BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3103324 · Received May 9, 2013

    Report

    Report Number
    2015691-2013-20042
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 11, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. EXPLANTS AT IMPLANT ARE TYPICALLY A RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. IN THIS CASE, THE HEALTHCARE PROVIDER HAS INDICATED THAT THERE WAS NO MALFUNCTION OF THE DEVICE. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITHOUT THE SAMPLE DEVICE, IT APPEARS THAT THIS EVENT WAS LIKELY DUE TO PATIENT AND PROCEDURAL RELATED FACTORS. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS IMPLANTED, THEN EXPLANTED DUE TO OBSTRUCTION OF THE CORONARIES. PER THE OP REPORT, THIS PATIENT HAD A RELATIVELY SMALL AORTIC ROOT, AND IT APPEARED THAT THE INITIAL PROSTHESIS (SUBJECT DEVICE) HAD SOME OBSTRUCTION OF THE LEFT MAIN CORONARY ARTERY ORIFICE AND POSSIBLY SOME DISTORTION THERE OF ADDITIONALLY. THEREFORE, IT WAS DECIDED TO EXPLANT THE VALVE AND IMPLANT NEW PROSTHESIS. THE HEALTHCARE PROVIDER ALSO NOTED THAT THERE WAS MALFUNCTION OF THE EXPLANTED VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204554 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention