This patient was part of the durability post approval study two stents were deployed in the target lesion (b)(6) 2015.The target area was the left sfa.According to the source, the second stent listed was placed in the upper (proximal) sfa lesion in the upper portion of the thigh and the other was placed distally over a total occlusion.The distal stent was at the terminus of the proximal stent, so there is no gap between the two.Per source documents, "both stents opened up very nicely." however, there was right groin pain that was indurated and erythematous, along with a right groin wound.Bedside incision, iv antibiotics, and drainage of the wound were performed.The event was noted as resolved on (b)(6) 2015.The right common femoral was normal in course and caliber.Per source this event is related to the index procedure, but not related to study device or requirements.
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