AFX Endovascular AAA SystemRecalls & reported problems across all models

We found 48 models of AFX Endovascular AAA System by Endologix LLC in the FDA's device registry (GUDID). Together they are named in 629 adverse event reports in the FDA's MAUDE database, received between Oct 26, 2015 and Jul 28, 2026 — classified as 30 deaths, 585 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (222 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 AFX Endovascular AAA System problems

AFX Endovascular AAA System models

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

• AFX Endovascular AAA System BA28-90/I20-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death50 reports
• AFX Endovascular AAA System BA28-100/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths44 reports
• AFX Endovascular AAA System BA28-100/I20-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths43 reports
• AFX Endovascular AAA System BA25-100/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death41 reports
• AFX Endovascular AAA System BA25-80/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths40 reports
• AFX Endovascular AAA System I20-13/C88F SA

  System, Endovascular Graft, Aortic Aneurysm Treatment
  35 reports
• AFX Endovascular AAA System BA25-90/I16-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  31 reports
• AFX Endovascular AAA System BA28-90/I16-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death31 reports
• AFX Endovascular AAA System BA28-120/I20-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  27 reports
• AFX Endovascular AAA System BA28-110/I20-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths21 reports
• AFX Endovascular AAA System BA28-80/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  20 reports
• AFX Endovascular AAA System BA22-90/I16-30

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

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death16 reports
• AFX Endovascular AAA System BA25-70/I16-30

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

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

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death15 reports
• AFX Endovascular AAA System BA25-120/I20-40

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

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths14 reports
• AFX Endovascular AAA System BA22-80/I16-40

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

  System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• AFX Endovascular AAA System BA28-70/I20-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death10 reports
• AFX Endovascular AAA System BA22-70/I16-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death8 reports
• AFX Endovascular AAA System BA25-80/I13-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  8 reports
• AFX Endovascular AAA System I20-13/C70F SA

  System, Endovascular Graft, Aortic Aneurysm Treatment
  8 reports
• AFX Endovascular AAA System BA25-80/I20-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  8 reports
• AFX Endovascular AAA System I20-20/C55F SA

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• AFX Endovascular AAA System IS20-25/C65 SA

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death7 reports
• AFX Endovascular AAA System BA25-60/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  6 reports
• AFX Endovascular AAA System BA28-60/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death6 reports
• AFX Endovascular AAA System BA25-90/I20-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  6 reports
• AFX Endovascular AAA System BA25-80/I16-55

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death5 reports
• AFX Endovascular AAA System I16-16/C88 SA

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death5 reports
• AFX Endovascular AAA System BA22-60/I16-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• AFX Endovascular AAA System A25-25/C75

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• AFX Endovascular AAA System BA25-110/I20-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• AFX Endovascular AAA System A28-28/C55

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• AFX Endovascular AAA System A25-25/C95

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• AFX Endovascular AAA System A25-25/C75-O20

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• AFX Endovascular AAA System A25-25/C95-O20

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• AFX Endovascular AAA System I16-16/C55F SA

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• AFX Endovascular AAA System BA25-110/I16-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• AFX Endovascular AAA System BA22-90/I20-30

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• AFX Endovascular AAA System BA22-60/I13-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death1 report
• AFX Endovascular AAA System A25-25/C55

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• AFX Endovascular AAA System A28-28/C95

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• AFX Endovascular AAA System A28-28/C75-O20

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• AFX Endovascular AAA System A28-28/C95-O20

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• AFX Endovascular AAA System BA22-40/I13-40

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report

Recent AFX Endovascular AAA System adverse event reports

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

• InjuryJul 28, 2026Complete Blockage; Off-Label Use; Separation Problem

  The patient was treated for an abdominal aortic aneurysm on (b)(6)2017. Coil embolization of the inferior mesenteric artery was performed. The AFX Bifurcated Stent Graft (BSG) and AFX Cuff were deployed via left access with a two-stent overlap. Final angiography confirmed no Endoleak, and the procedure was completed without issues. On (b)(6)2026, it was identified that the junction between the AFX BSG and the AFX Cuff had become partially separated. Although the patient was being managed under observation, a reintervention was planned because an enlargement of the aneurysm diameter was observed. Additionally, the AFX BSG left limb/common iliac artery is occluded and thrombectomy is scheduled to be performed concurrently. Reintervention is scheduled for (b)(6)2026.Reintervention was performed on (b)(6)2026 with the implant of an AFX Vela Infrarenal aligned with the proximal end. Although no Endoleak to the sac was confirmed, balloon touch-up was performed and the AFX Vela Infrarenal migrated proximally; therefore, a Gore (non-Endologix) Excluder Cuff was then deployed at the distal end of the AFX Vela Infrarenal to complete the procedure. The final patent status was not reported.

  Patient problems: Aneurysm; Clinical Endoleak; Obstruction/Occlusion

  MAUDE report 50056611 ↗
• InjuryMar 31, 2026Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2016 WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT BSG), AN AFX VELA SUPRARENAL STENT GRAFT, AN AFX LIMB EXTENSION, AND A GORE (NON-ENDOLOGIX) EXCLUDER CUFF. DURING THE INITIAL IMPLANTATION, FIRST THE INFERIOR MESENTERIC ARTERY WAS EMBOLIZED, THEN THE AFX BSG AND AFX VELA SUPRARENAL WERE DEPLOYED VIA LEFT ACCESS. SUBSEQUENTLY THE AFX ILIAC LIMB EXTENSION WAS DEPLOYED IN THE LEFT COMMON ILIAC ARTERY (CIA) AND THE GORE (NON-ENDOLOGIX) EXCLUDER CUFF WAS DEPLOYED IN THE RIGHT CA AFTER TOUCH-UP, IT WAS CONFIRMED THAT THERE WERE NO ENDOLEAKS, AND THE PROCEDURE WAS COMPLETED. REPORTEDLY ON (B)(6) 2026 THE DISTRIBUTOR WAS MADE AWARE OF A SUSPECTED TYPE IIIB ENDOLEAK APPROXIMATELY 12MM ABOVE THE AORTIC BIFURCATION. THE PATIENT IS CURRENTLY BEING MONITORED WHILE REINTERVENTION PLANS ARE BEING DISCUSSED.

  Patient problems: Clinical Endoleak

  MAUDE report 24743088 ↗
• InjuryDec 19, 2025Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AN EXCLUDER CUFF (NON-ENDOLOGIX) ON (B)(6) 2016. IN 2023, ANKLE-BRACHIAL INDEX (ABI) WAS 1.0. IN 2024, ABI WAS 0.9. IN 2025, ABI WAS LESS THAN 0.9 AND THE PATIENT'S PULSE WAS PALPABLE BUT PERCEIVED AS SLIGHTLY WEAK. CONTRAST CT SHOWED THE DISTAL END OF THE AFX (BSG) RIGHT LEG APPEARED TO BE LEANING INWARD. AN INTERVENTION FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND ADDITIONAL BARE STENT PLACEMENT WAS BEING CONSIDERED. ON (B)(6) 2025 THE PATIENTS WAS IN POOR CONDITION DUE TO ISSUES AT A SITE UNRELATED TO THIS EVENT. THE PHYSICIAN ELECTED TO NOT PERFORM THE PROCEDURE.

  Patient problems: Stenosis

  MAUDE report 23856825 ↗
• InjuryAug 18, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR A RIGHT ILIAC ANEURYSM ON (B)(6) 2015 WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX LIMB STENT GRAFT. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO THE ABSENCE OF AN ABDOMINAL AORTIC ANEURYSM. ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2025 IDENTIFIED THAT ALTHOUGH THE ILIAC IS STABLE, THE AORTA HAS GROWN ENOUGH TO THE POINT THAT THERE IS A SLIGHT FILLING AROUND THE INITIAL MAIN BODY CREATING A ABDOMINAL AORTIC ANEURYSM BUT NOT INTO THE RIGHT ILIAC ARTERY. REINTERVENTION WAS COMPLETED ON (B)(6) 2025. IT WAS LATER REPORTED THAT THE "SLIGHT FILLING" WAS COMING FROM A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN AFX VELA SUPRARENAL AND AN OVATION IX EXTENDER TO RESOLVE THE LEAK. THE FINAL PATIENT STATUS WAS REPORTED TO BE DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22829640 ↗
• InjuryAug 13, 2025Lack of Effect; Lack 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 CUFF. APPROXIMATELY EIGHT YEARS POST INITIAL PROCEDURE, ROUTINE FOLLOW UP, CONFIRMED THE JUNCTION WAS ABOUT TO SEPARATE. REINTERVENTION WAS COMPLETED ON (B)(6) 2025. THE INTRAOPERATIVE ANGIOGRAPHY CONFIRMED A TYPE IIIA ENDOLEAK. A AFX VELA INFRARENAL WAS IMPLANTED AT THE CENTER OF THE JUNCTION VIA THE LEFT ACCESS. THE PROCEDURE WAS COMPLETED AFTER PERFORMING BALLOON TOUCH UP.

  Patient problems: Clinical Endoleak

  MAUDE report 22797531 ↗
• InjuryMar 26, 2025Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2015 WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT (BSG) AND AFX VELA SUPRARENAL. ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2025 IDENTIFIED WHAT APPEARED TO BE A GRAFT SEPARATION AND POSSIBLE TYPE IIIA ENDOLEAK. REINTERVENTION WAS COMPLETED ON (B)(6) 2025 BY RELINING THE GRAFT WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL. PATIENT WAS REPORTED TO BE STABLE POST-SECONDARY PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21700622 ↗
• InjuryMar 19, 2025Migration; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA SUPRARENAL AORTIC EXTENSION FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2015. IT WAS REPORTED DURING A RECENT ROUTINE FOLLOW-UP, THE ANGIOGRAM REVEALED ANEURYSM ENLARGEMENT. THE ANGIOGRAM ON (B)(6) 2025 DEMONSTRATED THAT THERE IS A MINIMAL OVERLAP BETWEEN THE AFX BSG AND AFX VELA SUPRARENAL AORTIC EXTENSION. DUE TO THROMBOSIS THERE IS NO APPARENT ENDOLEAK VISIBLE, HOWEVER THERE IS AAA ENLARGEMENT MOST LIKELY DUE TO AN INDETERMINATE ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE THE ENTIRE ENDOGRAFT SYSTEM WITH THE IMPLANTATION OF AN AFX2 BSG AND AN AFX VELA SUPRARENAL AORTIC EXTENSION. THE CASE WAS COMPLETED, THERE WAS COMPLETE INCLUSION OF THE PREVIOUSLY IMPLANT STENT GRAFTS. THE PATIENT WAS STABLE POST INTERVENTION AND WAS DISCHARGED HOME ONE DAY POST INTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak; Thrombosis/Thrombus

  MAUDE report 21643287 ↗
• InjuryMar 11, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL EXTENSION, AND AN AFX ILIAC EXTENSION FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2021. APPROXIMATELY THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE IB ENDOLEAK IN THE RIGHT ILIAC LIMB WAS IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT AN AFX ILIAC LIMB ON (B)(6) 2025. THE FINAL COMPUTED TOMOGRAPHY (CT) REVEALED THAT THE DISTAL TYPE IB ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PATIENT WAS REPORTED AS DOING FINE POST SECONDARY PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21576358 ↗
• InjuryJan 7, 2025Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2017 WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT, AFX VELA SUPRARENAL, AND AFX VELA INFRARENAL. SECONDARY REINTERVENTION TREATED A TYPE II ENDOLEAK THAT WAS CAUSING ANEURYSM ENLARGEMENT BY COILING THE SAC ON (B)(6) 2021. REPORTEDLY A TYPE II ENDOLEAK HAS BEEN MONITORED SINCE 2022. ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2024 IDENTIFIED A TYPE IIIB ENDOLEAK. REINTERVENTION PLANS ARE TO TREAT THE TYPE IIIB ENDOLEAK WITH A NON-ENDOLOGIX DEVICE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 21091341 ↗
• InjuryDec 10, 2024Off-Label Use; Device-Device Incompatibility; Separation Problem; Off-Label Use; Device-Device Incompatibility; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT A FUSIFORM SHAPED ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY EIGHT (8) YEARS POST INITIAL PROCEDURE, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN SHOWED JUNCTION SEPARATION BETWEEN THE AFX2 BIFURCATED STENT GRAFT AND THE VELA AORTIC EXTENSION AND THERE WAS A TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN AFX AORTIC EXTENSION BETWEEN THE EXISTING STENT GRAFTS ON (B)(6) 2024. THE FINAL ANGIOGRAM SHOWED THAT THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PROCEDURE WAS COMPLETED. THE PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Clinical Endoleak

  MAUDE report 20891972 ↗
• InjuryOct 15, 2024Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2016 WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX LIMB STENT GRAFT DISTAL EXTENSION. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK (OF THE RIGHT COMMON ILIAC). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EXTENDING THE RIGHT LIMB GRAFT; ONE (1) ADDITIONAL AFX LIMB STENT GRAFT WAS IMPLANTED ON 07 AUGUST 2023. REPORTEDLY, THE PATIENT WAS IN STABLE CONDITION WITH NO ADDITIONAL PATIENT SEQUELAE. (REPORTED UNDER MFR# 2031527-2023-00024). NOW APPROXIMATELY ONE (1) YEAR POST-REINTERVENTION ON (B)(6) 2024, ROUTINE FOLLOW-UP SUSPECTED A TYPE III ENDOLEAK. AN ANGIOGRAM WAS SCHEDULED FOR (B)(6) 2024, HOWEVER IT HAS BEEN POSTPONED UNTIL (B)(6) 2024 FOR UNKNOWN REASON. THE PATIENT STATUS WAS REPORTED AS ALIVE AND WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 20451784 ↗
• InjurySep 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2015 WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND VELA SUPRARENAL. DURING ROUTINE FOLLOW-UP THE PATIENT PRESENTED WITH SOME SIGNIFICANT ANGULATION OF THE AORTA WHICH SEEMED TO RESULT IN MINIMAL OVERLAP. ANGIOGRAM CONDUCTED ON (B)(6) 2024 CONFIRMED NO IDENTIFIABLE ENDOLEAK, HOWEVER EVIDENCE DID APPEAR AS THOUGH THE OVERLAP WAS LESS THAN IDEAL. OUT OF PRECAUTION, THE PHYSICIAN DECIDED TO PLACE TWO BRIDGE STENTS IN ORDER TO ACHIEVE MAXIMUM OVERLAP AND PREVENT THE POSSIBILITY OF FUTURE DISCONNECTION. REINTERVENTION WAS SUCCESSFULLY COMPLETED ON (B)(6) 2024 WITH THE IMPLANT OF A VELA SUPRARENAL AND VELA INFRARENAL WITHOUT INCIDENT. PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY.

  Patient problems: Insufficient Information

  MAUDE report 20196813 ↗
• InjurySep 10, 2024Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT, ONE (1) ENDURANT (NON-ENDOLOGIX) ILIAC LIMB AND TWO (2) ENDURANT (NON-ENDOLOGIX) EXTENSIONS. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM PER DEVICE IFU. A TYPE II ENDOLEAK (NON-DEVICE-RELATED) FROM THE LUMBAR ARTERY WAS NOTED AT INITIAL IMPLANT. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH ANEURYSM ENLARGEMENT (ABOUT 5MM). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY CONVERTING TO OPEN SURGERY ON (B)(6) 2023. DURING THE RE-INTERVENTION, THE PHYSICIAN SLIGHTLY MOVED THE AFX BIFURCATED STENT GRAFT TO CHECK FOR OTHER ENDOLEAKS AND BLOOD LEAKED FROM MULTIPLE HOLES OF THE AFX DEVICE (CLASSIFIED AS TYPE IIIB ENDOLEAKS). AS THE BLOOD ONLY LEAKED FROM THESE HOLES IF THE PHYSICIAN PUSHED ON THE GRAFT, THE PHYSICIAN CHOSE TO NOT PERFORM ADDITIONAL TREATMENT AND CONCLUDED THE OPERATION. IT IS BELIEVED THAT THE FULLY EXPANDED ENDURANT STENT GRAFTS WERE SEALING THE HOLES. THE PATIENT IS REPORTEDLY DISCHARGED. THIS EVENT WAS REPORTED UNDER MFR# 2031527-2023-00203. ON

  Patient problems: Clinical Endoleak

  MAUDE report 20182862 ↗
• InjuryAug 22, 2024Off-Label Use; Off-Label Use

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND OVATION IX EXTENDER IN THE RIGHT LIMB TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE IB, A SUSPECTED TYPE IA ENDOLEAK WAS OBSERVED AND THE ILIACS HAD ENLARGED. INTERVENTION OCCURRED ON (B)(6) 2024 WITH THE IMPLANTATION OF AN AFX LIMB STENT GRAFT, A VELA SUPRARENAL, AND AN OVATION IX EXTENDER. IT WAS REPORTED THAT THE ENDOLEAK WAS SEALED AND THE PATIENT IS STABLE. NOTE: THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20032819 ↗
• InjuryJul 23, 2024Material Puncture/Hole; Lack of Effect; Material Puncture/Hole; Lack of Effect

  THE PATIENT INITIALLY RECEIVED TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6)2015, WITH THE IMPLANTATION OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. ON (B)(6) 2024, IT WAS REPORTED THAT A POSSIBLE TYPE IB ENDOLEAK HAD BEEN IDENTIFIED. ON (B)(6) 2024, THE PATIENT UNDERWENT A RE-INTERVENTION. DURING THIS PROCEDURE, THE PHYSICIAN IMPLANTED THREE (3) OVATION IX ILIAC LIMBS, OVATION PRIME FILL POLYMER, AND AN ALTO MAIN BODY. THE FINAL PATIENT STATUS REMAINS UNKNOWN, AS THIS INFORMATION WAS NOT PROVIDED TO ENDOLOGIX.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19812414 ↗

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