Manufacturer's ref.No : (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.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Cerenovus manufacturer's report numbers: 1226348-2021-00044, 1226348-2021-00045, 1226348-2021-00047, 1226348-2021-00048, 1226348-2021-00049, 1226348-2021-00050.Are related to the same incident.
|
This complaint is from a literature source.The following complications were reported in this publication: it was reported that 1 patient underwent stent-assisted coil embolization of an unruptured intracranial aneurysm and suffered parietal hematoma (cerebral hemorrhage) after 2 weeks post procedure.Intervention was not reported.Model and catalog number are not available, but the suspected device is enterprise.Other cnv devices that were also used in this study: none.Non-cnv devices that were also used in this study: solitaire ab, lvis (microvention).Publication details: title: microbleeds after stent-assisted coil embolization of unruptured intracranial aneurysms: incidence, risk factors and the role of thromboelastography.Objective: to analyze the incidence and risk factors of microbleeds lesions and to use thromboelastography (teg) to evaluate the relationship between perioperative platelet function and microbleed events in patients with unruptured intracranial aneurysms (uias) undergoing stent-assisted coil (sac) embolization.Methods: we retrospectively enrolled 261 patients with uias undergoing sac embolization between november 2017 and october 2019.All patients received unanimous antiplatelet protocol (aspirin 300 mg and clopidogrel 300 mg).Platelet function was evaluated by teg, and magnetic resonance susceptibility-weighted imaging (swi) was performed for microbleeds detection before and after surgery.Univariate and multivariate logistic regression analyses were used to identify potential risk factors for microbleeds following embolization.
|