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 transient ischemic attacks could not be determined.Furthermore, the reported patient effect of transient ischemic attack is listed in the mitraclip instructions for use as a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment 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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