The patient's 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: 3009784280-2021-00017.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.The lot number was not provided in the registry, thus the following information are unknown: unique id, model #, catalog #, expiration date, and manufacture date.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.Although the cause of death is unrelated to the study device, death is listed in the ifu 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 proximal and mid sfa.Approximately 2 months post index procedure, the patient expired due to cardiac arrest on (b)(6) 2020.The physician indicated this is not related to the study device or procedure.
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Block h1 (no.Of events (noe) summarized): in the initial report, the xml file shows the summary report and 123 events were included.However, this was inadvertently included due to a system error in the xml file, as it was not visible in the pdf copy.This field should be left blank.
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