BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGRAFT AORTIC VALVE AND CONDUIT

    MDR report key: 1850314 · Received August 9, 2010

    Report

    Report Number
    1063481-2010-00016
    Event Type
    Injury
    Date Received
    August 9, 2010
    Report Date
    July 10, 2010
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED, AND ANY ADDITIONAL INFO WILL BE REPORTED IN THE F/U REPORT.

    Additional Manufacturer Narrative · 1

    DURING A RETROSPECTIVE CLINICAL STUDY, IT WAS NOTED THAT SYNERGRAFT AORTIC VALVE AND CONDUIT (B)(4) WAS IMPLANTED IN A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) RECONSTRUCTION AND EXTRACARDIAC RA/PA CONDUIT PLACEMENT PROCEDURE TO REPLACE PULMONARY VALVE AND CONDUIT (B)(4). THE PULMONARY VALVE ALLOGRAFT WAS EXPLANTED APPROXIMATELY TWO YEARS AFTER IMPLANT. APPROXIMATELY TWO YEARS AFTER IMPLANT OF THE SYNERGRAFT AORTIC VALVE AND CONDUIT ALLOGRAFT, THE PATIENT DEVELOPED MILD PULMONARY REGURGITATION/INSUFFICIENCY. THE APPROXIMATELY 6.5 YEARS AFTER IMPLANTATION OF THE SYNERGRAFT ALLOGRAFT, THE VALVE WAS EXPLANTED DUE TO SEVERE STENOSIS (90 MMHG GRADIENT) AND MILD REGURGITATION. AS SUCH, THESE EVENTS WERE INVESTIGATED AS A COMPLAINT AND THE RESULTS ARE SUMMARIZED BELOW. A REVIEW OF THE PROCESSING RECORDS FOR BOTH THE SYNERGRAFT AORTIC VALVE AND CONDUIT ALLOGRAFT AND THE PULMONARY VALVE AND CONDUIT ALLOGRAFT REVEALED THAT BOTH ALLOGRAFTS MET ALL PROCESSING SPECIFICATIONS PRIOR TO RELEASE. REVIEW OF THE RELEVANT LITERATURE REVEALS THAT AN EXPLANT OF THIS NATURE IS NOT AN UNEXPECTED OUTCOME. THE PRECISE CAUSE OF THE EARLY VALVE FAILURES IN THIS PATIENT CAN NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THE SEVERE CONDUIT STENOSIS NOTED IN THE SGAV00 MAY BE A RESULT OF INTIMAL HYPERPLASIA AND/OR RELATIVE STENOSIS OF THE GRAFT DUE TO GROWTH OF THE RECIPIENT.

    Description of Event or Problem · 1

    DURING A RETROSPECTIVE CLINICAL STUDY, IT WAS NOTED THAT SYNERGRAFT AORTIC VALVE AND CONDUIT WAS IMPLANTED IN A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) RECONSTRUCTION AND EXTRACARDIAC RA-PA CONDUIT PLACEMENT PROCEDURE TO REPLACE A PULMONARY VALVE AND CONDUIT ALLOGRAFT DUE TO SEVERE TRICUSPID REGURGITATION. APPROXIMATELY TWO YRS AFTER IMPLANT, THE PT DEVELOPED MILD PULMONARY REGURGITATION/INSUFFICIENCY. THEN APPROXIMATELY 6.5 YRS AFTER THE IMPLANT OF THE SYNERGRAFT ALLOGRAFT, IT WAS EXPLANTED DUE TO SEVERE STENOSIS (90 MMHG GRADIENT) AND MILD REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGRAFT AORTIC VALVE AND CONDUIT HEART VALVE ALLOGRAFT, MIE MIE CRYOLIFE, INC. SGAV00

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention