The patient required revascularization of the treated lesion.This is being reported as a follow-up to the clinical study.Stellarex 0.035 otw drug-coated angioplasty balloon, paclitaxel drug, 3.2 mg, therapy date: (b)(6) 2015, the stellarex 0.035¿ otw drug-coated angioplasty balloon is indicated for the treatment of de-novo or re-stenotic lesions in the lower extremities to establish blood flow and to maintain vessel patency.Lot #: 14m0860801, expiration date: 06/14/2015, udi and pma numbers are not applicable.This device was used in clinical application prior to being available in the us.(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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It was reported through a clinical study that during the index procedure on (b)(6) 2015, a stellarex catheter was used to treat the target lesion of the right popliteal.Approximately 31 months post index procedure, the patient underwent a successful revascularization of the target lesion on (b)(6) 2017.Then, approximately 36 months post index procedure, the patient experienced ''arterial stenosis of target limb and target lesion''.A successful revascularization of the target lesion was performed on (b)(6) 2018.The physician indicated this is not related to the study device or procedure.
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