This event is being reported via the tvt registry.Exemption number e2019001.The device was not returned for analysis.Additionally, a review of the lot history records for the lots could not be conducted, because the lot numbers were not provided.The reported patient effect of death is listed in the mitraclip system electronic instructions for use as known possible complication associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported patient effect, and the relationship to the device, if any, cannot be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.The unique device identification (udi) is unknown as the part and lot numbers were not reported.
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This is being filed to report the patient death.It was reported through transcatheter valve therapy (tvt) registry data that a mitraclip device may be related to adverse events which are considered serious injury.The relationship of the adverse events to the mitraclip devices could not be determined based on the data received from the registry.Reportedly, 4 days post procedure, the patient presented with a hemorrhagic stroke and 14 days post procedure, the patient died.No additional information was provided.Estimated date of death for emdr filing purposes only.
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