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 part of the clinical study.Cross reference mfr report numbers: 3009784280-2020-00318, 3009784280-2020-00320, 3009784280-2020-00321.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 study.During the index procedure, the product worked as intended and the device was discarded, thus no product evaluation was performed.Per the ifu, occlusion is listed as a potential complications/ adverse events.
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It was reported through a clinical database that during the index procedure on (b)(6) 2018, four stellarex catheters were used to treat the target lesion of the right proximal and distal posterior tibial.Approximately 2 days post index procedure, the patient experienced an occlusion.A successful revascularization of the target lesion was performed on (b)(6) 2018.The physician indicated this is possibly related to the study device and is related to the procedure.
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