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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A review of the 2-year follow-up data of engager european pivotal trial has shown that 16 of 32 subjects implanted with a 23mm device have a mean gradient of = 20 mmhg at some point after the implant (average mean gradient at 2-year follow up: 22.0 ? 7.5 mmhg). gradient is a measure of the resistance to flow through the valve. a mean gradient of 20-40 mmhg is associated with mild stenosis (narrowing of the valve) per the valve academic research consortium (varc) -2 guideline. no interventions balloon valvuloplasty or surgical replacement were performed related to the elevated gradient on the 16 study patients. as a result of these data medtronic has made the decision to voluntarily discontinue sales and distribution of the 23mm bioprosthesis permanently. this recall affects only the 23mm engager bioprosthesis.
“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.