The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.The reported patient effect of atrial perforation is listed in the mitraclip system instructions for use, and is a known possible complication associated with mitraclip procedures.Based on the available information, a cause for the reported atrial perforation could not be determined.The reported additional therapy/non-surgical treatment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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This is filed to report the right to left shunt.It was reported that this was a mitraclip procedure performed to treat functional mitral regurgitation (mr) with an mr grade of 4.Two clips were implanted successfully reducing mr to 1.However, after removal of the steerable guide catheter, a right to left shunt occurred, requiring a closure device for treatment.No additional information was provided.
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