BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOLIFE INC.

    MDR report key: 728542 · Received June 14, 2006

    Report

    Report Number
    728542
    Event Type
    Injury
    Date Received
    June 14, 2006
    Date of Event
    June 2, 2006
    Report Date
    June 7, 2006
    Manufacturer
    CRYOLIFE INC
    Product Code
    MWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT CAME TO SURGERY FOR TRUNCUS ARTERIOSIS REPAIR AND CONDUIT REPLACEMENT. CRYOLIFE HOMOGRAFT WAS USED TO MAKE THE APPROPRIATE REPAIR. THE GRAFT KEPT COMING APART AS THEY SUTURED IT. THIS CAUSED THE PT TO NEED SEVERAL UNITS OF EXTRA BLOOD TO KEEP UP WITH ALL THE BLEEDING FROM THE HOLES AT THE GRAFT SITE. WHILE STILL IN THE SURGERY GRAFT DEVELOPED A LARGE TEAR THAT WAS NOT REPAIRABLE AND THE PT HAD TO BE PUT BACK ON BYPASS IN A EMERGENCY STATUS. THE NEW HOMOGRAFT HAD TO BE REMOVED AND A SECOND HOMOGRAFT HAD TO BE USED TO REPLACE THE GRAFT THAT WAS DEFECTIVE. THE PT WAS THEN TAKEN OFF BYPASS AFTER NEW GRAFT WAS IN PLACE AND BLEEDING WAS CONSIDERABLY LESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOLIFE INC. HOMOGRAFT CONDUIT MWH CRYOLIFE INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R