BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT® MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 4201256 · Received October 27, 2014

    Report

    Report Number
    2015691-2014-02515
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 29, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. WITHOUT THE RETURN OF THE DEVICE OR ADDITIONAL INFORMATION, EDWARDS IS UNABLE TO DRAW ANY CONCLUSIONS AS TO THE REASON FOR EXPLANT OR ROOT CAUSE. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    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, A 27MM AORTIC PERICARDIAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 3 MONTHS. THE REASON FOR EXPLANT IS UNKNOWN. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER 27MM PERICARDIAL VALVE. DESPITE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ON THE EVENT AND PATIENT, NO FURTHER DETAILS HAVE BEEN PROVIDED. SHOULD NEW INFORMATION BE RETRIEVED AT A LATER DATE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682313 CARPENTIER-EDWARDS PERIMOUNT® MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX27MM

    Patients

    Seq Age Sex Outcome Treatment
    1 80 Required Intervention