The patient required stenting of the target lesion to treat an aneurysmatic dilatation.This is being reported as a follow-up to the clinical study.Availability to enter this information 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 m, therapy date: 01/28/2015.Adjunct to pta in the treatment of denovo or post pta occluded/ stenotic or restenotic lesions (excluding in-stent) in fem-pop arteries.Lot #: 14m1050801.Expiration date: 06/15/2015.Udi and pma numbers are not applicable.This device was used in clinical application prior to being available in the us.Foreign-(b)(6) / 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, aneurysm is listed as a potential complications/adverse events.
|
On (b)(6) 2015, the patient underwent an index procedure of a 100 mm, 100% stenotic denovo lesion of the right distal-sfa.The lesion was predilated with a 4 x 100 mm balloon inflated to 8 atm, resulting in a residual 40% stenosis.Next, a 5 x 80 mm stellarex balloon was inflated to 10 atm for 3 minutes, resulting in a residual 30% stenosis.Then, a 5 x 80 mm stellarex balloon was inflated to 10 atm for 3 minutes, resulting in a residual 30% stenosis.The lesion was post-dilated with a balloon inflated to 4 atm, with a final residual 15% stenosis.No complications occurred, the patient was discharged per plan.On (b)(6) 2017, the patient experienced a sudden onset of severe pain at the right lower limb, especially the foot and an aneurysmatic dilatation of 1.2 cm in the distal sfa was noted.On (b)(6) 2017, the patient was hospitalized and underwent successful stenting of an aneurysmatic dilatation of the distal sfa.The physician indicated that it was unlikely related to the device or index procedure.On (b)(6) 2017, spnc determined that the event may be related to the drug coating on the device, but not related to the index procedure.
|