The patient's weight is unknown.This information was not available from the facility.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- italy/ 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.During the index procedure, the product worked as intended and the device was discarded, 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) 2017, a stellarex catheter was used to treat the target lesion of the left proximal sfa.Approximately 21 months post index procedure, the patient experienced ulcers and gangrene due to diabetes.A major amputation of the target limb was performed on (b)(6) 2019.The physician indicated this is not related to the study device or procedure.
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