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 registry.Cross reference mfr report numbers: 3009784280-2019-00737, 3009784280-2019-00738, 3009784280-2019-00739.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Report source: foreign country: (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, death 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) 2018, three stellarex catheters were used to treat the target lesion of the right proximal sfa.Approximately 11 months post index procedure, the patient expired from an unknown cause on (b)(6) 2019.Per clinical evaluation, this is not related to the study device or procedure.
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