Method: actual device not evaluated.Additional manufacturer narrative - although there have been attempts to retrieve the broken sizer, the product was not returned to edwards lifesciences for analysis as the hospital believes they discarded it.No additional information was provided by the hospital or surgeon to suggest that a serious injury occurred to the patient as a result of the fracture.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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