BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 3800980 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01064
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    November 24, 2009
    Report Date
    April 9, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STENOTIC BIOPROSTHETIC VALVE. ADDITIONAL MANUFACTURER NARRATIVE: IT WAS LEARNED THAT THIS PATIENT HAD A STENOTIC BIOPROSTHETIC VALVE. MANY FACTORS CAN CONTRIBUTE TO THE ONSET BIOPROSTHETIC STENOSIS, INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO CONFIRM THE ROOT CAUSE OF THIS EVENT. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A QUALITY DEFICIENCY RELATED TO THE EDWARDS VALVE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    TRANSCATHETER VALVE-IN-VALVE IMPLANTATION FOR FAILED BIOPROSTHETIC HEART VALVES STUDY: IT WAS IDENTIFIED THROUGH REVIEW OF THIS LITERATURE THAT THIS PATIENT EXPERIENCED MITRAL STENOSIS OF THEIR EDWARDS BIOPROSTHETIC VALVE AFTER AN IMPLANT DURATION OF APPROXIMATELY SEVEN (7) YEARS. THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE TRANSCATHETER MITRAL VALVE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277764 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R