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: 3008114965-2020-00149.Are related to the same incident.
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This complaint is from a literature source.As reported in the literature publication entitled, ¿vascular wall components in thrombi obtained by acute stroke thrombectomy: clinical significance and related factors.¿ 1 patient with acute stroke who underwent endovascular treatment experienced subarachnoid hemorrhage.Objective: the purpose of this study was to clarify the factors associated with vascular wall components (vwcs) in retrieved thrombi.Methods: consecutive acute stroke patients treated endovascularly using the penumbra aspiration catheter or stent retrievers (srs) at our institute from (b)(6) 2013 to (b)(6) 2016 were retrospectively reviewed, and the retrieved thrombi were evaluated histopathologically.
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