The patient required revascularization of the treated vessel.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 the report 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: (b)(6) 2013, adjunct to pta in the treatment of denovo or post pta occluded/ stenotic or restenotic lesions (excluding in-stent) in fem-pop arteries, lot #: 310k50801, expiration date: 02/06/2013.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.
|
It was reported through a clinical study that during the index procedure on (b)(6) 2013, two stellarex catheters were used to treat the target lesion of the left distal sfa.Approximately 48 months after the index procedure, the treated vessel was occluded.A successful revascularization of the treated vessel was performed on (b)(6) 2017.The physician indicated that this is not related to the procedure, but possibly related to the study device.
|