At the two year follow-up, a duplex ultrasound showed a calcified plaque in the treated lesion.As a result, the patient required revascularization using a pta balloon, stent implantation, and atherectomy.The drug information is noted below: stellarex 0.035 otw drug-coated angioplasty balloon, paclitaxel drug, 2.6 mg, therapy date: (b)(6) 2015, adjunct to pta in the treatment of denovo or post pta occluded/ stenotic or restenotic lesions (excluding in-stent) in fem-pop arteries, lot #: 15a0550802, expiration date: 07/08/2015.Udi and pma numbers are not applicable.This device was used in clinical application prior to being available in the us.Study name- (b)(6), patient (b)(6).Combination product is applicable.During the index procedure, the product worked as intended, thus no product evaluation was required.Per the ifu, restenosis is listed as a potential complications/adverse events.
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On (b)(6) 2015, the patient underwent the index procedure for treatment of a 140 mm, 90% stenotic denovo lesion in the right mid-sfa.The lesion was predilated initially with a 5 x 120 mm balloon at 8 atm and using a second 5 x 120 mm balloon which was inflated two times.Residual stenosis following predilatation was 60%.Next, a 6 x 120 mm stellarex balloon was inflated to 8 atm for 5 minutes.Then, a second stellarex 5 x 80 mm balloon was inflated to 6 atm for 5 minutes, resulting in a residual stenosis of 10%.No complications occurred and the subject was discharged as per plan on (b)(6) 2015.At the 2 year follow-up visit on (b)(6) 2017, a duplex ultrasound showed calcified plaque in the right mid sfa.On (b)(6) 2017, the patient complained of bilateral lower extremity claudication.On (b)(6) 2017, the patient underwent a successful revascularization procedure of the right mid sfa using pta, stent implantation and atherectomy.The physician has indicated that it is unlikely that the event is related to the device or procedure.
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