The udi is unknown due to the part/lot number was not provided.The devices were not returned for analysis.A review of the lot history record could not be performed as this incident was based on transcatheter valve therapy (tvt) registry data, and no device/lot information was provided.Based on available information, a cause for the reported perforation could not be determined.Furthermore, the reported patient effect of perforation is listed in the mitraclip instructions for use as a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention is the result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.
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