BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2091472 · Received May 5, 2011

    Report

    Report Number
    2953161-2011-00107
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    March 22, 2011
    Report Date
    May 4, 2011
    Manufacturer
    W. L. GORE AND ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. RESULTS: THE MANUFACTURING RECORDS REVIEW VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2009, THE PATIENT UNDERWENT TREATMENT FOR A 6.7 CM ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. NO ENDOLEAK WAS IDENTIFIED AT THE END OF THE PROCEDURE. THE PATIENT PRESENTED WITH A TYPE II ENDOLEAK APPROXIMATELY ONE MONTH LATER, AND THEN ANEURYSM ENLARGEMENT AND A PROXIMAL TYPE 1 ENDOLEAK ON (B)(6), 2011. ACCORDING TO THE PHYSICIAN, THE TYPE II ENDOLEAK CAUSED THE ANEURYSM ENLARGEMENT, AND THE ANEURYSMAL DISEASE PROGRESSION LED TO THE PROXIMAL TYPE I ENDOLEAK. ON (B)(6), 2011, THE PATIENT UNDERWENT ANOTHER PROCEDURE, AND THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED WITH AN AORTIC EXTENDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE AND ASSOCIATES WLG325 06178563

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R COUMADIN