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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Since initial market introduction of the perceval valve livanova has continued to gather feedback from users regarding critical procedural steps requiring careful execution in order to reduce the possibility of intraoperative complications such as valve malpositioning significant perivalvular or central regurgitation and permanent pacemaker implantation. following some cases of intra/peri-operative central leak livanova is providing clarifications on the implantation steps in order to integrate information addressed in the instructions for use and the inservice guide.