE (H4) WAS NOT PROVIDED. THE PRIMARY UDI NUMBER IN D4 IS UPDATED WITH ALL OF THE CURRENT INFORMATION AVAILABLE. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. ARTICLE TITLE: ¿BIVENTRICULAR CATHETERIZATION COMBINED WITH PRESSURE- VOLUME LOOP MONITORING PROVIDES INSIGHT INTO THE DYNAMIC EFFECTS OF LEFT VENTRICULAR ASSIST DEVICES RAMP ON RIGHT VENTRICULAR FUNCTION¿ GRADUATE SCHOOL OF BIOMEDICAL SCIENCES, ALIX SCHOOL OF MEDICINE, MEDICAL SCIENTIST TRAINING PROGRAM, MAYO CLINIC, ROCHESTER, MN, UNITED STATES; DEPARTMENT OF CARDIOVASCULAR MEDICINE, DIVISION OF CIRCULATORY FAILURE, MAYO CLINIC, ROCHESTER, MN, UNITED STATES, VANCLEVE CARDIAC REGENERATIVE MEDICINE PROGRAM AND FONG CHAO FOUNDATION, CENTER FOR REGENERATIVE MEDICINE, MAYO CLINIC, ROCHESTER, MN, UNITED STATES; DEPARTMENT OF CARDIOVASCULAR MEDICINE, DIVISION OF CIRCULATORY FAILURE, MAYO CLINIC, ROCHESTER, MN, UNITED STATES, VANCLEVE CARDIAC REGENERATIVE MEDICINE PROGRAM AND FONG CHAO FOUNDATION, CENTER FOR REGENERATIVE MEDICINE, MAYO CLINIC, ROCHESTER, MN, UNITED STATES, WILLIAM J VON LIEBIG CENTER FOR TRANSPLANTATION AND CLINICAL REGENERATION, MAYO CLINIC, ROCHESTER, MN, UNITED STATES. GARMANY, A., INGLIS, S. S., ATTA BEHFAR, & ROSENBAUM, A. N. (2024). BIVENTRICULAR CATHETERIZATION COMBINED WITH PRESSURE-VOLUME LOOP MONITORING PROVIDES INSIGHT INTO THE DYNAMIC EFFECTS OF LEFT VENTRICULAR ASSIST DEVICES RAMP ON RIGHT VENTRICULAR FUNCTION. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 103(5), 799¿802. HTTPS://DOI.ORG/10.1002/CCD.30993. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. A REVIEW OF THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE SERIAL NUMBER OF THE DEVICE WAS NOT COMMUNICATED/IDENTIFIED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C, IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE AND THROMBOEMBOLISM, THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POST-IMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS SECTION ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INTERNATIONAL NORMALIZED RATIO (INR) VALUES. NALLY, SECTION 6 OF THE IFU (UNDER ¿RIGHT HEART FAILURE¿) STATES THAT PATIENTS MAY DEVELOP RIGHT VENTRICULAR FAILURE DURING OR SHORTLY AFTER IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. THIS SECTION (UNDER ¿CAUTION!¿) ALSO EXPLAINS THAT RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LVAS DUE TO REDUCED FILLING OF THE PUMP. 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 ¿BIVENTRICULAR CATHETERIZATION COMBINED WITH PRESSURE- VOLUME LOOP MONITORING PROVIDES INSIGHT INTO THE DYNAMIC EFFECTS OF LEFT VENTRICULAR ASSIST DEVICES RAMP ON RIGHT VENTRICULAR FUNCTION¿ THAT HEARTMATE 3 (HM 3) MAY BE ASSOCIATED WITH RIGHT VENTRICULAR (RV) DYSFUNCTION, THROMBOSIS, AND MITRAL REGURGITATION. THIS CASE STUDY EVALUATED A 68-YEAR-OLD MALE WITH ISCHEMIC CARDIOMYOPATHY WHO UNDERWENT IMPLANTATION OF A HM 3 LVAD AS DESTINATION THERAPY 2 YEARS BEFORE PRESENTATION. THE PATIENT¿S COURSE WAS COMPLICATED BY STENT THROMBOSIS IN THE RIGHT CORONARY ARTERY REQUIRING URGENT PERCUTANEOUS CORONARY INTERVENTION EARLY AFTER IMPLANTATION. THE PATIENT PRESENTED WITH INTERMITTENT NEW YORK HEART ASSOCIATION (NYHA) CLASS III SYMPTOMS. TRANSTHORACIC ECHOCARDIOGRAPHY WAS NOTABLE FOR MODERATE RV SYSTOLIC DYSFUNCTION AND MODERATE MITRAL REGURGITATION (MR). TO EVALUATE THE ETIOLOGY OF THE PATIENT¿S DYSPNEA, THE PATIENT UNDERWENT A LEFT HEART CATHETER/RIGHT HEART CATHETER RAMP STUDY. EVALUATION OF THE RV WAS AIDED BY A CONDUCTANCE CATHETER SYSTEM FOR PRESSURE-VOLUME LOOPS UTILIZING 3D ECHOCARDIOGRAPHY FOR BASELINE RV VOLUMES. AT THE BASELINE SPEED OF 5300 RPM, RIGHT ATRIAL PRESSURE WAS 16 MMHG, MEAN PULMONARY ARTERY (PA) PRESSURE WAS 26 MMHG, AND PULMONARY CAPILLARY WEDGE PRESSURE WAS 15 MMHG. LV END-DIASTOLIC PRESSURE (EDP) WAS 14 MMHG AND CARDIAC INDEX (CI) WAS 2.01 L/MIN/M2. BY BOTH PV-LOOP ANALYSIS AND 3D ECHO, THE RV EJECTION FRACTION (EF) WAS 36%. RV CONTRACTILITY WAS 188 MMHG/S. THE END-SYSTOLIC PRESSURE-VOLUME RELATIONSHIP OF THE RV WAS 0.16 MMHG/ML AND ARTERIAL ELASTANCE WAS 0.34 MMHG/ML. TRENDS IN HEMODYNAMICS WITH RAMP (5300¿5800 RPMS) REVEALED PROGRESSIVE UNLOADING OF THE LV (LVEDP 9 MMHG) WITH A DECREASE IN MEAN PA PRESSURE (23 MMHG) AS EXPECTED. ADDITIONALLY, RAMP (5300¿5800 RPMS) REVEALED AN ADVERSE TREND FOR VENTRICULAR-ARTERIAL COUPLING ASSESSED AS THE RATIO OF ARTERIAL ELASTANCE AND END-SYSTOLIC ELASTANCE. HOWEVER, THERE WAS A TREND TOWARD WORSENING OF ALL MARKERS OF RV SYSTOLIC FUNCTION, INCLUDING RVEF (-6% [-17% REDUCTION]), RV ESPVR (-0.035 MMHG/ML [-22%]), AND RV +DP/DT (-38 MMHG/S [-20%]), DESPITE NO INCREASE IN RA PRESSURE OR RVEDP. DUE TO REDUCED STROKE VOLUME AND END-SYSTOLIC PRESSURE, RV EA INCREASED BY 0.033 MMHG/ML DESPITE THE DECREASE IN PA PRESSURE. AS A RESULT, THERE WAS NO APPRECIABLE NET INCREASE IN CI (+0.04 L/MIN/M2) WITH INCREASED SPEED. CONSEQUENTLY, INOTROPIC THERAPY WAS ADVISED TO SUPPORT RV FUNCTION AND THE LVAD SPEED WAS INCREASED TO OUTCOMPETE MR. IN THIS PATIENT, ALTHOUGH INCREASING SPEED IMPROVED LV UNLOADING WITH A TREND TOWARD WORSE VENTRICULAR ARTERIAL COUPLING, THERE WAS AN ASSOCIATED COMPROMISE IN RV SYSTOLIC PERFORMANCE. DESPITE DECREASING PA PRESSURES (RV AFTERLOAD), PV LOOP ASSESSMENT DOCUMENTED A DROP IN RV STROKE VOLUME AND CONTRACTILITY WITH RAMPING OF LVAD SPEEDS, PROVIDED ADDED DIAGNOSTIC INSIGHT, AND INFORMED AN ALTERNATE MANAGEMENT STRATEGY. THE HEMODYNAMIC FINDINGS IN THE PRESENT CASE ILLUSTRATE THAT EVEN IN THE PRESENCE OF RESIDUAL MR, RV SYSTOLIC FUNCTION MAY BE JEOPARDIZED BY INCREASING LVAD SPEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417612 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Life Threatening| O