BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RING 620RG31 DURAN ANCORE ANNULOPLASTY C

    MDR report key: 6429884 · Received March 23, 2017

    Report

    Report Number
    2025587-2017-00458
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    February 23, 2017
    Report Date
    October 17, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    UDI-DI
    00613994758989
    PMA / PMN Number
    K032810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. 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) WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (1) MICK ET AL, ANN CARDIOTHORAC SURG 2015; 4(3):230-237.

    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 31 MM ANNULOPLASTY RING IN THE MITRAL POSITION, THIS DEVICE WAS EXPLANTED AND REPLACED WITH A 29 MM ANNULOPLASTY RING. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211444 RING 620RG31 DURAN ANCORE ANNULOPLASTY C RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 620R 00613994758989

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention