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.A conclusive cause for the reported patient effect(s), 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.The reported patient effect(s) of angina and stenosis are listed in the supera peripheral stent systems instructions for use as a potential adverse event.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) 2022, the 5.5x150 mm supera self expanding stent was implanted in the right superficial femoral artery (sfa) with calcification and 90% stenosis.Less than 365 days later, on (b)(6) 2023, revascularization was performed in the supera stent and the patient was experiencing angina.Atherectomy was performed and then angioplasty performed to treat the area.There were no reported adverse patient sequela.No additional information was provided.
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