It was reported that on (b)(6) 2013, the patient underwent a stenting procedure with placement of a 7-10 x 40 mm acculink stent in the left internal carotid artery.On (b)(6) 2014, in-stent restenosis was noted in the acculink stent.The patient was re-hospitalized on (b)(6) 2014 for a revascularization procedure at the target lesion.The patient condition resolved on (b)(6) 2014 and the patient was discharged to home on (b)(6) 2014.No additional information was provided.
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(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.
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