BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21925937 · Received April 29, 2025

    Report

    Report Number
    2916596-2025-02833
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    January 1, 2023
    Report Date
    April 29, 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

    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. B3: THE EVENT DATE HAS BEEN ENTERED AS 01JAN2023 AS PATIENTS WERE IMPLANTED BETWEEN 2016 AND 2023. AUTHOR INFORMATION: ROSENBAUM, A. N., BEHFAR, A., ROSSMAN, T. L., & LUNDGREN, S. W. (2025). PULSATILITY OF PULMONARY ARTERY WAVEFORMS BEFORE AND AFTER LEFT VENTRICULAR ASSIST DEVICE IS ASSOCIATED WITH RIGHT VENTRICULAR FAILURE. ASAIO JOURNAL, 71(3), E38-E40. DOI:HTTP://DX.DOI.ORG/10.1097/MAT.0000000000002272. DEPARTMENT OF CARDIOVASCULAR MEDICINE, DIVISION OF CIRCULATORY FAILURE, MAYO CLINIC, ROCHESTER, MN, UNITED STATES, WILLIAM J. VON LIEBIG CENTER FOR TRANSPLANTATION AND CLINICAL REGENERATION, MAYO CLINIC, ROCHESTER, MN, UNITED STATES, VAN CLEVE CARDIAC REGENERATIVE MEDICINE PROGRAM, CENTER FOR REGENERATIVE MEDICINE, MAYO CLINIC, ROCHESTER, MN, UNITED STATES [email protected]. DIVISION OF ENGINEERING, MAYO CLINIC, ROCHESTER, MN, UNITED STATES. DIVISION OF CARDIOVASCULAR MEDICINE, DEPARTMENT OF INTERNAL MEDICINE, UNIVERSITY OF NEBRASKA MEDICAL CENTER, OMAHA, NE, UNITED STATES. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) DEVICES AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE REPORTED INFORMATION WAS OBTAINED THROUGH A LITERATURE REVIEW. THE HEARTMATE 3 DEVICE SERIAL NUMBERS AND OTHER SPECIFIC CASE/PATIENT INFORMATION ARE NOT AVAILABLE. THE HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HM3 LVAS. SECTION 6 "PATIENT CARE AND MANAGEMENT" (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. SECTION 6 (UNDER CAUTION!) STATES: "RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED 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 LITERATURE REVIEW ARTICLE, "PULSATILITY OF PULMONARY ARTERY WAVEFORMS BEFORE AND AFTER LEFT VENTRICULAR ASSIST DEVICE IS ASSOCIATED WITH RIGHT VENTRICULAR FAILURE¿ THAT LEFT VENTRICULAR ASSIST DEVICE (LVAD) PATIENT HAD AN INCIDENCE OF RIGHT VENTRICULAR FAILURE (RVF) OF ROUGHLY 35% CONTINUED TO PLAGUE CONTEMPORARY DEVICES AND IS ASSOCIATED WITH SIGNIFICANT LONG-TERM MORBIDITY AND MORTALITY. NUMEROUS SCORING SYSTEMS HAVE BEEN INVESTIGATED IN THE ATTEMPT TO PREDICT POSTIMPLANT RV FAILURE, BUT UNFORTUNATELY, DESPITE INCREASING SOPHISTICATION OF THESE SCORING SYSTEMS, OVERALL DISCRIMINATION OF PATIENTS AT RISK FOR RV FAILURE, PARTICULARLY LATE RV FAILURE, WAS MODEST. ALL PATIENTS WERE EVALUATED AT A SINGLE INSTITUTION UNDERGOING LVAD IMPLANTATION BETWEEN 2016 AND 2023 WHO HAD A PA PRESSURE SENSOR IN SITU AT THE TIME OF IMPLANTATION AND HAD AT LEAST TWO BUT UP TO TEN READINGS NOT REJECTED BY CARDIOMEMS FOR POOR SIGNAL, BEFORE AND AFTER LVAD IMPLANTATION (15/19, 79% HAD 10 READINGS BOTH BEFORE AND AFTER IMPLANT). ON AVERAGE, PATIENTS WERE 55 PLUS OR MINUS 13 YEARS OLD, PREDOMINANTLY WHITE (89%) MALES (68%) IMPLANTED WITH A HEARTMATE 3 (84%) AS DESTINATION THERAPY (68%). WITHIN THE COHORT, SEVEN PATIENTS (37%) EXPERIENCED RV FAILURE. PREIMPLANT PPI WAS ASSOCIATED WITH THE DEVELOPMENT OF RV FAILURE (AREA UNDER THE CURVE (AUC) = 0.79, P = 0.012) WITH OPTIMAL STRATIFICATION AT 0.25. SIMILARLY, POSTIMPLANT PPI WAS ASSOCIATED WITH THE DEVELOPMENT OF RV FAILURE (AUC = 0.71, P = 0.05) WITH OPTIMAL STRATIFICATION AT 0.35. IT WAS BELIEVED THAT THE HIGH NEGATIVE PREDICTIVE VALUE OF THE QUANTITY COMPLEMENTS CURRENT SCORING SYSTEMS, WHICH HAVE A HIGH POSITIVE PREDICTIVE VALUE FOR RVF ON LVAD THERAPY, SUCH AS MARKERS OF LIVER DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427845 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening