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.Foreign report source: (b)(6).Study name: saver- 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.Per the ifu, 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) 2017, a stellarex catheter was used to treat the target lesion of the right mid sfa.Approximately 5 months post index procedure, the patient experienced critical limb ischemia with gangrene.A major amputation of the target limb was performed on (b)(6)2018.
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