BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RING 620RG35 DURAN ANCORE ANNULOPLASTY C

    MDR report key: 6291902 · Received February 1, 2017

    Report

    Report Number
    2025587-2017-00166
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    December 30, 2016
    Report Date
    February 14, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K032810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD A HISTORY OF SEVERE MITRAL REGURGITATION AND A MITRAL PROLAPSE. THE PHYSICIAN ATTEMPTED TO REPLACE THE DEVICE WAS THE ANNULOPLASTY BAND, BUT THE REPAIR FAILED. THE PHYSICIAN REMOVED THE DEVICE AND IMPLANTED A BIOPROSTHETIC VALVE DURING THE PROCEDURE.

    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.

    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 OCCURRENCES 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). THE NATIVE VALVE WAS NOT REPAIRABLE AS IT WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. (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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT AFTER ATTEMPTED IMPLANT OF THIS ANNULOPLASTY BAND, THERE WAS AN UNSPECIFIED DIFFICULTY WITH THE ATTEMPTED VALVE REPAIR. THE DEVICE WAS REPLACED WITH A BIOPROSTHETIC VALVE DURING THE SAME PROCEDURE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76027 RING 620RG35 DURAN ANCORE ANNULOPLASTY C RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 620B

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention