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 375 nanocross balloons, with all of these being used in the past 12 months for dilatation of stenoses in the iliac arteries, femoral arteries, ilio-femoral arteries, popliteal arteries, infra-popliteal arteries, and renal arteries.
The nanocross 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 arrhythemia (associated with vascular spasms and pseudoaneurysm (within the stochastic norm, no outside spaces) which were not previously reported to medtronic.
The events were considered to be somewhat concerning.
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