Same case as mdr# 2134265-2017-08879, 2134265-2017-08948, and 2134265-2017-08878.It was reported that hypotension, bradycardia, cardiac arrest and death occurred.Vascular access was obtained via the femoral artery.The 95% stenosed, 18 mm x 3 mm, concentric, denovo, target lesion was located in a non tortuous, severely calcified mid left anterior descending artery (lad).Following rotablation with a 1.50 mm rotalink¿ plus there was slow flow.Medication was administered and timi-3 restored.The lesion was successfully stented with a 3.00 x 28 mm promus element¿ plus.A 12 x 3.00 mm nc quantum apex¿ balloon catheter and a 2.00 x 12 mm maverick²¿ balloon catheter were used during the procedure.The patient was moved to the intensive care unit and while there developed hypotension followed by bradycardia.The patient went into cardiac arrest and died.
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