The patient's ethnicity and race are unknown.This information was not available from the facility.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: saver: 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.Although the cause of restenosis is unrelated to the study device, restenosis is listed in the ifu 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, a stellarex catheter was used to treat the target lesion of the left distal sfa.Approximately 21 months post index procedure, the patient experienced restenosis.A successful revascularization of the target lesion was performed on (b)(6) 2019.Per clinical evaluation, this is not related to the study device or procedure.
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