It was reported that on (b)(6) 2012, the patient underwent a stenting procedure with placement of a 6-8 x 30 mm acculink stent in the left internal carotid artery.On (b)(6) 2014, diagnostic angiography was performed and in-stent restenosis was noted in the acculink stent.On (b)(6) 2014, the patient was re-hospitalized and revascularization was performed at the target lesion.The patient condition resolved on (b)(6) 2014 and the patient was discharged the following day.No additional information was provided.
|
(b)(4).There was no reported device malfunction, and the product was not returned.The reported patient effect of stenosis is a known observed and potential patient effect as listed in the rx acculink, domestic, 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.
|