BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAN ANCORE RING

    MDR report key: 6061154 · Received October 27, 2016

    Report

    Report Number
    2025587-2016-01687
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    March 4, 2013
    Report Date
    October 14, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K960356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: TIRONE E. DAVID ARTICLE TITLE:.. LATE OUTCOMES OF MITRAL VALVE REPAIR FOR MITRAL REGURGITATION DUE TO DEGENERATIVE DISEASE JOURNAL TITLE: CIRCULATION 2013 127(14):1485-92 10.1161/CIRCULATIONAHA.112.000699. DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING LATE OUTCOMES OF MITRAL VALVE (MV) REPAIR FOR MITRAL REGURGITATION (MR) DUE TO DEGENERATIVE DISEASE. ALL DATA WERE COLLECTED FROM A MULTIPLE CENTER BETWEEN 1985 AND 2004 IN BIENNIAL INTERVALS UP TO 26 YEARS, MEDIAN 10.4 YEARS. THE STUDY POPULATION INCLUDED 840 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 60 YEARS). THE NUMBER OF PATIENTS WHO WERE IMPLANTED WITH A MEDTRONIC DURAN RING (SERIAL NUMBERS NOT PROVIDED) WAS NOT INDICATED. AMONG ALL PATIENTS 183 DEATHS OCCURRED DUE TO: CONGESTIVE HEART FAILURE, STROKE, MYOCARDIAL INFARCTION, ANTICOAGULATION RELATED HEMORRHAGE, INTRACRANIAL HEMORRHAGE IN PATIENTS WITHOUT ANTICOAGULATION, REPEAT CARDIAC SURGERY, AND GASTROINTESTINAL BLEEDING WITHOUT ANTICOAGULATION. BASED ON THE AVAILABLE INFORMATION, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: REOPERATION, MITRAL STENOSIS, PANNUS, HEMOLYTIC ANEMIA, HEMORRHAGE DUE TO ANTICOAGULATION, INFECTIVE ENDOCARDITIS, ATRIAL FIBRILLATION (AFIB), COMPLETE HEART BLOCK (CHB), REPEAT MV SURGERY, THROMBOEMBOLIC EVENTS, STROKE, RECURRENT SEVERE MITRAL REGURGITATION (MR), AND MODERATE MR. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT EXCEPT FOR 5 PATIENTS WHO DEVELOPED MITRAL STENOSIS DUE TO EXCESSIVE PANNUS ON THE ANNULOPLASTY RING WITH EXTENSION INTO THE LEAFLETS AND WERE REOPERATED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711934 DURAN ANCORE RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 620R

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention