During its post-market surveillance activities on (b)(6) 2022, penumbra inc.Became aware of a journal article titled, "endovascular treatment of medium and large intracranial aneurysms with large volume coils: a single center experience" (saal-zapata et al.2022).In this single center retrospective review, thirty-three patients with ruptured and unruptured intracranial aneurysms were treated between november 2017 and september 2019 using penumbra coil 400s (pc400s), a penumbra coil detachment handle (handle), a px slim delivery microcatheter (px slim), a neuron max 6f 088 long sheath (neuron max) and a guidewire (0.014¿).One patient who underwent a stent-assisted coiling (sac) procedure to treat a ruptured paraclinoid aneurysm using pc400s experienced intraprocedural coil protrusion into the parent artery.Despite stenting, internal carotid artery (ica) thrombosis occurred without clinical consequences due to a patent anterior communicating artery (aca).It was also reported that one pc400 migrated within the vessel, but without clinical consequences.It was not possible to ascertain specific device information from the article, nor to match the events reported with previously reported complaints.Therefore, this report addresses all malfunctions and/or adverse events within this literature source.
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