BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    MDR report key: 4111578 · Received September 23, 2014

    Report

    Report Number
    2015691-2014-02217
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE EXPLANTED ANNULOPLASTY RING WAS NOT RETURNED TO EDWARDS FOR EVALUATION. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO FURTHER ACTION IS REQUIRED AT THIS TIME, EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT AN ANNULOPLASTY TRICUSPID RING, IMPLANTED APPROXIMATELY ONE (1) YEAR AND TEN (10) MONTHS, WAS EXPLANTED DUE TO REGURGITATION/INSUFFICIENCY. THE RING AND THE PATIENT'S NATIVE VALVE WERE REPLACED WITH AN EDWARDS BIOPROSTHETIC MITRAL VALVE. THERE WERE NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592321 CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 4500

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R