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 the 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: 3008114965-2020-00151.3008114965-2020-00152.3011370111-2020-00034.3008114965-2020-00153.3011370111-2020-00035.Are related to the same incident.
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This complaint is from a literature source.As reported in the literature publication entitled, ¿recanalization rate per retrieval attempt in mechanical thrombectomy for acute ischemic stroke.¿ 2 patients with acute ischemic stroke from 0¿2a group who underwent mechanical thrombectomy experienced subarachnoid hemorrhage.This study assessed the recanalization rate and clinical outcome per retrieval maneuver.Methods¿in this analysis, 330 patients with acute large vessel occlusion treated exclusively with stentrieval devices were included.Successful recanalization was defined as thrombolysis in cerebral infarction 2b-3, a good clinical outcome was defined as modified rankin scale at 90 days of =2.
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