It was reported through a clinical study that during the index procedure on (b)(6) 2021, three stellarex catheters (3011416935-2022-00002, 3011416935-2022-00003) were used to treat the target lesion of the right proximal and distal anterior tibial artery.Approximately 13 months post index procedure, the patient expired due to infection after a major amputation of a non-target limb on (b)(6) 2022.The physician reported this is not related to the study device or procedure.This adverse event is being submitted because the patient expired due to infection after a major amputation of a non-target limb.This is being reported as a follow-up to the clinical study.
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The patient's date of birth, ethnicity, and race are unknown.This information was not available from the facility.Report source foreign: (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.
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