The patient required revascularization of the target lesion.This is being reported as a follow-up to the clinical registry.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.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 registry.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 registry that during the index procedure on (b)(6) 2019, a stellarex catheter was used to treat the target lesion of the right proximal and mid sfa.Approximately 7 months post index procedure, the patient experienced restenosis.A successful revascularization of the target lesion was performed on (b)(6) 2019.
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