BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 3944992 · Received July 18, 2014

    Report

    Report Number
    2015691-2014-01633
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    K923367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: EXPLANT OF A MITRAL ANNULOPLASTY RING AFTER AN IMPLANT DURATION OF APPROXIMATELY 17 YEARS DUE TO MITRAL REGURGITATION. THE EXPLANTED RING HAS NOT BEEN RETURNED FOR EVALUATION. THE CAUSES OF RE-OPERATION FOR A FAILED ANNULOPLASTY REPAIRS ARE WELL DOCUMENTED IN THE LITERATURE. RE-OPERATIONS ARE PRIMARILY THE RESULT OF A PROGRESSION OF DISEASE OR TECHNICAL FAILURES AND ARE NOT RELATED TO PRODUCT MALFUNCTIONS. UNLIKE PROSTHETIC HEART VALVES, ANNULOPLASTY RINGS ARE AN ADJUNCT TO THE VALVE REPAIR. THERE IS NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A 32MM ANNULOPLASTY RING WAS EXPLANTED DUE TO SEVERE MITRAL REGURGITATION AFTER AN IMPLANT DURATION OF APPROXIMATELY . THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421420 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 4600

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R