Explant investigation: a fragment was returned to w.L.Gore & associates for investigation.Submitted in formalin was a gore-tex stretch vascular graft fragment.The device fragment had been transected, prior to arrival at w.L.Gore and associates.The abluminal surface was generally devoid of tissue, except for scattered, plagues of tan/brown tissue.The lumen was generally devoid of tissue, with small fragments of white/tan to red/brown gelatinous tissue scattered on the luminal surface.The lumen was widely patent.Histopathological examination of one transverse section was performed.The gross and microscopic observations of proteinaceous fluid within the eptfe graft interstices and acellular protein coagulum on the abluminal surface was consistent with the clinical assessment of graft seroma.There was no evidence of inflammation or collagenous organization within the graft or abluminal coagulum.The fragment was subjected to an enzymatic digestion process to remove biologic debris.Following digestion, the fragment was examined for material disruptions with the aid of a stereomicroscope.The material disruptions identified were consistent with interaction with surgical instrumentation, likely used during a surgical procedure.Disruptions identified were not associated with handling or manufacturing process at w.L.Gore & associates.The disruptions are consistent with a surgical procedure.No disruptions that would contribute to seroma were identified on the returned fragment.The cause of the seroma could not be determined with the information provided.
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