It was reported in a research article which evaluated 308 limbs which were implanted with a supera self expanding stent for calcified femoropopiteal lesions.The primary outcome measure was freedom from restenosis at 1 and 2 years and the secondary outcome measure was freedom from clinically driven target lesion revascularization.Clinical parameters with loss of patency were explored.There was death due to cardiovascular death, pneumonia and sepsis.Other adverse effects included transfusion-requiring bleeding, acute occlusion, distal emboli, major amputation, target lesion revascularization, and dissection.Stent elongation was documented as 3.5%.It was found that supera stents demonstrate clinically acceptable patency after sufficient pre-dilatation.Additional details can be found in the attached article "endovascular therapy with interwoven nitinol stent placement after predilation for heavily calcified femoropopliteal artery disease: results of the burdock study".
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B3: date of event has been estimated.The device was not returned for evaluation.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number was not provided.The reported patient effects of dissection, sepsis, hemorrhage, and embolism are listed in the supera peripheral stent system instructions for use (ifu) as potential adverse events.The investigation determined a conclusive cause for the reported stretched-stent cannot be determined.A conclusive cause for the reported dissection, sepsis, hemorrhage and embolism, and the relationship to the product, if any, cannot be determined.The treatment(s) 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 deaths reported in the article are captured under a separate medwatch report number.Literature attachment: article title: endovascular therapy with interwoven nitinol stent placement after predilation for heavily calcified femoropopliteal artery disease: results of the burdock study.
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