During its post-market surveillance activities on (b)(6) 2022, penumbra inc.Became aware of a journal article titled, "functional outcome after minimally invasive endoscopic evacuation of thalamic intracerebral hemorrhage" (song et al.2021).In this single center retrospective review, fifteen patients underwent minimally invasive endoscopic evacuation (mis) to treat spontaneous intracerebral hemorrhage (ich) using the apollo system and six patients were treated using the artemis neuro evacuation device (artemis) between december 2015 and october 2018.It was reported that two patients experienced ventriculitis.However, the relationship between the ventriculitis and the penumbra device was not specified.Additionally, one patient experienced a seizure.However, the relationship between the seizure and the penumbra device was not specified.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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From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported events.The product lot numbers for both the devices were not provided, therefore, the manufacturing records could not be reviewed.Potential adverse events in the labeling with the artemis neuro evacuation device include, but are not limited to, hematoma expansion, intraventricular hemorrhage, edema, re-bleeding, infections, seizures, thromboembolic events, including death.Potential adverse events in the labeling with the apollo system include, but are not limited to, hematoma expansion, intraventricular hemorrhage, edema, re-bleeding, infections, seizures, thromboembolic events, including death.This report is associated with mfr report number: 3005168196-2022-00312.
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