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: 3008114965-2020-00200.3008114965-2020-00202.3008114965-2020-00203.3008114965-2020-00204.3008114965-2020-00205.3008114965-2020-00206.Are related to the same incident.
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This complaint is from a literature source.As reported in the literature publication entitled, ¿mechanical thrombectomy for ischaemic stroke: the first uk case series.¿ 1 patient with acute ischemic stroke who underwent endovascular treatment with thrombectomy experienced vasospasm in the basilar artery (ba).Purpose: endovascular treatments have the potential to accelerate reperfusion in acute ischaemic stroke with large vessel occlusion.Results of the first 106 endovascular treatments (evt) in the uk were presented in the article.Methods: from december 2009 to january 2013 106 patients (mean age 64 years, median baseline nihss 18) were treated with evt (thrombectomy ± iat 83%, iat (intra-arterial thrombolysis) alone 13%, neither 4%).
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