Adverse event/outcomes to adverse event: the patient required revascularization of the target lesion.This is being reported as a follow-up to the clinical registry.Tests/laboratory data and dates: 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/510k: pma number is not applicable.The device is a commercial product with a ce mark that was used as part of a clinical registry.Device evaluated by mfr: during the index procedure, the product worked as intended.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) 2018, a stellarex catheter was used to treat the target lesion of the left distal sfa.During the procedure, the patient experienced a distal embolization.A successful revascularization of the target vessel was performed on (b)(6) 2018.
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