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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Edwards lifesciences has been made aware of user reports that the loader assembly of the ascendra balloon catheter provided an insufficient seal around the proximal end of the pusher resulting in the leakage of blood during the transapical procedure to deliver the sapien thv transcatheter heart valve (used under special access). edwards lifesciences issued a training bulletin on this subject and has chosen to augment and emphasize the proper use of the loader assembly by way of a field safety notice to increase physician awareness of proper technique.