Event and implant dates: dates estimated.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, the major vascular events were due to case specific circumstances.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 7 major vascular events which is considered a 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 71 years, ranging from 39 - 92 years.71% patients were male, 29% patients were female.Tvt registry data is reported as a summary per summary reporting exemption approval number - e2015009.No additional information was provided.
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