BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC¿ VALVE (MITRAL)

    MDR report key: 19097787 · Received April 12, 2024

    Report

    Report Number
    2135147-2024-01667
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    March 15, 2024
    Report Date
    May 2, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. LITERATURE ATTACHMENT: TRANSCATHETER MITRAL VALVE-IN-VALVE EXPLANT: LESSONS LEARNED.

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, TRANSCATHETER MITRAL VALVE-IN-VALVE EXPLANT: LESSONS LEARNED. 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. LITERATURE ATTACHMENT: ARTICLE TITLE TRANSCATHETER MITRAL VALVE-IN-VALVE EXPLANT: LESSONS LEARNED INTRODUCTION.

    Description of Event or Problem · 0

    THE ARTICLE, "TRANSCATHETER MITRAL VALVE-IN-VALVE EXPLANT: LESSONS LEARNED", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 74-YEAR-OLD MALE PATIENT WITH CHRONIC KIDNEY DISEASE AND PRIOR CORONARY ARTERY BYPASS GRAFT. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 29MM EPIC VALVE WAS IMPLANTED. IT WAS THEN REPORTED 8 YEARS POST-PROCEDURE ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH DYSPNEA DUE TO SEVERE MITRAL STENOSIS. A DECISION WAS MADE TO PERFORM A TRANSCATHETER VALVE-IN-VALVE PROCEDURE WITH A 29MM SAPIEN VALVE. ONE YEAR POST-INTERVENTION ON AN UNKNOWN DATE, AN ECHOCARDIOGRAM SHOWED A GRADIENT OF 10MMHG WITH RECURRENT SYMPTOMS. COMPUTED TOMOGRAPHY DID NOT CONFIRM ANY THROMBUS. IT WAS THEN REPORTED TWO YEARS POST-INTERVENTION, A DECISION WAS MADE TO SURGICALLY REMOVE BOTH 29MM EPIC VALVE WITH THE EMBEDDED 29MM SAPIEN VALVE. A 33MM EPIC PLUS VALVE WAS THEN IMPLANTED. POST-OPERATIVELY, THE PATIENT SUFFERED AN ACUTE KIDNEY INJURY BUT WAS RESOLVED AND RETURNED TO NORMAL. THE ARTICLE CONCLUDED THAT MITRAL VALVE-IN-VALVE EXPLANT IS TECHNICALLY FEASIBLE. THE AUTHORS RECOMMENDED EN BLOC REMOVAL OF BOTH VALVES AS THE SAFEST METHOD OF VALVE EXPLANT. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MOHAMMAD BASHIR, UNIVERSITY OF IOWA CARVER COLLEGE OF MEDICINE, DEPARTMENT OF CARDIOTHORACIC SURGERY, IOWA CITY, IOWA 52242, WITH CORRESPONDING EMAIL: [email protected]].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508961 EPIC¿ VALVE (MITRAL) HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| H