The device was not returned for analysis.A review of the lot history record could not be performed due to unknown lot information.Based on the available information, a cause for the reported atrial perforation could not be determined.The reported patient effect of atrial perforation is listed in the mitraclip system instructions for use and is a known possible complication associated with mitraclip procedures.The reported additional therapy/non-surgical treatment and hospitalization were results of case-specific circumstances, as further hospitalization and implantation of an asd closure device were needed to treat the atrial perforation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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