The patient required revascularization of the treated lesion.This is being reported as a follow-up to the clinical study.Patient information regarding relevant tests or laboratory data is unknown.This information was not available from the facility.Availability to enter this information in section c is still work in progress at spnc, thus the drug information is noted below: stellarex 0.035 otw drug-coated angioplasty balloon.Paclitaxel drug, 2.6 mg.Therapy date: 08/07/2014.The stellarex 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 #:14f0450802.Expiration date: 12/09/2014.(b)(4).Udi and pma numbers are not applicable.This device was used in clinical application prior to being available in the us.Foreign- (b)(4) / study name- (b)(6).(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) 2014, two stellarex catheters were used to treat the target lesion of the left proximal and distal sfa.Approximately 38 months post index procedure, the patient experienced a restenosis.A successful revascularization of the target lesion was performed on (b)(6) 2017.The physician indicated this is not related to the study device or procedure.
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