BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAN ANCORE RING

    MDR report key: 6744062 · Received July 26, 2017

    Report

    Report Number
    2025587-2017-01242
    Event Type
    Injury
    Date Received
    July 26, 2017
    Date of Event
    April 28, 2016
    Report Date
    July 11, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K960356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DEBONIS M ET AL. LONG-TERM RESULTS OF MITRAL REPAIR IN PATIENTS WITH SEVERE LEFT VENTRICULAR DYSFUNCTION AND SECONDARY MITRAL REGURGITATION: DOES THE TECHNIQUE MATTER? EUR J CARDIOTHORAC SURG (2016) 50 (5): 882-889. DOI.ORG/10.1093/EJCTS/EZW139 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 LONG-TERM RESULTS OF MITRAL REPAIR IN PATIENTS WITH SEVERE LEFT VENTRICLE DYSFUNCTION AND SECONDARY MITRAL REGURGITATION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 1998 AND 2007. THE STUDY POPULATION INCLUDED 105 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 63 YEARS), LESS THAN 10 OF WHICH WERE IMPLANTED WITH MEDTRONIC DURAN FLEXIBLE RING (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MODERATE MITRAL REGURGITATION, LOW OUTPUT SYNDROME, SEPSIS, STROKE, HEMATOMA, RE-EXPLORATION FOR BLEEDING, MEDIASTINITIS, RE-OPERATION FOR VALVE REPLACEMENT, VALVE-IN-RING IMPLANT, AND ADDITIONAL RE-REPAIR. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525272 DURAN ANCORE RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 620R

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention