BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY RING

    MDR report key: 1953345 · Received January 8, 2011

    Report

    Report Number
    2015691-2011-14646
    Event Type
    Death
    Date Received
    January 8, 2011
    Date of Event
    September 21, 2010
    Report Date
    December 9, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED AND IT IS UNKNOWN IF AN AUTOPSY WAS DONE. THE PATIENT WAS ALSO IMPLANTED WITH A VALVE IN THE AORTIC POSITION ON THE SAME DATE OF IMPLANT AS THE REPORTED DEVICE. (B)(4). NO FURTHER DETAILS WERE PROVIDED. HOWEVER, THE INVESTIGATION IS ON-GOING. THE DHR REVIEW WAS COMPLETED. 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, THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF 36 DAYS (1.17 MONTHS). CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 R-10B0265

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| H| R