During the index procedure,one medtronic pta was used to treat a lesion located in the anastomosis of the left arm.Approximately 2.5 months post index procedure, patient suffered avf stenosis.Event was treated with medication and revascularization carried out using non-medtronic pta in the in cannulation zone.Investigator and sponsor assessed that the event was not related to index device, procedure or antiplatelets medication.Event is resolved.Cec adjudicated the event as not related to procedure or therapy but related to the device.Revascularization was clinically driven and was adjudicated as a target lesion revascularisation procedure.
|