BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEMO 3D SEMIRIGID ANNULOPLASTY RING

    MDR report key: 16782945 · Received April 21, 2023

    Report

    Report Number
    3005687633-2023-00110
    Event Type
    Death
    Date Received
    April 21, 2023
    Date of Event
    September 4, 2022
    Report Date
    June 22, 2023
    Manufacturer
    CORCYM S.R.L.
    Product Code
    KRH
    UDI-DI
    08022057013132
    PMA / PMN Number
    K071327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLETE MANUFACTURING AND MATERIAL RECORDS REVIEW FOR THE DEVICE MEMO3D #32 SN E81585B 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 IS FOLLOWING UP WITH THE SITE TO RETRIEVE FURTHER INFORMATION REGARDING THIS EVENT AND THE DEVICE INVOLVED. A FOLLOW UP REPORT WILL BE PROVIDED UPON RECEIPT OF ANY FURTHER INFORMATION. UNKNOWN DEVICE DISPOSITION.

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION RELEVANT TO THE ESTABLISHMENT OF A POSSIBLE ROOT CAUSE HAVE BEEN RECEIVED BY THE MANUFACTURER. AS SUCH, THE MANUFACTURER WILL CLOSE THE CASE AT THIS STAGE. SHOULD FURTHER INFORMATION BE RECEIVED IN THE FUTURE, THE MANUFACTURER WILL SUBMIT A NEW FOLLOW UP REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED THROUGH MANTRA STUDY THAT A PATIENT IMPLANTED WITH A MEMO 3D SIZE 32 MITRAL ANNULOPLASTY RING PASSED AWAY ON (B)(6) 2022. THE EVENT WAS A SUDDEN DEATH OCCURRING DURING THE NIGHT WHILE THE PATIENT WAS SLEEPING. THE RING HAD BEEN IMPLANTED ON (B)(6) 2021 THROUGH MEDIAN STERNOTOMY AND CONCOMITANT CABG HAD BEEN PERFORMED IN THE SAME SURGERY PRIOR TO RING IMPLANTATION. THE PATIENT WAS IN PARTICULARLY COMPLEX HEALTH CONDITIONS AND SUFFERED FROM BRONCHOPATHY WITH SLEEP APNEA. HE HAD A PREVIOUS HISTORY OF CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION (<= 90 DAYS AT THE TIME OF SURGERY), ISCHEMIC HEART FAILURE, DIABETES MELLITUS TYPE II, DYSLIPIDEMIA. HE ALSO HAD A TOBACCO HISTORY AND WAS NYHA CLASS III.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED THROUGH MANTRA STUDY THAT A PATIENT IMPLANTED WITH A MEMO 3D SIZE 32 MITRAL ANNULOPLASTY RING PASSED AWAY ON (B)(6) 2022. THE EVENT WAS A SUDDEN DEATH OCCURRING DURING THE NIGHT WHILE THE PATIENT WAS SLEEPING. THE MANUFACTURER WAS INFORMED THAT AUTOPSY WAS NOT PERFORMED. NO OTHER INFORMATION IS AVAILABLE REGARDING THE EVENT. THE RING HAD BEEN IMPLANTED ON (B)(6) 2021 THROUGH MEDIAN STERNOTOMY AND CONCOMITANT CABG (>4 VESSELS) HAD BEEN PERFORMED IN THE SAME SURGERY PRIOR TO RING IMPLANTATION. AT THE 30 DAYS FOLLOW-UP THE ECHO EXAM SHOWED AN OVERALL GOOD FUNCTIONALITY OF THE ANNULOPLASTY RING WITH TRACE OF MITRAL REGURGITATION AND NO SAM REPORTED. EF WAS 45% AND LVEDD 50 MM . REPORTEDLY, THE PATIENT WAS IN PARTICULARLY COMPLEX HEALTH CONDITIONS AND SUFFERED FROM BRONCHOPATHY WITH SLEEP APNEA. HE HAD A PREVIOUS HISTORY OF CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION (<= 90 DAYS AT THE TIME OF SURGERY) , ISCHEMIC HEART FAILURE, DIABETES MELLITUS TYPE II, DYSLIPIDEMIA. HE ALSO HAD A TOBACCO HISTORY AND WAS NYHA CLASS III AT THE TIME OF SURGERY. THE SITE ASSESSED THE EVENT AS ¿POSSIBLY DEVICE RELATED¿ SINCE THE RELATIONSHIP WITH THE DEVICE CANNOT BE EXCLUDED AND PROBABLY RELATED TO OTHER MEDICAL CONDITIONS DUE TO THE OVERALL PATIENT STATUS (COMPLEX MEDICAL HISTORY, BRONCHOPATHY WITH SLEEP APNEA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684898 MEMO 3D SEMIRIGID ANNULOPLASTY RING MITRAL ANNULOPLASTY RING KRH CORCYM S.R.L. SMD32 08022057013132

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Death