It was reported that on (b)(6) 2013, the patient underwent a stenting procedure with placement of a 7-10 x 40 mm rx acculink stent in the left internal carotid artery.On (b)(6) 2014, bilateral carotid duplex ultrasound was performed and noted in-stent restenosis in the acculink stent.Diagnostic angiography was performed on (b)(6) 2014 and noted in-stent restenosis.On (b)(6) 2014, the patient was re-hospitalized for percutaneous transluminal angioplasty at the target lesion and the patient condition resolved.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.
|