It was reported through a research article, identifying the supera peripheral stent system as follows: in july 2019, patient presented with bilateral intermittent claudication (rutherford classification 3).A 5.5x80mm and a 6.0x80mm supera self-expanding stent and two non-abbott stents were implanted in the right superficial femoral artery (sfa).A 5.5x120mm supera stent, along with two non-abbott stents were implanted in the left superficial femoral arteries, resolving the intermittent claudication.Six months after stent implantation, the patient experienced intermittent claudication and was hospitalized.In-stent restenosis (isr) was observed at the supera stent sites.Balloon angioplasty was performed and stents were implanted resolving the restenosis and claudication.Details are listed in the article, titled clinical performance of polymer-coated paclitaxel-eluting stent implanted for diffuse and calcified superficial femoral artery stenotic lesions: insights from a patient on hemodialysis.
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The device was not returned for analysis.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 restenosis is listed in the supera instructions for use, as a known potential patient effect associated with the use of the device.In this case, there was no reported device malfunction associated with the supera self-expanding stent system (sess).Based on the case information, a conclusive cause for the reported patient effects, 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.
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