BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAILOR FLEXIBLE RING AND BAND

    MDR report key: 10003091 · Received April 27, 2020

    Report

    Report Number
    2648612-2020-00049
    Event Type
    Injury
    Date Received
    April 27, 2020
    Report Date
    April 27, 2020
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    KRH
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN A RESEARCH ARTICLE, OUT OF 95 PATIENTS IMPLANTED WITH AN ANNULOPLASTY RING, 10 WERE IMPLANTED WITH A TAILOR FLEXIBLE RING. COMPLICATIONS INCLUDED 8 PATIENTS WITH LOW CARDIAC OUTPUT SYNDROME, 2 WITH A BLOOD TRANSFUSION, 1 WITH A PLEURAL EFFUSION, 2 WHICH REQUIRED SURGICAL INTERVENTION DUE TO BLEEDING, 8 WHICH HAD A NEW ONSET OF ATRIAL FIBRILLATION, 1 PATIENT WHO REQUIRED A PACEMAKER, 3 WHICH NEEDED REOPERATION DUE TO MITRAL VALVE REGURGITATION AND 17 PATIENTS WHO HAD MITRAL REGURGITATION. IT WAS NOT REPORTED IF THE PATIENTS WHO EXPERIENCED COMPLICATIONS WERE IMPLANTED WITH THE TAILOR FLEXIBLE RING. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE TITLED, "EXCELLENT LONG-TERM RESULTS WITH MINIMALLY INVASIVE EDGE-TO-EDGE REPAIR IN MYXOMATOUS DEGENERATIVE MITRAL VALVE REGURGITATION¿ THAT BETWEEN DECEMBER 1999 AND DECEMBER 2006, 97 PATIENTS WITH SEVERE MYXOMATOUS MITRAL REGURGITATION UNDERWENT MITRAL REPAIR. 95 PATIENTS HAD AN ANNULOPLASTY RING IMPLANTED WITH SEGUIN SEMI RIGID RING IN 85 PATIENTS, AND TAILOR FLEXIBLE POSTERIOR RING IN 10 OTHER PATIENTS. COMPLICATIONS POST PROCEDURE INCLUDED PLEURAL EFFUSION, SURGICAL INTERVENTION AND BLOOD TRANSFUSION DUE TO BLEEDING, REOPERATION DUE TO MITRAL VALVE REGURGITATION, NEW ONSET OF ATRIAL FIBRILLATION, PACEMAKER IMPLANTATION, LOW CARDIAC OUTPUT SYNDROME, AND MITRAL REGURGITATION DURING FOLLOW UP. ADDITIONAL INFORMATION WAS NOT OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466662 TAILOR FLEXIBLE RING AND BAND RING, ANNULOPLASTY KRH ST. JUDE MEDICAL PUERTO RICO, INC. CVD0036

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R