Manufacturer's investigation conclusion: the report of a reinforcing thread in the lumen of the graft could not be confirmed.The customer reported that a linear material was observed in the lumen of the graft via echocardiography.It was indicated that this was the fourth occurrence of this observation with the patient and was believed to be caused by the graft being punctured during dialysis.It was also noted that blood flow was low and thrombus tended to adhere in the area.The material was removed using biopsy forceps.A photograph and infrared spectrum were provided for review.The photo appeared to show a strand of material consistent with the reinforcing monofilament.The provided spectrum was dated 12oct2022 and was reportedly comparing the material removed from the patient¿s graft to a sample of the monofilament, which appeared to be a match.However, the files provided for review appeared to be from one of the patient¿s prior incidents and not the event on 28dec2022.The device history records could not be reviewed because the lot number of the graft was reported to be unknown.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.Needle 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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