BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAN ANCORE RING

    MDR report key: 6795827 · Received August 15, 2017

    Report

    Report Number
    2025587-2017-01396
    Event Type
    Injury
    Date Received
    August 15, 2017
    Date of Event
    August 8, 2016
    Report Date
    July 25, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K780568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: H. TAKANO, ET AL. SEVERE TRICUSPID REGURGITATION AFTER MITRAL VALVE SURGERY: THE RISK FACTORS AND RESULTS OF THE AGGRESSIVE APPLICATION OF PROPHYLACTIC TRICUSPID VALVE REPAIR. SURG TODAY (2017) 47:445¿456. DOI: 10.1007/S00595-016-1395-4 EARLIEST 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING SEVERE TRICUSPID REGURGITATION AFTER MITRAL VALVE SURGERY: THE RISK FACTORS AND RESULTS OF THE AGGRESSIVE APPLICATION OF PROPHYLACTIC TRICUSPID VALVE REPAIR. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 1987 AND 2006. THE STUDY POPULATION INCLUDED 125 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 58 YEARS), SEVEN OF WHICH WERE IMPLANTED WITH MEDTRONIC DURAN RING (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS 38 LATE DEATHS OCCURRED. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MODERATE AND SEVERE TRICUSPID REGURGITATION, TRICUSPID VALVE ANNULOPLASTY. BASED ON THE AVAILABLE INFORMATION, THESE ADVERSE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576235 DURAN ANCORE RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 620R

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention