Edwards received notification of a pascal precision procedure in mitral position where three pascal precision ace devices were implanted.The mitral regurgitation (mr) was 4+ (massive) before the indexed procedure and 2+ (moderate) after three devices.On post-op day 2, the mr was again at 4+.The patient sought acute help for dyspnea and the echo showed leaflet tearing and recurrent mr.Patient mr etiology is barlows disease.The patient underwent corrective surgery, and the findings were a chord rupture.A video was taken during the surgery which shows the chordae rupture at the lateral commissure.The pascal ace devices were removed, and the patient received a bioprothesis.As per medical opinion the event was not caused by the device.No chords were grasped during the index procedure or other procedural complications.Physicians do not think that pascal devices caused the rupture.
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