BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMULUS SEMI-RIGID ANNULOPASTY RING

    MDR report key: 6944688 · Received October 12, 2017

    Report

    Report Number
    2025587-2017-01825
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 19, 2017
    Report Date
    October 12, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    UDI-DI
    00643169182103
    PMA / PMN Number
    K072655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 PROCEDURE TO IMPLANT THIS 26MM ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED. THE PHYSICIAN STATED THE SIZE OF THE RING WAS TOO BIG TO ADEQUATELY SHRINK ANNULUS FOR PROPER COAPTATION OF LEAFLETS AND DID NOT RESOLVE THE MITRAL REGURGITATION (MR). (1) MICK ET AL, ANN CARDIOTHORAC SURG 2015; 4(3):230-237.

    Additional Manufacturer Narrative · 1

    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 THAT DURING THE PROCEDURE TO IMPLANT THIS 26MM ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED. THE PHYSICIAN STATED THE SIZE WAS TOO BIG TO ADEQUATELY SHRINK ANNULUS FOR PROPER COAPTATION OF LEAFLETS AND DID NOT RESOLVE THE MITRAL REGURGITATION (MR). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724234 SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 800SR 00643169182103

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention