BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC¿ VALVE (AORTIC)

    MDR report key: 20853747 · Received December 5, 2024

    Report

    Report Number
    2135147-2024-06123
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    November 13, 2024
    Report Date
    January 2, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE: ARTICLE TITLED " MANAGEMENT OF GIANT LEFT ATRIAL THROMBUS LATE AFTER TRANSCATHETER MITRAL VALVE-IN-RING REPLACEMENT USING A TRANSCATHETER AORTIC VALVE: A CASE REPORT "

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, MANAGEMENT OF GIANT LEFT ATRIAL THROMBUS LATE AFTER TRANSCATHETER MITRAL VALVE-IN-RING REPLACEMENT USING A TRANSCATHETER AORTIC VALVE: A CASE REPORT. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLED " MANAGEMENT OF GIANT LEFT ATRIAL THROMBUS LATE AFTER TRANSCATHETER MITRAL VALVE-IN-RING REPLACEMENT USING A TRANSCATHETER AORTIC VALVE: A CASE REPORT "

    Description of Event or Problem · 0

    THE ARTICLE, "MANAGEMENT OF GIANT LEFT ATRIAL THROMBUS LATE AFTER TRANSCATHETER MITRAL VALVE-IN-RING REPLACEMENT USING A TRANSCATHETER AORTIC VALVE: A CASE REPORT", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 78-YEAR-OLD FEMALE PATIENT WITH FRAILTY, HEART FAILURE, AND ATRIAL FIBRILLATION. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 33MM EPIC VALVE WAS IMPLANTED. POST-PROCEDURE, WHILE PRESENTING UNEVENTFUL IN THE FIRST HOURS AFTER SURGERY, THE PATIENT DEVELOPED SEPSIS AND ACUTE KIDNEY FAILURE. A DECISION WAS MADE TO ADMINISTER HIGH DOSE CATECHOLAMINES INCLUDING VASOPRESSIN AS WELL AS TRANSIENT HEMODIALYSIS. AFTER 13 DAYS OF INTENSIVE CARE UNIT TREATMENT, THE PATIENT WAS TRANSFERRED TO NORMAL WARD FOR ANOTHER 4 WEEKS BEFORE BEING DISCHARGED WITH CONTINUED HEMODIALYSIS AT OUTPATIENT CARE ALONG WITH ANTICOAGULATION WITH VITAMIN K ANTAGONIST. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MARCUS FRANZ, DEPARTMENT OF INTERNAL MEDICINE I, CARDIOLOGY, ANGIOLOGY, INTENSIVE MEDICAL CARE, UNIVERSITY HOSPITAL JENA, AM KLINIKUM 1, 07747 JENA, GERMANY, WITH CORRESPONDING EMAIL: [email protected]]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490485 EPIC¿ VALVE (AORTIC) HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| L