BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 2091834 · Received May 17, 2011

    Report

    Report Number
    2015691-2011-15550
    Event Type
    Death
    Date Received
    May 17, 2011
    Date of Event
    January 27, 2011
    Report Date
    April 18, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. IT WAS LEARNED THAT THE DEVICE WAS NOT EXPLANTED AT THE TIME OF DEATH. DESPITE MULTIPLE FOLLOW-UPS WITH THE HEALTHCARE PROVIDER, THE CAUSE OF DEATH, OPERATIVE REPORT, AND RELEVANT MEDICAL RECORDS HAVE NOT BEEN PROVIDED. THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED INTO THE ROOT CAUSE OF THIS EVENT. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY.

    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 LEARNED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF 14 DAYS. THE CAUSE OF DEATH HAS NOT BEEN PROVIDED DESPITE MULTIPLE FOLLOW-UP ATTEMPTS WITH THE HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 R-10H2246

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| R