On (b)(6) 2014, the subject underwent the index procedure on a 180mm, 90% stenotic de-novo lesion of the left mid-sfa.The subject was randomized to the bare balloon.The lesion was pre-dilated with an unknown 4x50 pta balloon resulting in a residual stenosis of 30%.The 5x120 evercross pta balloon was inserted and inflated to 10 atm for 5 minutes resulting in 0% residual stenosis.Following that, another 5x080 evercross pta balloon was inserted and inflated to 10 atm for 10 minutes resulting in 0% stenosis.The subject was discharged on (b)(6) 2014 with no complications.Third evercross balloon, 5x40, (lot number 9788708) was not inflated.Unknown reason.On (b)(6) 2017, the clinical site became aware that the subject had died on (b)(6) 2017.No additional information is available at this time.
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