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.Based on the information reviewed, there is no indication of a product quality issue.The reported patient effect of emboli (thrombus) as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.All the available information was investigated.The cause for the reported thrombosis couldn¿t be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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