Vela Proximal Endograft System A34-34/C100-O20 VRecalls & reported problems

Summary

The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 00818009013651), received between Nov 5, 2015 and May 13, 2026 — classified as 3 deaths, 148 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (46 reports).

16 other recalls cover devices cleared under the same FDA submission (P040002); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 152 reports, 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryNov 5, 2024Fracture; Off-Label Use; Material Puncture/Hole; Migration; Fracture; Off-Label Use; Material Puncture/Hole; Migration

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL ON SEPTEMBER 28, 2016. APPROXIMATELY EIGHT (8) YEARS AFTER THE INITIAL PROCEDURE, DURING A ROUTINE FOLLOW-UP, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A TYPE IIIB ENDOLEAK. ON OCTOBER 8, 2024, THE PHYSICIAN OPTED TO EXPLANT THE DEVICE. THE PATIENT'S POST-OPERATIVE CONDITION WAS REPORTED AS GOOD.

  Patient problems: Aneurysm; Clinical Endoleak; Exsanguination

  MAUDE report 20609369 ↗
• InjurySep 9, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2019 WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL. AN ANGIOGRAM CONDUCTED DURING ROUTINE FOLLOW-UP ON APPROXIMATELY 19 AUGUST 2024 IDENTIFIED A POSSIBLE ENDOLEAK OF INDETERMINATE ORIGIN HOWEVER, IT WAS ULTIMATELY DETERMINED TO BE A TYPE 1A ENDOLEAK. REINTERVENTION WAS SUCCESSFULLY COMPLETED ON 26 AUGUST 2024. THE INITIALLY IMPLANTED GRAFT WAS RELINED WITH AN AFX2 BIFURCATED STENT GRAFT; HOWEVER, THE ENDOLEAK WAS STILL PRESENT. A PROXIMAL VELA SUPRARENAL WAS PLACED HIGHER THAN THE ORIGINAL PROXIMAL EXTENSION HOWEVER, THE ENDOLEAK STILL PERSISTED. A PALMAZ (NON-ENDOLOGIX) BALLOON MOUNTED STENT WAS PLACED IN THE PROXIMAL EXTENSION AND INFLATED TWICE. THE SECOND INFLATION STOPPED THE TYPE 1A ENDOLEAK. THE PATIENT WAS RELEASED HOME THE NEXT DAY.

  Patient problems: Clinical Endoleak

  MAUDE report 20172225 ↗
• InjuryMay 16, 2024Material Puncture/Hole; Migration; Material Puncture/Hole; Migration

  THE PATIENT WAS TREATED FOR ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2017 WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL AND AFX LIMB STENT GRAFT. ON (B)(6) 2024 AN AORTOGRAM SHOWED A SUSPECTED TYPE IIIB ENDOLEAK FROM THE VELA SUPRARENAL AND A TYPE IB ENDOLEAK FROM THE LEFT LIMB. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19336001 ↗
• InjuryMar 21, 2024Off-Label Use; Material Puncture/Hole; Migration; Off-Label Use; Material Puncture/Hole; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AN AFX VELA SUPRARENAL AORTIC EXTENSION AND AN OVATION IX EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, IT WAS REPORTED THAT THE PATIENT DID NOT COME BACK FOR FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCANS. THE AFX AORTIC EXTENSION WAS FOUND TO HAVE SLIPPED OVER THAT TIME RESULTING IN A TYPE 1A ENDOLEAK AND THE ANEURYSM HAD GROWN TO 12CM. THE PHYSICIAN ELECTED TO RE-LINE THE ORIGINAL IMPLANTED DEVICES WITH A MEDTRONIC (NON-ENDOLOGIX) GRAFT TO RESOLVE THIS EVENT. THE FINAL PATIENT STATUS WAS REPORTED AS STABLE POST SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 18953766 ↗
• InjuryMar 5, 2024Material Puncture/Hole; Lack of Effect; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2007, WITH THE IMPLANT OF A VISIFLEX BIFURCATED STENT GRAFT AND A PEEK CUFF STENT GRAFT. ON (B)(6) 2010, THE PATIENT HAD A NON-DEVICE RELATED INTUITRAK INFRARENAL AORTIC EXTENSION IMPLANTED. ROUTINE FOLLOW-UP ON (B)(6) 2021, IDENTIFIED A RIGHT COMMON ILIAC ANEURYSM DISTAL TO THE EXISTING LIMB THAT IS IN PLACE (NON-DEVICE RELATED). REINTERVENTION WAS COMPLETED ON (B)6) 2022, WITH THE IMPLANT OF AN AFX VELA SUPRARENAL AND AN AFX LIMB STENT GRAFT. THE PATIENT WAS REPORTED TO BE STABLE. ON (B)(6) 2024, IT WAS REPORTED THAT A ROUTINE FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN (DONE AT AN OUTSIDE FACILITY) IDENTIFIED AN INDETERMINANT ENDOLEAK. REINTERVENTION PLANS HAVE NOT YET BEEN PROVIDED. THE PATIENT IS REPORTED TO BE STABLE. THE PATIENT IS CHOOSING NOT TO DO ANYTHING FURTHER. THE CLINICAL ASSESSMENT DETERMINED THAT THE AFX, ENDOLEAK (INDETERMINATE ORIGIN) COMPLAINT WAS FOUND TO BE A TYPE IIIB ENDOLEAK OF THE DISTAL MAIN BODY OF THE VISIFLEX IMPLANTED (B)(6) 2007. THE PRODUCT HAS EXCEEDED ITS LIFE EXPECTANCY AND THERE IS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTI

  Patient problems: Clinical Endoleak

  MAUDE report 18838490 ↗
• InjuryNov 1, 2023Malposition of Device; Malposition of Device

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AFX INFRARENAL ON (B)(6) 2022. THE ROUTINE FOLLOW-UP COMPUTED TOMOGRAPHY (CT) PERFORMED ON (B)(6) 2023 FOUND THAT THE ANEURYSM SAC REMAINS THE SAME SIZE AT 8.25CM. THE ANGIOGRAMS FROM THE INDEX PROCEDURE WERE REVIEWED AGAIN AND IT WAS FOUND THAT THE PROXIMAL EXTENSION (AFX VELA SUPRARENAL) HAD LANDED LOW TO THE RENAL. THOUGH CONTRAST WAS NOT SEEN ON THE RECENT CT, THE PHYSICIAN SUSPECTS A TYPE IA ENDOLEAK. ADDITIONALLY, THERE IS A POSSIBLE TYPE IB ENDOLEAK. REPORTEDLY, PRE-REINTERVENTION, THE PATIENT WAS DOING FINE AND DID NOT HAVE ANY SYMPTOMS. REINTERVENTION WAS COMPLETED ON (B)(6) 2023. AT REINTERVENTION, THE TYPE IA OR TYPE IB ENDOLEAKS WERE UNABLE TO BE CONFIRMED AS THE SAC WAS FILLED WITH THROMBUS. THE PRIMARY INDICATOR OF THE POSSIBLE ENDOLEAKS IS THAT THE AAA HAD GROWN SLIGHTLY OVER THE PAST TWO (2) YEARS. IT WAS ALSO NOTED THAT THE ORIGINAL PROXIMAL EXTENSION LANDED VERY LOW IN THE NECK AND DID NOT HAVE ADEQUATE SEAL LENGTH-ONLY ABOUT 5MM OF SEAL; THEREFORE, AN ADDITIONAL AFX VELA SUPRARENAL WAS IMPLANTED. THOUGH A TYPE IB ENDOLEAK

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18052180 ↗
• InjurySep 12, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, ANEURYSM ENLARGEMENT DUE TO AN UNKNOWN SOURCE WAS IDENTIFIED. THE PHYSICIAN ELECTED TO PERFORM AN OPEN SURGERY. DURING THE SURGERY A PIN HOLE TYPE 3B ENDOLEAK WAS IDENTIFIED ORIGINATING FOR THE VELA SUPRARENAL AORTIC EXTENSION. THE AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION WERE EXPLANTED AND VASCULAR REPLACEMENT WAS PERFORMED. THE PATIENT WAS REPORTED BEING STABLE POST THE EXPLANT PROCEDURE. THE EXPLANTED STENT GRAFTS ARE NOT AVAILABLE FOR RETURN.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17733531 ↗
• InjurySep 5, 2023Patient-Device Incompatibility; Lack of Effect; Patient-Device Incompatibility; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY SIX AND A HALF (6.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IA ENDOLEAK. THE PATIENT IS REPORTEDLY IN STABLE CONDITION. IT IS UNKNOWN IF THE PHYSICIAN PLANS TO RE-INTERVENE. ADDITIONAL INFORMATION: AN INTERNAL CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST ANEURYSM ENLARGEMENT OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE SAC ENLARGEMENT WAS DISCOVERED DURING REVIEW OF THE 86 MONTH POST IMPLANT CT SCAN.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17685917 ↗
• InjuryAug 8, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX VELA SUPRARENAL, AN AFX2 BIFURCATED STENT GRAFT, AND TWO (2) AFX LIMB STENT GRAFTS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE PATIENT REQUIRED A RE-OPERATION (OPEN SURGERY) DUE TO THE RAPID ENLARGEMENT OF THE SAC, DESPITE NO APPARENT ENDOLEAK BEING OBSERVED ON A COMPUTERIZED TOMOGRAPHY (CT) SCAN. DURING THIS SECOND SURGERY, TWO HOLES WERE VISUALLY IDENTIFIED ON THE VELA DEVICE REPRESENTING A TYPE 3B ENDOLEAK. THE DEVICES WERE EXPLANTED, AND A VASCULAR REPLACEMENT PROCEDURE WAS PERFORMED. THE FINAL PATIENT STATUS REMAINS UNKNOWN. THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17484963 ↗
• InjuryAug 3, 2023Material Puncture/Hole; Deformation Due to Compressive Stress; Material Puncture/Hole; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE A TYPE 3B ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT, VELA SUPRARENAL AORTIC EXTENSION, VELA INFRARENAL AORTIC EXTENSION, AND OVATION IX EXTENDER TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak; Rupture

  MAUDE report 17456211 ↗
• InjuryApr 20, 2023Migration or Expulsion of Device; Off-Label Use; Patient-Device Incompatibility; Migration or Expulsion of Device; Off-Label Use; Patient-Device Incompatibility

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY SIX AND A HALF YEARS POST INITIAL PROCEDURE, ROUTINE FOLLOW-UP COMPUTERIZED TOMOGRAPHY ANGIOGRAM IDENTIFIED THAT THE AORTIC NECK IS NOW BLOWN OUT AND THERE IS ALSO A THORACIC ANEURYSM THAT NEEDS TREATED. THE AFX VELA SUPRARENAL APPEARS TO HAVE MIGRATED AND THERE IS A TYPE IA ENDOLEAK. THE PATIENT HAS BEEN REFERRED OUT TO A DIFFERENT PHYSICIAN AT ATRIUM HEALTH IN CHARLOTTE, NORTH CAROLINA TO BE TREATED AT THEIR TERTIARY AORTIC CENTER.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16781883 ↗
• InjuryFeb 15, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT, AND AN AFX VELA SUPRARENAL. APPROXIMATELY TWO (2) YEARS AFTER POST INITIAL PROCEDURE, IT WAS IDENTIFIED DURING A ROUTINE FOLLOW-UP OF A COMPUTED TOMOGRAPHY (CT) SCAN AN ENDOLEAK TYPE IA. THE PHYSICIAN PLANS TO RE-INTERVENE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16382228 ↗
• InjuryFeb 9, 2023Material Puncture/Hole; Obstruction of Flow; Lack of Effect; Material Puncture/Hole; Obstruction of Flow; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, ON (B)(6) 2022, ANEURYSM ENLARGEMENT WITH A TYPE IIIB ENDOLEAK OF THE AFX VELA SUPRARENAL, AND THROMBOSIS IN THE AFX2 BIFURCATED STENT GRAFT WAS IDENTIFIED. REINTERVENTION WAS PERFORMED ON (B)(6) 2023. THE INITIALLY IMPLANTED STENT GRAFTS WERE RE-LINED WITH A MEDTRONIC (NON-ENDOLOGIX) ENDURANT STENT. THE RESULTS WERE SUCCESSFUL, AND THE PATIENT STATUS WAS GOOD.

  Patient problems: Aneurysm; Clinical Endoleak; Thrombosis/Thrombus

  MAUDE report 16337580 ↗
• InjuryDec 14, 2022Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available; Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY EIGHT (8) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE III ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) AFX2 BIFURCATED STENT GRAFT AND ONE (1) ADDITIONAL AFX VELA SUPRARENAL PROXIMAL EXTENSION ON (B)(6) 2022. THE PATIENT REPORTEDLY TOLERATED THE RE-INTERVENTION PROCEDURE WELL.

  Patient problems: Aneurysm; Clinical Endoleak; Failure of Implant

  MAUDE report 15983781 ↗
• InjuryJul 20, 2022Material Puncture/Hole; Deformation Due to Compressive Stress; Insufficient Device Problem Information; Material Puncture/Hole; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 6 YEARS POST INITIAL PROCEDURE ANEURYSM ENLARGEMENT WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. REPORTEDLY, THE PATIENT IS STABLE AND IS PENDING A RE-INTERVENTION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15067335 ↗
• InjuryJul 18, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IA ENDOLEAK AND NECK DILATION TO A DIAMETER OF 39-40MM (POSSIBLE ANEURYM SAC ENLARGEMENT). THE PATIENT WILL BE REFERRED TO ANOTHER HOSPITAL FOR POTENTIALLY A PROXIMAL FENESTRATION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15043498 ↗
• InjuryMay 26, 2022Migration; Migration

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN AFX VELA INFRARENAL. APPROXIMATELY SEVEN AND A HALF (7.5) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH AN UNSTABLE RUPTURED ANEURYSM. ANGIOGRAPHY IDENTIFIED THAT THE AFX VELA INFRARENAL HAD MIGRATED DOWN, AND A TYPE IA ENDOLEAK WAS EVIDENT. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO RE-EXTEND THE AORTIC NECK. ANGIOGRAPHY WAS PERFORMED ONE DAY POST-REINTERVENTION, REPORTEDLY THE AAA IS NOT SEALED. THE PATIENT IS REPORTED TO BE IN THE ICU AND INTUBATED; HOWEVER, IMPROVING.

  Patient problems: Failure of Implant; Ruptured Aneurysm

  MAUDE report 14519159 ↗
• InjuryMay 17, 2022Material Puncture/Hole; Improper or Incorrect Procedure or Method; Material Puncture/Hole; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT, AFX VELA SUPRARENAL, AND AFX VELA INFRARENAL STENT-GRAFT EXTENSIONS. APPROXIMATELY THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM AND A TYPE IIIA ENDOLEAK. REINTERVENTION WAS COMPLETED ON JANUARY 17, 2018, WITH THE IMPLANT OF TWO GORE (NON-ENDOLOGIX) THORACIC STENT GRAFTS SUCCESSFULLY RESOLVING THE TYPE IIIA ENDOLEAK. (REPORTED UNDER MFR# 2031527-2018-00090). NOW, APPROXIMATELY FOUR YEARS POST REINTERVENTION, AT ROUTINE FOLLOW-UP, A TYPE IA ENDOLEAK WITH IMPLANT MIGRATION OF THE GORE (NON-ENDOLOGIX) THORACIC STENT GRAFTS WERE IDENTIFIED VIA COMPUTERIZED TOMOGRAPHY SCAN. THE PATIENT IS BEING MONITORED AND IS TO BE REFERRED TO A DIFFERENT PHYSICIAN. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Failure of Implant

  MAUDE report 14420389 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040002. One submission often covers many models, so check the product and lot details in each record.

• Z-1048-2017 · Jan 4, 2017 · Terminated
  AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C
• Z-1049-2017 · Jan 4, 2017 · Terminated
  AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 B
• Z-1047-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoili
• Z-1038-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (A
• Z-1054-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• Z-1037-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1039-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• Z-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• Z-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• Z-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL

…and 1 more.