Worldwide Distribution -- United States (TX and FL), GERMANY, FRANCE and UNITED KINGDOM.
Product Description
Prot¿g¿ EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. || Prot¿g¿ EverFlex" Self-Expanding Peripheral Stent System (for Outside United States distribution). 6 x 100mm, Model Number PRP35-06-100-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. || In the United States, the stent is intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the United States, it is intended indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, superficial femoral, proximal popliteal, or subclavian arteries.
“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.