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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There is a risk the joint may separate during deployment. a failure of this joint would represent a device malfunction and were it to occur during a procedure may result in a partial stent deployment. the clinical effect of a partial deployment may be a need for surgical intervention or may result in vessel trauma or an embolic event.