Health Canada — Medical Devices · Canada · 2017-04-04 · Type II
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Reported risk: This specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure. At the time of implant procedure this permeability variation may cause the physician to categorize a type IV endoleak (which typically self-resolves over time) as an acute type ill fabric endoleak because the leak may appear to be focal or a localized leak as opposed to a diffused leak (blush). The misclassification as an acute type ill fabric endoleak may lead to unnecessary secondary interventions.
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