This is filed to report atrial perforation, thrombus, and medical intervention.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.It was noted thrombus found on a previously implanted lead.After successful clip-deployment, the steerable guide catheter (sgc) was removed; however, an atrial septal defect (asd) was closed with a closure device due to the thrombus possibly migrated to the left side of the heart and embolized.The thrombus was not resolved.Two clips were implanted, reducing mr to 2.There was no reported 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.In this case, there was no reported device malfunction associated with the steerable guide catheter.Based on the information provided a conclusive cause for the reported thrombosis cannot be determined.The reported atrial perforation is the result of procedural conditions.The reported embolism is the result of the thrombosis.The reported patient effects of thrombosis, atrial perforation, and embolism, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.
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