It was reported via a research article that 341 patients who had rutherford class 2 to 6 peripheral artery disease and underwent endovascular therapy (evt) with either covered stent-graft (csg) or supera peripheral stent (sps) for femoropopliteal lesions.The aim of this study was to compare the safety and efficacy between csg and sps in calcified femoropopliteal lesions in clinical practice.The primary outcome measure was freedom from loss of primary patency and the secondary outcome measures included freedom from target lesion revascularization (tlr), limb salvage (freedom from major amputation), and overall survival (freedom from all-cause mortality).Color doppler ultrasound was performed routinely at 6 and 12 months after evt to evaluate vascular patency.Post-procedure follow-ups reported the following adverse patient effects potentially related to the supera stents: death, restenosis, vascular intervention, vessel rupture after post-dilatation and major amputation (surgery).The article conclusion was that in patients with bilaterally calcified femoropopliteal lesions, 1-year primary patency was not significantly different between treatments using csg and sps after the propensity score matching.The interaction effect analysis suggested that csg might have a lower restenosis rate than sps in the subgroup with long calcification.Additional details can be found in the attached article, "retrospective multicenter comparison between viabahn covered stent-grafts and supera interwoven nitinol stents for endovascular treatment in severely calcified femoropopliteal artery disease: the armadillo study (adjusted retrospective comparison of scaffolds in calcified lesions).".
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D4.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record could not be conducted because the part and lot number was not provided.The reported patient effect of death is listed in the supera peripheral stent system instructions for use as a potential adverse effect of peripheral percutaneous intervention.A conclusive cause for the reported death 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 additional adverse patient effects referenced in b5 are captured under a separate medwatch report.Attachment: article titled "retrospective multicenter comparison between viabahn covered stent-grafts and supera interwoven nitinol stents for endovascular treatment in severely calcified femoropopliteal artery disease: the armadillo study (adjusted retrospective comparison of scaffolds in calcified lesions).".
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