BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC VALVE & CONDUIT SG

    MDR report key: 2132930 · Received June 17, 2011

    Report

    Report Number
    1063481-2011-00036
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    OHA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, A REOPERATION WAS REQUIRED ON A PATIENT WHO RECEIVED AN AORTIC VALVE AND CONDUIT SG ALLOGRAFT EIGHT YEARS AFTER IMPLANT. THE SURGEON STATED THAT THE ALLOGRAFT WAS VERY CALCIFIED AND IT WAS NOT AN EASY PROCEDURE. THE SURGEON EXPRESSED CONCERN WITH THE AMOUNT OF CALCIFICATION THAT WAS SEEN EIGHT YEARS POST-OPERATIVELY. A REVIEW OF PROCESSING RECORDS INDICATES THAT THE ALLOGRAFT MET ALL PROCESSING SPECIFICATIONS PRIOR TO RELEASE. THE EVENTS DESCRIBED IN THE REPORT ARE CONSISTENT WITH STRUCTURAL VALVE DETERIORATION. STRUCTURAL VALVE DETERIORATION IS A KNOWN POTENTIAL COMPLICATION OF HUMAN HEART VALVE TRANSPLANTATION AND HAS BEEN FREQUENTLY REPORTED IN THE LITERATURE. THE PRECISE CAUSE OF THE REPORTED EVENT IS UNKNOWN; HOWEVER, CALCIFICATION IS A KNOWN MODE OF FAILURE FOR HUMAN HEART VALVE ALLOGRAFTS. DATA HAS SHOWN THAT CALCIFICATION IS MORE LIKELY IN PEDIATRIC PATIENTS THAN IN ADULTS. THERE IS NO EVIDENCE TO SUGGEST THAT THERE WAS AN INTRINSIC PROBLEM WITH THE VALVE PRIOR TO IMPLANT. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, A REOPERATION WAS REQUIRED ON A PATIENT WHO RECEIVED AN AORTIC VALVE AND CONDUIT SG ALLOGRAFT SIX YEARS AGO. THE SURGEON STATED THAT THE ALLOGRAF WAS VERY CALCIFIED AND IT WAS NOT AN EASY PROCEDURE. THE SURGEON EXPRESSED CONCERN WITH THE AMOUNT OF CALCIFICATION THAT WAS SEEN SIX YEARS POST-OPERATIVELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention