Medtronic (covidien) received information that during a flow diversion treatment of a left unruptured internal carotid artery (ica) cavernous and ophthalmic segment wide neck, fusiform aneurysm, the physician observed that the green coating was detached from the delivery wire after two pipeline devices were delivered.Both of the pipeline devices were implanted successfully.The physician did not experience any difficulties during the delivery of the devices; however the physician felt resistance trying to pull the system out of patient in the entire parts of both catheters.The loose coat pieces were found in the microcatheter and the rhv.One pushwire with the coating loose problem was sent for device investigation.The other pushwire and the microcatheters were discarded.No patient injury was reported as a result of this procedure.
|