It was reported that on (b)(6) 2012, the patient underwent a stenting procedure with placement of a 9.0 x 40 mm acculink stent in the left internal carotid artery.On (b)(6) 2014, the patient was rehospitalized.Angiography was performed and 70% in-stent restenosis was noted.Percutaneous transluminal angioplasty was performed at the target lesion and the patient condition resolved on (b)(6) 2014.The patient was discharged to home.No additional information was provided.
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(b)(4).It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.The reported patient effect of stenosis is a known observed and potential patient effect as listed in the electronic instructions for use, rx acculink, domestic.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.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A similar incident query is not required as the complaint details and the lot history record review did not reveal a potential device issue related to the reported incident.Based on the information reviewed, there is no indication of a product deficiency.
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