“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.
The COREVALVE system from Medtronic is intended for the replacement of a poor aortic heart valve trans-luminal porentrega. Its purpose is to restore normal function to the deficient aortic valve of the patient. The MEDtronic COREVALVE system is indicated for patients with symptomatic native aortic valve stenosis or a failure of the surgical bio-prosthesis of the valve (defined as deficient, stenosed, or both) that need replacement. of valve presenting vessels of ataxillary / subclavian or femoral access with diameters greater than oigual to 6 mm or ascending aortic access point (direct aortic) greater than or equal to 60mm from the basal plane.
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Description du dispositif
EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. || Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.