BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CG FUTURE BAND

    MDR report key: 6404289 · Received March 14, 2017

    Report

    Report Number
    2025587-2017-00401
    Event Type
    Injury
    Date Received
    March 14, 2017
    Date of Event
    February 23, 2017
    Report Date
    February 23, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    UDI-DI
    00613994758651
    PMA / PMN Number
    K061127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE RETURNED PRODUCT SPECIMEN WAS VISUALLY EXAMINED. THE ANNULOPLASTY RING SHOWED STAINING DUE TO BLOOD CONTACT. RADIOGRAPHY TESTING SHOWED THAT THE RING WAS INTACT. THERE WERE NO FRACTURES OBSERVED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE ANALYSIS OF THE DEVICE DID NOT SHOW ANY ANOMALY THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. AS NOTED BY MICK ET AL, 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 RING 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 ADDITION, IN THIS CASE, IT APPEARS THAT THE NATIVE VALVE WAS UNREPAIRABLE AS IT WAS SUBSEQUENTLY REPLACED WITH A BIOPROSTHETIC VALVE. OVERALL, THE EVENT WAS NOT ATTRIBUTED TO THE DESIGN OF THE DEVICE. THE (1) MICK ET AL, ANN CARDIOTHORACIC 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

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS ANNULOPLASTY RING, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO MITRAL INSUFFICIENCY. THIS DEVICE WAS REPLACED WITH A REPLACEMENT MITRAL VALVE TO COMPLETE THE PROCEDURE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186920 CG FUTURE BAND RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 638R 00613994758651

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention