BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBOL-X SLIM INTRA AORTIC FILTER

    MDR report key: 730181 · Received June 26, 2006

    Report

    Report Number
    6000002-2006-00369
    Event Type
    Death
    Date Received
    June 26, 2006
    Date of Event
    May 31, 2006
    Report Date
    June 1, 2006
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Product Code
    DTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6. THE DEVICE WAS DISPOSED AND THEREFORE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    PT WAS SCHEDULED IN 2006 FOR AN AORTIC VALVE REPLACEMENT (AVR) EMBOL-X SYSTEM WAS INSERTED WITHOUT DIFFICULTY. AT COMPLETION OF AVR AND AORTA CLOSURE, PT WAS NOTED TO HAVE EXCESSIVE BLEEDING, WHICH WAS IDENTIFIED AS COMING FROM THE AORTA. THE PT WAS PLACED BACK ON BYPASS WITH CANNULATION. A PERFORATION WAS NOTED ON THE BACK WALL OF THE AORTA, WHERE BLEEDING WAS NOTED. PT WAS RETURNED TO ICU FOR RECOVERY. PT EXPIRED THE NEXT DAY. THE PHYSICIAN STATED THAT THERE WERE NO DEFECTS OBSERVED ON THE EMBOL-X SYSTEM. MEDICAL RECORD INDICATES THAT PT EXPIRED HAVING RENAL FAILURE AND HYPOTENSION REFRACTORY TO ALL PRESSORS IN MASSIVE DOSES, DESPITE TREATMENT WITH METHYLENE BLUE. THE PHYSICIAN STATED THAT PT'S AORTA APPEARED TO BE "THINNER THAN SOME".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOL-X SLIM INTRA AORTIC FILTER BLOOD FILTER DTM EDWARDS LIFESCIENCES RESEARCH MEDICAL EXMMD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death