Manufacturer's investigation conclusion: the report of an obstruction could not be confirmed.The graft remains in use and no product or echo images were available for evaluation.Graft preparation and implantation are addressed in the vectra vascular access graft (vag) instructions for use (ifu) (rev u).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.The cannulation section of the ifu states that vectra grafts may be punctured for vascular access within 24 hours after implant, provided no contraindications are present.If the blood access needle is inserted such that the angle between the needle axis and the graft is too small, tears in the wall of the graft can occur.This section advises to rotate cannulation sites.Repeated cannulation in the same area may lead to damage of the graft wall and/or formation of hematoma or pseudoaneurysm.Need sites should be equally spaced along the subcutaneous length of the graft.No further information was provided.The manufacturer is closing the file on this event.
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