BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

    MDR report key: 1380631 · Received May 14, 2009

    Report

    Report Number
    2015691-2009-10580
    Event Type
    Injury
    Date Received
    May 14, 2009
    Date of Event
    April 14, 2009
    Report Date
    April 14, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: HEAVY CALCIFICATION IS DETECTED IN THE CUSP AREA OF LEAFLET 3. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLET AND POSSIBLY CONTRIBUTED TO STENOSIS. TWO TEARS ARE DETECTED AT THE FREE MARGIN AND ALONG THE ATTACHMENT AT OPPOSITE ENDS OF LEAFLET 3, AT BOTH COMMISSURE 2 AND COMMISSURE 3. BOTH TEARS MEASURE TO APPROXIMATELY 4MM. SIGNIFICANT MISMATCH IS EVIDENT IN LEAFLET 3 BY 5MM AT THE GREATEST POINT. THE MISMATCH IS POSSIBLY DUE TO THE TEARS DESCRIBED ABOVE. OPAQUE AND THICKER TISSUE, IN COMPARISON TO A NEW VALVE TISSUE, IS EVIDENT IN THE FREE MARGINS AND ALONG THE ATTACHMENT OF LEAFLET 1 AT COMMISSURE 1 AND LEAFLET 3 AT COMMISSURE 3; DELAMINATION IS ALSO OBSERVED THE DESCRIBED AREAS. THE X-RAY DEMONSTRATES HEAVY CALCIFICATION IN LEAFLET 3.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AORTIC PERICARDIAL VALVE WAS EXPLANTED, IT IS LISTED AS A BAXTER VALVE. THE SURGEON WANTS TO SEND THIS VALVE BACK TO THE "COMPANY" BUT I NEED HELP FINDING OUT WHERE TO SEND IT. I AM AWARE THAT YOU DO NOT SUPPLY VALVES AT THIS TIME, BUT WHO ACQUIRED THE VALVES? I HAVE OUR PATHOLOGY DEPARTMENT HOLDING THE VALVE UNTIL I (WE) CAN FIND AN ANSWER. ANY HELP YOU CAN PROVIDE IS APPRECIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 270021MM NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention