BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 1984357 · Received February 10, 2011

    Report

    Report Number
    2015691-2011-14772
    Event Type
    Death
    Date Received
    February 10, 2011
    Date of Event
    September 15, 2010
    Report Date
    January 13, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    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: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. NOTIFICATION OF DEATH WAS MADE BY THE FAMILY. THE RETURNED PATIENT IDENTIFICATION CARD NOTED "MY FATHER.... PASSED AWAY RIGHT AFTER THIS SURGERY." NO ADDITIONAL INFORMATION WAS PROVIDED. THE DATE OF DEATH HAS NOT BEEN CONFIRMED BY THE HEALTH CARE PROVIDER. IT IS UNKNOWN IF THE DEVICE WAS EXPLANTED OR IF AN AUTOPSY WAS CONDUCTED. THE OPERATIVE REPORT AND DISCHARGE SUMMARY HAVE BEEN REQUESTED BUT HAVE NOT BEEN PROVIDED.

    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 ZERO DAYS DUE TO UNKNOWN REASONS. NO CAUSE OF DEATH HAS BEEN PROVIDED. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 10E110

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| H| R