The patient required revascularization of the target lesion.This is being reported as a follow-up to the clinical study.Report source: foreign- (b)(6)/ study name: (b)(6),patient id # (b)(6).Pma number is not applicable.The device is a 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.
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It was reported through a clinical study that during the index procedure on (b)(6) 2019, a stellarex catheter was used to treat the target lesion of the left mid sfa and tibioperoneal trunk.Approximately 8 months post index procedure, the patient experienced restenosis.A successful revascularization of the target lesion was performed on (b)(6) 2019.The physician indicated this is not related to the study device or procedure.
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