BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21515726 · Received March 4, 2025

    Report

    Report Number
    2916596-2025-01405
    Event Type
    Death
    Date Received
    March 4, 2025
    Date of Event
    November 1, 2014
    Report Date
    March 4, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. SHIH, H., MONDELLINI, G. M., KURLANSKY, P. A., SUN, J., NING, Y., FELDMAN, V. R., TIBURCIO, M., MAGUIRE, C. W., LADANYI, A., CLERKIN, K., NAKA, Y., SAYER, G. T., URIEL, N., COLOMBO, P. C., TAKEDA, K., & YUZEFPOLSKAYA, M. (2024). UNPLANNED HOSPITAL READMISSIONS FOLLOWING HEARTMATE 3 IMPLANTATION: READMISSION RATES, CAUSES, AND IMPACT ON SURVIVAL. ARTIFICIAL ORGANS, 48(9), 1049¿1059. HTTPS://DOI.ORG/10.1111/AOR.14763. DEPARTMENT OF SURGERY, DIVISION OF CARDIOTHORACIC AND VASCULAR SURGERY, COLUMBIA UNIVERSITY MEDICAL CENTER, NEW YORK, NEW YORK, USA; DIVISION OF CARDIOVASCULAR MEDICINE, DEPARTMENT OF CARDIOLOGY, NEW YORK PRESBYTERIAN HOSPITAL, COLUMBIA UNIVERSITY, NEW YORK, NEW YORK, USA; CENTER FOR INNOVATION AND OUTCOMES RESEARCH, DEPARTMENT OF SURGERY, COLUMBIA UNIVERSITY, NEW YORK, NEW YORK, USA 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 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C, 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. THE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WERE NOT REPORTED AND WERE NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. 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 ¿UNPLANNED HOSPITAL READMISSIONS FOLLOWING HEARTMATE 3 IMPLANTATION: READMISSION RATES, CAUSES, AND IMPACT ON SURVIVAL¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH HOSPITAL READMISSION DUE TO INFECTION, STROKE, BLEEDING, ARRHYTHMIA, VOLUME OVERLOAD (DEFINED AS CLINICAL EVIDENCE OF VOLUME OVERLOAD AND NEED FOR INTRAVENOUS DIURETIC), RIGHT HEART FAILURE, DEVICE MALFUNCTION, PUMP THROMBOSIS, AND DEATH. THIS RETROSPECTIVE STUDY EVALUATED ALL 182 CONSECUTIVE PATIENTS WHO WERE IMPLANTED WITH THE HM3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) AT COLUMBIA UNIVERSITY IRVING MEDICAL CENTER BETWEEN NOVEMBER 2014 TO DECEMBER 2019. ALL READMISSIONS TO THE IMPLANTING CENTER AFTER THE INDEX HOSPITAL DISCHARGE WERE REVIEWED AND THE PRIMARY REASON FOR READMISSION WAS RECORDED. 10 PATIENTS DIED DURING THE IMPLANT HOSPITALIZATION AND 5 UNDERWENT A HEART TRANSPLANTATION. THE MEDIAN AGE OF THE COHORT WAS 61.2 YEARS, 62.3% OF THE COHORT WERE WHITE, 83% WERE MALE, 62% HAD AN INTERMACS PROFILE LESS THAN OR EQUAL TO 2, AND 82% RECEIVED HM3 AS DESTINATION THERAPY. DURING A MEDIAN FOLLOW UP OF 727 DAYS, THERE WERE 407 UNPLANNED READMISSIONS. 125 PATIENTS HAD AT LEAST ONE READMISSION. 7 PATIENTS HAD AT LEAST ONE POSTOPERATIVE GASTROINTESTINAL BLEED (GIB), 6 HAD POSTOPERATIVE STROKE (4 HEMORRHAGIC, 2 ISCHEMIC), AND 21 HAD POSTOPERATIVE RIGHT VENTRICULAR ASSIST DEVICE (RVAD). 29.3% OF READMISSIONS WERE DUE TO MAJOR INFECTION, INCLUDING 10.6% FOR LVAD-RELATED INFECTION. 13.2% WERE DUE TO BLEEDING, INCLUDING 11.5% GIB AND 1.7% OTHER CAUSES. 12.5% WERE DEVICE RELATED, INCLUDING 9.1% DEVICE ALARMS, 3.4% DEVICE MALFUNCTION, AND 0.2% PUMP THROMBOSIS. 9.8% WERE FOR ARRHYTHMIA, 7.1% WERE FOR VOLUME OVERLOAD, AND 28% WERE FOR OTHER CAUSES. ONE YEAR AND 900-DAY SURVIVAL WERE UNAFFECTED BY THE NUMBER OF READMISSIONS AND REMAINED >90%. UNPLANNED HOSPITAL READMISSIONS AFTER HM3 ARE COMMON, WITH INFECTIONS AND BLEEDING ACCOUNTING FOR THE MAJORITY OF READMISSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146736 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death