BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC¿ VALVE (AORTIC)

    MDR report key: 23205751 · Received October 2, 2025

    Report

    Report Number
    2135147-2025-05609
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    January 1, 2011
    Report Date
    October 2, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF EPIC STENTED PORCINE HEART VALVE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING CORONARY ARTERY DISEASE, CHRONIC KIDNEY DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CEREBROVASCULAR DISEASE, DIABETES MELLITUS, HEMODIALYSIS, ARTERY DISEASE, THORACIC AORTIC ANEURYSM, ATRIAL FIBRILLATION, AND LIVER CIRRHOSIS. COMPLICATIONS REPORTED INCLUDED DEATH, SURGICAL INTERVENTION (REDO, PACEMAKER), HOSPITALIZATION, STROKE, ENDOCARDITIS, HEART FAILURE; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE ARTICLE, "LONG-TERM VALVE PERFORMANCE OF ST JUDE MEDICAL EPIC PORCINE BIOPROSTHESIS IN AORTIC POSITION", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY TO REVIEW LONG-TERM CLINICAL OUTCOMES AND HEMODYNAMIC PERFORMANCE OF THE EPIC VALVE IN AORTIC POSITION. DEVICES INCLUDED IN THE STUDY WERE SOLELY EPIC SUPRA AORTIC VALVE. THE ARTICLE CONCLUDED THAT LONG-TERM CLINICAL OUTCOMES AND VALVE PERFORMANCE IN PATIENTS UNDERWENT EPIC SUPRA VALVE IMPLANTATION WERE SATISFACTORY. SUBGROUP ANALYSIS OF PATIENTS UNDERWENT 19-MM EPIC SUPRA VALVE IMPLANTATION ALSO SHOWED SATISFACTORY RESULTS, SUGGESTING ITS ACCEPTABILITY IN ELDERLY PATIENTS WITH A SMALL BODY SURFACE AREA (BSA). [THE PRIMARY AND CORRESPONDING AUTHOR WAS SHUSAKU MAEDA, DEPARTMENT OF CARDIOVASCULAR SURGERY, FUKUI CARDIOVASCULAR CENTER, 2-228 SHINPO, FUKUI 9100833, JAPAN, WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2011 TO MARCH 2022. A TOTAL OF 44 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH ALL RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 74.7 YEARS, AND THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED CORONARY ARTERY DISEASE, CHRONIC KIDNEY DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CEREBROVASCULAR DISEASE, DIABETES MELLITUS, HEMODIALYSIS, ARTERY DISEASE, THORACIC AORTIC ANEURYSM, ATRIAL FIBRILLATION, AND LIVER CIRRHOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277790 EPIC¿ VALVE (AORTIC) HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL UNK EPIC STENTED PORCINE HV

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability| L| H| R