BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 2022649 · Received March 17, 2011

    Report

    Report Number
    2015691-2011-15038
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    April 17, 2010
    Report Date
    February 15, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PARAVALVULAR LEAK. DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION (E.G.: OPERATIVE REPORT, DISCHARGE SUMMARY, ETC.) WAS REQUESTED; HOWEVER, DUE TO PATIENT PRIVACY REGULATIONS THEY COULD NOT BE OBTAINED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 1 YEAR AND 8 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO A PARAVALVULAR LEAK. THE PATIENT'S VALVE WAS REPLACED WITH AN EDWARDS BIOPROSTHETIC VALVE. UNFORTUNATELY, NO OTHER DETAILS WERE PROVIDED. ACCORDING TO THE SURGEON, THE REASON FOR EXPLANTING THE DEVICE WAS NOT RELATED TO A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 R-08F1244

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention