Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE; ENBF2516C120EE; ENBF2516C145EE; ENBF2516C170EE; ENBF2813C145EE; ENBF2813C170EE; ENBF2816C120EE; ENBF2816C145EE; ENBF2816C170EE; ENBF3216C120EE; ENBF3216C145EE; ENBF3216C170EE; ENBF3616C145EE; ENBF3616C170EE; ENCF2323C45EE; ENCF2525C45EE; ENCF2828C45EE; ENCF3232C45EE; ENCF3636C45EE; ENTF2323C70EE; ENTF2525C70EE; ENTF2828C70EE; Medtronic Endurant II Stent Graft System Model/REF ETBF2313C124E; ETBF2313C124EE; ETBF2313C145EE; ETBF2313C145EJ; ETBF2313C166EE; ETBF2313C166EJ; ETBF2316C124E; ETBF2316C124EE; ETBF2316C124EJ; ETBF2316C145E; ETBF2316C145EE; ETBF2316C145EJ; ETBF2316C166E; ETBF2316C166EE; ETBF2316C166EJ; ETBF2513C124E; ETBF2513C124EE; ETBF2513C124EJ; ETBF2513C145EE;
Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.
Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MOMS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Afri
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0657-2022