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 issue.The reported patient effect of tissue damage as listed in the eifu, mitraclip ntr/xtr instructions for use c.E.(ifu) is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported tissue damage was due to procedural conditions.There is no indication of a product issue with respect to manufacture, design or labeling.
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