The patient required revascularization of the treated lesion.This is being reported as a follow-up to the clinical registry.Patient information regarding relevant tests or laboratory data is unknown.This information was not available from the facility.The drug information is noted below: stellarex 0.035 otw drug-coated angioplasty balloon; paclitaxel drug, 3.9 mg; therapy date: (b)(6) 2016; 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 #: fxx16j08a; expiration date: 09/16/2018; (b)(4).(b)(4).Pma number is not applicable.The device is commercial product with a ce mark that was used as part of a clinical registry./ 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 registry that during the index procedure on (b)(6) 2016, four stellarex catheters were used to treat the target lesion of the left proximal, mid, and distal sfa and pop.Approximately 5 months post index procedure, the patient experienced an occlusion.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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