BEUDAMED
    FDA Adverse Event Death Summary report: N

    AV00-AORTIC VALVE + CONDUIT

    MDR report key: 793429 · Received February 28, 2006

    Report

    Report Number
    1063481-2006-00004
    Event Type
    Death
    Date Received
    February 28, 2006
    Report Date
    November 10, 2005
    Manufacturer
    CRYOLIFE INC.- KENNESAW
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE CONDUCTS PRE-IMPLANT CULTURES ON ALL ALLOGRAFTS, AND OVER AN UNKNOWN PERIOD OF TIME, ACCUMULATED THREE POSITIVE CULTURES FOR S. AUREUS. (THEY DO NOT SEEM TO HAVE OCCURRED AS A CLUSTER OR WITHIN A BRIEF PERIOD OF TIME). THE CULTURES FOR TWO OF THE ALLOGRAFTS (PRODUCED BY CRYOLIFE) WERE METHICILLIN-RESISTANT, AND THE THIRD (PRODUCED BY LIFENET) WAS METHICILLIN-SENSITIVE. ALL 3 CULTURES WERE OF DIFFERENT CLONAL BACKGROUNDS. THIS REPORT IS CLOSED, UNLESS OTHERWISE SPECIFIED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) RECEIVED INFORMATION VIA A USER FACILITY REGARDING THREE REPORTS OF STAPHYLOCOCCUS AUREUS PRE-IMPLANT CULTURES. TWO OF THE PRE-IMPLANT CULTURES INVOLVED CRYOLIFE AORTIC VALVES, WHILE THE THIRD WAS ASSOCIATED WITH A VALVE FROM A SEPARATE MANUFACTURER. INITIAL CORRESPONDENCE GAVE NO INDICATION OF PATIENT IMPACT AND REPORTED ONLY THE EXISTENCE OF THE PRE-IMPLANT CULTURES. SUBSEQUENT CONTACT WITH BOTH THE HOSPITAL AND THE CDC INDICATED THAT THE TWO CASES INVOLVING CRYOLIFE VALVES EXHIBITED POSITIVE CULTURES FOR METHICILLIN RESISTANT STRAINS; HOWEVER, THE CDC NOTED THAT THE REPORTED CULTURES, AND SUBSEQUENT UNCONFIRMED INFECTIONS, WERE LIKELY THE RESULT OF HOSPITAL CONTAMINATION. ADDITIONALLY, BOTH THE USER FACILITY AND THE CDC ACKNOWLEDGED THAT THERE WAS NO INDICATION THAT CONTAMINATION SPECIFICALLY CAME FROM EITHER TISSUE DONOR, AND THAT IT WAS POSSIBLE THESE STRAINS WERE INTRODUCED TO THE HOSPITAL BY OTHER MEANS. THE USER FACILITY EXPLAINED THAT ONE OF THE THREE PATIENTS BECAME SYMPTOMATIC, INCLUDING FEBRILE EPISODES APPARENT APPROXIMATELY ONE TO TWO WEEKS POST OPERATIVELY. THE HOSPITAL CONTACT HAS INDICATED THAT THESE EPISODES WERE ATTRIBUTED TO A SEPTIC CONDITION; HOWEVER, IT IS NOT CLEAR WHAT OTHER CONDITIONS OR SYMPTOMS WERE CONSIDERED IN ESTABLISHING THIS CONNECTION. THE PATIENT RECEIVED VANCOMYCIN, POSSIBLY PROPHYLACTICALLY IN RESPONSE TO THE CULTURE RESULTS, BUT SUBSEQUENTLY EXPIRED WITH NO EXACT CLINICAL DETERMINATION AS TO THE CAUSE OF DEATH; FURTHERMORE, NO POST MORTEM CULTURES INDICATED ANY PRESENCE OF S. AUREUS. FOR REPORTING PURPOSES, IT APPEARS THAT THE PATIENT'S DEATH IS ASSOCIATED WITH THE ALLOGRAFT NOTED IN THIS REPORT; HOWEVER, SUBSEQUENT ATTEMPTS TO VERIFY THIS INFORMATION WITH THE HOSPITAL HAVE NOT BEEN SUCCESSFUL. A MANUFACTURING RECORDS REVIEW WAS CONDUCTED AND INDICATES THAT THIS ALLOGRAFT WAS MANUFACTURED ACCORDING TO PROCEDURE, AND A QUALITY REVIEW NOTED THAT THE DONOR MET ALL RELEASE CRITERIA BOTH NOW AND AT THE TIME OF RELEASE. WHILE IT APPEARS THAT THE NOTED EVENTS ARE NOT LIKELY ATTRIBUTED TO THE ALLOGRAFT, WITH THE AVAILABLE INFORMATION, NO SPECIFIC DETERMINATIONS CAN BE MADE IN REGARDS TO THE SOURCE OF THE REPORTED PRE-IMPLANT CULTURE OR CAUSE OF THE REPORTED DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AV00-AORTIC VALVE + CONDUIT CRYOVALVE (HUMAN TISSUE) MIE CRYOLIFE INC.- KENNESAW NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO Death