The patient's date of birth, ethnicity and race are unknown.This information was not available from the facility.Cross reference mfr report numbers: 3011416935-2021-00035, 3011416935-2021-00036, 3011416935-2021-00038.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.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) 2016, four stellarex catheters were used to treat the target lesion of the right proximal, mid, distal sfa and popliteal p1.Approximately 24 months post index procedure, the patient expired due to cardiac decompensation and ischemic cardiomyopathy on (b)(6) 2018.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 cardiac decompensation and ischemic cardiomyopathy.This is being reported as a follow-up to the clinical registry.
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