BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE SG

    MDR report key: 2013256 · Received March 10, 2011

    Report

    Report Number
    1063481-2011-00016
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    September 29, 2008
    Report Date
    March 9, 2011
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY ((B)(4)). SERIOUS EVENT, DEATH, AND EXPLANT FORMS WERE RECEIVED THAT INDICATED FOUR ALLOGRAFTS HAD BEEN EXPLANTED. EACH OF THE FOUR EXPLANTS WAS ATTRIBUTED TO UNACCEPTABLE HEMODYNAMICS AND INSUFFICIENCY. ADDITIONAL CONTRIBUTING FACTORS INCLUDE CALCIFICATION, VALVE LEAFLET DEGENERATION, PERIVALVULAR LEAK, AND STENOSIS/OBSTRUCTION OF THE VALVE. EACH OF THESE OBSERVATIONS IS CONSIDERED CHARACTERISTICS OF STRUCTURAL VALVE DETERIORATION. ALTHOUGH THE FORMS DID NOT INDICATE THAT THE EVENT WAS RELATED TO A FAILURE OF A CRYOLIFE ALLOGRAFT THE EVENT DETAILS SUGGEST THE POSSIBILITY AND THEREFORE EACH EVENT WAS INVESTIGATED AS A COMPLAINT. THE PROCESSING RECORDS FOR EACH OF THE ALLOGRAFTS IN QUESTION WERE REVIEWED AND IT WAS DETERMINED THAT ALL OF THE ALLOGRAFTS WERE PROCESSED ACCORDING TO ALL PROCESSING SPECIFICATIONS. A REVIEW OF RELEVANT CLINICAL LITERATURE REVEALS THAT FREEDOM FROM STRUCTURAL VALVE DETERIORATION OF A HUMAN HEART ALLOGRAFT IN A PATIENT LESS THAN (B)(4) YEARS OF AGE IS 47% AT 10 YEARS. THE FOUR ALLOGRAFTS IN QUESTION WERE EXPLANTED BETWEEN 5.5-7.75 YEARS AFTER IMPLANTATION. THEREFORE, EXPLANTATION OF THESE VALVES IS NOT UNEXPECTED. NO FURTHER ACTION IS WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    AS PART OF THE CRYOVALVE SG AORTIC HUMAN HEART VALVE RETROSPECTIVE/PROSPECTIVE, MULTI-CENTER, (B)(4), AN EXPLANT FORM INDICATING THE FOLLOWING EVENT WAS RECEIVED. ON (B)(6) 2008, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR THE FOLLOWING: UNACCEPTABLE HEMODYNAMICS; ALONG WITH INSUFFICIENCY AND STENOSIS OR OBSTRUCTION OF VALVE. AS PART OF THE CRYOVALVE SG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVALVE SG AORTIC VALVE & CONDUIT SG MIE CRYOLIFE, INC. SGAV00

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention