Product complaint # (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 no lot number was provided by the customer.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission. information regarding patient weight, height, medical history, race, and ethnicity was not reported.Cerenovus manufacturer's report numbers: 3008114965-2020-00155.Are related to the same incident.
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This complaint is from a literature source.As reported in the literature publication entitled, ¿comparing outcome and recanalization results in patients with anterior circulation stroke following endovascular treatment with and without a treatment with rt-pa: a single-center study.¿ 2 patients with acute ischemic stroke who underwent endovascular treatment (et-group) experienced symptomatic intracerebral hemorrhage.Objectives comparison of et with iv rt-pa versus et alone in patients with stroke is done using a proximal intracranial arterial occlusion (internal carotid artery, middle cerebral artery (m1-segment)).Methods: during a 5-year period (2011¿2016), 236 patients who undergoing endovascular treatment (et) with or without intravenous recombinant tissue plasminogen activator iv rt-pa were included and analyzed.
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