The patient required amputation on the treated limb.This is being reported as a follow-up to the clinical registry.Patient information regarding relevant tests or 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, thus no product evaluation was required.Per the ifu, thrombosis, ischemia, and amputation are listed as potential complications/adverse events.
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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 distal sfa and popliteal p1.Approximately 9 months post index procedure, the patient experienced thrombosis on the right arteria femoralis superficialis with subacute ischemia.A major amputation of the left limb was performed on (b)(6) 2019.
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