BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMO 3D SEMIRIGID ANNULOPLASTY RING

    MDR report key: 11898159 · Received May 27, 2021

    Report

    Report Number
    1718850-2021-01100
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    April 2, 2021
    Report Date
    September 9, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    KRH
    UDI-DI
    08022057013118
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLETE MANUFACTURING AND MATERIAL RECORDS REVIEW FOR THE DEVICE HAS BEEN PERFORMED. THE RESULTS CONFIRMED THAT THE DEVICE SATISFIED ALL MATERIAL, VISUAL AND PERFORMANCE STANDARDS REQUIRED AT THE TIME OF MANUFACTURE AND RELEASE. THE MANUFACTURER ATTEMPTED TO FOLLOW UP ON THIS EVENT HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. BASED ON THE INFORMATION PROVIDED THE ROOT CAUSE CAN BE ESTABLISHED. BASED ON THE DHR THERE APPEARS TO BE NO ISSUE WITH THE VALVE, SINCE THE VALVE IS NOT BEING RETURNED NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME, THE CASE WILL BE CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED AT A LATER STAGE A FOLLOW UP REPORT WILL BE PROVIDED. IT SHOULD BE NOTED THAT NO ALLEGATION OF A DEVICE MALFUNCTION AND/OR NOTIFICATION OF A SERIOUS ADVERSE EVENT HAVE BEEN REPORTED FROM THE SITE.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A MEMO 3D SEMIRIGID ANNULOPLASTY RING SMD28 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2021. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788971 MEMO 3D SEMIRIGID ANNULOPLASTY RING MITRAL ANNULOPLASTY RING KRH CORCYM S.R.L. SMD28 08022057013118

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention