This is being filed to report the thrombus.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.After the steerable guide catheter (sgc) crossed the septum, thrombus was noted on the guide wire in the left atrium.The procedure was continued, and thrombus was noted on the steerable guide catheter (sgc).The thrombus was aspirated with the sgc and the patient was given additional anticoagulant.Two clips were implanted, reducing mr to 1+.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 the reported event.Based on the available information, a definitive cause for the reported thrombosis could not be determined.However, the reported patient effect of thrombosis is listed in the instruction for use (ifu) is known possible complications associated with mitraclip procedures.The reported additional therapy/non-surgical treatment and treatment with medication were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.
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