BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 1841788 · Received September 22, 2010

    Report

    Report Number
    2015691-2010-14094
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    June 24, 2010
    Report Date
    August 23, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.THIS EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEATLH-CARE PROVIDER VIA FAX, THE OPERATIVE REPORT WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS. ON 09/20/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO AORTIC INSUFFICIENCY DETECTED AFTER THE PATIENT WAS SEPARATED FROM BYPASS. PER THE OPERATIVE REPORT OF (B)(6)2010, "THE AORTIC VALVE WAS VISUALIZED AND WAS OBSERVED TO DEMONSTRATE SLIGHT DEFECT UNDER TWO OF THE PLEDGETS." THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER 23 MM BIOPROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800TFX R-10B0441

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention