Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess the performance of medtronic¿s nanocross and rapidcross pta balloons.Survey results received for an interventional radiologist with 21 years¿ experience who has been using both the nanocross pta balloon and rapidcross pta balloon since 2019.The physician has used a total of 350 rapidcross balloons, with all of these being used in the past 12 months for dilatation for dilatation of stenoses in the iliac arteries, femoral arteries, ilio-femoral arteries, popliteal arteries, infra-popliteal arteries, and renal arteries.The rapidcross pta was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and for stent post-dilation in the peripheral vasculature.The respondent reports device related complications of arteriovenous fistula (due to too much pressure), artery injury described as an intimal rupture in the case of cross manoeuvre, and pseudoaneurysm which was pressure related during use of the rapidcross device.None of these events were previously reported to medtronic.The arteriovenous fistula, and artery injury (such as dissection, perforation, or rupture) events were reported to be somewhat concerning, however the pseudoaneurysm event was reported to be not at all concerning.
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