The patient required revascularization of the treated vessel.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.Stellarex 0.035 otw drug-coated angioplasty balloon.Paclitaxel drug, 2.6 mg.Therapy date: (b(6) 2017.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 #: fbw17b15a.Expiration date: 03/09/2019.(b(4).(b(6).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) 2017, two stellarex catheters were used to treat the target lesion of the right mid and distal sfa.Approximately 6 months post index procedure, the patient experienced an occlusion.A successful revascularization of the target vessel was performed on (b(6) 2017.
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