BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20193852 · Received September 11, 2024

    Report

    Report Number
    2916596-2024-06030
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    March 1, 2022
    Report Date
    October 22, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010616
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT HAS BEEN ENTERED AS 01MARCH2022 SINCE THE DATE COLLECTION OCCURRED BETWEEN JANUARY 2021 AND MARCH 2022. ZHULDYZ NURMYKHAMETOVA ET AL., J EXTRA CORPOR TECHNOL 2024, 56, 10¿15, 2024. HTTPS://DOI.ORG/10.1051/JECT/2023048. DEPARTMENT OF PERFUSIOLOGY AND ASSISTED CIRCULATION LABORATORY, NATIONAL RESEARCH CARDIAC SURGERY CENTER, ASTANA 010000, KAZAKHSTAN. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RENAL DYSFUNCTION AND BLEEDING, 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 TITLED ¿PRELIMINARY REPORT OF EXTRACORPOREAL BLOOD PURIFICATION THERAPY IN PATIENTS RECEIVING LVAD: CYTOSORB OR JAFRON HA330¿ IDENTIFYING THAT HEARTMATE 3 (HM3) IS ASSOCIATED ELEVATED PROINFLAMMATORY CYTOKINES, KIDNEY INJURY, POSTOPERATIVE BLEEDING, AND DEATH DUE MULTIORGAN FAILURE. THIS IS A RETROSPECTIVE STUDY THAT REVIEWED PROSPECTIVELY COLLECTED DATA FROM 15 PATIENTS WHO UNDERWENT LEFT VENTRICULAR ASSIST DEVICE (LVAD) HM 3 IMPLANTATION AT A SINGLE TERTIARY CARE CENTER BETWEEN JANUARY 2021 AND MARCH 2022. INTRAOPERATIVELY, PATIENTS WERE SINGLE RANDOMIZED 1:1:1 TO THREE GROUPS: GROUP 1, PATIENTS WHO RECEIVED CYTOSORB THERAPY (N = 5; INSTALLED IN THE CARDIOPULMONARY BYPASS (CPB) CIRCUIT); GROUP 2, PATIENTS WHO RECEIVED JAFRON HA330 (N = 5; INSTALLED IN THE CPB CIRCUIT); AND CONTROL GROUP 3, PATIENTS WHO DID NOT RECEIVE FILTER (N = 50) USUAL CARE, NEITHER CYTOSORB NOR JAFRON DURING CPB. DATA WERE OBTAINED FROM A PROSPECTIVELY COLLECTED INSTITUTIONAL LVAD DATABASE THAT INCLUDED DETAILED INFORMATION ON PATIENT DEMOGRAPHICS, BASELINE CLINICAL CHARACTERISTICS, LABORATORY AND HEMODYNAMIC PARAMETERS, INTRAOPERATIVE VARIABLES, AND POSTOPERATIVE OUTCOMES. THE PATIENTS WERE FOLLOWED UP FOR 30 DAYS AFTER HOSPITAL DISCHARGE. TO EVALUATE THE IMPACT OF CYTOKINE ADSORPTION ON ADDITIONAL CLINICALLY RELEVANT PARAMETERS, IT WAS DETERMINED INTERLEUKIN (1ALFA,6,8), PROCALCITONIN (PCT), N-TERMINAL PRO-B-TYPE NATRIURETIC PEPTIDE (NT-PROBNP), C-REACTIVE PROTEIN (CRP), LEUKOCYTE, TUMOR NECROSIS FACTOR ALPHA (TNF-A) LEVELS BEFORE AND AFTER THE ONSET OF HA AS A MEASURE OF HEMODYNAMIC STABILIZATION IN ALL GROUPS. ALL THE PATIENTS IN THE THREE GROUPS HAD ELEVATED LEVELS OF INFLAMMATORY MARKERS IN THE PERIOPERATIVE AND IMMEDIATE POSTOPERATIVE PERIODS. AFTER 72 H OF INTENSIVE CARE, THE LEVELS OF BLOOD INFLAMMATION MARKERS TENDED TO DECLINE. NO IN-HOSPITAL MORTALITY WAS OBSERVED. OVER A MEDIAN FOLLOW-UP OF 1 YEAR BETWEEN THE GROUPS, THERE WERE NO SURVIVAL DIFFERENCES (80%, 100%, AND 80%). IN BOTH CASES, THE CAUSE OF DEATH WAS MULTIORGAN FAILURE. THE MEAN ICU STAY DURATION (1, 2, AND 2 DAYS) AND HOSPITAL STAY DURATION (32, 29 AND 24 DAYS) WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN THE CYTOSORB, JAFRON, AND CONTROL GROUPS. IN-HOSPITAL MAJOR ADVERSE EVENTS, SUCH AS ACUTE KIDNEY INJURY, THE NEED FOR HEMODIALYSIS, AND POSTOPERATIVE BLEEDING, WERE SIMILAR IN ALL GROUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575508 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024010616

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H