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.Based on available information, the cause of the reported perforation could not be determined.The reported perforation is listed in the mitraclip system instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported minor injury/ illness / impairment was the 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 perforation.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 3-4 and an enlarged atrium.A mitraclip ntw was successfully implanted, reducing mr to a grade of 1.However, after the removal of the steerable guide catheter, a right to left shunt was observed.No additional treatment was performed.There was no clinically significant delay in the procedure.No additional information was provided.
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