The patient's ethnicity and race are unknown.This information was not available from the facility.The patient's cause of death was unrelated to the study device or procedure.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: (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 registry.During the index procedure, the product worked as intended and the device was discarded, thus no product evaluation was required.(b)(4).
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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 right mid sfa.Approximately 31 months post index procedure, the patient expired due to gangrene, peripheral vascular disease, colon cancer, diabetes mellitis type ii, frailty, and copd on (b)(6) 2021.The physician indicated this is not related to the study device or procedure.
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