Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Rapid emptying of the fill polymer syringe when it is connected to the auto injector during the fill polymer injection step of the primary implant procedure has resulted in incomplete aortic body graft fill transient hypotension response prolonged procedure time and/or failure to exclude the aneurysm.