This is filed for atrial septal defect resulting in increased heart failure.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.Two clips were implanted and the mr was reduced to grade 2+.On (b)(6) 2018, the patient was re-hospitalized.The right to left atrial shunt was increased, resulting in increased heart failure and pulmonary hypertension.The mr remained unchanged.Moderate tricuspid regurgitation was noted.Medication was administered.No additional information was provided.
|
(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the information reviewed, there is no indication of a product quality issue.The reported patient effects of hypertension, heart failure, cardiac perforation (atrial perforation) as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.Based on this information, the reported patient effect of atrial perforation appears to be related due to procedural circumstances.Reported patient effects of hypertension, heart failure and tricuspid regurgitation appears to be the cascading effects caused due to atrial perforation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|