The patient required revascularization of the target lesion.This is being reported as part of the clinical registry.Cross reference mfr report numbers: 3009784280-2020-00123, 3009784280-2020-00124.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, thrombosis is listed as a potential complications/adverse events.
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It was reported through a clinical registry that during the index procedure on (b)(6) 2020, two stellarex catheters were used to treat the target lesion of the left mid sfa.During the index procedure, the patient experienced thrombosis of the target lesion.A successful revascularization of the target lesion was performed on (b)(6) 2020.The physician indicated this is not related to the use of the study device or procedure.No device malfunction reported.
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