It was reported that on (b)(6) 2013 an rx acculink stent was implanted in the right internal carotid artery.On (b)(6) 2013, the patient experienced left sided weakness and was hospitalized.During hospitalization, the patient was treated with tissue plasminogen activator (tpa) for stroke symptoms.Magnetic resonance imaging (mri), computed tomography (ct) scan and ultrasound were performed, showing the distal portion of the stent was occluded.No further treatment was provided at the time as the patient had a patent right communicating artery.On (b)(6) 2013, the patient was discharged.The condition is noted to be continuing.There was no additional information provided.
|
(b)(4).There was no reported device malfunction and the product was not returned.The reported patient effects cerebrovascular accident and stenosis are known observed and potential patient effects as listed in the instructions for use (ifu).Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality deficiency with respect to manufacturing, design or labeling.
|