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 the reported event.Additionally, a review of the complaint history identified no other incidents reported from this lot.Based on the available information, a cause for the unintended movement could not be determined.The reported pericardial effusion appears to have been a result of procedural conditions.The cardiac tamponade and tachycardia appear to have been cascading events of the pericardial effusion.The reported patient effects of pericardial effusion, cardiac tamponade, and tachycardia are listed in the mitraclip system instructions for use and are known possible complications associated with mitraclip procedures.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 the pericardial effusion requiring intervention.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was placed in the left atrium (la) when the clip introducer of the clip delivery system (cds) was inserted into the hemostatic valve of the sgc.The tip of the sgc moved forward and injured the lateral wall, causing a pericardial effusion.The patients heart rate increased and blood pressure dropped.The patient was hemodynamically stabilized and the effusion punctured.The procedure was continued with one clip implanted, reducing mr to 1-2.The patient was hospitalized for further monitoring.No additional information was provided.
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