BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3183236 · Received June 21, 2013

    Report

    Report Number
    2015691-2013-20402
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    March 26, 2013
    Report Date
    June 21, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, ALL THREE LEAFLETS APPEARED SLIGHTLY DEHYDRATED. LEAFLETS APPEARED SLIGHTLY SHRUNKEN AND SLIGHTLY STIFF. NO OTHER VISIBLE INCONSISTENCIES OBSERVED ON ALL THREE LEAFLETS. THE WIREFORM WAS INTACT, AS EVIDENT IN THE X-RAY. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE, NO ADDITIONAL INFORMATION REGARDING THE REASON FOR EXPLANT WAS PROVIDED. THE EXPLANTED DEVICE WAS RETURNED FOR EVALUATION. UNFORTUNATELY, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED BASED ON THE AVAILABLE INFORMATION. CONTINUED ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL DETAILS REGARDING THIS CASE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT ANY NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 DAYS. THE REASON FOR EXPLANT IS UNKNOWN. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. THE DEVICE WAS REPLACED WITH ANOTHER EDWARDS VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282458 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R