Medtronic received report of intraprocedural pipeline flex failure to open as well as vessel occlusion.The patient was undergoing flow diversion treatment of an unruptured, amorphous aneurysm in the right, cavernous internal carotid artery (ica).Vessel tortuosity was described as severe.The aneurysm max.Diameter was 20 mm and neck diameter was 11 mm.The landing zone was 3 mm distal and 4.9 mm proximal.The patient had been administered dual antiplatelets and was within the therapeutic range.The devices were prepared as indicated in the ifu.A pipeline flex 5 x 30 mm was attempted to be placed.The pipeline flex reportedly did not open on the distal end when initially deployed.After full deployment, the proximal end was also flattened.When capturing the delivery wire, the catheter was used to open up the flattened proximal section of the pipeline flex.To open the distal end, a j-curve wire was used then balloon angioplasty, which resulted in the pipeline flex opening and apposing to the vessel wall.When the balloon was deflated, the vessels distal to the pipeline flex (pcom, distal ica, anterior cerebral artery) were occluded.A balloon was inflated at the occlusion site to open the distal ica.Afterward, an aspiration catheter was passed several times removing clot.A reopro bolus was administered and a continuous drip was set up.Image runs were performed over a period of 30-45 minutes to determine effectiveness of the reopro.At the end, some branches of the aca and right pcom were not filling when the patient was removed from the table.The next day, the patient was not moving on the left side.The patient reportedly experienced nerve palsy.
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