It was reported that the procedure was to treat a superficial femoral artery (sfa) and a popliteal artery performed on (b)(6) 2014.The sfa was treated with a 5.5 x 60 mm supera stent and the popliteal was treated with a 4.5 x 100 mm supera stent.There were no issues during the procedure.On (b)(6) 2014, the patient presented with pain in the leg and no blood flow and on (b)(6) 2014, femoropopliteal bypass surgery was performed.Angiography was not performed to see if there was thrombosis or restenosis in the supera stents.It is unknown at this time why bypass was performed.No additional information was provided.
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other supera referenced is being filed under a separate medwatch mfr number.
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(b)(4).There was no reported device malfunction, and the product was not returned.The job traveler for the reported lot revealed no nonconforming reports (ncr).The reported patient effects of ischemia, occlusion, pain, and surgery are listed in the supera peripheral stent system, instructions for use (ifu).Although 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 deficiency.
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