It was reported that on (b)(6) 2013, the patient underwent a stenting procedure with placement of a 6-8 x 40 mm acculink stent in the moderately calcified right internal carotid artery.On (b)(6) 2014, the patient presented to the emergency room with left-sided facial numbness.The patient was re-hospitalized and in-stent restenosis was noted in the acculink stent.Revascularization was performed with an additional non-abbott stent implanted at the target lesion.The patient condition resolved on (b)(6) 2014 and the patient was discharged to home.No additional information was provided.
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported device malfunction, and the product was not returned.The reported patient effects of neurological deficit/dysfunction and stenosis are known observed and potential patient effects 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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