The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of stenosis is listed in the supera peripheral stent system instructions for use as a potential adverse event.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that on (b)(6) 2021 a 6x150mm supera peripheral self-expanding stent system (sess) was implanted in the mildly calcified, 87% stenosed left superficial femoral artery (sfa) without issue.On (b)(6) 2022 the patient presented with in-stent restenosis.Atherectomy was performed, followed by percutaneous transluminal angioplasty (pta), and an absolute pro self-expanding stent system (sess) was implanted without issue.There was no adverse patient sequela.No additional information was provided.
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