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 was unable to be determined.The reported patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
|
It was reported 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 removal of the steerable guide catheter (sgc), a right to left shunt was observed.Therefore, an atrial septal defect (asd) closure device was implanted.There was no clinically significant delay in the procedure.
|