The patient required revascularization of the target lesion.This is being reported as a follow-up to the clinical registry.Cross reference mfr report numbers: 3009784280-2019-00720, 3009784280-2019-00721, 3009784280-2019-00722.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) 2017, three stellarex catheters were used to treat the target lesion of the right proximal, mid, distal sfa.Approximately 34 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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