The patient required amputation on the treated limb.This is being reported as a follow-up to the clinical registry.Cross reference mfr report number: 3009784280-2020-00151.Patient information regarding relevant tests or 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 amputation is unrelated to the study device; amputation, necrosis, and infection are listed as potential complications/ adverse events.
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It was reported through a clinical registry that during the index procedure on (b)(6) 2019, two stellarex catheters were used to treat the target lesion of the right mid sfa and popliteal p1.Approximately 2 weeks post index procedure, the patient experienced gangrene and necrosis.A major amputation of the right lower leg was performed on (b)(6) 2019.Eighteen days later, the patient experienced a non-healing wound and necrosis on the amputation site.Additional amputation of the right lower leg was performed on (b)(6) 2019.Approximately 1 month later, the patient experienced an infection.Additional amputation of the right upper leg, at the knee area was performed on (b)(6) 2019.The physician indicated this is not related to the study device or procedure.
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