BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1246390 · Received November 21, 2008

    Report

    Report Number
    6000002-2008-09337
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 28, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: VALVE WAS RECEIVED WITH SERRATED MARKS ON ALL LEAFLETS. ON LEAFLET ONE: 5 MM FROM COMMISSURE ONE, 2 MM AND 6 MM FROM COMMISSURE TWO. ON LEAFLET TWO: 2 MM FROM COMMISSURE TWO, 1 MM, 2 MM AND 4 MM FROM COMMISSURE THREE. ON LEAFLET THREE: 1 MM, 2 MM AND 3 MM FROM COMMISSURE THREE. SURFACE DAMAGE/CUTS WERE ALSO OBSERVED ON TWO OF THE LEAFLETS. CUTS/SURFACE DAMAGES WERE NOTED ON LEAFLET TWO AND THREE, EACH 1 MM IN LENGTH. THE SEWING RING WAS CUT NEAR COMMISSURE TWO. NO VISIBLE INCONSISTENCIES WERE NOTED IN THE X-RAY. VALVE WAS SENT TO R&D FOR FUNCTIONAL TESTING. RESULTS: NO VISIBLE INCONSISTENCIES OBSERVED. THE DEVICE IS BEING SENT TO EDWARDS' R & D DEPARTMENT FOR FURTHER EVALUATION. ECHO REVIEW RESULTS: PROVIDED BY EDWARD'S INDEPENDENT CONSULTANT: IMPRESSION - AFTER THE FIRST PUMP RUN, THERE IS A BIOPROSTHESIS IN THE AORTIC POSITION WITH ASSOCIATED AORTIC REGURGITATION. AORTIC REGURGITATION APPEARS TO BE OF PARAPROSTHETIC ORIGIN, ORIGINATING NEAR THE COMMISSURAL POST BETWEEN THE RIGHT AND LEFT CORONARY CUSPS; AND IS PROBABLY MODERATE IN SEVERITY. THE BIOPROSTHESIS APPEARS OTHERWISE NORMAL AS VISUALIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER IMPLANT DUE TO AORTIC INSUFFICIENCY OBSERVED ON THE POST OP TEE. THE PHYSICIAN SURGEON PROVIDED A COPY OF THE PATIENT'S POST OP TEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 3000TFX R-08H1802

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention