It was reported that in 2017 a non-abbott stent was implanted in the superficial femoral artery (sfa).In 2020, 3 supera stents and 3 non-abbott stents were implanted in the sfa.On (b)(6) 2022, restenosis was noted in the non-abbott stent implanted in 2020, which resulted in thrombotic occlusion in the 3 implanted supera stents.Thrombectomy was performed to suction the thrombus and 3 additional supera stents were implanted, resolving the event.The patient did well with no adverse sequela.No additional information was provided.
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Date of implant ¿ estimated.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 thrombosis is listed in the supera peripheral stent system instructions for use (ifu) as a potential adverse effect of peripheral percutaneous intervention.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.The 2 other supera stents are filed under a separate medwatch report.
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