BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CG COMPOSITE RING

    MDR report key: 1833839 · Received September 8, 2010

    Report

    Report Number
    2025587-2010-00103
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    June 29, 2010
    Report Date
    August 11, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    KRH
    PMA / PMN Number
    K061127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE FOR EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS VALVE MET ALL MFG SPECIFICATION FOR PRODUCT RELEASE FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS ANNULOPLASTY RING, IMPLANTED 6 WEEKS, WAS EXPLANTED DUE TO MITRAL REGURGITATION, SECONDARY TO DEHISCENCE. IT WAS REPORTED THAT AT DISCHARGE, ECHOCARDIOGRAPHIC FINDINGS SHOWED THE RING IN STABLE POSITION. HOWEVER, 6 WEEKS AFTER IMPLANTATION, THE PT RETURNED WITH MITRAL INSUFFICIENCY. ECHOCARDIOGRAPHIC FINDINGS AT THAT TIME REVEALED DEHISCENCE OF THE POSTERIOR PART OF THE RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CG COMPOSITE RING KRH MEDTRONIC HEART VALVES, INC. 638R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention