BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAN ANCORE RING

    MDR report key: 1933797 · Received December 13, 2010

    Report

    Report Number
    2025587-2010-00160
    Event Type
    Injury
    Date Received
    December 13, 2010
    Report Date
    December 3, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    KRH
    PMA / PMN Number
    K032810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL METHOD - DEVICE HISTORY COULD NOT BE REVIEWED AS NO SERIAL NUMBER WAS REPORTED. RESULTS: NO PRODUCT WAS RETURNED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS - NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. REDUCED PERFORMANCE OF THE VALVE IS ATTRIBUTED TO HOST TISSUE OVERGROWTH. THESE FINDINGS ARE GENERALLY CONSIDERED A PT RELATED CONDITION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THROUGH A CASE REPORT IN A JOURNAL ARTICLE (ANN THORAC SURG 2010; 90: E93-4) THAT A 25-MM DURAN FLEXIBLE RING WAS EXCISED 7 YEARS AFTER IMPLANT DURING A REOPERATION TO REPAIR MITRAL STENOSIS AND TRICUSPID REGURGITATION. THE RING WAS ORIGINALLY IMPLANTED IN A PT WITH DEGENERATIVE MITRAL REGURGITATION. SEVEN YEARS LATER, THE PT PRESENTED WITH MODERATE DYSPNEA ON EXERTION. INTRAOPERATIVE TRANS-ESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED NO MITRAL REGURGITATION, MILD TRICUSPID REGURGITATION AND MODERATE PULMONARY HYPERTENSION. OPERATIVE FINDINGS SHOWED PANNUS OVERGROWTH OF THE ANNULOPLASTY RING, WHICH HAD NARROWED THE MITRAL ORIFICE. THE RING AND PANNUS WERE REMOVED WITHOUT DAMAGE TO THE VALVE LEAFLET. COMMISSURAL FUSION, DUE TO THE PANNUS, WAS CORRECTED BY COMMISSUROTOMY. TRICUSPID ANNULOPLASTY WAS PERFORMED CONCOMITTANTLY. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAN ANCORE RING KRH MEDTRONIC HEART VALVES, INC. 620R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention