Vela Proximal Endograft SystemRecalls & reported problems across all models

We found 12 models of Vela Proximal Endograft System by Endologix LLC in the FDA's device registry (GUDID). Together they are named in 374 adverse event reports in the FDA's MAUDE database, received between Nov 5, 2015 and May 13, 2026 — classified as 13 deaths, 359 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (118 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 Vela Proximal Endograft System problems

Vela Proximal Endograft System models

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

• Vela Proximal Endograft System A34-34/C100-O20 V

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths152 reports
• Vela Proximal Endograft System A28-28/C95-O20 V

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths66 reports
• Vela Proximal Endograft System A34-34/C80-O20 V

  System, Endovascular Graft, Aortic Aneurysm Treatment
  39 reports
• Vela Proximal Endograft System A34-34/C100 V

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths26 reports
• Vela Proximal Endograft System A28-28/C75-O20 V

  System, Endovascular Graft, Aortic Aneurysm Treatment
  26 reports
• Vela Proximal Endograft System A28-28/C75 V

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

  System, Endovascular Graft, Aortic Aneurysm Treatment
  14 reports
• Vela Proximal Endograft System A25-25/C95-O20 V

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death12 reports
• Vela Proximal Endograft System A25-25/C95 V

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• Vela Proximal Endograft System A34-34/C80 V

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death7 reports
• Vela Proximal Endograft System A25-25/C75 V

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths6 reports
• Vela Proximal Endograft System A25-25/C75-O20 V

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports

Recent Vela Proximal Endograft System adverse event reports

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

• InjuryMay 13, 2026Material Puncture/Hole; Material Deformation

  THE PATIENT WAS INITIALLY TREATED FOR A FUSIFORM ABDOMINAL AORTIC ANEURYSM (AAA) WITH A SHAGGY AORTA ON (B)(6) 2023 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA SUPRARENAL STENT GRAFT THAT WERE DEPLOYED VIA RIGHT ACCESS. THE INITIAL PROCEDURE WAS COMPLETED WITHOUT BALLOON TOUCH-UP AFTER ANGIOGRAPHY CONFIRMED THE ABSENCE OF ENDOLEAKS. IT WAS REPORTED THAT THE PREVIOUSLY IMPLANTED STENT GRAFT WAS EXPANDING. THE DIAMETER OF THE AFX VELA SUPRARENAL STENT GRAFT HAS GRADUALLY EXPANDED SINCE ONE-YEAR POST-PROCEDURE, EVENTUALLY REACHING AN AVERAGE OF APPROXIMATELY 40 MM. DUE TO THE DEGREE OF EXPANSION, THERE IS A POSSIBILITY THAT THE GRAFT FABRIC ITSELF MAY BE DAMAGED. REINTERVENTION WAS COMPLETED ON (B)(6) 2026 WHERE THE PHYSICIAN ELECTED TO RE-LINE THE GRAFT WITH A GORE (NON-ENDOLOGIX) EXCLUDER CUFF. THE FINAL PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Clinical Endoleak

  MAUDE report 25166288 ↗
• InjuryMar 11, 2026Off-Label Use; Unintended Movement

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM MINOR AXIS DIAMETER OF 51.5MM WITH THE LEFT COMMON ILIAC ARTERY (CIA) WITH A DILATED PORTION WITH A MAXIMUM DIAMETER OF 25MM ON (B)(6) 2019. THE LEFT INTERNAL ILIAC ARTERY (IIA) EMBOLIZED WITH A PLUG VIA A RIGHT FEMORAL APPROACH, A GORE (NON-ENDOLOGIX) EXCLUDER LEG WAS DEPLOYED FROM THE LEFT CIA TO THE EXTERNAL ILIAC ARTERY (EIA) VIA A LEFT APPROACH. THE AFX2 BIFURCATED STENT GRAFT (BSG) AND THE AFX VELA SUPRARENAL WERE DEPLOYED ACCORDING TO THE STANDARD PROCEDURE. INTRAOPERATIVE ANGIOGRAPHY (DSA) CONFIRMED A TYPE IA ENDOLEAK AT THE PROXIMAL SIDE OF THE AFX VELA SUPRARENAL; THEREFORE, A GORE (NON-ENDOLOGIX) EXCLUDER CUFF (28.5-33) WAS DEPLOYED AS AN INTERNAL LINING. THE PROCEDURE WAS COMPLETED AFTER CONFIRMING THE RESOLUTION OF THE ENDOLEAK. ON (B)(6) 2026, JUNCTION SEPARATION BETWEEN THE AFX2 MAIN BODY AND THE VELA WAS CONFIRMED DURING A ROUTINE FOLLOW-UP. REINTERVENTION WAS PERFORMED ON (B)(6) 2026. THERE WAS NO SIGNIFICANT LEAK OBSERVED AT THE JUNCTION BETWEEN THE AFX2 BSG AND AFX VELA SUPRARENAL. A AFX VELA INFRARENAL WAS DEPLOYED AT THE JUNCTION, AND THE PROCEDURE WAS COMPLETED. NOTE: THE AFX2 SYSTEM WAS E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573292 ↗
• InjuryMar 3, 2026Off-Label Use

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2021 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) VIA RIGHT ACCESS, AN AFX VELA SUPRARENAL JUST BELOW THE RENAL ARTERIES, AND A GORE (NON-ENDOLOGIX) EXCLUDER CUFF IN THE RIGHT COMMON ILIAC ARTERY ALIGNED WITH THE COMMON ILIAC ARTERY BIFURCATION TO PRESERVE THE INTERNAL ILIAC ARTERY. ON 27 JANUARY 2026 A CONTRAST-ENHANCED COMPUTED TOMOGRAPHY CONFIRMED AN ENDOLEAK, ALTHOUGH THERE WAS NO ANEURYSM SAC ENLARGEMENT OBSERVED. THE ORIGIN OF THE ENDOLEAK COULD NOT BE IDENTIFIED AND WAS SUSPECTED TO BE EITHER A TYPE IA OR TYPE III ENDOLEAK. REINTERVENTION WAS COMPLETED ON (B)(6) 2026. FIRST AN ANGIOGRAPHY WAS PERFORMED FROM THE PROXIMAL END OF THE AFX VELA SUPRARENAL THAT CONFIRMED IT WAS A TYPE IA ENDOLEAK; HOWEVER, THE ANGIOGRAPHY FROM WITHIN THE AFX2 BSG DID NOT SHOW ANY TYPE III ENDOLEAK. THEREFORE, THE CONDITION WAS DIAGNOSED AS A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A GORE (NON-ENDOLOGIX) EXCLUDER CUFF ALIGNED WITH THE PROXIMAL END OF THE AFX VELA SUPRARENAL. AFTER BALLOON TOUCH-UP, THE TYPE IA ENDOLEAK WAS CONFIRMED TO HAVE RESOLVED, AND THE PROCEDURE WAS COMPLETED. THE FINAL PATIENT

  Patient problems: Clinical Endoleak

  MAUDE report 24503253 ↗
• InjuryJan 9, 2026Deformation Due to Compressive Stress

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AN AFX VELA SUPRARENAL AND TWO OVATION IX ILIAC LIMBS ON (B)(6) 2025. THE FOLLOWING DAY A FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE VELA INFRARENAL WAS BENT OVER FROM THE ANGLE IN THE PATIENT¿S NECK AND CAUSING A STENOSIS. INTERVENTION OCCURRED ON (B)(6) 2025 WITH IMPLANTATION OF VELA INFRARENAL AND VELA SUPRARENAL. STENOSIS WAS FIXED AND PATIENT IS OUT OF HE HOSPITAL.

  Patient problems: Stenosis

  MAUDE report 24030667 ↗
• InjuryJan 7, 2026Off-Label Use; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT SYSTEM, AN AFX VELA SUPRARENAL EXTENSION, AND AFX VELA INFRARENAL EXTENSION FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025. IT WAS REPORTED ON (B)(6) 2025 THE PATIENT PRESENTED EMERGENTLY, AN ANGIOGRAM REVEALED A TYPE IA ENDOLEAK. THE PHYSICIAN IMPLANTED AN AFX VELA SUPRARENAL AORTIC CUFF EXTENSION EXTENDING PROXIMALLY CLOSER TO THE RENAL ARTERIES, AND A SEAL WAS ACHIEVED. THE TYPE IA ENDOLEAK WAS RESOLVED. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 23991929 ↗
• InjuryDec 12, 2025Off-Label Use; Material Puncture/Hole; Lack of Effect; Off-Label Use; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2016 WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL. ON (B)(6) 2025 THE PATIENT PRESENTED EMERGENTLY IN PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN WAS TAKEN AND A TYPE IIIB ENDOLEAK IN THE AFX VELA INFRARENAL WAS OBSERVED. THE PHYSICIAN ELECTED TO RELINE WITH A NEW AFX VELA SUPRARENAL. THE ENDOLEAK WAS RESOLVED AND THE PATIENT¿S FINAL STATUS WAS REPORTED AS OKAY.

  Patient problems: Clinical Endoleak; Pain

  MAUDE report 23790594 ↗
• InjuryJul 16, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, A TYPE 1A ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT AN AFX VELA INFRARENAL ON (B)(6) 2025 WHICH SUCCESSFULLY RESOLVED THE ENDOLEAK.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22522661 ↗
• InjuryJul 5, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY NINE YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH LOWER BACK PAIN. THE PHYSICIAN DETERMINED IT WAS A TYPE IA ENDOLEAK AND ELECTED TO PERFORM AN INTERVENTION. AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN AFX LIMB STENT GRAFT WERE IMPLANTED AND THE TYPE IA ENDOLEAK WAS RESOLVED. THE PATIENT WAS REPORTED AS RECOVERING WELL.

  Patient problems: Abdominal Pain; Clinical Endoleak; Pain; Rupture; Unspecified Infection

  MAUDE report 22407202 ↗
• InjuryJun 13, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BIF) AND AN AFX VELA SUPRARENAL. THE PATIENTS¿ NECK WAS TAPERED. THE AFX2 BIF WAS IMPLANTED VIA THE LEFT ACCESS AND THEN THE AFX VELA WAS IMPLANTED. DUE TO THE DIAMETER GAP BETWEEN THE PROXIMAL AND DISTAL NECK, THE PROXIMAL SIDE OF THE BIF DID NOT ACHIEVE FULL APPOSITION TO THE DISTAL SIDE OF THE VELA. IT WAS REPORTED THAT THERE WAS SUFFICIENT OVERLAP (OVER THREE STENTS). NO ENDOLEAKS WERE CONFIRMED AND THE PROCEDURE WAS COMPLETED. APPROXIMATELY ONE YEAR POST INITIAL PROCEDURE, THE PHYSICIAN ELECTED TO PERFORM AN ANEURYSM SUTURE DUE TO ANEURYSM ENLARGEMENT (59MM TO 63MM) CAUSED BY A TYPE II ENDOLEAK FORM THE LUMBAR ARTERY. THE FIRST FOLLOW UP CONFIRMED THE ANEURYSM HAD SHRUNK TO 47MM, BUT DURING THE TWO YEAR FOLLOW UP, THE ANEURYSM WAS SHOWN TO HAVE ENLARGED TO 59MM. THE PHYSICIAN ELECTED TO PERFORM AN OPEN SURGERY. THE THROMBUS AND VELA WERE REMOVED AND ARTIFICIAL GRAFT REPLACEMENT SURGERY WAS PERFORMED. AFTER THE THROMBUS WAS REMOVED, BLOOD SPURTED OUT FROM THE POSTERIOR SIDE OF THE STENT GRAFT BUT THE PHYSICIAN COULD NOT DETERMINE IF IT WAS FROM THE BIF OR THE

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22203397 ↗
• InjuryMay 28, 2025Lack of Effect; Lack 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. ROUTINE FOLLOW-UP PERFORMED IN (B)(6) 2025 IDENTIFIED A POSSIBLE TYPE IB ENDOLEAK OR POSSIBLE TYPE II ENDOLEAK. REINTERVENTION WAS COMPLETED ON (B)(6) 2025. ANGIOGRAPHY CONFIRMED A TYPE IA ENDOLEAK WHICH WAS SUCCESSFULLY TREATED WITH THE IMPLANT OF AN OVATION IX EXTENDER. THE FINAL PATIENT STATUS WAS REPORTED TO BE DOING WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 22094881 ↗
• InjuryMay 6, 2025Fracture; Separation Problem; Fracture; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL ON (B)(6) 2016, TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS AFTER THE INITIAL PROCEDURE, THE PATIENT PRESENTED WITH FLANK PAIN, AND A TYPE IIIA ENDOLEAK WAS IDENTIFIED. AT AN UNKNOWN DATE AND LOCATION, THE PHYSICIAN IMPLANTED AN ADDITIONAL VELA LIMB TO ADDRESS THE ISSUE. (MRN 2031527-2019-00495). ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER) DUE TO ANOTHER TYPE IIIA ENDOLEAK. IMAGING STUDIES, INCLUDING A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA), REVEALED STENT FRACTURES IN WHAT APPEARS TO BE THE ORIGINAL VELA, WHICH HAD PREVIOUSLY BEEN RELINED WITH ANOTHER VELA. THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 21970155 ↗
• InjuryApr 17, 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 VELA SUPRARENAL. ROUTINE FOLLOW-UP PERFORMED ON (B)(6) 2025 IDENTIFIED A TYPE IA ENDOLEAK. REINTERVENTION WAS COMPLETED ON (B)(6) 2025 WITH THE IMPLANT OF AN AFX VELA INFRARENAL. THE TYPE IA ENDOLEAK WAS SEALED AND THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21860932 ↗
• InjuryApr 4, 2025Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS BEING TREATED FOR A 71MM DIAMETER ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2022 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AFX VELA SUPRARENAL, AND AFX INFRARENAL. AN EPIC (NON-ENDOLOGIX) VASCULAR STENT (10-40) WAS ADDED TO REINFORCE THE LEFT LEG, AND THE PROCEDURE WAS COMPLETED AFTER ENSURING THAT THERE WAS NO ENDOLEAK. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX2 SYSTEM PER THE IFU. FOLLOW-UPS IN (B)(6) 2023 INITIALLY SHOWED DECREASE IN ANEURYSM SIZE TO 68MM AND 59MM RESPECTIVELY; HOWEVER, FOLLOW-UPS IN (B)(6) 2024 SHOWED INCREASE IN ANEURYSM SIZE TO 63MM AND 64MM RESPECTIVELY. REPORTEDLY AT THE (B)(6) 2024 FOLLOW-UP, THERE WAS A SENSE OF DISCOMFORT IN HOW THE STENT GRAFT HAD BEEN IMPLANTED. OPEN SURGERY WAS PERFORMED ON (B)(6) 2025 TO EXPLANT ALL THE AFX DEVICES, AND THEY WERE REPLACED WITH A "Y" (NON-ENDOLOGIX) GRAFT. THE PHYSICIAN REPORTEDLY FOUND HOLES IN MULTIPLE LOCATIONS THAT HAVE BECOME ENLARGED OVER TIME AS WELL AS ENLARGEMENT OF THE GRAFT. FINAL PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Clinical Endoleak

  MAUDE report 21774329 ↗
• InjuryApr 1, 2025Off-Label Use; Material Puncture/Hole; Deformation Due to Compressive Stress; Lack of Effect; Off-Label Use; Material Puncture/Hole; Deformation Due to Compressive Stress; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL AORTIC EXTENSION. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE 1A ENDOLEAK WAS IDENTIFIED WITH ANEURYSM ENLARGEMENT TO 9CM. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER AFX2 BIFURCATED STENT GRAFT AND EXTENDED PROXIMALLY WITH A VELA SUPRARENAL AORTIC EXTENSION AND SNORKELED (PARALLEL GRAFTED) BOTH RENAL ARTERIES AND THE SUPERIOR MESENTERIC ARTERY (SMA) TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21739636 ↗
• InjuryMar 13, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, TWO VELA SUPRARENALS AND AN AFX VELA INFRARENAL. APPROXIMATELY (2) TWO YEARS POST INITIAL PROCEDURE, THE PATIENT WAS IDENTIFIED WITH AN ENDOLEAK OF INDETERMINATE ORIGIN. THE PATIENT IS CURRENTLY BEING MONITORED AND AWAITING AN ANGIOGRAPHY TO DETERMINE THE ISSUE. THIS WAS PREVIOUSLY REPORTED UNDER MDR # 2031527-2022-00224. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING ROUTINE FOLLOW-UP ON (B)(6)2025 THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN AFX VELA SUPRARENAL AORTIC EXTENSION TO RESOLVE THIS EVENT ON (B)(6)2025. THE PATIENT WAS REPORTED AS STABLE POST SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21596547 ↗

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