BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3914346 · Received July 3, 2014

    Report

    Report Number
    2015691-2014-01533
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 6, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THEREFORE, THE ROOT OF THIS EVENT COULD NOT BE DETERMINED. 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 A BIOPROSTHETIC AORTIC VALVE IMPLANTED APPROXIMATELY ELEVEN (11) YEARS AND TEN (10) MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389559 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R