BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANNULOFLEX MITRAL ANNULOPLASTY RING

    MDR report key: 12009388 · Received June 16, 2021

    Report

    Report Number
    1718850-2021-01115
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    April 20, 2021
    Report Date
    September 9, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    KRH
    UDI-DI
    08022057013620
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, 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 TO RETRIEVE ADDITIONAL INFORMATION ON THE EVENT. HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. SINCE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO ESTABLISH A DEFINITIVE CONCLUSION TO THE REPORTED EVENT. HOWEVER, PER THE DOCUMENT REVIEW PERFORMED, NO MANUFACTURING DEFICIENCIES HAVE BEEN IDENTIFIED. SHOULD FURTHER INFORMATION BE RECEIVED IN THE FUTURE, THE MANUFACTURER WILL PROVIDE AN UPDATE TO THIS REPORTING ACTIVITY.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, AN ANNULOFLEX RING AF-830 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY 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
    903836 ANNULOFLEX MITRAL ANNULOPLASTY RING MITRAL ANNULOPLASTY RING KRH CORCYM S.R.L. AF-830 08022057013620

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention