Date of event, death, implant: estimated dates.The device was not returned for analysis.A review of the lot history record and similar complaint review could not be performed as the part and lot information regarding the complaint device was not provided.Based on the available information, a cause for the reported patient effect of death could not be determined.The reported patient effect of death, as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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