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, a cause of the reported patient effect of perforation could not be determined.The reported patient effect of perforation as listed in the mitraclip system instructions for use is 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.
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This is being filed to report that after removal of the steerable guide catheter (sgc), a right to left shunting at the septum was observed.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4.One clip was implanted, reducing mr to 1.After removal of the steerable guide catheter (sgc) from the left atrium, a right to left shunt at the intra-atrial septum was observed.A closure device was implanted for treatment.No additional information was provided.
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