The patient's date of birth, ethnicity, and race are unknown.This information was not available from the facility.Foreign- netherlands/ study name: btk pm- 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 required.Although the cause of death is unrelated to the study device, death is listed in the ifu as a potential complications/ adverse events.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
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It was reported through a clinical study that during the index procedure on (b)(6) 2020, two stellarex catheters (3011416935-2023-00001) were used to treat the target lesion of the left, tibioperoneal trunk, proximal peroneal, and distal posterior tibial artery.Approximately 23 months post index procedure, it was reported that the patient expired due to cardiac arrest on (b)(6) 2022.The physician indicated this is not related to the study device or procedure.This adverse event is being submitted because the patient expired due to cardiac arrest.This is being reported as a follow-up to the clinical study.
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