BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM SGUIN SEMI-RIGID ANNULOPLASTY RING

    MDR report key: 11170000 · Received January 14, 2021

    Report

    Report Number
    2648612-2021-00005
    Event Type
    Death
    Date Received
    January 14, 2021
    Report Date
    January 14, 2021
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    KRH
    PMA / PMN Number
    K092310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN A RESEARCH ARTICLE, 452 CONSECUTIVE PATIENTS UNDERWENT MITRAL REPAIR BETWEEN JANUARY 2002 AND DECEMBER 2008; 260 PATIENTS WERE IMPLANTED WITH A TAILOR FLEXIBLE RING AND 192 PATIENTS WERE IMPLANTED WITH A SEGUIN SEMI-RIGID ANNULOPLASTY RING. AN EVENT OF 1 IN-HOSPITAL DEATH DUE TO CARDIOGENIC SHOCK WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REFERENCE NUMBER: 2648612-2021-00004, 2648612-2021-00003. THE ARTICLE, "LONG-TERM RESULTS OF MITRAL REPAIR WITH COMPLETE SEMI-RIGID RINGS VS POSTERIOR FLEXIBLE BANDS" WAS REVIEWED. THE RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE WHETHER THE TYPE OF RING USED HAD AN IMPACT ON THE LONG-TERM RESULTS OF MITRAL REPAIR FOR DEGENERATIVE MITRAL REGURGITATION (MR), DUE TO POSTERIOR LEAFLET PROLAPSE, TREATED WITH QUADRANGULAR/TRIANGULAR RESECTION. TAILOR FLEXIBLE RING AND BAND AND SEGUIN SEMI-RIGID ANNULOPLASTY RING WERE ASSOCIATED WITH THE STUDY. THERE IS NO ALLEGATION OF MALFUNCTION OF THE ABBOTT DEVICES. THE ARTICLE CONCLUDED THAT THE TYPE OF ANNULOPLASTY RING HAS NO IMPACT ON THE INCIDENCE OF CARDIAC DEATH AND RECURRENCE OF MITRAL REGURGITATION AT 14 YEARS. THE PRIMARY AND CORRESPONDENCE AUTHOR IS ANDREA BACCELLI, MD, DEPARTMENT OF CARDIAC SURGERY, IRCCS SAN RAFFAELE UNIVERSITY HOSPITAL, VITA-SALUTE SAN RAFFAELE UNIVERSITY, VIA OLGETTINA 60, 20132, MILANO, ITALY WITH THE EMAIL [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69525 SJM SGUIN SEMI-RIGID ANNULOPLASTY RING RING, ANNULOPLASTY KRH ST. JUDE MEDICAL PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death