BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC¿ VALVE (AORTIC)

    MDR report key: 21396783 · Received February 18, 2025

    Report

    Report Number
    2135147-2025-00795
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    September 7, 2020
    Report Date
    March 12, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, A VALVE-IN-VALVE (VIV) TRANSCATHETER AORTIC VALVE IMPLANTATION WITH LITHOTRIPSY-ASSISTED TRANSFEMORAL APPROACH. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLED "A VALVE-IN-VALVE (VIV) TRANSCATHETER AORTIC VALVE IMPLANTATION WITH LITHOTRIPSY-ASSISTED TRANSFEMORAL APPROACH".

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE: ARTICLE TITLED "A VALVE-IN-VALVE (VIV) TRANSCATHETER AORTIC VALVE IMPLANTATION WITH LITHOTRIPSY-ASSISTED TRANSFEMORAL APPROACH".

    Description of Event or Problem · 0

    THE ARTICLE, "A VALVE-IN-VALVE (VIV) TRANSCATHETER AORTIC VALVE IMPLANTATION WITH LITHOTRIPSY-ASSISTED TRANSFEMORAL APPROACH", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 77-YEAR-OLD MALE PATIENT WITH PRIOR BYPASS GRAFT. IT WAS REPORTED ON AN UNKNOWN DATE, A 23MM EPIC AORTIC VALVE WAS IMPLANTED. IT WAS THEN REPORTED ON AN UNKNOWN DATE POST-PROCEDURE, THE PATIENT WAS ADMITTED FOR ACUTE HEART FAILURE SYMPTOMS. ECHOCARDIOGRAPHY REVEALED A MEAN PRESSURE GRADIENT OF 53MMHG. THE PATIENT'S LEFT INTERNAL MAMMARY ARTERY (LIMA) WAS PATENT AND WAS DIRECTLY UNDER STERNUM. DUE TO PATIENT'S COMORBIDITIES AND LIMA'S ANATOMICAL POSITION, THE PATIENT WAS OPTED FOR TRANSCATHETER AORTIC VALVE-IN-VALVE PROCEDURE WITH A 23MM EVOLUT R VALVE. A POST-DILATATION WAS PERFORMED WITH A 22MM BALLOON. [THE PRIMARY AND CORRESPONDING AUTHOR WAS NIKOLAOS TSANAXIDIS, CARDIOLOGY DEPARTMENT, NEW CROSS HOSPITAL, HEART & LUNG CENTRE, ROYAL WOLVERHAMPTON NHS TRUST, WV10 0QP, UNITED KINGDOM, WITH CORRESPONDING EMAIL: [email protected]].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209617 EPIC¿ VALVE (AORTIC) HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| H