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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Notification to surgeons of a possible safety risk for patients requiring preimplant circulatory rescue intervention. pre-liminary data analysis from intermacs companion post approval study suggests there may be a higher mortality rate when patient supported by the c2 driver system.