(b)(6) study.
It was reported that dissection occurred.
In (b)(6) 2018, the subject¿s qualifying condition as rutherford category 2.
In (b)(6) 2018 the index procedure was performed.
Target lesion #1 was located in the right superficial femoral artery (sfa) had 99% stenosis, reference vessel diameter of 6 mm, a length of 110 mm, and tasc ii lesion classification was unknown.
Target lesion #1 was treated with pre-dilatation using 6 mm x 220 mm balloon and standard percutaneous transluminal angioplasty (pta) was performed with 6 mm x 220 mm sterling¿ balloon.
Post- dilatation was performed using 6 mm x 220 mm balloon and following this, a grade 'd' dissection was noted.
Grade d dissection was treated with bare metal stent bailout.
The event was considered recovered/resolved.
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