BEUDAMED
    FDA Adverse Event Death Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 2080881 · Received May 7, 2011

    Report

    Report Number
    2015691-2011-15475
    Event Type
    Death
    Date Received
    May 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. TO DATE, THERE HAS BEEN NO RESPONSE TO OUR REPEATED ATTEMPTS TO CONTACT THE HEALTH CARE PROVIDER. WITHOUT THE DATE OF DEATH OR CAUSE OF DEATH, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS MODEL IS DISTRIBUTED OUTSIDE OF THE UNITED STATES AND IS BEING REPORTED AS SIMILAR TO MODEL 2800, WHICH IS MARKETED WITHIN THE UNITED STATES. METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: DESPITE OUR ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO RESPONSE OR SAMPLE FOR EVALUATION WAS RECEIVED FROM THE HEALTH-CARE PROVIDER. LOCATION OF DEATH WAS NOT PROVIDED. CAUSE OF DEATH WAS NOT PROVIDED. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR STERILIZED 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. THE DATE OF PATIENTS' DEATH AND IMPLANT DURATION ARE UNKNOWN. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 10A014

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R