BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT THEON¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 1883711 · Received October 27, 2010

    Report

    Report Number
    2015691-2010-14259
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. REQUESTS WERE MADE FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION IS ONGOING. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE - THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 6900PTFX, 31MM, (B)(4) WAS IMPLANTED, THEN REMOVED AND A 29MM DEVICE WAS IMPLANTED INSTEAD. THE EXPLANTED DEVICE IS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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 R-09E1107

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention