BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMO 4D ANNULOPLASTY RING

    MDR report key: 11891792 · Received May 27, 2021

    Report

    Report Number
    3005687633-2021-00128
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    November 26, 2020
    Report Date
    July 27, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    KRH
    PMA / PMN Number
    K180411
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED REPORTING TO INCLUDE UDI IN SECTION D.

    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 RING WAS DISCARDED NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. HOWEVER, BASED ON THE MEDICAL JUDGMENT RECEIVED, THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE PROCEDURE (REPAIR NOT SATISFACTORY AND THUS REQUIRING A DIFFERENT RING SIZE) AND NOT TO THE DEVICE.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A MEMO 4D ANNULOPLASTY RING 4DM-36 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF ANY DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED, IT WAS CLARIFIED THAT THE MEMO 4DM-36 WAS REMOVED AS THE SIZING WAS INCORRECT. IT WAS REPLACED WITH A LARGER MEMO 4D RING ON THE DAY (4DM-40). BASED ON THE MEDICAL JUDGMENT RECEIVED, THERE WAS NO MALFUNCTION IN THE RING. THE INITIAL REPAIR WAS DEEMED NOT SATISFACTORY AND THUS REQUIRING A DIFFERENT SIZE OF THE RING. AS REPORTED, THERE WAS NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A MEMO 4D ANNULOPLASTY RING 4DM-36 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF ANY DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED, IT WAS CLARIFIED THAT THE MEMO 4DM-36 WAS REMOVED AS THE SIZING WAS INCORRECT. IT WAS REPLACED WITH A LARGER MEMO 4D RING ON THE DAY (4DM-40).

    Additional Manufacturer Narrative · 1

    UNKNOWN DEVICE DISPOSITION.

    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 4D ANNULOPLASTY RING 4DM-36 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF ANY 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
    792830 MEMO 4D ANNULOPLASTY RING MITRAL ANNULOPLASTY RING KRH CORCYM S.R.L. 4DM-36

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention