This will be filed as a serious injury summary report per fda exemption approval number - e2015009.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 conclusive cause for the adverse events with procedure related issues could not be determined.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 20 events with procedure related issues which are considered serious injury.The relationship of the adverse events to the mitraclip device could not be determined based on the limited data received from the registry.Patients¿ mean age 68 years, ranging from 37 - 83 years.50% patients were male, 50% patients were female.This will be filed by 7/31/2020 as a serious injury summary report per fda exemption approval number - e2015009.No additional information was provided.
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