BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3222928 · Received July 12, 2013

    Report

    Report Number
    2015691-2013-20579
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE ATTEMPTS WITH THE HEALTHCARE PROVIDER, THE EXPLANTED VALVE HAS NOT YET BEEN RETURNED TO EDWARDS FOR EVALUATION. STENOSIS OF AN BIOPROSTHETIC VALVES IS DEPENDENT ON BOTH PATIENT FACTORS AND INTRINSIC PROPERTIES OF BIOPROSTHETIC VALVES. WITHOUT RETURN OF DEVICE, THE NATURE OF THE REPORTED SEVERE STENOSIS CANNOT BE IDENTIFIED OR EVALUATED. STENOSIS MAY BE DUE TO CALCIFIC TISSUE DEGENERATION, NON CALCIFIC TISSUE DEGENERATION, AND/OR NON-STRUCTURAL DYSFUNCTION. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SURGEON THAT AN EDWARDS AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED FROM A YOUNG PATIENT AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 YEARS DUE TO SEVERE PROSTHETIC AORTIC STENOSIS. OPERATIVE REPORT INDICATES, " AFTER QUITE SOME TIME, IT WAS POSSIBLE TO EXPLANT THE BIOPROSTHESIS. CLEARLY THE LEAFLETS WERE HEAVILY INVOLVED WITH CALCIFICATION AND WERE RELATIVELY IMMOBILE." THE SUBJECT VALVE WAS REPLACED WITH A MECHANICAL PROSTHESIS. PATIENT CONDITION WAS STABLE POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323909 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-08E0902

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R