System, Endovascular Graft, Aortic Aneurysm Treatment

FDA product code MIH · Class 3 · 1,312 devices · 11,904 reports · 1,044 deaths reported · 272 devices named in recalls

• GORE TAG Conformable Thoracic Stent Graft TGMR313110

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths20 reports
• GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA230005

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths20 reports
• AFX Endovascular AAA System BA28-80/I16-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  20 reports
• AFX2 Bifurcated Endograft System BEA25-110/I16-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death20 reports
• Alto™ Abdominal Stent Graft System TV-AB2080-N

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  20 reports
• Zenith Spiral-Z G55239

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths20 reports
• Ovation iX Abdominal Stent Graft System Aortic Body

  Trivascular, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  20 reports
• AFX2 Bifurcated Endograft System BEA28-120/I16-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  19 reports
• Zenith Spiral-Z G55241

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  19 reports
• VALIANT® Captivia VAMF4040C200TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 deaths18 reports
• GORE TAG Conformable Thoracic Stent Graft TGM343410

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths18 reports
• GORE TAG Conformable Thoracic Stent Graft TGM454520

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths18 reports
• Valiant Navion™ VNMC3737C223TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 deaths18 reports
• AFX2 Bifurcated Endograft System BEA25-70/I20-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death18 reports
• AFX2 Bifurcated Endograft System BEA22-40/I13-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  5 deaths18 reports
• Zenith G32543

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  6 deaths18 reports
• Zenith Spiral-Z G55246

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death18 reports
• Ovation Prime Adominal Stent Graft System Aortic Body

  Trivascular, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  18 reports
• VALIANT® Captivia VAMF3838C150TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths17 reports
• GORE EXCLUDER AAA Endoprosthesis PXT231414

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death17 reports
• GORE EXCLUDER AAA Endoprosthesis PXT261414

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  17 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU343415

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths17 reports
• GORE EXCLUDER AAA Endoprosthesis PLA280300

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths17 reports
• Valiant Navion™ VNMF3737C229TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths17 reports
• Valiant Navion™ VNMC3434C90TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths17 reports
• AFX2 Bifurcated Endograft System BEA25-70/I16-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  17 reports
• Zenith G32554

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths17 reports
• Zenith Spiral-Z G55231

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  17 reports
• Endurant® II ETLW1620C156E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  16 reports
• GORE EXCLUDER AAA Endoprosthesis PXC201200

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  16 reports
• GORE TAG Conformable Thoracic Stent Graft TGM343420

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths16 reports
• AFX Endovascular AAA System BA22-90/I16-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death16 reports
• AFX Endovascular AAA System BA28-110/I16-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death16 reports
• ENDURANT® ENBF3216C166E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  15 reports
• GORE EXCLUDER AAA Endoprosthesis PXC181000

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  15 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR373710

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths15 reports
• GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA260005

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death15 reports
• GORE TAG Thoracic Branch Endoprosthesis TAC083715A

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths15 reports
• AFX Endovascular AAA System BA25-70/I16-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  15 reports
• AFX Endovascular AAA System BA28-70/I16-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death15 reports
• AFX Endovascular AAA System BA25-100/I20-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death15 reports
• Zenith G32542

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death15 reports
• Zenith Flex G48407

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  15 reports
• Zenith Flex G48408

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths15 reports
• Zenith Flex G48418

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  15 reports
• Zenith Flex G48428

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  15 reports
• Zenith Spiral-Z G55233

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  15 reports
• Ovation Prime Abdominal Stent Graft System Aortic Body

  Trivascular, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  15 reports
• Endurant® II ETLW1620C124E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  14 reports
• Endurant® II ETLW1610C93E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death14 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU404020

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death14 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU343420

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  14 reports
• GORE EXCLUDER AAA Endoprosthesis PLA260300

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  14 reports
• GORE EXCLUDER AAA Endoprosthesis PLL161007

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths14 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231214

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death14 reports
• GORE TAG Conformable Thoracic Stent Graft TGMR404015

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths14 reports
• GORE TAG Conformable Thoracic Stent Graft TGM282810

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  14 reports
• Valiant Navion™ VNMC3737C90TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  6 deaths14 reports
• Valiant Navion™ VNMC4034C200TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths14 reports
• AFX Endovascular AAA System BA25-120/I20-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death14 reports
• AFX Endovascular AAA System BA28-80/I20-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths14 reports
• Vela Proximal Endograft System A28-28/C75 V

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death14 reports
• Vela Proximal Endograft System A28-28/C95 V

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  14 reports
• AFX2 Bifurcated Endograft System BEA25-60/I16-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths14 reports
• Zenith G32539

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  14 reports
• Zenith Alpha G35359

  William Cook Europe ApS · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths14 reports
• Zenith Flex G48417

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  14 reports
• ENDURANT® ENBF2816C166E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  13 reports
• VALIANT® Captivia VAMF4646C200TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths13 reports
• VALIANT® Captivia VAMF3636C150TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 deaths13 reports
• VALIANT® Captivia VAMF3434C150TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  13 reports
• VALIANT® Captivia VAMF3232C150TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 deaths13 reports
• Endurant® II ETLW1616C82E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  13 reports
• GORE EXCLUDER AAA Endoprosthesis PXC121200

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• GORE EXCLUDER AAA Endoprosthesis PXC141400

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death13 reports
• GORE EXCLUDER AAA Endoprosthesis PXT231416

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• GORE EXCLUDER AAA Endoprosthesis PXT261412

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• GORE EXCLUDER AAA Endoprosthesis PXT261416

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281414

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• GORE EXCLUDER AAA Endoprosthesis PLA320400

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• Valiant Navion™ VNMF3737C97TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths13 reports
• AFX Endovascular AAA System BA22-80/I16-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• AFX Endovascular AAA System IS20-25/C55 SA

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• AFX2 Bifurcated Endograft System BEA25-80/I13-40

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths13 reports
• Zenith G32537

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death13 reports
• Zenith G32538

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths13 reports
• Zenith Flex G48413

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  13 reports
• Zenith Spiral-Z G55234

  Cook Incorporated · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  13 reports
• Endurant® II ETLW1624C156E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death12 reports
• GORE EXCLUDER AAA Endoprosthesis PXC141000

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  12 reports
• GORE EXCLUDER AAA Endoprosthesis PXL161407

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death12 reports
• GORE EXCLUDER AAA Endoprosthesis PLA230300

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths12 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281218

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  12 reports
• GORE TAG Conformable Thoracic Stent Graft TGM282815

  W. L. Gore & Associates, Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
  12 reports
• Valiant Navion™ VNMC3131C90TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths12 reports
• Valiant Navion™ VNMC3428C207TU

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  12 reports
• Endurant® II ETLW1616C146E

  Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  12 reports
• Vela Proximal Endograft System A25-25/C95-O20 V

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death12 reports
• AFX2 Bifurcated Endograft System BEA28-70/I20-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death12 reports
• AFX2 Bifurcated Endograft System BEA28-70/I16-30

  Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
  12 reports