BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21397075 · Received February 18, 2025

    Report

    Report Number
    2916596-2025-01035
    Event Type
    Death
    Date Received
    February 18, 2025
    Date of Event
    September 1, 2021
    Report Date
    February 17, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: 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. HERMA HEART INSTITUTE, CHILDREN¿S WISCONSIN, AND DEPARTMENT OF PEDIATRICS, SECTION OF CRITICAL CARE, MEDICAL COLLEGE OF WISCONSIN, MILWAUKEE, WISCONSIN; AND ¿HEART INSTITUTE, CINCINNATI CHILDREN¿S HOSPITAL MEDICAL CENTER, CINCINNATI, OHIO. LEE, J., SHEZAD, M. F., ZAFAR, F., & NIEBLER, R. A. (2024). OUTCOMES OF INTRACORPOREAL CONTINUOUS AND PARACORPOREAL PULSATILE VENTRICULAR ASSIST DEVICES IN PEDIATRIC PATIENTS 10-30 KG. ASAIO JOURNAL, 70(7), 616-620. DOI:HTTP://DX.DOI.ORG/10.1097/MAT.000000000000216. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED PATIENT DEATHS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WERE NOT REPORTED AND WERE NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, INCLUDING DEATH. 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 "OUTCOMES OF INTRACORPOREAL CONTINUOUS AND PARACORPOREAL PULSATILE VENTRICULAR ASSIST DEVICES IN PEDIATRIC PATIENTS 10¿30 KG" THAT HEARTMATE 3 MAY BE ASSOCIATED WITH DEATH, STROKE, HEMOLYSIS, BLEEDING, INFECTION, NEUROLOGICAL DYSFUNCTION, RENAL DYSFUNCTION, AND RIGHT HEART FAILURE. THIS RETROSPECTIVE STUDY EVALUATED 95 PATIENTS WHO WEIGHED BETWEEN 10 KILOGRAMS (KG) AND 30 KG AND RECEIVED AN INTRACORPOREAL CONTINUOUS (IC) OR PARACORPOREAL PULSATILE (PP) VENTRICULAR ASSIST DEVICE (VAD) BETWEEN JUN2018 AND SEP2021. 10 OF THE PATIENTS WERE ON HEARTMATE 3 AND 31 PATIENTS HAD HEARTWARE, WITH A TOTAL OF 41 PATIENTS ON IC VADS. THE REMAINING 54 PATIENTS HAD PP VADS, 54 WITH EXCOR, 1 WITH PEDIMAG, AND 2 WITH ROTAFLOW. EACH DEVICE WAS USED AS A LEFT VAD. THE PATIENTS WITH IC VADS WERE OLDER (MEDIAN [IQR] = 7.7 [5.6¿10.1] YEARS, P < 0.001) AND HAD A HIGHER WEIGHT (MEDIAN [IQR] = 21.9 [17.5¿27] KG, P = 0.001) COMPARED TO THE PP GROUP (MEDIAN AGE [IQR] = 3.7 [2.9¿6.1] YEARS, MEDIAN WEIGHT [IQR] = 14.3 [11.9¿17.8] KG). THERE WAS NO STATISTICAL DIFFERENCE IN DIAGNOSIS, OR INOTROPE USE AT THE TIME OF IMPLANTATION, HOWEVER THE PARACORPOREAL GROUP HAD MORE THAN TWICE AS MANY PATIENTS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AT THE TIME OF VAD IMPLEMENTATION, COMPARED TO THE INTRACORPOREAL GROUP (16 [29.6%] VS. 6 [14.6%], P = 0.086). IN THE PATIENTS WITH IC VADS, 11 PATIENTS REMAINED ALIVE ON THE DEVICE, 6 PATIENTS PASSED AWAY, 23 PATIENTS WERE TRANSPLANTED, AND 1 PATIENT HAD VENTRICULAR RECOVERY AND WAS WEANED. OF THE IC VAD IMPLANTED PATIENTS, 1 HAD HEMOLYSIS, 14 HAD MAJOR BLEEDING, 1 HAD AN EXTRA-AXIAL HEMORRHAGE, 1 HAD A HEMORRHAGIC STROKE, 3 HAD AN ISCHEMIC STROKE, 3 HAD RENAL DYSFUNCTION, 4 HAD RIGHT HEART FAILURE, AND 20 HAD MAJOR INFECTIONS (INCLUDING MEDIASTINITIS, SEPSIS, LOCALIZED NON-DEVICE INFECTIONS, MAJOR INFECTIONS ASSOCIATED WITH THE INTERNAL PUMP, INFLOW OR OUTFLOW TRACTS, AND PERCUTANEOUS SITE OR POCKET INFECTIONS.) STROKE WAS NUMERICALLY MORE COMMON IN THE PP COHORT WITH 4.6 ADVERSE EVENTS PER 100 PATIENT MONTHS COMPARED TO 1.45 ADVERSE EVENTS PER 100 PATIENT MONTHS IN THE IC GROUP, BUT DID NOT REACH STATISTICAL SIGNIFICANCE (P = 0.07). HEMOLYSIS WAS GREATER IN THE PP GROUP WITH 4.2 ADVERSE EVENTS PER 100 PATIENT MONTHS COMPARED TO 0.36 ADVERSE EVENTS PER 100 PATIENT MONTHS (P = 0.004). THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES IN MAJOR BLEEDING OR MAJOR INFECTION. DEVICE MALFUNCTION WAS HIGHER IN THE PP COHORT WITH 6.04 ADVERSE EVENTS PER 100 PATIENT MONTHS COMPARED TO NONE IN THE IC COHORT (P = 0.001). THERE WAS ALSO NO DIFFERENCE IN CLINICAL OUTCOMES, INCLUDING PATIENTS ALIVE ON DEVICE (P = 0.343) AND PATIENTS ALIVE AND TRANSPLANTED (P = 0.42). ONE PATIENT (2%) IN THE IC COHORT HAD VENTRICULAR RECOVERY AND WEANED FROM DEVICE. THERE WAS NO DIFFERENCE IN NUMBER OF DEVICE DAYS (IC MEDIAN [IQR] = 124 [47.5¿257] DAYS, PP MEDIAN [IQR] = 107.5 [51.2¿161] DAYS, P = 0.170) OR TOTAL OF ICU DAYS POSTIMPLANT (IC MEDIAN [IQR] = 34.5 [21¿66.75] DAYS, PP MEDIAN [IQR] = 60 [20¿114] DAYS, P = 0.109). FOUR PATIENTS (9.8%) IN THE IC GROUP WERE DISCHARGED ON DEVICE. IN THIS STUDY OF PEDIATRIC PATIENTS WEIGHING 10¿30 KG, WE FOUND NO STATISTICALLY SIGNIFICANT DIFFERENCE IN MORTALITY BETWEEN THE IC AND PP COHORTS. SIGNIFICANT DIFFERENCES WERE FOUND IN HIGHER RATES OF HEMOLYSIS AND DEVICE MALFUNCTION IN THE PP GROUP, WITH NUMERICALLY HIGHER BUT NOT STATISTICALLY DIFFERENT RATES OF STROKE. FURTHER STUDIES TO EVALUATE THE POTENTIAL BENEFITS OF THESE DEVICES IN SMALLER PEDIATRIC PATIENTS REMAIN IMPORTANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191032 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death