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 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 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, intra or post procedure, there was a device related issue that required a mechanical assist device and the patient was sent for open heart surgery.Two days post procedure, a major vascular complication occurred.The patient went into cardiac arrest and intervention was performed however the patient died.No additional information was provided.
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