BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS ANNULOFLEX ANNULOPLASTY RING

    MDR report key: 11898675 · Received May 27, 2021

    Report

    Report Number
    1718850-2021-01104
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    May 12, 2021
    Report Date
    September 9, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    KRH
    UDI-DI
    08022057013637
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, 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. SINCE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. BASED ON THE ADDITIONAL INFORMATION RECEIVED, IT APPEARS THAT THE CORCYM DEVICE WAS ATTEMPTED TO BE IMPLANTED FROM THE OPERATIONAL REPORT THE CODING HAS BEEN REVISED. THIS EVENT IS NOT RELATED TO THE ANNULOFLEX RING, THE TAVI PROCEDURE IS RELATED TO A SAINT JUDE VALVE. THE ROOT CAUSE CAN BE ATTRIBUTED TO PATIENT CONDITIONS. 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.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, AN ANNULOFLEX ANNULOPLASTY RING AF-832 WAS IMPLANTED ON (B)(6) 2015. AS OF (B)(6) 2021, THE PATIENT IS REPORTED TO HAVE A MITRAL VALVE STENOSIS AND UNDERGOING AN EVALUATION FOR A RE-OPERATION. 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. THE MANUFACTURER HAS FOLLOWED UP AND RECEIVED THE FOLLOWING INFORMATION FROM THE HOSPITAL. THE PATIENT HAD A SURGERY IN 2015 WHERE ONE REPAIR AND ONE REPLACEMENT WAS PLANNED, BUT ULTIMATELY RECEIVED 2 VALVES (AORTIC AND MITRAL). THE PATIENT RECEIVED A 29MM ST JUDE EPIC VALVE IN MITRAL POSITION, WHICH REQUIRED A RE-INTERVENTION FOR MITRAL STENOSIS ON (B)(6) 2021. A TRANSCATHETER MITRAL VALVE REPLACEMENT WITH A 26-MM SAPIENS S3 VALVE WAS PERFORMED., WITH A GOOD OUTCOME.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, AN ANNULOFLEX /ANNULOPLASTY RING AF-832 WAS IMPLANTED ON (B)(6) 2015. AS OF (B)(6) 2021, THE PATIENT IS REPORTED TO HAVE A MITRAL VALVE STENOSIS AND UNDERGOING AN EVALUATION FOR A RE-OPERATION AT BANNER HEART HOSPITAL. 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
    790876 CARBOMEDICS ANNULOFLEX ANNULOPLASTY RING MITRAL ANNULOPLASTY RING KRH CORCYM S.R.L. AF-832 08022057013637

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other