BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3980462 · Received August 5, 2014

    Report

    Report Number
    2015691-2014-01784
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 7, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO MANUFACTURER. WITHOUT RECEIPT OF THE REPORTED DEVICE, THE REPORTED CLINICAL OBSERVATION CANNOT BE CONFIRMED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS.

    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. EDWARDS RECEIVED INFORMATION THAT A 21MM BIOPROSTHETIC AORTIC VALVE, IMPLANTED APPROXIMATELY NINE (9) YEARS AND ONE (1) MONTH, WAS EXPLANTED DUE TO REGURGITATION SECONDARY TO CALCIFICATION. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER BIOPROSTHETIC VALVE. EXPLANTED DEVICE WAS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED AT HOSPITAL. THERE ARE NO ADVERSE EVENTS REPORTED FOLLOWING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456894 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R