The patient required amputation on the treated limb.This is being reported as a follow-up to the clinical study.However, clinical evaluation determined that an amputation was inevitable due to the prior medical history of the patient.Per clinical evaluation, it is likely the paclitaxel drug did not cause or contribute to the amputation.Udi and pma numbers are not applicable.This device was used in clinical application prior to being available in the us.Foreign- (b)(6) / study name: illumenate global- patient id #(b)(6).Combination product is applicable.During the index procedure, the product worked as intended, thus no product evaluation was required.Per the ifu, amputation is listed as a potential complications/adverse events.
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On (b)(6) 2018, it was reported through a clinical study that during the index procedure on (b)(6) 2015, three stellarex catheters were used to treat the target lesion of the right mid and distal sfa.Approximately 32 months post index procedure, the patient experienced ''ischemia in right leg'' and an amputation above the right knee was scheduled on (b)(6) 2018.On (b)(6) 2018, it was confirmed that the amputation did occur as scheduled.The physician indicated this is probably related to the study device and procedure.
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