BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE SG

    MDR report key: 1983557 · Received February 10, 2011

    Report

    Report Number
    1063481-2011-00006
    Event Type
    Injury
    Date Received
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, DURING AN UNRELATED SURGICAL PROCEDURE THE SURGEON NOTICED THAT THE PULMONARY VALVE & CONDUIT (B)(6) HAD BECOME STENOTIC AND WAS EXPLANTED. A REVIEW OF THE PROCESSING RECORDS INDICATES THAT THE ALLOGRAFT WAS PROCESSED ACCORDING TO ALL SPECIFICATIONS. A REVIEW OF THE RELEVANT LITERATURE REVEALS THAT SIGNS OF STRUCTURAL VALVE DETERIORATION AT 6 MONTHS POST IMPLANT WOULD BE CONSIDERED AN EARLY AND RARE EVENT. HOWEVER, IT HAS BEEN DOCUMENTED IN THE LITERATURE. HISTOLOGIC EVALUATION OF THE RETURNED SEGMENTS SHOWED EVIDENCE OF INTIMAL HYPERPLASIA, A KNOWN POTENTIAL COMPLICATION OF CARDIAC ALLOGRAFT TRANSPLANTATIONS; WHICH MAY LEAD TO VALVE STENOSIS. ADDITIONALLY, A MODERATE CHRONIC INFLAMMATORY INFILTRATE COMPRISED OF LYMPHOCYTES AND PLASMA CELLS WERE OBSERVED. HOWEVER, THIS WAS ONLY PRESENT AT THE SUTURE LINE. THERE IS NO INDICATION THAT ANY DONOR ATTRIBUTES OR PROCESSING ANOMALIES CONTRIBUTED TO THIS EVENT. NO FURTHER ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, DURING UNRELATED CARDIAC OPERATION THE SURGEON NOTICED THE PULMONARY VALVE & CONDUIT SG ALLOGRAFT HAD STENOSED AND NEEDED TO BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVALVE SG PULMONARY VALVE & CONDUIT SG MIE CRYOLIFE, INC. SGPV00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R