Catalog Number UNKNOWN RX ACCULINK |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bradycardia (1751); Headache (1880); Intracranial Hemorrhage (1891); Low Blood Pressure/ Hypotension (1914); Neurological Deficit/Dysfunction (1982)
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Event Date 10/01/2012 |
Event Type
Injury
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Manufacturer Narrative
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Dates estimated the additional devices referenced are being filed under separate medwatch report #s.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.The reported patient effects of hemorrhage, neurological deficit / dysfunction, bradycardia, hypotension, and headache are listed in the rx acculink instructions for use as known potential patients effects associated with the use of the device.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The additional treatment, treatment with medications and hospitalization were likely due to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.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 stentingna.
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Event Description
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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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Search Alerts/Recalls
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