BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE - AORTIC VALVE AND CONDUIT

    MDR report key: 1942421 · Received December 30, 2010

    Report

    Report Number
    1063481-2010-00071
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 30, 2010
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, AORTIC VALVE AND CONDUIT ((B)(6)) WAS EXPLANTED DUE TO INSUFFICIENCY. THE ALLOGRAFT WAS IMPLANTED FOR 9.7 YEARS. A PORTION OF THE ALLOGRAFT WAS RETURNED AND EVALUATED. THE RETUNED TISSUE WAS A SINGLE LEAFLET WITH APPROXIMATELY 3 MM OF FOCAL PLAQUE. HISTOLOGIC EVALUATION DEMONSTRATED NO SIGNIFICANT INFLAMMATORY INFILTRATE OR CALCIFIC NODULES. REVIEW OF THE RELEVANT CLINICAL LITERATURE REVEALS THAT AN EXPLANT OF AN AORTIC VALVE ALMOST 10 YEARS AFTER IMPLANT IN A (B)(6) PATIENT SHOULD NOT BE UNEXPECTED. CORRECTED DATA: "OPERATOR OF DEVICE" WAS REPORTED TO BE A PHYSICIST IN THE INITIAL REPORT, THE OPERATOR OF THE DEVICE WAS A PHYSICIAN.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE AORTIC VALVE AND CONDUIT WAS EXPLANTED DUE TO INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVALVE - AORTIC VALVE AND CONDUIT HEART VALVE, ALLOGRAFT (AORTIC VALVE AND CONDUIT) MIE CRYOLIFE, INC. AV00

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other