AFX2 Bifurcated Endograft SystemRecalls & reported problems across all models

We found 37 models of AFX2 Bifurcated Endograft System by Endologix LLC in the FDA's device registry (GUDID). Together they are named in 1,053 adverse event reports in the FDA's MAUDE database, received between Jun 3, 2016 and Aug 5, 2026 — classified as 67 deaths, 974 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (277 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported AFX2 Bifurcated Endograft System problems

AFX2 Bifurcated Endograft System models

37 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AFX2 Bifurcated Endograft System BEA28-100/I20-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths107 reports
• AFX2 Bifurcated Endograft System BEA28-90/I20-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths67 reports
• AFX2 Bifurcated Endograft System BEA25-100/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths62 reports
• AFX2 Bifurcated Endograft System BEA25-90/I16-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death53 reports
• AFX2 Bifurcated Endograft System BEA28-100/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths50 reports
• AFX2 Bifurcated Endograft System BEA25-100/I20-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths50 reports
• AFX2 Bifurcated Endograft System BEA22-90/I16-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths48 reports
• AFX2 Bifurcated Endograft System BEA28-90/I16-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 deaths47 reports
• AFX2 Bifurcated Endograft System BEA28-120/I20-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths45 reports
• AFX2 Bifurcated Endograft System BEA28-80/I20-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death43 reports
• AFX2 Bifurcated Endograft System BEA25-90/I20-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths43 reports
• AFX2 Bifurcated Endograft System BEA28-110/I20-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  38 reports
• AFX2 Bifurcated Endograft System BEA28-80/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths36 reports
• AFX2 Bifurcated Endograft System BEA25-80/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths35 reports
• AFX2 Bifurcated Endograft System BEA22-60/I13-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 deaths30 reports
• AFX2 Bifurcated Endograft System BEA22-70/I16-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths26 reports
• AFX2 Bifurcated Endograft System BEA25-80/I20-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  25 reports
• AFX2 Bifurcated Endograft System BEA22-80/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths23 reports
• AFX2 Bifurcated Endograft System BEA25-110/I16-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death20 reports
• AFX2 Bifurcated Endograft System BEA28-120/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  19 reports
• AFX2 Bifurcated Endograft System BEA25-70/I20-30

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

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 deaths18 reports
• AFX2 Bifurcated Endograft System BEA25-70/I16-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  17 reports
• AFX2 Bifurcated Endograft System BEA25-60/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths14 reports
• AFX2 Bifurcated Endograft System BEA25-80/I13-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths13 reports
• AFX2 Bifurcated Endograft System BEA28-70/I20-30

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

  System, Endovascular Graft, Aortic Aneurysm Treatment
  12 reports
• AFX2 Bifurcated Endograft System BEA22-90/I20-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death12 reports
• AFX2 Bifurcated Endograft System BEA28-110/I16-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death11 reports
• AFX2 Bifurcated Endograft System BEA25-120/I20-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  10 reports
• AFX2 Bifurcated Endograft System BEA25-120/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death10 reports
• AFX2 Bifurcated Endograft System BEA25-110/I20-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death9 reports
• AFX2 Bifurcated Endograft System BEA22-80/I20-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  8 reports
• AFX2 Bifurcated Endograft System BEA22-70/I20-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• AFX2 Bifurcated Endograft System BEA28-60/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  6 reports
• AFX2 Bifurcated Endograft System BEA22-60/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  6 reports
• AFX2 Bifurcated Endograft System BEA25-80/I16-55

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports

Recent AFX2 Bifurcated Endograft System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Off-Label Use

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 50144704 ↗
• InjuryJul 27, 2026Lack of Effect

  The patient was treated for an abdominal aortic aneurysm on (b)(6)2022 with the implant of an AFX2 Bifurcated Stent Graft and an AFX Vela Suprarenal. On (b)(6)2026, an indeterminate endoleak was identified during a medical checkup. Reintervention was performed on (b)(6)2026 to treat bilateral Type IB Endoleaks. An Ovation iX Iliac Limb was deployed in the left leg while preserving the left internal iliac artery (IIA). For the right leg, an attempt was made to preserve the right IIA at the time of deployment using a fenestrated AFX Limb Extension; however, cannulation into the right IIA was difficult. During the attempt, angiography performed with an altered C-arm angle revealed a clear Type IB Endoleak from the right leg. Consequently, preservation of the right IIA was abandoned, and another AFX Limb Extension was also deployed for relining. Final angiography confirmed the resolution of the Type IB Endoleak, and the procedure was completed. It was noted, based on imaging findings, that the sit-on/landing of the device might have been insufficient during the initial procedure.

  Patient problems: Clinical Endoleak

  MAUDE report 50046403 ↗
• InjuryJun 9, 2026Lack of Effect

  THE PATIENT PREVIOUSLY UNDERWENT IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT AS A TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2021. DURING A REGULAR FOLLOW-UP, IMAGING WAS PERFORMED USING COMPUTED TOMOGRAPHY (CT). THE REVIEW OF THESE IMAGES REVEALED THE PRESENCE OF A TYPE 1A ENDOLEAK. GIVEN THE FINDINGS, THE PROPOSED PLAN IS TO ADD AN AORTIC EXTENSION. SUFFICIENT AORTIC NECK REMAINS AVAILABLE, WHICH WILL ALLOW FOR RESTORATION OF PROPER SEALING WITH THE EXTENSION. AT PRESENT, THE PATIENT IS STABLE AND CONTINUES TO BE MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 25447561 ↗
• InjuryJun 5, 2026Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL ON (B)(6) 2022. ON (B)(6) 2025 A FOLLOW UP CT WAS TAKEN, REVIEWED, AND WAS DEEMED CLEAN. ON (B)(6) 2026, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN AT AN UNKNOWN FACILITY. AN ANGIOGRAM SUBSEQUENTLY IDENTIFIED A TYPE IIIB ENDOLEAK AT THE LEVEL OF THE AORTIC BIFURCATION. PATIENT REFERRED TO AO MAURIZIANO TORINO WHERE REINTERVENTION WAS PERFORMED IMMEDIATELY. AN AFX2 BSG, AN AFX VELA INFRARENAL, AND TWO ENDURANT ILIAC LIMBS (NON-ENDOLOGIX) WERE IMPLANTED. THE PATIENT IS REPORTED AS BEING FINE WITH NO OTHER SYMPTOMS AND HAS BEEN DISCHARGED HOME.

  Patient problems: Abdominal Pain; Clinical Endoleak

  MAUDE report 25409955 ↗
• InjuryJun 4, 2026Separation Problem

  THE REPORTED INCIDENT WAS IDENTIFIED BY ENDOLOGIX THROUGH A RETROSPECTIVE REVIEW OF AN JOURNAL ARTICLE AND BY THE DISTRIBUTOR, JAPAN LIFELINE. DOI: 10.3400/AVD.CR.25-00129 A 76-YEAR-OLD MALE WAS REFERRED FOR TREATMENT OF AN INFRARENAL AAA IDENTIFIED DURING SCREENING COMPUTED TOMOGRAPHY (CT). THE ANEURYSM WAS FUSIFORM, WITH A MAXIMUM DIAMETER OF 65 MM AND A LONGITUDINAL LENGTH OF 85 MM. THE PROXIMAL NECK MEASURED 37 MM IN LENGTH WITH AN ANGULATION OF 55 DEGREES. THE DISTAL AORTA AT THE AORTIC BIFURCATION MEASURED 18 MM IN DIAMETER, WHICH PROMPTED THE SELECTION OF THE AFX ENDOGRAFT. ALTHOUGH THE LARGE ANEURYSM SIZE RAISED CONCERNS ABOUT SECURE FIXATION BETWEEN THE AFX2 MAIN BODY AND THE VELA EXTENSION, IT WAS ASSUMED THAT THE PRESENCE OF EXTENSIVE MURAL THROMBUS WOULD MITIGATE THE RISK OF MIGRATION. EVAR WAS PERFORMED USING A LONG AFX2 MAIN BODY (BEA25-90-116) AND A SUPRARENAL VELA EXTENSION (A28-28-C95-020V) ON 05 JANUARY 2022. INTRAOPERATIVE ANGIOGRAPHY AND POSTOPERATIVE CT REVEALED NO EVIDENCE OF AN ENDOLEAK. THE REQUIRED OVERLAP BASED ON THE MANUFACTURER'S RECOMMENDATION (ANEURYSM RADIUS +20MM) WAS CALCULATED TO BE 52.5 MM. THE OVERLAP WAS SHORTER ON THE OUTER CURVATURE SIDE THAN

  Patient problems: Clinical Endoleak

  MAUDE report 25395170 ↗
• InjuryMay 19, 2026Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2019 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL. IT WAS REPORTED ON 23 APRIL 2026 THAT THERE IS A POSSIBLE ENDOLEAK. REINTERVENTION WAS COMPLETED ON (B)(6) 2026. DURING REINTERVENTION IT WAS CONFIRMED THAT THE POSSIBLE ENDOLEAK WAS A TYPE IIIB ENDOLEAK. THE INITIALLY IMPLANTED AFX2 BIFURCATED STENT GRAFT WAS RELINED WITH A NEW AFX2 BIFURCATED STENT GRAFT. THE TYPE IIIB ENDOLEAK WAS RESOLVED AND PATIENT IS DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 25217968 ↗
• InjuryMay 15, 2026Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2017 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. ON (B)(6) 2026, ANEURYSM GROWTH WITH A POSSIBLE TYPE II ENDOLEAK OR TYPE IIIB ENDOLEAK WERE IDENTIFIED. THE PATIENT IS STABLE. REINTERVENTION IS SCHEDULED FOR (B)(6) 2026. REINTERVENTION WAS COMPLETED ON (B)(6) 2026 WITH THE IMPLANT OF AN AFX VELA INFRARENAL, AN AFX VELA SUPRARENAL AND AN OVATION IX ILIAC LIMB EXTENSION. AT REINTERVENTION THE POSSIBLE TYPE IIIB WAS CONFIRMED TO BE A TYPE IB ENDOLEAK WHICH WAS SUCCESSFULLY RESOLVED. A MILD TYPE II ENDOLEAK STILL REMAINS. THE PATIENT WAS STABLE POST REINTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 25184935 ↗
• InjuryMay 14, 2026Detachment of Device or Device Component; Separation Problem

  THE PATIENT WAS TREATED FOR A FUSIFORM ANEURYSM WITH TWO SACS AND A SLIGHTLY ANGULATED NECK WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT(BSG) AND AN AFX VELA SUPRARENAL ON (B)(6) 2019. ON (B)(6) 2026 THE PHYSICIAN REPORTED THAT UNCOUPLING BETWEEN THE AFX2 BSG AND THE VELA SUPRARENAL WAS CONFIRMED. FURTHERMORE, THE BARE STENT PORTION OF THE VELA SUPRARENAL WAS FOUND TO BE PARTIALLY DETACHED FROM THE GRAFT, SUGGESTING POTENTIAL DAMAGE. AN INTERVENTION USING DEVICES FROM ANOTHER MANUFACTURER IS PLANNED FOR AN UNKNOWN DATE.

  Patient problems: Clinical Endoleak

  MAUDE report 25178663 ↗
• InjuryMay 5, 2026Off-Label Use; Separation Problem

  THE PATIENT UNDERWENT IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA SUPRARENAL EXTENSION, AND A NON ENDOLOGIX EXCLUDER ILIAC LEG FOR TREATMENT OF A RIGHT COMMON ILIAC ARTERY ANEURYSM (CIAA) AND AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THE INITIAL PROCEDURE, THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND AN EXCLUDER LEG WAS DEPLOYED FROM THE RIGHT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. THE AFX2 BSG WAS DEPLOYED VIA A RIGHT FEMORAL ARTERY APPROACH. AN AFX VELA SUPRARENAL EXTENSION WAS SUBSEQUENTLY PLACED, ALIGNED WITH THE LEFT RENAL ARTERY, FOLLOWED BY COMPLETE TOUCH UP MOLDING. FINAL ANGIOGRAPHY IDENTIFIED A TYPE II ENDOLEAK; HOWEVER, THE PROCEDURE WAS CONCLUDED WITH A PLAN FOR ROUTINE SURVEILLANCE. APPROXIMATELY EIGHT YEARS FOLLOWING THE INDEX PROCEDURE, IT WAS REPORTED THAT THE OVERLAP BETWEEN THE AFX2 BSG AND THE AFX VELA SUPRARENAL EXTENSION HAD DECREASED TO APPROXIMATELY ONE STENT LENGTH, RESULTING IN A TYPE IIIA ENDOLEAK AND ANEURYSM SAC ENLARGEMENT TO 80 MM. ON (B)(6) 2026, AN ADDITIONAL EVAR PROCEDURE WAS PERFORMED. INTRAOPERATIVE ANGIOGRAPHY OF THE JUNCTION BETWEEN THE AFX2 BIFURCATED STENT GRAFT AND THE AFX VELA CUFF SHOWED NO EVIDENCE

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 25085442 ↗
• InjuryApr 30, 2026Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Device Stenosis

  THE PATIENT WAS TREATED FOR A RIGHT COMMON ILIAC ARTERY (CIA) ANEURYSM ON (B)(6) 2026. THE PATIENT'S AORTA WAS HIGHLY ANGULATED. THE RIGHT INTERNAL ILIAC ARTERY (IIA) WAS EMBOLIZED WITH A PLUG, AND AN EXCLUDER (NON-ENDOLOGIX) LEG WAS DEPLOYED FROM THE RIGHT CIA TO THE EXTERNAL ILIAC ARTERY (EIA). THE AFX2 BIFURCATED STENT GRAFT (BSG) WAS DEPLOYED VIA LEFT FEMORAL ARTERY APPROACH. ALTHOUGH FINAL ANGIOGRAPHY CONFIRMED ANTEGRADE FLOW IN THE LUMBAR ARTERY, THE PROCEDURE WAS COMPLETED AS THERE WAS NO BLOOD FLOW INTO THE ANEURYSM. ON (B)(6) 2026, THE PATIENT PRESENTED TO THE HOSPITAL COMPLAINING OF LEG PAIN AND IMMOBILITY. A COMPUTED TOMOGRAPHY SCAN CONFIRMED A BIRD-BEAK OCCURRED AT THE LESSER CURVATURE OF THE PROXIMAL END OF THE AFX2 BSG. DUE TO BLOOD PRESSURE ENTERING THE RESULTING GAP, THE MID-SECTION OF THE AFX2 BSG WAS COMPRESSED, CAUSING OCCLUSION FROM THE MID-SECTION OF THE AFX2 BSG TO THE RIGHT EIA AND THE LEFT CIA. REINTERVENTION WAS PERFORMED. FOLLOWING BILATERAL FEMORAL CUT-DOWNS, A GUIDEWIRE WAS INSERTED FROM THE LEFT FEMORAL ARTERY AND ADVANCED WITHOUT ISSUE. ANGIOGRAPHY CONFIRMED SEVERE STENOSIS DUE TO THROMBUS. TO AVOID ACCIDENTAL ENTRY OF THE WIRE INTO THE DEVICE, THE STE

  Patient problems: Pain; Stenosis

  MAUDE report 25052528 ↗
• DeathApr 9, 2026Off-Label Use

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM AND LEFT COMMON ILIAC ARTERY ANEURYSM ON (B)(6) 2019 WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA INFRARENAL. DUE TO THE OCCLUSION OF THE LEFT ILIAC ARTERY, AN EXCLUDER LEG (NON-ENDOLOGIX) WAS DEPLOYED FROM THE LEFT COMMON ILIAC ARTERY (LCIA) TO THE EXTERNAL ILIAC ARTERY. AN AFX2 BSG WAS IMPLANTED VIA THE RIGHT APPROACH FOLLOWED BY PLACEMENT OF AN AFX VELA INFRARENAL JUST BELOW THE RENAL ARTERIES. AN ANEURYSM WAS ALSO NOTED IN IN THE RIGHT COMMON ILIAC ARTERY (RCIA); HOWEVER, THE PROCEDURE WAS CONCLUDED AS A STAGED EMBOLIZATION OF THE RCIA WAS PLANNED BUT IT IS UNKNOWN WHETHER THE EMBOLIZATION WAS PERFORMED. ON (B)(6) 2021 A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A TYPE IB ENDOLEAK FROM THE DISTAL RIGHT LEG AND MIGRATION OF THE PROXIMAL STENT GRAFT. CONSEQUENTLY, A SECONDARY ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED USING AN EXCLUDER AORTIC EXTENSION (NON-ENDOLOGIX) AND AN EXCLUDER LEG (NON-ENDOLOGIX), ALONG WITH EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY. THIS EVENT WAS REPORTED IN MDR # 3011063223-2026-00041. ON (B)(6) 2023, THE PATIENT PRESENTED TO A HOSPITAL WITH SUDDEN LOWER

  Patient problems: Clinical Endoleak; Pain; Ruptured Aneurysm

  MAUDE report 24836005 ↗
• InjuryApr 9, 2026Off-Label Use; Migration

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM AND LEFT COMMON ILIAC ARTERY ANEURYSM ON (B)(6) 2019 WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA INFRARENAL. DUE TO THE OCCLUSION OF THE LEFT ILIAC ARTERY, AN EXCLUDER LEG (NON-ENDOLOGIX) WAS DEPLOYED FROM THE LEFT COMMON ILIAC ARTERY (LCIA) TO THE EXTERNAL ILIAC ARTERY. AN AFX2 BSG WAS IMPLANTED VIA THE RIGHT APPROACH FOLLOWED BY PLACEMENT OF AN AFX VELA INFRARENAL JUST BELOW THE RENAL ARTERIES. AN ANEURYSM WAS ALSO NOTED IN IN THE RIGHT COMMON ILIAC ARTERY (RCIA); HOWEVER, THE PROCEDURE WAS CONCLUDED AS A STAGED EMBOLIZATION OF THE RCIA WAS PLANNED BUT IT IS UNKNOWN WHETHER THE EMBOLIZATION WAS PERFORMED. ON (B)(6) 2021 A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A TYPE IB ENDOLEAK FROM THE DISTAL RIGHT LEG AND MIGRATION OF THE PROXIMAL STENT GRAFT. CONSEQUENTLY, A SECONDARY ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED USING AN EXCLUDER AORTIC EXTENSION (NON-ENDOLOGIX) AND AN EXCLUDER LEG (NON-ENDOLOGIX), ALONG WITH EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY. NOTE: THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DE

  Patient problems: Clinical Endoleak

  MAUDE report 24835976 ↗
• InjuryApr 6, 2026Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2023. AFTER BILATERAL INTERNAL ILIAC ARTERY EMBOLIZATION, AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL WERE DEPLOYED VIA THE RIGHT ACCESS. THE PROCEDURE WAS COMPLETE AFTER CONFIRMING THE ABSENCE OF ENDOLEAKS ON THE FINAL ANGIOGRAPHY. IMMEDIATELY POST-PROCEDURE, THE PATIENT DEVELOPED ACUTE RENAL FAILURE THAT WAS COMPLICATED BY SYSTEMATIC THROMBOSIS. PARAPARESIS WAS NOTED. DUE TO THE PATIENT REFUSING DIALYSIS, NO ADDITIONAL TREATMENT WAS PERFORMED. THE PATIENT PASSED AWAY THE FOLLOWING DAY. REPORTEDLY, DUE TO THE PATIENT'S SIGNIFICANT SHAGGY AORTA, IT IS SUSPECTED THAT THROMBI WERE DISLODGED INTO THE RENAL ARTERIES DURING DEVICE MANEUVERS WHICH LED TO RENAL FAILURE. GIVEN THE PRESENCE OF A SHAGGY AORTA FROM THE DESCENDING TO THE ABDOMINAL AORTA, THIS EVENT COULD HAVE OCCURRED WITH ANY DEVICE DUE TO THE UNDERLYING VASCULAR CONDITION. WHILE THIS CASE SHOULD ORIGINALLY HAVE BEEN TREATED WITH SURGICAL GRAFT REPLACEMENT, A STENT GRAFT WAS SELECTED BECAUSE THE PATIENT REQUESTED ENDOVASCULAR ANEURYSM REPAIR.

  Patient problems: Renal Failure

  MAUDE report 24789901 ↗
• InjuryMar 30, 2026Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL, A VELA INFRARENAL, AN AFX ILIAC LIMB, AND AN OVATION IX ILIAC LIMB TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2026. THREE (3) DAYS POST INITIAL PROCEDURE, THE PATIENT WAS SCHEDULED FOR AN ADDITIONAL PROCEDURE FOR AN UNKNOWN REASON; HOWEVER, THE PROCEDURE WAS CANCELLED AS THE PATIENT CHANGED THEIR MIND ABOUT HAVING THIS PROCEDURE AND WAS MOVED TO COMFORT CARE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. NOTE: THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED.

  Patient problems: Insufficient Information

  MAUDE report 24711860 ↗
• InjuryMar 26, 2026Off-Label Use; Improper or Incorrect Procedure or Method

  THE PATIENT WAS TREATED FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2026. A COOK THORACIC STENT GRAFT (NON-ENDOLOGIX) WAS IMPLANTED FIRST AND THEN THE AFX2 BIFURCATED STENT GRAFT (BSG) WAS IMPLANTED. THE RUPTURE WAS TREATED AND SEAL WAS OBTAINED WITH A MILD TYPE IA ENDOLEAK OF THE COOK THORACIC STENT GRAFT WAS PRESENT. THE TYPE IA ENDOLEAK WAS LEFT UNTREATED AS IT WAS EXPECTED TO RESOLVE ONCE OFF HEPARIN. THE DISCHARGE COMPUTED TOMOGRAPHY SCAN ON (B)(6) 2026, FOUND THE TYPE IA ENDOLEAK FROM THE COOK THORACIC STENT GRAFT AND A TYPE IB ENDOLEAK FROM THE RIGHT LIMB OF THE AFX2 BSG WAS OBSERVED. THE SAME DAY REINTERVENTION WAS PERFORMED WITH IMPLANT OF AN OVATION IX ILIAC LIMB RESOLVING THE TYPE IB ENDOLEAK. A GORE TAG GRAFT (NON-ENDOLOGIX) WAS IMPLANTED TO RESOLVE THE TYPE IA ENDOLEAK AS WELL AS A PALMAZ STENT (NON-ENDOLOGIX) TO PUSH THE AORTIC CUFFS OPEN WITH BETTER APPOSITION. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NOTE: THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED. ALSO, THIS PROCEDURE WAS OFF LABEL DUE TO THE AB

  Patient problems: Clinical Endoleak

  MAUDE report 24703350 ↗

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