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.(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.Although the cause of death is unrelated to the study device, death is listed in the ifu 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) 2019, a stellarex catheter was used to treat the target lesion of the right distal sfa and popliteal p1.Approximately 18 months post index procedure, the patient expired due to cardiac failure on (b)(6) 2020.The physician indicated this is not related to the study device or procedure.
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