BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 2572029 · Received May 11, 2012

    Report

    Report Number
    2015691-2012-17478
    Event Type
    Injury
    Date Received
    May 11, 2012
    Date of Event
    April 12, 2012
    Report Date
    April 12, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS STATED, NO ADDITIONAL RECORDS OR EVENT INFORMATION WAS RECEIVED DESPITE MULTIPLE ATTEMPTS WITH HEALTHCARE PROVIDER. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. DURING FOLLOW-UP FOR THE EXPLANTED DEVICE, IT WAS LEARNED THAT IT HAD BEEN SENT TO AN INDEPENDENT LABORATORY BY THE HOSPITAL, AND WILL NOT BE RELEASED TO EDWARDS FOR EVALUATION. THE AVAILABLE INFORMATION SUGGESTS NOTHING TO INDICATE A QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. UPDATES WILL BE REPORTED IF ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS MITRAL BIOPROSTHESIS WAS EXPLANTED DUE TO "A NON COMPLIANT LEAFLET" (AS PER THE SURGEON), AFTER AN IMPLANT DURATION OF APPROXIMATELY (B)(6) MONTHS MULTIPLE FOLLOW UP ATTEMPTS WITH THE HEALTHCARE PROVIDER TO OBTAIN ADDITIONAL EVENT DETAILS AND PATIENT UPDATES HAVE BEEN UNSUCCESSFUL. THE HCP WAS UNABLE TO LOCATE PATIENT RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX 6D0903

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R