BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYXO ETLOGIX RING

    MDR report key: 1201772 · Received October 15, 2008

    Report

    Report Number
    6000002-2008-08951
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    April 1, 2006
    Report Date
    May 8, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED: PLEASE NOTE THAT THE INITIAL REPORTER WAS THE PATIENT INVOLVED IN THE REPORTED EVENT. WE HAVE OMITTED THEIR NAME, ADDRESS AND TELEPHONE NUMBER DUE TO HIPA REGULATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED COMPLICATIONS INCLUSIVE OF SHORTNESS OF BREATH, ALLERGIC REACTION TO THE DEVICE, AND EVENTUAL SEVERE MITRAL STENOSIS REQUIRING FURTHER SURGICAL PROCEDURES, HEART FAILURE AND OTHER PERMANENT AND PECUNIARY LOSSES. THE SPECIFIC DATE THAT THE PATIENT BECAME SYMPTOMATIC (POST OP) IS UNKNOWN. REPORTEDLY, THE PATIENT DEVLOPED AN INTENSE GENERALIZED, INFLAMMATORY REACTION INVOLVING BOTH MITRAL LEAFLETS, FOLLOWED BY PERICARDITIS AND PERICARDIAL EFFUSION REQUIRING PIGTAIL CATHETER DRAINAGE. THE PATIENT REQUIRED RE-OPERATIVE MITRAL VALVE SURGERY FOR MITRAL STENOSIS AND A REDO MAZE PROCEDURE. THE PATIENT NOW HAS NYHA CLASS 2 HEART FAILURE AND NEEDS A PERMANENT PACEMAKER, AND IS BEING EVALUATED FOR A FORMAL HEART TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYXO ETLOGIX RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 5100 6C0554

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention