BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMULUS SEMI-RIGID ANNULOPASTY RING

    MDR report key: 6946276 · Received October 12, 2017

    Report

    Report Number
    2025587-2017-01834
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 21, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    UDI-DI
    00643169182257
    PMA / PMN Number
    K072655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: SURGEONS OFTEN ATTEMPT TO REPAIR MITRAL VALVES IN LIEU OF REPLACING THEM DUE TO IMPROVED LONG TERM CLINICAL OUTCOMES. THERE ARE TIMES WHEN A VALVE REPAIR IS ATTEMPTED USING AN ANNULOPLASTY DEVICE AND SUBSEQUENT POST REPAIR EVALUATION DEMONSTRATES INADEQUATE RESULTS. THIS IS OFTEN DUE TO SUBOPTIMAL ANATOMY, SURGICAL TECHNIQUE, OR INAPPROPRIATE SIZING, AND NOT A MALFUNCTION OF THE DEVICE (1). IN THIS CASE, MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 36MM ANNULOPLASTY RING, THE PHYSICIAN NOTED THAT THERE WAS CONTINUED MITRAL REGURGITATION FROM THE PATIENTS NATIVE TISSUE. THE PHYSICIAN THEN EXPLANTED THE 36MM RING AND REPLACED IT WITH A 31MM BIOPROSTHETIC MITRAL VALVE. THE EVENT APPEARS TO BE SIZING RELATED. (1) MICK ET AL, ANN CARDIOTHORAC SURG 2015; 4(3):230-237.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 36MM ANNULOPLASTY RING, THE PHYSICIAN NOTED THAT THERE WAS CONTINUED MITRAL REGURGITATION FROM THE PATIENTS NATIVE TISSUE. THE PHYSICIAN THEN EXPLANTED THE 36MM RING AND REPLACED IT WITH A 31MM BIOPROSTHETIC MITRAL VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725469 SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 800SR36 00643169182257

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention