During an internal audit, it was determined that complaints for similar devices, and device malfunctions that have the potential to harm the patient if they were to recur, were not reported as per fda guidance.After retrospective review, this event is determined to be mdr reportable.
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Summary: the inner sheath was accidentally retracted while being advanced in the aortic arch.Description / sequence of events: (b)(6) 2017 -tevar for zone2 was performed with left subclavian artery to common carotid artery bypass grafting.-after bypass grafting procedure, 6fr sheath and a guidewire (lounderquist double-curved) was inserted into the right femoral artery for tevar.-the delivery system of this replyplus was then inserted as planned, and the inner sheath was advanced out from the outer sheath before reaching the aortic arch.-the inner sheath was then advanced further, and while passing the aortic arch, the inner sheath was confirmed to be retracted slightly and the first covered stent was deployed.Deployed stent on the greatest curvature side was stuck at the entry of left subclavian artery, and it became difficult to advance it further.-the bare stent was still fixed on the apex holder, so it was not deployed.Only the inner sheath was retracted.-during the procedure (when the inner sheath was advanced out from the outer sheath), its diameter looked bigger than usual, but it is unknown if the inner sheath was already retracted and the first covered stent was deployed at that point.In addition, when advancing the inner sheath, d-shaped maker on the inner sheath was found on more distal than usual.-there was some difficulty, but the inner sheath finally could be advanced until it reached the desired point, and the stentgraft was deployed under the left common carotid artery.-the procedure was completed without further problems.".
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