It was reported that a ped-425-12 and a ped-450-10 were implanted into the cavernous segment of the internal carotid artery (ica) with no issues.A third pipeline was then selected (ped-475-10), prepared per the instructions for use (ifu), and delivered to the aneurysm site.It was noticed the distal segment of the pipeline failed to open upon unsheathing from the phenom 27 catheter.The pipeline was not positioned in a bend, less than 50% was opened, resheathing was performed less than three times, and no additional steps were taken in an attempt to open the pipeline.The doctor removed the pipeline from the patient.There was no injury to the patient, and post-procedure angiography showed the aneurysm neck was covered with the two implanted pipelines.The patient was undergoing surgery for treatment of a saccular, thrombosed aneurysm of the right cavernous segment of the ica with a max diameter of 6 mm and a 3 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was within acceptable levels.
|