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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Based on recent complaints and subsequent investigation cordis has determined that products made between april 27 2015 and november 22 2015 have been associated with an increased frequency of incidents of deployment difficulty and in some instances outer member shaft separation resulting in inability to deploy the stent or partial stent deployment. product manufactured after november 22 2015 including product currently manufactured and supplied are not affected. there have been no patient injuries reported to us related to this issue. however considering the products risk analysis the potential impact of inability to deploy the stent or partial stent deployment include an intra-procedural delay while a replacement device is prepared vessel damage requiring unplanned percutaneous or surgical intervention to prevent permanent injury or impairment or in most severe cases transient ischemic attack or stroke.