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: 3008114965-2020-00138.3008114965-2020-00139.3008114965-2020-00140.3008114965-2020-00141.Are related to the same incident.
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This complaint is from a literature source.As reported in the literature publication entitled, ¿effectiveness of revive se in the rapid registry revive acute ischemic stroke patients immediately (rapid) prospective multicenter trial.¿ 2 patients with acute ischemic stroke who were treated with the revive se experienced symptomatic intracranial hemorrhage (sich) within 24h.Purpose the prospective, multicenter revive acute ischemic stroke patients immediately (rapid) trial was carried out to evaluate the real-world safety and efficacy of the revive se stent retriever.Methods from (b)(6) 2017 the study planned to enroll 100 patients with acute ischemic stroke who were treated with the revive se as a first pass.Cerenovus devices (revive stent retrievers) were used in this study.No devices specific information (including catalog and the lot number) were provided in the article.
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