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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This field corrective action is a notification specific to the sizing of the medtronic mosaic porcine aortic bioprosthesis using the current mosaic obturators/sizers and the ieoa mosaic aortic bioprosthesis sizing chart. medtronic has determined that the practice of substantial oversizing can lead to cases of higher-than expected transvalvular gradients. this field corrective action is designed to improve the accuracy of valve sizing thus reducing the occurrence of high gradients.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.