Adverse event, outcomes to adverse event: the patient required amputation on the treated limb.This is being reported as a follow-up to the clinical registry.Tests/laboratory data and dates: 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/510k: pma number is not applicable.The device is a commercial product with a ce mark that was used as part of a clinical registry.Device evaluated by mfr: during the index procedure, the product worked as intended, thus no product evaluation was required.Per the ifu, amputation is 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) 2014, two stellarex catheters were used to treat the target lesion of the left mid sfa.Approximately 56 months post index procedure, the patient experienced atherosclerosis of the extremity arteries: pelvis and legs, with gangrene.A thigh amputation on the target limb was performed on (b)(6) 2018.
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