BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21113471 · Received January 9, 2025

    Report

    Report Number
    2916596-2025-00175
    Event Type
    Death
    Date Received
    January 9, 2025
    Date of Event
    January 1, 2023
    Report Date
    January 9, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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. INVOLVED HOSPITAL: HEART FAILURE AND TRANSPLANT UNIT, ONASSIS CARDIAC SURGERY CENTRE, 356 SYNGROU AVENUE, KALLITHEA, ATTICA 176 74, GREECE. BONIOS, M., MILIOPOULOS, D., GKOUZIOUTA, A., KOGERAKIS, N., FRAGKOULIS, S., ARMENIS, I., ZARKALIS, D., IEROMONACHOS, K., KOLIOPOULOU, A., LEONTIADIS, E., GEORGIADOU, P., VARTELA, V., TSIAPRAS, D., SFIRAKIS, P., KAPELIOS, C., DIMOPOULOS, S., KAKLAMANIS, L., NTEGIANNIS, D., ANTONIOU, T., ADAMOPOULOS, S. (2024). COMPARISON OF CONTINUOUS FLOW CENTRIFUGAL LEFT VENTRICULAR ASSIST DEVICES AS A BRIDGE TO TRANSPLANT STRATEGY IN A LOW ORGAN DONATION ENVIRONMENT: SINGLE CENTER EXPERIENCE. HELLENIC JOURNAL OF CARDIOLOGY. HTTPS://DOI.ORG/10.1016/J.HJC.2024.10.004 MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REVISION B, IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, 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, "COMPARISON OF CONTINUOUS FLOW CENTRIFUGAL LEFT VENTRICULAR ASSIST DEVICES AS A BRIDGE TO TRANSPLANT STRATEGY IN A LOW ORGAN DONATION ENVIRONMENT: SINGLE CENTER EXPERIENCE", THAT THE HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH DEATH, INFECTION, RIGHT VENTRICULAR FAILURE (RVF), ARRHYTHMIAS, AND OTHER VARIOUS COMPLICATIONS. THIS RETROSPECTIVE STUDY EVALUATED 68 PATIENTS WITH ADVANCED HEART FAILURE, WHO UNDERWENT CONTINUOUS FLOW LVAD IMPLANT AS BRIDGE TO TRANSPLANT BETWEEN 2009 AND 2023. BASELINE CHARACTERISTICS INCLUDED BLOOD TESTS, DEMOGRAPHICS, ECHOCARDIOGRAPHIC, AND RIGHT HEART CATHETERIZATION DATA BEFORE IMPLANTATION. OUT OF THE 68 PATIENTS, 41 PATIENTS RECEIVED A HEARTWARE (HVAD) PUMP AND 27 PATIENTS RECEIVED A HEARTMATE 3 (HM3) DEVICE. THE HM3 PATIENTS HAD SIGNIFICANTLY BETTER SURVIVAL RATES (P=0.010) AND LOWER COMPLICATION RATES (P=0.025) THAN THE HVAD PATIENTS. BOTH GROUPS WERE DIVIDED INTO ADDITIONAL SUBGROUPS BASED ON WHETHER THEY RECEIVED A HEART TRANSPLANT OR NOT. THE GROUP OF PATIENTS THAT DID NOT RECEIVE A HEART TRANSPLANT (NOHTX) HAD SIGNIFICANTLY HIGHER COMPLICATION RATES COMPARED WITH THE GROUP OF PATIENTS THAT RECEIVED A HEART TRANSPLANT (HTX) (P=0.00041). OF THE 27 HM3 PATIENTS, THERE WERE 2 RECORDED DEATHS AND 14 RECORDED TRANSPLANTS, WHICH WAS COMPARED WITH THE 17 DEATHS AND 21 TRANSPLANTS FROM THE GROUP OF HVAD PATIENTS. MORE PATIENTS IN THE NO HEART TRANSPLANT GROUP WERE ON ECMO THAN THE NUMBER OF PATIENTS IN THE GROUP THAT RECEIVED HEART TRANSPLANTS. WHILE SUPPORTED BY THE LVAD IMPLANT, THERE WERE 10 HM3 PATIENTS AND 21 HVAD PATIENTS ON TEMPORARY INTRA-AORTIC BALLOON PUMP (IABP) SUPPORT, 1 HM3 PATIENT AND 3 HVAD PATIENTS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, AND 0 HM3 PATIENTS AND 1 HVAD PATIENT ON SUPPORT FROM AN IMPELLA DEVICE. THERE WERE 5 HM3 PATIENTS, COMPARED TO 23 HVAD PATIENTS, THAT EXPERIENCED ADVERSE EVENT COMPLICATIONS WHILE ON LVAD SUPPORT (P=0.0021). THERE WERE 2 HM3 PATIENTS, COMPARED TO 14 HVAD PATIENTS, THAT EXPERIENCED INFECTION WHILE ON LVAD SUPPORT (P=0.011), 3 HM3 PATIENTS EXPERIENCED RVF COMPARED TO 2 HVAD PATIENTS WHILE ON LVAD SUPPORT (P=0.3353), AND 1 HM3 PATIENT EXPERIENCED ARRHYTHMIAS COMPARED TO 0 HVAD PATIENTS WHILE ON LVAD SUPPORT (P=0.2144). THERE WERE NO HM3 PATIENTS THAT EXPERIENCED THE FOLLOWING ADVERSE EFFECTS, WHICH WERE EXPERIENCED BY HVAD PATIENTS: STROKE (P=0.009), GASTROINTESTINAL BLEEDING (P = 0.0594), PUMP THROMBOSIS (P=0.0594), AND DRIVELINE TRANSECTION (P=0.4136). THE STUDY CONCLUDED THAT PATIENTS WITH ADVANCED HEART FAILURE GAINED SUBSTANTIAL BENEFIT FROM LVADS AWAITING HEART TRANSPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379405 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death