BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC PLUS

    MDR report key: 22749322 · Received August 8, 2025

    Report

    Report Number
    2135147-2025-04392
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    March 18, 2025
    Report Date
    August 29, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    UDI-DI
    05415067033093
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT PERICARDIAL EFFUSION AND BLEEDING WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. IT IS POSSIBLE PROCEDURAL CONDITIONS CONTRIBUTED TO THE REPORTED EVENT; HOWEVER, THIS CANNOT BE CONFIRMED. THE REPORTED INTERVENTIONS WERE RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IMPLANTED IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    CLINICAL INFORMATION: (B)(6) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM EPIC PLUS MITRAL VALVE WAS SUCCESSFULLY IMPLANTED A PATIENT. NO DIFFICULTY WAS ENCOUNTERED DURING THE IMPLANTATION OF THE 31 MM EPIC PLUS MITRAL VALVE. IN THE FIRST FEW HOURS POST-SURGERY, THE PATIENT EXPERIENCED HYPERTENSION WITH SYSTOLIC BLOOD PRESSURE PEAKS OF 180¿220 MMHG, LEADING TO ELEVATED MEDIASTINAL DRAINAGE OUTPUT (1,100 ML IN 7 HOURS). SURGICAL REVISION WAS PERFORMED, REVEALING DIFFUSE BLEEDING FROM THE STERNAL AREA, LIKELY DUE TO THE HYPERTENSIVE EMERGENCY, BUT NO ACTIVE BLEEDING AT CARDIAC SUTURES. A MODERATE 18MM PERICARDIAL EFFUSION WAS ALSO NOTED TO HAVE DEVELOPED, WHICH IMPROVED AFTER MEDICATION ADJUSTMENT. DUE TO THE SEVERITY OF BLEEDING, HEPARIN WAS NOT ADMINISTERED, AND ACTIVATED CLOTTING TIME (ACT) LEVELS WERE NOT AVAILABLE. AT THE TIME OF RE-OPERATION, THE INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.25, AND AT DISCHARGE, IT WAS 1.22. ONE POOL OF PLATELETS WAS TRANSFUSED IN THE INTENSIVE CARE UNIT (ICU) BEFORE REINTERVENTION, WITH NO FURTHER TRANSFUSIONS REQUIRED. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE PATIENT WAS DISCHARGED ON THE 13TH POSTOPERATIVE DAY AND IS CURRENTLY IN GOOD CLINICAL CONDITION, ALTHOUGH EXPERIENCING ASTHENIA DUE TO POOR BLOOD PRESSURE CONTROL, WITH A TENDENCY TOWARD HYPOTENSION. ANTIHYPERTENSIVE MEDICATIONS ARE BEING OPTIMIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051976 EPIC PLUS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL E200-31M BR00046610 05415067033093

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Hospitalization| R