BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEOFORM ANNULOPLASTY RING MITRAL

    MDR report key: 3846708 · Received June 4, 2014

    Report

    Report Number
    2015691-2014-01287
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K032250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RING OR VALVE DEHISCENCE MAY OCCUR EARLY OR LATE. WHEN IT OCCURS IN THE EARLY POST-OPERATIVE PERIOD, IT IS TYPICALLY A RESULT OF AN INADEQUATE VALVE REPAIR OR PROSTHETIC VALVE IMPLANTATION IN COMBINATION WITH FRIABLE MYOCARDIAL TISSUE. LATE DEHISCENCE CAN OCCUR AS A RESULT OF SUCCESSIVE DILATATION OF CARDIAC STRUCTURES THAT RESULT FROM PROGRESSION OF DISEASE. NO PATIENT SPECIFICS WERE PROVIDED. NO DEVICE IS AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    ARTICLE: THREE-DIMENSIONAL VALVE REPAIR¿THE BETTER CARE? MIDTERM RESULTS OF A SADDLE-SHAPED, RIGID ANNULOPLASTY RING IN PATIENTS WITH ISCHEMIC MITRAL REGURGITATION. ACQUIRED CARDIOVASCULAR DISEASE, ACCEPTED FOR PUBLICATION 08/22/2013. OBJECTIVES: UNDERSIZED RING ANNULOPLASTY IS THE TREATMENT OF CHOICE FOR FUNCTIONAL MITRAL REGURGITATION. HOWEVER, RECURRENCE OF MITRAL REGURGITATION WITHIN THE FIRST YEARS IS FREQUENT. THE AIM OF THIS STUDY WAS TO ANALYZE THE FUNCTIONAL AND CLINICAL OUTCOME AFTER MITRAL VALVE REPAIR WITH THE 3-DIMENSIONAL SADDLE-SHAPED EDWARDS GEOFORM (EDWARDS LIFESCIENCES LLC, (B)(4)) ANNULOPLASTY RING IN PATIENTS WITH ISCHEMIC MITRAL REGURGITATION. THE ARTICLE INDICATES THREE PATIENTS REQUIRED A MITRAL VALVE¿RELATED REOPERATION FOR RING DEHISCENCE. CONCLUSIONS: MITRAL VALVE REPAIR WITH THE 3-DIMENSIONAL SADDLE-SHAPED EDWARDS GEOFORM ANNULOPLASTY RING IN CASE OF ISCHEMIC MITRAL REGURGITATION SHOWS A LOW RATE OF RECURRENT REGURGITATION AT 4 YEARS. CLINICALLY RELEVANT MITRAL STENOSIS WAS NOT DETECTED. THE IMPORTANCE OF SECURE ANCHORING OF THE DEVICE IN THE MITRAL ANNULUS HAS TO BE EMPHASIZED TO PREVENT RING DEHISCENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327792 GEOFORM ANNULOPLASTY RING MITRAL RING, ANNULOPLASTY KRH EDWARDS LIFESCIENCES 4200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R