The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the neuron max system include, but are not limited to, hematoma or hemorrhage at the site, acute occlusion, intracranial hemorrhage, ischemia, including death.Therefore, it was determined that the reported adverse events were anticipated complications.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.
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Penumbra inc.Became aware on (b)(6) 2020 during its post-market surveillance activities of a neurosurgery journal article titled, "transradial approach for complex anterior and posterior circulation interventions: technical nuances and feasibility of using current devices" (snelling, et al.2019).It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints.Therefore, this report addresses all malfunctions and/or adverse events within this literature source.The patient in the first event underwent a thrombectomy procedure.Post-procedural testing following the use of a neuron max 6f 088 long sheath (neuron max) revealed a radial artery occlusion (rao), despite the use of anti-spasmolytics and patent hemostasis.However, no hand ischemia was seen.It was also reported that the patient eventually failed the transfemoral approach (tfa) due to significant aortic arch tortuosity when the physician attempted to cross over to this approach.It is unclear how this procedure was completed; however, there was no report of an adverse effect to the patient in this case.
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