The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.The reported patient effects of restenosis, sepsis, occlusion, amputation or limb loss are listed in the supera instructions for use as known potential adverse effects of peripheral percutaneous intervention.Based on the case information, a conclusive cause for the reported stenosis, occlusion, sepsis and amputation, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The udi # is unknown as the part and lot #s were not provided.The patient deaths referenced are being filed under a separate medwatch report #.Literature article title "treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: midterm results from the leipzig supera 500 registry".
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It was reported through a research article that supera stents may be related to death, sepsis, pneumonia, leg amputations, restenosis, occlusions, hospitalizations, medication and intervention.This article summarizes clinical outcomes of 470 patients that were treated with supera stents.Specific patient information is documented as unknown.Details are listed in the article titled: "treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: midterm results from the leipzig supera 500 registry.'.
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