BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPIC MAX VALVE (AORTIC)

    MDR report key: 25338345 · Received May 29, 2026

    Report

    Report Number
    2135147-2026-03690
    Event Type
    Death
    Date Received
    May 29, 2026
    Date of Event
    August 1, 2023
    Report Date
    May 29, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B2: DEATH DATE WAS ESTIMATED. B3: EVENT DATE WAS 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, "THE LATEST PORCINE AORTIC BIOPROSTHESIS VALVE: EARLY HEMODYNAMIC PROFILES", WAS REVIEWED. THIS RESEARCH ARTICLE IS A PROSPECTIVE SINGLE-CENTER EXPERIENCE TO EVALUATE EARLY HEMODYNAMICS IN THE EPIC MAX VALVE BY PROSTHESIS LABEL SIZE. THE DEVICE INCLUDED IN THE STUDY WAS THE EPIC MAX VALVE. THE ARTICLE CONCLUDED THAT THE EPIC MAX VALVE FUNCTIONS AS DESIGNED, WITH EARLY HEMODYNAMICS FAVORABLE COMPARED TO OTHER VALVES INT HE CURRENT MARKET. EVEN IN PATIENTS WITH SEVERE PRESUMED PROSTHESIS-PATIENT MISMATCH AND NORMAL LEFT VENTRICULAR SYSTOLIC FUNCTION, TRANS-PROSTHESIS GRADIENTS REMAINED LOW. [THE PRIMARY AND CORRESPONDING AUTHOR WAS JOSE FERRE, DEPARTMENT OF THORACIC AND CARDIOVASCULAR SURGERY, CLEVELAND CLINIC, CLEVELAND, OHIO, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED PATIENTS WHO UNDERWENT SURGICAL AORTIC VALVE REPLACEMENT WITH THE EPIC MAX VALVE FROM 01 AUGUST 2023 TO 31 AUGUST 2025. A TOTAL OF 197 PATIENTS WERE INCLUDED IN THE STUDY, ALL OF WHICH RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 69.4 YEARS. THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED AORTIC STENOSIS, AORTIC REGURGITATION, ATRIAL FIBRILLATION/FLUTTER, COMPLETE HEART BLOCK, VENTRICULAR TACHYCARDIA FIBRILLATION, MYOCARDIAL INFARCTION, CONGESTIVE HEART FAILURE, PERIPHERAL ARTERIAL DISEASE, HYPERTENSION, DIABETES, AND ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505829 EPIC MAX VALVE (AORTIC) HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL UNK EPIC MAX VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1