BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    MDR report key: 3981639 · Received August 5, 2014

    Report

    Report Number
    2015691-2014-01790
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 7, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    K083470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPLANTED DEVICE WAS NOT RETURNED TO MANUFACTURER AS IT WAS DISCARDED AT HOSPITAL, THUS AN EVALUATION WAS NOT PERFORMED. ANNULOPLASTY RING 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 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. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING OR 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 A 32MM BIOPROSTHETIC MITRAL RING, IMPLANTED APPROXIMATELY THREE (3) YEARS AND TWENTY-FOUR (24) DAYS, WAS EXPLANTED DUE TO SEVERE REGURGITATION & PARAVALVULAR LEAK (PVL), SECONDARY TO RING DEHISCENCE. THE EXPLANTED DEVICE (ANNLULOPLASTY RING) WAS REPLACED WITH A BIOPROSTHETIC VALVE. THE PATIENT UNDERWENT A TRICUSPID VALVE REPAIR DURING THE SAME SURGERY, AND IS REPORTED IN STABLE AND SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456278 CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 5200

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R