BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2905409 · Received January 9, 2013

    Report

    Report Number
    2015691-2013-19063
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 12, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON OUR FOLLOW-UP, IT WAS LEARNED THAT THIS REPORT IS A DUPLICATE OF REPORT NUMBER 2015691-2012-18859, SUBMITTED ON (B)(4) 2012. PLEASE REFERENCE THAT REPORT FOR FUTURE INQUIRIES. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE SAMPLE DEVICE WAS NOT RETURNED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. FOLLOW UP FOR ADDITIONAL INFORMATION IS CURRENTLY BEING MADE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT THAT ANY NEW INFORMATION IS RECEIVED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AT IMPLANT. UNFORTUNATELY, THE REASON FOR EXPLANT AT IMPLANT HAS NOT BEEN PROVIDED. NO OTHER DETAILS REPORTED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION OR QUALITY DEFICIENCY. THE SUBJECT DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10434 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention