This is being filed to report the thrombus.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with grade of 4.After the transseptal puncture, the steerable guide catheter (sgc) was advanced across the septum.Ten minutes into the procedure, a clot was noted on the right atrial side, flaring into the left side.Aspiration was performed, the wire was pulled out and the patient was given anticoagulant and the clot was gone.The physician at this point decided to abort the procedure to prevent further clotting going to the left side of the heart.The patient remained stable and mr remained at 4.No additional information was provided.
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Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot 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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