BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2964083 · Received February 15, 2013

    Report

    Report Number
    2015691-2013-19297
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    August 30, 2012
    Report Date
    January 17, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED; REMAINS IMPLANTED IN PATIENT. THERE ARE SEVERAL POTENTIAL CAUSES FOR PROSTHETIC VALVE STENOSIS (E.G. CALCIFICATION, PANNUS GROWTH) AND INSUFFICIENCY (E.G. LEAFLET TEAR). UNFORTUNATELY, THE VALVE WAS EXPLANTED FROM THE PATIENT, AND THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE INVESTIGATED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS REPORTED THAT THE PATIENT UNDERWENT REDO VALVE REPLACEMENT WITH A TRANSCATHETER HEART VALVE. IMPLANT DURATION OF THE SUBJECT DEVICE WAS 12 YEARS AND 9 MONTHS. THROUGH FOLLOW UP, IT WAS LEARNED THAT THIS DEVICE WAS REPLACED DUE TO PROSTHETIC MITRAL VALVE STENOSIS AND INSUFFICIENCY. NO OPERATIVE COMPLICATIONS REPORTED. IT WAS ALSO NOTED THAT THE PATIENT HAD AN UNCOMPLICATED POST-OPERATIVE COURSE, COMPLICATED ONLY BY HYPERTENSION AND ANTICOAGULANT CLOSING. PATIENT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67383 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R