During the index procedure, one medtronic standard pta balloon was used to treat a lesion located in the left venous outflow.Approximately 8 months post index procedure, the patient suffered avf shunt stenosis.The event was treated with a non-medtronic pta in the anastomosis (non target lesion) on the next day and with medication.The investigator assessed the event as not related to index device, procedure or therapy.The event is resolved.Cec adjudicated the event as not related to procedure or therapy but related to device.Cec adjudicated the location of the revascularisation as the target lesion and that the revascularisation procedure was clinically driven.
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