BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMULUS SEMI-RIGID ANNULOPASTY RING

    MDR report key: 6494320 · Received April 14, 2017

    Report

    Report Number
    2025587-2017-00590
    Event Type
    Injury
    Date Received
    April 14, 2017
    Date of Event
    January 19, 2017
    Report Date
    October 17, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    UDI-DI
    00643169182264
    PMA / PMN Number
    K072655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 AN 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 IMMEDIATELY FOLLOWING IMPLANT OF THIS 34 MM ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 32 MM ANNULOPLASTY RING DUE TO PERSISTENT LEAK. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. THESE TYPES OF EVENTS DO NOT MEET THE CRITERIA FOR FORMAL INVESTIGATION AS EVENTS DO NOT APPEAR TO BE RELATED TO THE DESIGN OF THE DEVICE. EVENT APPEARS TO BE SIZING RELATED. (1) MICK ET AL, ANN CARDIOTHORAC SURG 2015; 4(3):230-237. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT SPECIMEN HAS NOT BEEN RETURNED FOR DEVICE ANALYSIS. CONCLUSION: MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION AND REQUEST PRODUCT RETURN HAVE BEEN MADE; HOWEVER, THESE ATTEMPTS HAVE BEEN UNSUCCESSFUL. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING IMPLANT OF THIS 34 MM ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 32 MM ANNULOPLASTY RING DUE TO PERSISTENT LEAK. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276531 SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 800 00643169182264

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention