BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC¿ VALVE (AORTIC)

    MDR report key: 22689316 · Received August 1, 2025

    Report

    Report Number
    2135147-2025-04266
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    January 1, 2021
    Report Date
    August 1, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF OUTCOMES FOLLOWING TOTALLY ENDOSCOPIC MITRAL VALVE REPLACEMENT VERSUS MITRAL VALVE REPLACEMENT THROUGH RIGHT THORACOTOMY WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING DIABETES MELLITUS TYPE 2, HYPERTENSION, ATRIAL FIBRILLATION, RHEUMATIC MITRAL STENOSIS/REGURGITATION, MITRAL PROLAPSE, AND HEART FAILURE. SOME OF THE COMPLICATIONS REPORTED WERE STROKE, SEPSIS, HEMORRHAGE, THROMBOSIS; 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 B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: OUTCOMES FOLLOWING TOTALLY ENDOSCOPIC MITRAL VALVE REPLACEMENT VERSUS MITRAL VALVE REPLACEMENT THROUGH RIGHT THORACOTOMY: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY.

    Description of Event or Problem · 0

    THE ARTICLE, "OUTCOMES FOLLOWING TOTALLY ENDOSCOPIC MITRAL VALVE REPLACEMENT VERSUS MITRAL VALVE REPLACEMENT THROUGH RIGHT THORACOTOMY: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY", WAS REVIEWED. THE ARTICLE PRESENTED A SINGLE-CENTER, PROSPECTIVE STUDY TO DETERMINE THE ADVANTAGES AND DISADVANTAGES OF TOTALLY ENDOSCOPIC MITRAL VALVE REPLACEMENT (TEMVR) AND RIGHT ANTEROLATERAL THORACOTOMY MITRAL VALVE REPLACEMENT (RATMVR) TECHNIQUES ALONG WITH THE RELATIVE IMPROVEMENT OF QUALITY OF LIFE. DEVICES INCLUDED IN THE STUDY WAS SORIN BICARBON FITLINE - LIVANOVA AND ST. JUDE/ABBOTT EPIC. THE ARTICLE CONCLUDED THAT THE TEMVR TECHNIQUE WAS A FAVORABLE OPTION, PARTICULARLY FOR PATIENTS SEEKING TO MINIMIZE THE POSTOPERATIVE BURDEN OF PAIN AND RESPIRATORY DISCOMFORT WHILE ENJOYING IMPROVED LONG-TERM QUALITY OF LIFE AND SATISFACTION. [THE PRIMARY AND CORRESPONDING AUTHOR WAS SANDIP SARDAR, VIVEKANANDA INSTITUTE OF MEDICAL SCIENCES, RAMAKRISHNA MISSION SEVA PRATISHTHAN, KOLKATA, INDIA, WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2021 TO JANUARY 2023. A TOTAL OF 80 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 5 (6.3%) RECEIVED AN ABBOTT DEVICE. IN GROUP A, THE AVERAGE AGE WAS 39.08 YEARS AND THE MAJORITY GENDER WAS FEMALE. IN GROUP B, THE AVERAGE AGE WAS 36.18 YEARS AND THE GENDER DISTRIBUTION WAS EVEN (20 OUT OF 40 WERE FEMALE). COMORBIDITIES INCLUDED DIABETES MELLITUS TYPE 2, HYPERTENSION, ATRIAL FIBRILLATION, RHEUMATIC MITRAL STENOSIS/REGURGITATION, MITRAL PROLAPSE, AND HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981521 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 Required Intervention| S| L