Edwards received notification of a pascal precision procedure in mitral position where three pascal precision ace devices were implanted.On post-op day 2, 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 showed 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.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+.Per information received in follow-up, no chords were grasped during the index procedure or other procedural complications.Physicians do not think that pascal devices caused the rupture.
|
The complaint for reduced therapeutic efficacy over time / other was confirmed with objective evidence.No manufacturing non-conformities were identified from the imaging evaluation.There is no allegation of device deficiency.Furthermore, the device history record review was completed, and this device passed all manufacturing and sterilization inspections.No nonconformances related to the complaint event were identified.Available information suggests that patient conditions (patient mr etiology is barlows disease) may have contributed to the reported event.However, a definite root cause is unable to be determined.
|