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.
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This complaint is from a literature source.As reported in the literature publication entitled, ¿factors associated with postprocedural diffusion-weighted imaging positive lesions in endovascular treatment for unruptured cerebral aneurysms keisuke.31 patients with cerebral aneurysms who underwent stent-assisted coil embolization with stents enterprise experienced asymptomatic thromboembolic lesions detected by postprocedural diffusion-weighted imaging (dwi).The aim of this study was to clarify factors associated with postprocedural dwi-positive lesions in endovascular treatment for unruptured cerebral aneurysms.Methods: patients with untreated unruptured cerebral aneurysms undergoing endovascular treatment were consecutively enrolled.Treatment techniques were classified into simple coiling, balloon-assisted coiling, stent-assisted coiling, and flow-diverter placement.Head magnetic resonance imaging was performed within 3 months before and 24 hours after the procedure to assess the appearance of dwi-positive lesions.
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