The patient required revascularization of the target lesion.This is being reported as part of the clinical registry.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Foreign- (b)(6)/ study name: (b)(4): 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.The device was discarded, thus no product evaluation was performed.Per the ifu, thrombosis is listed as a potential complications/adverse events.
|
It was reported through a clinical registry that during the index procedure on (b)(6) 2018, three stellarex catheters were used to treat the target lesion of the right proximal, mid, and distal sfa.After the procedure, the patient experienced vessel thrombosis.A successful revascularization of the target lesion was performed on the same day.
|