BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND

    MDR report key: 6848561 · Received September 7, 2017

    Report

    Report Number
    9612164-2017-01232
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    August 10, 2017
    Report Date
    August 18, 2017
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    KRH
    UDI-DI
    00643169182363
    PMA / PMN Number
    K052899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 THIS 33MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE DUE TO A SIZING ERROR. IT WAS REPLACED WITH A 37MM MITRAL ANNULOPLASTY BAND OF THE SAME MODEL. (1) MICK ET AL, ANN CARDIOTHORAC SURG 2015; 4(3):230-237.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS 33MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE DUE TO A SIZING ERROR. THE DEVICE WAS TOO SMALL FOR THE PATIENT. IT WAS REPLACED WITH A 37MM MITRAL ANNULOPLASTY BAND OF THE SAME MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629010 SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND RING, ANNULOPLASTY KRH MEDTRONIC MEXICO 700FC 00643169182363

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention