Medtronic received information regarding difficulty with positioning of a pipeline device and failure of the middle segment to open.
The patient was undergoing a procedure for flow diverter implantation to treat an unruptured saccular aneurysm of an internal carotid artery (ica) c3 segment.
The aneurysm max diameter was 11.
42mm and theneck diameter was 4.
2mm.
the blood vessel diameter of m1 was about 3mm, and the blood vessel diameter from the internal carotid (ic) top to the ophthalmic artery was about 4mm.
Vessel tortuosity was moderate.
It was reported that the pipeline flex with shield was prepared according to the instructions for use (ifu).
An attempt was made to deploy the ped in the m1 but the deployment was insufficient.
As the microcatheter was repeatedly raised and lowered from the sleeve to the middle of the pipeline, the distal end developed a trumpet shape and the middle section did not open at all.
It was thought the device was possibly damaged so it was retrieved and replaced with a different lot.
However, the replacement pipeline also had difficulties with deployment resistance with the sleeve.
It was considered that the pipeline size might not be correct so the device was resheathed to retrieve.
During retrieval, the pushwire broke so the device and microcatheter were removed together.
Another device was used to complete the event.
There was no harm or injury to the patient.
Post-operative angiography was normal.
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