BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1315427 · Received February 13, 2009

    Report

    Report Number
    2953161-2009-00033
    Event Type
    Injury
    Date Received
    February 13, 2009
    Date of Event
    January 28, 2009
    Report Date
    February 13, 2009
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ANEURYSM GROWTH IN THE ABSENCE OF ENDOLEAK HAD BEEN DEFINED AS ENDOTENSION. ONE HYPOTHESIS FOR THE SOURCE OF ENDOTENSION IS THE TRANSMURAL MOVEMENT OF SEROUS FLUID ACROSS THE MATERIAL USED TO FABRICATE DEVICES USED TO TREAT THE AORTIC ABDOMINAL ANEURYSM. IN RESPONSE TO THIS ISSUE, GORE ELECTED TO PROVIDE A DESIGN ENHANCEMENT TO THE ORIGINAL GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. PLEASE REFER TO PMA SUPPLEMENT P020004 S006. PLEASE NOTE ADDITIONAL DEVICES IMPLANTED: PCL161407/032651601 AND PCC141200/030307205.

    Description of Event or Problem · 1

    IN 2004, THE PT WAS IMPLANTED WITH THREE (3) GORE EXCLUDER BIFURCATED ENDOPROSTHESES. ON AN UNK DATE, AN UNK TEST SHOWED ANEURYSM GROWTH OF 2-3 MM. ENDOTENSION WAS SUSPECTED. IN 2009, THE PT UNDERWENT A REINTERVENTION TO RELINE THE ORIGINAL ENDOGRAFT SYSTEM. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 030910401

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention