BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC PLUS

    MDR report key: 22749618 · Received August 8, 2025

    Report

    Report Number
    2135147-2025-04401
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    May 18, 2025
    Report Date
    September 23, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO FATIGUE AFTER 3 WEEKS OF EPIC VALVE IMPLANTATION. ALSO REPORTED THAT THE PATIENT WAS LATER DIAGNOSED WITH A COMPLETE HEART BLOCK. FIELD INDICATED NO DIFFICULTY WAS EXPERIENCED DURING THE IMPLANTATION. 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 INFORMATION RECEIVED, THE CAUSE OF THE COMPLETE HEART BLOCK WAS POSSIBLY RELATED TO THE IMPLANT PROCEDURE. HOWEVER, THE EXACT CAUSE OF FATIGUE AND HEART BLOCK COULD NOT BE DETERMINED. THE REPORTED SURGICAL INTERVENTION WAS A RESULT OF A PERMANENT PACEMAKER IMPLANT. THERE WAS NO REPORTED ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE. PLEASE NOTE THAT PER THE INSTRUCTIONS FOR USE, "THE SAFETY AND EFFECTIVENESS OF THE EPIC¿ PLUS AND EPIC¿ PLUS SUPRA VALVES HAS NOT BEEN ESTABLISHED FOR THE FOLLOWING SPECIFIC POPULATIONS: PATIENTS REQUIRING PULMONIC OR TRICUSPID VALVE REPLACEMENT."

    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 33MM EPIC PLUS MITRAL VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT WITH PRE-EXISTING ATRIAL FIBRILLATION AND CONTROLLED VENTRICULAR RESPONSE. IT'S NOTED THAT 33MM EPIC PLUS MITRAL VALVE WAS USED AS PART OF A TRICUSPID VALVE REPLACEMENT PROCEDURE. NO DIFFICULTY WAS EXPERIENCED DURING THE IMPLANTATION OF THE 33 MM EPIC PLUS MITRAL VALVE. ON (B)(6) 2025, IT WAS NOTED THAT THE PATIENT WAS HOSPITALIZED DUE TO FATIGUE. UPON READMISSION, ELECTROCARDIOGRAMS REVEALED TRACES OF BLOCKED ATRIAL FIBRILLATION WITH A VENTRICULAR RATE OF 45 BEATS PER MINUTE (BPM) AND INCOMPLETE RIGHT BUNDLE BRANCH BLOCK (RBBB), ALONG WITH PATTERNS CONSISTENT WITH SLOW ATRIAL FIBRILLATION AROUND 50 BPM. DURING CARDIOLOGICAL ASSESSMENT¿CONDUCTED MORE THAN 24 HOURS AFTER THE LAST DOSE OF BETA-BLOCKERS¿THE PATIENT EXHIBITED SLOW ATRIAL FIBRILLATION AT 50 BPM WITH A POOR CHRONOTROPIC RESPONSE TO EXERCISE. THE PATIENT WAS LATER DIAGNOSED WITH A COMPLETE HEART BLOCK. ON (B)(6) 2025, THE DECISION WAS MADE TO IMPLANT A PERMANENT PACEMAKER. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE CAUSE OF THE COMPLETE HEART BLOCK IS ATTRIBUTED TO THE IMPLANT PROCEDURE. CURRENTLY, THE PATIENT IS IN VERY GOOD CLINICAL CONDITION AND WAS DISCHARGED FIVE DAYS AFTER PACEMAKER IMPLANTATION.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999424 EPIC PLUS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL E200-33M BR00048952

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| H