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.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.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, 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) 2019, a stellarex catheter was used to treat the target lesion of the right popliteal p1, p2.Approximately 4 months post index procedure, the patient expired due to left heart decompensation on (b)(6) 2019.
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