Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the evercross pta balloon catheter.Survey results received for an interventional cardiologist practicing in spain who within the last 12 months used an evercross pta balloon catheter for dilatation of stenoses in the iliac arteries (26 procedures), femoral arteries (32 procedures), ilio-femoral arteries (16 procedures), popliteal arteries (22 procedures), infra-popliteal arteries (19 procedures), and renal arteries (29 procedures).The evercross pta balloon catheter was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (6 procedures) and for stent post dilatation in the peripheral vasculature (6 procedures).This interventional cardiologist also used a fortrex pta balloon catheter for dilatation of stenoses in the iliac arteries (23 procedures), femoral arteries (41 procedures), ilio-femoral arteries (19 procedures), popliteal arteries (18 procedures), infra-popliteal arteries (12 procedures), and renal arteries (33 procedures).The evercross pta balloon catheter was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (9 procedures) and for stent post dilatation in the peripheral vasculature (61 procedures).Related to the evercross pta balloon catheter, two aneurysm events are reported during use for dilatation of stenoses in the femoral arteries and popliteal arteries.Three fever events are reported during use for dilatation of stenoses in the iliac arteries.One venous thromboembolism event is also reported.The aneurysm events are reported to be very concerning.The fever events and venous thromboembolism event are reported to be not at all concerning.One aneurysm event (during percutaneous treatment) is reported to be device related.One fever event is reported to be device related and attributed to local effects.The venous thromboembolism is also reported to be device related and anticoagulant treatment is mentioned.Related to the fortrex pta balloon catheter, one artery perforation or rupture event is reported to have occurred during treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.Two hematoma events are reported during dilatation of stenoses in the iliac arteries and popliteal arteries; and also, during stent post dilatation in the peripheral vasculature.Three haemorrhage events are reported during dilatation of stenoses in the femoral arteries, during treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, and during stent post dilatation in the peripheral vasculature.The artery perforation or rupture event is reported to be very concerning but not related to the device.The hematoma events were reported to be not at all concerning but one is reported as being related to the device itself and was given local treatment.The haemorrhage events are reported to be somewhat concerning and one is reported to have been related to the device itself and local pressure treatment was applied.
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