BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22336630 · Received June 26, 2025

    Report

    Report Number
    2916596-2025-03804
    Event Type
    Death
    Date Received
    June 26, 2025
    Date of Event
    March 1, 2024
    Report Date
    July 18, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. DATE OF EVENT HAS BEEN ENTERED AS 01MAR2024, AS PATIENTS WERE IMPLANTED BETWEEN JUN2019 AND MAR2024. DEPARTMENT OF CARDIOVASCULAR SURGERY, OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE, OSAKA, JAPAN, DEPARTMENT OF THORACIC AND CARDIOVASCULAR, SURGERY, DOKKYO MEDICAL UNIVERSITY SAITAMA MEDICAL CENTER, SAITAMA, JAPAN IMAOKA, S., YOSHIOKA, D., SAITO, S., KAWAMURA, T., KAWAMURA, A., MATSUURA, R., MISUMI, Y., TODA, K., & MIYAGAWA, S. (2025). INFLUENCE OF PREOPERATIVE ANATOMICAL CHARACTERISTICS ON THE DIRECTION OF INFLOW CANNULA IN HEARTMATE 3. ARTIFICIAL ORGANS. HTTPS://DOI.ORG/10.1111/AOR.15018 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 PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RESEARCH ARTICLE TITLED, ¿INFLUENCE OF PREOPERATIVE ANATOMICAL CHARACTERISTICS ON THE DIRECTION OF INFLOW CANNULA IN HEARTMATE 3¿, WAS RECEIVED. THIS ARTICLE SOUGHT TO INVESTIGATE THE INFLUENCE OF ANATOMICAL CHARACTERISTICS ON INFLOW CANNULA (IC) DIRECTION IN PATIENTS WITH IMPLANTED WITH THE HEARTMATE 3 LVAS THROUGH ANALYSIS OF COMPUTED TOMOGRAPHY (CT) IMAGES AND ASSESSMENT OF IC DIRECTION AND PROGNOSIS. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBER AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE CURRENT REVISION OF THE IFU CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU, REV. A IS CURRENTLY AVAILABLE. THE IFU LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. 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 ¿INFLUENCE OF PREOPERATIVE ANATOMICAL CHARACTERISTICS ON THE DIRECTION OF INFLOW CANNULA IN HEARTMATE 3¿ THAT THE ANATOMICAL CHARACTERISTICS RELATED TO INFLOW CANNULA (IC) DIRECTION WAS INVESTIGATED THROUGH ANALYSIS OF COMPUTED TOPOGRAPHY (CT) IMAGES AND RELATION BETWEEN PROGNOSIS AND INFLOW CANNULA DIRECTION. 48 PATIENTS WERE REVIEWED WHO HAD UNDERWENT HM 3 IMPLANTATION, BETWEEN JUNE 2019 AND MARCH 2024, AND HAD CT IMAGES TAKE PRE- AND POST-IMPLANTATION. THE DIRECTION OF INFLOW CANNULA FOR GROUP A (N=18) WAS THE LEFT VENTRICULAR ANTERIOR/LATERAL WALL, GROUP B (N=21) WAS THE AORTIC/MITRAL VALVE, AND GROUP C (N=9) WAS LEFT VENTRICULAR POSTERIOR/INFERIOR WALL. THE MEAN AGE OF THE PATIENTS WAS 53 (44¿59) YEARS, AND 40 (83%) WERE MALE. ON PREOPERATIVE CT, GROUP A HAD A HIGHER MITRAL VALVE HEIGHT FROM THE LV APEX THAN GROUP B (68 ± 13 AND 52 ± 14 MM, RESPECTIVELY; P < 0.01). GROUP C HAD A LONGER DISTANCE BETWEEN THE LV APEX AND CHEST WALL THAN GROUP B (20 ± 9 AND 9 ± 6 MM, P < 0.01). GROUP C HAD A SHORTER THORACIC DEPTH FROM THE LV APEX THAN DID GROUP B (24 ± 9 AND 39 ± 11 MM, P < 0.01). THE IC DIRECTION IN HM3 WAS INFLUENCED BY THE PREOPERATIVE POSITION OF THE MITRAL VALVE, LV APEX, CHEST WALL, AND DIAPHRAGM. THE IC DIRECTION IN HM3 DID NOT SIGNIFICANTLY AFFECT SURVIVAL RATES. COMPLICATIONS AFTER HM3 IMPLANTATION INCLUDED CEREBRAL INFARCTION, CEREBRAL HEMORRHAGE, BLEEDING COMPLICATIONS INCLUDING GASTROINTESTINAL BLEEDING, HEART FAILURE, AND ARRHYTHMIA. CEREBROVASCULAR ACCIDENT (CVA) WAS EXPERIENCED BY 1 PATIENT IN GROUP A, 1 PATIENT IN GROUP B, AND 1 PATIENT IN GROUP C. HEART FAILURE WAS EXPERIENCED BY 2 PATIENTS IN GROUP A, 5 PATIENTS IN GROUP B, AND 1 PATIENT IN GROUP C. ARRYTHMIA WAS EXPERIENCED BY 2 PATIENTS IN GROUP A, 2 PATIENTS IN GROUP B, AND 3 PATIENTS IN GROUP C. BLEEDING COMPLICATIONS WERE EXPERIENCED BY 2 PATIENTS IN GROUP A, 3 PATIENTS IN GROUP B, AND 1 PATIENT IN GROUP C. LOW FLOW ALARMS WERE EXPERIENCED BY 1 PATIENT IN GROUP A, 2 PATIENTS IN GROUP B, AND 1 PATIENT IN GROUP C. THE IC DIRECTION WAS CONSIDERED TO HAVE LITTLE INFLUENCE ON LVAD DRIVELINE INFECTION. THUS, LVAD DRIVELINE INFECTION WAS EXCLUDED FROM COMPLICATIONS AFTER HM3 IMPLANTATION IN THIS STUDY. THE SURVIVAL RATES AFTER HM3 IMPLANTATION AT 3 YEARS IN GROUPS A, B, AND C WERE 88%, 90%, AND 100%, RESPECTIVELY (P = 0.67). THE RATES OF FREEDOM FROM COMPLICATIONS AFTER HM3 IMPLANTATION AT 3 YEARS IN GROUPS A, B, AND C WERE 50%, 43%, AND 20%, RESPECTIVELY (P = 0.70).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792965 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death