BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS

    MDR report key: 2060471 · Received April 17, 2011

    Report

    Report Number
    2015691-2011-15249
    Event Type
    Death
    Date Received
    April 17, 2011
    Date of Event
    October 25, 2010
    Report Date
    March 18, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE REMAINS IMPLANTED, AND WILL NOT BE RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE SUBJECT DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT REMAINS IMPLANTED. THE DEVICE HISTORY RECORD REVIEW HAS BEEN COMPLETED, AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. OF NOTE, THERE HAS BEEN NO ALLEGATION OF A DEVICE MALFUNCTION, AS IT WAS NOTED THAT NO AORTIC INSUFFICIENCY DETECTED AFTER IMPLANT.

    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 (B)(6) 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 PATIENT HAS EXPIRED 7 DAYS POST OPERATION DUE TO "SEVERE DIFFUSE INTESTINAL ISCHEMIA".. IT WAS NOTED IN THE OPERATIVE REPORT THAT THE EDWARDS' AORTIC VALVE WAS WELL SEATED WITH NO AORTIC INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700 R-10E1196

    Patients

    Seq Age Sex Outcome Treatment
    1 72 Death