BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC¿ VALVE (AORTIC)

    MDR report key: 21395053 · Received February 18, 2025

    Report

    Report Number
    2135147-2025-00790
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    March 1, 2016
    Report Date
    March 7, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. ARTICLE TITLE: BIOPROSTHETIC VALVE FRACTURE: TECHNICAL INSIGHTS FROM A MULTICENTER STUDY.

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF EPIC/EPIC SUPRA WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING PREVIOUS VALVE SURGERY. COMPLICATIONS REPORTED INCLUDED SURGICAL INTERVENTION (VALVE-IN-VALVE), HOSPITALIZATION, AORTIC REGURGITATION, AORTIC STENOSIS, DEVICE STENOSIS, DEVICE REGURGITATION; 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: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE: ARTICLE TITLE: "BIOPROSTHETIC VALVE FRACTURE: TECHNICAL INSIGHTS FROM A MULTICENTER STUDY".

    Description of Event or Problem · 0

    THE ARTICLE, "BIOPROSTHETIC VALVE FRACTURE: TECHNICAL INSIGHTS FROM A MULTICENTER STUDY", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, MULTICENTER STUDY TO EXPLORE FACTORS INFLUENCING THE FINAL PROCEDURAL HEMODYNAMICS FOLLOWING VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT (VIV TAVR) WITH BIOPROSTHETIC VALVE FRACTURE (BVF). DEVICES INCLUDED IN THE STUDY WERE MAGNA, PERIMOUNT 2800, MAGNA EASE, MITROFLOW, MOSAIC, EPIC/EPIC SUPRA, COREVALVE, AND SAPIEN. THE ARTICLE CONCLUDED THAT BVF CAN BE PERFORMED SAFELY AND RESULTS IN REDUCED RESIDUAL TRANSVALVULAR GRADIENTS. PERFORMING BVF AFTER VIV TAVR AND USING LARGER BALLOON APPEARS TO ACHIEVE THE BEST HEMODYNAMIC RESULTS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS KEITH B. ALLEN, SAINT LUKE¿S MID AMERICA HEART INSTITUTE AND UNIVERSITY OF MISSOURI-KANSAS CITY SCHOOL OF MEDICINE, 4320 WORNALL RD, MEDICAL PLAZA II, STE 50, KANSAS CITY, MO 64111, WITH CORRESPONDING E-MAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM MARCH 2016 TO APRIL 2018. A TOTAL OF 75 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 9 (12%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 74.4 YEARS AND GENDER MAJORITY WAS NOT REPORTED. NO COMORBIDITIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489777 EPIC¿ VALVE (AORTIC) HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown