Date of event: date is estimated.The additional devices referenced are being filed under separate medwatch report #s.The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the information provided in the research article, a conclusive cause for the difficulty withdrawing the epd could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The udi is unknown as the part and lot numbers were not provided.Attachment: article title: predictive values of carotid high-resolution magnetic resonance imaging for large embolus shedding in carotid artery stenting.
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It was reported through a research article identifying acculink that may be related to the following: patient hyperperfusion, intracranial hemorrhage, bradycardia, hypotension, headache, neurological deficit, medication, revascularization, and rehospitalization.Additionally, it was identified that accunet and emboshield nav6 may be related to the following: difficulty withdrawing the systems.This article summarizes clinical outcomes of 195 patients that were treated with acculink stents and accunet/emboshield nav6 embolic protection systems.Specific patient information is documented as unknown.Details are listed in the attached article, titled "predictive values of carotid high-resolution magnetic resonance imaging for large embolus shedding in carotid artery stenting.".
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