The patient required revascularization of the target lesion.This is being reported as a follow-up to the clinical study.Cross reference mfr report numbers: 3009784280-2019-00754, 3009784280-2019-00756, 3009784280-2019-00757, 3009784280-2019-00758.Report source: foreign- (b)(6)/ study name: (b)(6): patient id (b)(6).Pma number is not applicable.The device is a non-commercial product with a ce mark that was used as part of a clinical study.During the index procedure, the product worked as intended and the device was discarded, thus no product evaluation was performed.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) 2017, four stellarex catheters were used to treat the target lesion of the right proximal, mid, and distal sfa and popliteal, p1 and p3.Approximately 24 months post index procedure, the patient experienced restenosis.A successful revascularization of the target lesion was performed on (b)(6) 2019.
|