The patient experienced distal embolization unrelated to the study device.This is being reported as part of the clinical registry.Patient information regarding relevant tests/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 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, there was no report of a device malfunction.Device was discarded, thus no product evaluation was performed.Per the ifu, embolism is listed as a potential complications/adverse events.
|
It was reported through a clinical registry that during the index procedure on (b)(6) 2020, a stellarex catheter was used to treat the target lesion of the left mid and distal sfa.During the index procedure, the patient experienced distal embolization, however was asymptomatic.The patient was placed on bed rest until the next morning and blood thinners were administered.The physician indicated this is not related to the study device.
|