BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAILOR FLEXIBLE RING AND BAND

    MDR report key: 10988272 · Received December 10, 2020

    Report

    Report Number
    2648612-2020-00134
    Event Type
    Injury
    Date Received
    December 10, 2020
    Report Date
    December 21, 2020
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, 151 PATIENTS UNDERWENT MITRAL VALVE REPAIR BETWEEN DECEMBER 1997 AND DECEMBER 2013 WITH CARPENTIER EDWARDS COSGROVE RINGS, ST. JUDE MEDICAL TAILOR RINGS, MEDTRONIC DURAN RINGS, CARPENTIER EDWARDS PHYSIO RINGS, AND MC3 RINGS. A TOTAL OF 59 PATIENTS WERE IMPLANTED WITH A ST. JUDE MEDICAL TAILOR RING; EVENTS OF MODERATE-SEVERE MITRAL REGURGITATION, MODERATE-SEVERE TRICUSPID REGURGITATION, INCREASED GRADIENTS, AND PACEMAKER IMPLANTATION 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.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ARTICLE, "IS PROPHYLACTIC TRICUSPID ANNULOPLASTY BENEFICIAL FOR DEGENERATIVE MITRAL VALVE REPAIR?", WAS REVIEWED. THE RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE THE LONG-TERM CLINICAL IMPACTS OF PROPHYLACTIC TRICUSPID ANNULOPLASTY (TAP) IN PATIENTS WITH MILD TRICUSPID REGURGITATION (TR) WHO UNDERWENT MITRAL VALVE REPAIR. CARPENTIER EDWARDS COSGROVE RING , ST. JUDE MEDICAL TAILOR RING, MEDTRONIC DURAN RING, CARPENTIER EDWARDS PHYSIO RING AND MC3 RINGS WERE ASSOCIATED WITH THE STUDY. THERE IS NO ALLEGATION OF MALFUNCTION OF THE ABBOTT DEVICE. THE ARTICLE CONCLUDED THAT PROPHYLACTIC TRICUSPID ANNULOPLASTY IN MILD TRICUSPID REGURGITATION MAY NOT HAVE BENEFICIAL EFFECT ON THE PROGRESSION OF TRICUSPID REGURGITATION IN DEGENERATIVE MITRAL REGURGITATION AND THAT FURTHER LARGE STUDIES ARE NECESSARY. THE PRIMARY AUTHOR OF THE ARTICLE IS HEEMOON LEE, MD,PHD, DEPARTMENT OF THORACIC AND CARDIOVASCULAR SURGERY, SAMSUNG MEDICAL CENTER, SUNGKYUNKWAN UNIVERSITY SCHOOL OF MEDICINE, SEOUL, KOREA. THE CORRESPONDING AUTHOR IS PYO WON PARK, MD,PHD , DEPARTMENT OF THORACIC AND CARDIOVASCULAR SURGERY, SAMSUNG MEDICAL CENTER, SUNGKYUNKWAN UNIVERSITY SCHOOL OF MEDICINE,81 IRWON-RO, GANGNAM-GU, SEOUL 06351, KOREA WITH THE EMAIL [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446379 TAILOR FLEXIBLE RING AND BAND RING, ANNULOPLASTY KRH ST. JUDE MEDICAL PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention