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 effects of cardiac arrest and death are listed in the mitraclip system electronic instructions for use as known possible complications 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 unplanned surgery or intervention, cardiac arrest and 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, 2 days post procedure, a major vascular complication occurred resulting in an unplanned surgery.Then 8 days post procedure, the patient went into cardiac arrest and died.No additional information was provided.
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