This is filed to report pericardial effusion, prolonged hospitalization and medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation with a grade of 4+.The steerable guide catheter (sgc) was advanced to the mitral valve, and one clip was successfully deployed, reducing mr to 1.Later on after the procedure ended, a mild pericardial effusion (pe) was observed.Then the patient's blood pressure dropped and imaging confirmed that the pe had increased in size.Therefore, the patient remained hospitalized longer and pericardiocentesis was performed.The patient is stable and was transferred to a post holding unit for observation.The patient no longer has a pe.The physician stated that the sgc may have caused the pe.No other 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, a cause of the reported pericardial effusion could not be determined.The reported hypotension was a secondary effect of the reported pericardial effusion.The reported patient effect of pericardial effusion and hypotension as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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