BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1031156 · Received April 16, 2008

    Report

    Report Number
    2953161-2008-00074
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    May 3, 2001
    Report Date
    April 16, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK WAS NOT POSSIBLE SINCE THE DEVICE LOT NUMBER WAS UNAVAILABLE. ANEURYSM GROWTH IN THE ABSENCE OF ENDOLEAKS HAS BEEN DEFINED AS ENDOTENSION IN THE LITERATURE. 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. EVIDENCE SUPPORTING THIS HYPOTHESIS HAS BEEN GATHERED DURING SURGICAL CONVERSIONS, TRANSLUMBAR PUNCTURES OF THE AORTIC ABDOMINAL ANEURYSM, AND LAPAROSCOPIC EXPLORATION OF AORTIC ABDOMINAL ANEURYSM SAC CONTENTS. DUE TO THESE OBSERVATIONS, GORE ELECTED TO PROVIDE A DESIGN ENHANCEMENT TO THE ORIGINAL GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. THE DEVICE USED IN THIS PARTICULAR CASE WAS THE ORIGINAL GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. PLEASE NOTE ADDITIONAL DEVICE IMPLANTED IN THIS PT: PCT231416/LOT# UNK.

    Description of Event or Problem · 1

    IN 2001, THE PT WAS IMPLANTED WITH A GORE EXCLUDER BIFURCATED ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT AND CONTRALATERAL LEG COMPONENT. IT WAS REPORTED THAT THE ANEURYSM HAD GROWN FROM A PRE-OPERATIVE SIZE OF 49MM TO A CURRENT SIZE OF 60MM WITHOUT EVIDENCE OF AN ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES, INC. WLG325 UNK-54-2

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other