The patient's cause of death was unrelated to the study device.This is being reported as a follow-up to the clinical study.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Udi and pma numbers are not applicable.This device was used in clinical application prior to being available in the us.Foreign- belgium/ study name: illuminate global- patient id #(b)(6).During the index procedure, the product worked as intended and the device was discarded, thus no product evaluation was performed.Per the ifu, death is listed as potential complications/adverse.
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It was reported through a clinical study that during the index procedure on (b)(6) 2015, a stellarex catheter was used to treat the target lesion of the right distal sfa.Approximately 54 months post index procedure, the patient expired from carcinoma of the right lung on (b)(6)2019.The physician indicated this is not related to the study device or procedure.
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