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.Cerenovus manufacturer's report numbers: 3008114965-2020-00138.3008114965-2020-00139.3008114965-2020-00140.3008114965-2020-00142.Are related to the same incident.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.
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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.¿ 1 patient with acute ischemic stroke who was treated with the revive se experienced post-procedure subarachnoid hemorrhage.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 january 2017 the study planned to enroll 100 patients with acute ischemic stroke who were treated with the revive se as a first pass.
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