The patient's cause of death was unrelated to the study device or procedure.This is being reported as a follow-up to the clinical study.Patient information regarding relevant tests or laboratory data is unknown.This information was not available from the facility.The patient's death was unrelated to the stellarex device or procedure, thus the paclitaxel drug did not cause or contribute to the patient¿s death.Foreign- (b)(6)/ study name: illumenate isr- patient id (b)(6).Pma number is not applicable.This device was used in clinical application prior to being available in the us.Combination product is applicable.During the index procedure, the product worked as intended, thus no product evaluation was required.Per the ifu, death is listed as a potential complications/adverse events.
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It was reported through a clinical study that during the index procedure on (b)(6) 2017, three stellarex catheters were used to treat the target lesion of the left proximal, mid, and distal sections of the sfa and popliteal.Approximately 2 months post index procedure, the patient expired on (b)(6) 2017 due to a stroke.The physician indicated this is not related to the study device or procedure.
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