BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    MDR report key: 3833934 · Received May 27, 2014

    Report

    Report Number
    2015691-2014-01242
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 28, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K912554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THIS RING WAS REPLACED DUE TO REGURGITATION; PERIVALVULAR LEAK; AND PANNUS OVERGROWTH. 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. IN THIS CASE, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT UNDERWENT VALVE-IN-RING PROCEDURE WITHIN AN EXISTING EDWARDS ANNULOPLASTY RING. THE IMPLANT DURATION OF THE EDWARDS DEVICE AT THE TIME OF THE PROCEDURE WAS APPROXIMATELY 13 YEARS. THE REASON FOR REOPERATION WAS REPORTED AS: REGURGITATION; PERIVALVULAR LEAK; PANNUS OVERGROWTH. NO OTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310908 CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4400

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R