BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1253705 · Received December 5, 2008

    Report

    Report Number
    2953161-2008-00412
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    November 3, 2008
    Report Date
    December 5, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IN 2008, THIS PT WAS IMPLANTED WITH A GORE EXCLUDER CONTRALATERAL LEG ENDOPROSTHESIS. THE FOLLOWING MONTH, A REINTERVENTION OCCURRED WHEREBY AN ADDITIONAL GORE EXCLUDER CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED. FURTHER INVESTIGATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 05582717

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention