The patient's date of birth, ethnicity and race are unknown.This information was not available from the facility.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: 3011416935-2021-00003, 3011416935-2021-00004.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Report source: (b)(6).Pma/510k: 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.Although the cause of death is unrelated to the study device, death is listed in the ifu as a potential complications/ adverse events.Component codes intentionally left blank.No device malfunction was reported during the index procedure.
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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 right proximal, mid sfa.Approximately 9 months post index procedure, the patient expired due to respiratory failure during hospitalization for sigmoid diverticulosis on (b)(6) 2021.The physician reported this is not related to the study device or procedure.
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