The patient's date of birth, ethnicity and race are unknown.This information was not available from the facility.Cross reference mfr report numbers: 3011416935-2021-00017.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.(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) 2018, two stellarex catheters were used to treat the target lesion of the left popliteal p2 and p3.Approximately 39 months post index procedure, the patient expired due to a massive myocardial infarction on (b)(6) 2021.This adverse event is being submitted because the patient expired due to a massive myocardial infarction.This is being reported as a follow-up to the clinical registry.
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