Health Canada — Medical Devices · Canada · 2020-10-02 · Type II
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Reported risk: Medtronic is providing this notice regarding a labeling update to ensure awareness among users, which describes the existing risks and potential patient harms associated with separation or fracture. This labeling change further clarifies certain conditions where the risk of separation may be increased, such as under conditions of increased vessel tortuosity and/or excessive resistance during advancement or retraction of the device. The Instructions For Use (IFU) device already contains warnings and cautions related to potential of fracture or separation. Medtronic will be supplementing the Instructions For Use with further updates to one of the precaution and warning statements and the device complications section.
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