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 this event.The investigation was unable to determine a conclusive cause for the atrial perforation and heart failure.The reported patient effects of atrial perforation and heart failure are listed in the mitraclip nt system instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.
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This is filed to report an atrial perforation and heart failure.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.One clip was successfully implanted, reducing mr to a grade of 1.However, after the clip was implanted, a left to right shunt was observed that possibly worsened right sided heart failure.For treatment, a closure device was implanted.There was no clinically significant delay in the procedure.No additional information was provided.
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