Manufacturer's investigation conclusion: the ¿suspended matter¿ visible in the submitted images was unable to be identified.The distributor reported that the graft was implanted in the patient¿s forearm on (b)(6) 2019.During a regular follow-up on 24mar2021, an ultrasound reviewed ¿suspended matter¿ in the graft lumen.It was reported that there were no changes in patient condition or anticoagulation that would have contributed to the observation.A still image and video of the ultrasound screen were submitted for review.The cross-sectional view of the vessel appeared to show line-shaped objects overlapping across the center of the lumen.The longitudinal view appeared to show the overlapping objects extending down an unknown length of the graft.The objects were unable to be identified based on review of the imagery.It was reported that there was no issue with patient¿s subsequent medical care following the observation and there are no actions planned to address the issue.No further issues have been reported.Review of the device history records showed no deviations from manufacturing or qa specifications, including visual and dimensional inspection.Graft preparation and implantation are addressed in the vectra vascular access graft (vag) instructions for use (ifu).The ifu states that the graft should not be pulled (axially elongated) or stretched during handling at implantation.The graft should be trimmed long enough to prevent stress on the anastomosis and allow for a full range of body motion when implanted.Excessive elongation or stretching of the graft will damage the microporous layers of the graft.Occlusion, stenosis, and thrombosis are listed as potential complications with the use of a vascular prosthesis.Intragraft obstruction is listed as a potential complication in table 2 in the summary of vectra vag clinical experience section of the ifu.No further information was provided.The manufacturer is closing the file on this event.
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