This is filed to report a pericardial effusion it was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.One nt clip was inserted and successfully implanted, reducing mr to a grade of 1+.However, after removing a steerable guide catheter (sgc), the patient¿s blood pressure decreased, and a pericardial effusion (pe) occurred.It is unknown what caused the pe.There was no clinically significant delay in the procedure.No additional information was provided.
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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 hypotension and pericardial effusion was unable to be determined.The reported patient effects of hypotension and pericardial effusion, as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.The reported minor injury/ illness/ impairment 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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