The device is available, but has still not been received at the manufacturer for further investigation.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
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Phr: a review of the manufacturing records indicated the lot met all pre-release specifications.Explant investigation: the device fragment was returned to w.L.Gore & associates for investigation.Submitted in formalin was a gore propaten vascular graft fragment (vgf).Vgf had been transected at both extremities prior to arrival at w.L.Gore & associates.A section of light tan to yellow artery was present, around the abluminal device surface.The abluminal surface had mild amounts of tan/brown fibrous, connective tissue and scant, tan/brown, adherent, soft tissue.Mild amounts of tan/brown soft tissue were observed, partially occupying the lumen.The lumen was patent (verified via running water test).Four histopathological specimens were collected from vgf and histopathologic analysis was complete.The examined sections of vgf exhibited normal healing traits of an outer covering of mature fibrous connective tissue with minimal foreign body inflammatory response along the abluminal aspect of the graft (eptfe).The observed lumina were patent with mild accumulations of fibrin thrombus.Microbial agents were observed, however, there was a lack of an inflammatory response to the microbes, which were most likely post-explant environmental contamination and overgrowth of bacteria.Vgf was subjected to an enzymatic digestion process to remove biologic debris.Following digestion, vgf was examined for material disruptions with the aid of a stereomicroscope.Multiple material disruptions were identified (i.E., transections, forceps marks, suture needling holes/pull-through holes, radial film disruption), which were consistent with those caused by interaction with surgical instruments (i.E., scissors/scalpel, forceps/clamps, suture needle), likely used during a surgical procedure.An area with multifocal radial film disruptions was also identified.The time and cause of these radial film disruptions could not be identified.The disruptions identified were not associated with handling or manufacturing process at w.L.Gore & associates.
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