Date of event: date are estimated.This will be filed as a death summary report per fda exemption approval number - (b)(4).The devices were not returned for analysis.A review of the lot history record could not be performed due to unknown lot information.Based on the limited information reviewed, a cause for the reported neurological deficit/ dysfunction and death could not be determined.The reported patient effect of neurological deficit/dysfunction and death, as listed in the mitraclip instructions for use (ifu), are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.
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It was reported through transcatheter valve therapy (tvt) registry data that mitraclip devices may be related to 5 death events with the clarifier na and neurological deficit dysfunction.The relationship of the deaths to the mitraclip device could not be determined based on the limited data received from the registry.Patients¿ mean age 71 years, ranging from 62 - 84 years.60% patients were male, 40% patients were female.Tvt registry data is reported as a summary per summary reporting exemption approval number - (b)(4).No additional information was provided.
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