(b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Information regarding patient weight, height, medical history, race, and ethnicity was not reported cerenovus manufacturer's report numbers: 3008114965-2020-00101, 3008114965-2020-00102.Are related to the same incident.(b)(4).
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This complaint is from a literature source.As reported in the literature publication entitled, ¿comparison of aspiration versus stent retriever thrombectomy as the preferred strategy for patients with acute terminal internal carotid artery occlusion: a propensity score matching analysis¿ 6 patients with acute terminal internal carotid artery occlusion who underwent stent retriever thrombectomy (from the stent retriever thrombectomy group) experienced intracerebral hemorrhage.The purpose of this study was to evaluate the comparative safety and efficacy of preferred aspiration thrombectomy and stent retriever thrombectomy for revascularization in patients with isolated terminal ica occlusion.Materials and methods: a retrospective analysis of patients with terminal ica occlusion treated with aspiration thrombectomy or stent retriever thrombectomy was performed, from (b)(6) 2013 to (b)(6) 2018.
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