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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Involve difficulty deploying the graft from the delivery system and/or using the handle portion of the device. no adverse events have been experienced/reported though the potential for adverse events due to deployment difficulties includes additional intervention up to and including open surgical repair. this failure mode applies only to the delivery system and not the implantable stent graft portion of the device. previously implanted grafts are not affected.