BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 19601501 · Received June 24, 2024

    Report

    Report Number
    2916596-2024-03804
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    January 1, 2017
    Report Date
    July 18, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ABSTRACT. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT HAS BEEN ENTERED AS 01JAN2017 AS THE IMPLANT DATE OCCURRED BETWEEN 2015 AND 2017. SAKIR AKINA, ET AL. JOURNAL OF CRITICAL CARE, 2024-06-01, VOLUME 81, ARTICLE 154662 DOI:10.1016/J.JCRC.2024.154662 . DEPARTMENT OF INTENSIVE CARE, HAGA HOSPITAL, THE HAGUE, THE NETHERLANDS, AND GALWAY UNIVERSITY HOSPITAL, HEALTH SERVICE EXECUTIVE AND CORRIBCORE LAB, NATIONAL UNIVERSITY OF IRELAND GALWAY (NUIG), H91 V4AY GALWAY, IRELAND. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    E1: THE SITE WAS (B)(6) . REPORTER CONTACT INFORMATION WAS NOT AVAILABLE H6: HEALTH EFFECT - IMPACT CODE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. 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, "INTRODUCTION," LISTS RENAL FAILURE AS A POTENTIAL ADVERSE EVENT WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. 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 ABSTRACT TITLED ¿MICROCIRCULATORY ALTERATIONS AND RENAL OUTCOME FOLLOWING HEART MATE II AND 3 LEFT VENTRICULAR ASSIST DEVICE IMPLANTATIONS¿ IDENTIFYING HEARTMATE 3 MAY BE RELATED WITH ACUTE KIDNEY INJURY AND DEATH. THE AIM OF THIS STUDY WAS TO EVALUATE SUBLINGUAL MICROCIRCULATION TO EARLY PREDICT SEVERE AKI. IT WAS EVALUATED 30 PATIENTS IMPLANTED WITH LVAD WHERE 73% WERE IMPLANTED WITH HM3 BETWEEN 2015 AND 2017. BEDSIDE MICROSCOPY WITH CYTOCAM-IDF TO MONITOR SUBLINGUAL MICROCIRCULATION INVOLVED BEFORE AND AFTER LVAD IMPLANTATION. A TOTAL OF 23 PATIENTS (77%) SHOWED MILD TO SEVERE AKI. ONE WAY ANOVA PAIRED TEST OF MICROCIRCULATORY PARAMETERS TOTAL VESSEL DENSITY (TVD), FUNCTIONAL CAPILLARY DENSITY (FCD), PORTION OF THE PERFUSED VESSELS (PPV), RED BLOOD CELL VELOCITY (RBCV) AND TISSUE RED BLOOD CELL PERFUSION (TRBCP) REVEALED HIGH ASSOCIATION WITH MILD TO SEVERE AKI (RESPECTIVELY PRE-AND POST LVAD WITH P = 0,0466; P = 0,0472; P = 0.027 AND = 0.0051). FURTHERMORE, EARLY MORTALITY FOLLOWING LVAD IS HIGHLY ASSOCIATED WITH DEVELOPMENT OF SEVERE AKI (P = 0.002). SUBLINGUAL MICROCIRCULATION WAS REPORTED TO BE PROMISING PREDICTOR FOR MILD TO SEVERE AKI FOLLOWING LVAD IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435084 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other