BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR 3D ANNULOPLASTY RING

    MDR report key: 12124999 · Received July 6, 2021

    Report

    Report Number
    2025587-2021-02108
    Event Type
    Injury
    Date Received
    July 6, 2021
    Date of Event
    February 19, 2021
    Report Date
    July 6, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K101212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DZILIC E, ET AL. INTERMEDIATE-TERM RESULTS OF TRICUSPID VALVE REPAIR USING A THREE-DIMENSIONAL ANNULOPLASTY RING IN FUNCTIONAL TRICUSPID REGURGITATION. THORAC CARDIOVASC SURG 2021; 69(S 01): S1-S85. DOI: 10.1055/S-0041-1725685. PUBLICATION DATE: 19 FEBRUARY 2021 (ONLINE). EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ABSTRACT REGARDING THE INTERMEDIATE-TERM OUTCOMES OF TRICUSPID VALVE REPAIR USING THE CONTOUR 3D ANNULOPLASTY RING. ALL DATA WAS RETROSPECTIVELY COLLECTED AND ANALYZED. THE STUDY COHORT CONSISTED OF 468 PATIENTS WHO UNDERWENT TRICUSPID VALVE REPAIR WITH THE MEDTRONIC CONTOUR 3D ANNULOPLASTY RING IN A CONCOMITANT CARDIAC PROCEDURE (82.7% = MITRAL VALVE, 22.6% = AORTIC VALVE, AND 26.5% = CORONARY ARTERY BYPASS GRAFTING) BETWEEN DECEMBER 2010 TO JANUARY 2017. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, THE 30-DAY MORTALITY RATE WAS 4.7%. THE CIRCUMSTANCES OF THE DEATHS WERE NOT DISCLOSED, AND NO CORRELATION WAS MADE BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: REOPERATION OF THE TRICUSPID VALVE (SIX CASES), RE-REPAIR OF THE TRICUSPID VALVE (THREE CASES), PERMANENT PACEMAKER IMPLANTATION, AND RECURRENT TRICUSPID REGURGITATION (MILD TO SEVERE). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021916 CONTOUR 3D ANNULOPLASTY RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 690R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention