The device was not returned for analysis.A review of the lot history record did not identify any manufacturing nonconformities issued to the reported lot.Based on the information reviewed, a definite cause for the reported thrombosis could not be determined.The reported patient effect of thrombosis as listed in the mitraclip system instructions for use, is a known possible complication 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 thrombus noted on the steerable guide catheter during use.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.After the transseptal puncture, thrombus was noted on the transseptal needle.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 anticoagulant.One clip was implanted, reducing mr to 1.No additional information was provided.
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