The patient required revascularization of the treated lesion and a hematoma was noted.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, 3.9 mg.Therapy date: (b)(6) 2017.Adjunct to pta in the treatment of denovo or post pta occluded/ stenotic or restenotic lesions (excluding in-stent) in fem-pop arteries.Lot #: fwv16l18a.Expiration date: 12/02/2018.(b)(4).Foreign- (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 and hematoma are listed as a potential complications/adverse events.
|
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 left mid and distal sfa.The patient reported unchanged claudication symptoms.Duplex ultrasound showed a localized re-occlusion of the sfa and left popliteal artery.A successful revascularization of the target lesion was performed on (b)(6) 2017.After the revascularization, a large hematoma was visible in the area of the puncture site; however, this was stable in size under conservative measures.The physician indicated this is not related to the study device or procedure.
|