AFX2 Bifurcated Endograft System BEA25-80/I20-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00818009014689), received between Oct 5, 2017 and May 15, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (9 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 25 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryJul 28, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2021 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN AFX LIMB STENT GRAFT. ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2025 IDENTIFIED A TYPE IIIB ENDOLEAK. REINTERVENTION PLANS ARE BEING DISCUSSED TO RE-LINE THE GRAFT. PATIENT STATUS WAS REPORTED TO BE STABLE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22636504 ↗
• InjuryJun 24, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2018 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL AND AN AFX LIMB STENT GRAFT. COMPUTED TOMOGRAPHY CONDUCTED ON APPROXIMATELY (B)(6) 2025 IDENTIFIED A TYPE IIIB ENDOLEAK. REPORTEDLY ACCORDING TO THE PHYSICIAN, THE MATERIAL TEAR APPEARS TO BE AT THE AORTIC BIFURCATION AND HAS CAUSED NEW GROWTH OF THE AORTA. RE-INTERVENTION WAS COMPLETED ON (B)(6) 2025 WITH A SUCCESSFUL RELINE OF THE PREVIOUSLY PLACED GRAFT. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 22322409 ↗
• InjuryMay 16, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AN AFX LIMB STENT GRAFT, AND AN OVATION IX EXTENDER. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH PAIN AND THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES. THE FINAL PATIENT STATUS IS REPORTED AS OKAY. 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.

  Patient problems: Pain

  MAUDE report 22035258 ↗
• InjuryMay 15, 2025Off-Label Use; Material Puncture/Hole; Device-Device Incompatibility; Off-Label Use; Material Puncture/Hole; Device-Device Incompatibility

  THE PATIENT WAS BEING TREATED FOR AN INTERNAL ILIAC ARTERY (IIA) ANEURYSM WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND OVATION IX ILIAC LIMB STENT GRAFTS ON (B)(6) 2025. 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. IT WAS REPORTED THAT THE OVATION IX ILIAC LIMB WAS PLACED ON THE RIGHT EXTERNAL ILIAC ARTERY (EIA) FOLLOWED BY IMPLANT OF A 12MM BARE METAL (NON-ENDOLOGIX) STENT AT THE DISTAL END OF IT FOR FIXATION. ALSO, AFTER AN OVATION IX WAS PLACED ON THE LEFT EXTERNAL ILIAC ARTERY (EIA) A 10MM BARE METAL (NON-ENDOLOGIX) STENT WAS IMPLANTED AT THE DISTAL END OF IT FOR FIXATION. THE AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL WERE IMPLANTED. AN ANGIOGRAM INSIDE THE GRAFT SHOWED AN ENDOLEAK NEAR THE AORTIC BIFURCATION. THE PHYSICIAN DETERMINED THAT THIS WAS A TYPE 3B ENDOLEAK AND IMPLANTED ANOTHER AFX2 BIFURCATED STENT GRAFT WITHIN THE ALREADY IMPLANTED ONE. ALSO, A 14MM BARE METAL (NON-ENDOLOGIX) STENT WAS IMPLANTED AT THE JUNCTION OF THE AFX AND THE OVATION IX ILIAC LIMB ON THE RIGHT COMMON ILIAC ARTERY (CIA). THE ENDOLEAK DIMINISHED AND THE DECISION WAS MADE TO

  Patient problems: Clinical Endoleak

  MAUDE report 22028900 ↗
• InjuryJan 15, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024, WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT AN AFX ILIAC LIMB AND AN AFX VELA INFRARENAL AORTIC EXTENSION. AFTER THE IMPLANTATION, A BALLOON TOUCH-UP WAS PERFORMED, AND ANGIOGRAPHY REVEALED A PERSISTENT LEAK NEAR THE RIGHT COMMON ILIAC ARTERY (CIA), INITIALLY SUSPECTED TO BE A TYPE IB ENDOLEAK BUT LATER RULED OUT. FURTHER ANGIOGRAPHY INDICATED A POTENTIAL TYPE IIIB ENDOLEAK. A LIMB EXTENSION WAS ADDED; HOWEVER, MINOR LEAKAGE PERSISTED. CONSIDERING THE PATIENT¿S AGE AND THE MINIMAL NATURE OF THE LEAKAGE, THE DECISION WAS MADE TO MONITOR THE SITUATION THROUGH FOLLOW-UP, WITH THE POSSIBILITY OF ADDITIONAL INTERVENTION IF SAC GROWTH IS OBSERVED IN ONE MONTH.

  Patient problems: Clinical Endoleak

  MAUDE report 21160365 ↗
• InjuryJul 24, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2019. IT WAS REPORTED THAT APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE DURING ROUTINE SURVEILLANCE THERE WAS AN INDETERMINATE ENDOLEAK AND ANEURYSM ENLARGEMENT. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19823378 ↗
• InjuryJun 7, 2024Off-Label Use; Device-Device Incompatibility; Off-Label Use; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED AN AFX2 BIFURCATED STENT GRAFT AN AFX VELA SUPRARENAL AORTIC EXTENSION AND AN OVATION IX ILIAC LIMB 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 21 MONTHS POST THE INITIAL PROCEDURE, A SECONDARY PROCEDURE WAS PERFORMED. THE PHYSICIAN STATED THAT THERE IS NO KNOWN ENDOLEAK OR DEVICE ISSUE. THE PHYSICIAN WANTS TO PERFORM AN ELECTIVE PROCEDURE ON THE PATIENT TO IMPLANT AN OVATION EXTENSION IN ONE OF THE LIMBS DUE TO PLACEMENT NOT BEING HIGH ENOUGH. THE INITIAL IMPLANT SHOWED GOOD RESULTS AND THERE IS NO ALLEGED DEVICE MALFUNCTION. APPROXIMATELY SEVEN AND A HALF (7.5) YEARS POST INITIAL PROCEDURE, THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFTS FOR AN UNKNOWN REASON. THE EXPLANTED STENT GRAFT HAS NOT BEEN RETURNED TO ENDOLOGIX. THE PATIENT CONDITION AFTER THE EXPLANT WAS NOT REPORTED. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 3011063223-2024-00053. ADDITIONAL INFORMATION: IT WAS DETERMINED THAT THERE WAS A TYPE 1B ENDOLEAK OF THE RIGHT COMMON ILIAC ARTERY THAT WAS NOT PREVIOUSLY REP

  Patient problems: Clinical Endoleak

  MAUDE report 19489274 ↗
• InjuryApr 26, 2024Off-Label Use; Off-Label Use

  THE PATIENT WAS BEING TREATED FOR RIGHT COMMON ILIAC ARTERY (CIA) ANEURYSM ON 02 MARCH 2023. THE RIGHT INTERNAL ILIAC ARTERY (IIA) WAS OCCLUDED WITH COILS AND GORE (NON-ENDOLOGIX) EXCLUDER LEG WAS IMPLANTED IN THE RIGHT EXTERNAL ILIAC ARTERY (EIA). THE AFX2 BIFURCATED STENT GRAFT AND THE AFX VELA SUPRARENAL WERE IMPLANTED FROM THE LEFT ACCESS. THE FINAL ANGIOGRAM SHOWED NO ENDOLEAK. THE PATIENT WAS MOVED TO THE ICU AND COMPLAINED OF SEVERE RIGHT BUTTOCK PAIN AND RIGHT LOWER LIMB WEAKNESS. THE PHYSICIAN DETERMINED THAT THE PAIN WAS COMPLICATION AFTER RIGHT IIA COIL OCCLUSION. PARAPLEGIA WAS SUSPECTED OF THE RIGHT LOWER LIMB WEAKNESS, AND A DRUG WAS ADMINISTERED. BLOOD PRESSURE CONTROL AND OXYGEN THERAPY WERE ALSO PERFORMED. ON THE SECOND DAY POST-PROCEDURE, A SPINAL MAGNETIC RESONANCE IMAGING WAS TAKEN, AND IT SHOWED SPINAL INFARCTION AT T12-L1. AFTER SPINAL DRAINAGE, THE RIGHT LOWER LIMB WEAKNESS WAS IMPROVED. REPORTEDLY, MULTIPLE VESSELS AROUND LUMBAR ARTERY WERE OCCLUDED AT ONCE BY THE ENDOVASCULAR ANEURYSM REPAIR TREATMENT AND THE PHYSICIAN STATED THAT THIS CAUSED THESE COMPLICATIONS. THE PATIENT STILL HAD INTERMITTENT CLAUDICATION; HOWEVER, THEY COULD WALK INDEPENDENTLY, AND TH

  Patient problems: Pain; Paraplegia

  MAUDE report 19192466 ↗
• InjuryApr 4, 2024Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED AN AFX2 BIFURCATED STENT GRAFT AN AFX VELA SUPRARENAL AORTIC EXTENSION AND AN OVATION IX ILIAC LIMB 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 21 MONTHS POST THE INITIAL PROCEDURE, A SECONDARY PROCEDURE WAS PERFORMED. THE PHYSICIAN STATED THAT THERE IS NO KNOWN ENDOLEAK OR DEVICE ISSUE. THE PHYSICIAN WANTS TO PERFORM AN ELECTIVE PROCEDURE ON THE PATIENT TO IMPLANT AN OVATION EXTENSION IN ONE OF THE LIMBS DUE TO PLACEMENT NOT BEING HIGH ENOUGH. THE INITIAL IMPLANT SHOWED GOOD RESULTS AND THERE IS NO ALLEGED DEVICE MALFUNCTION. APPROXIMATELY SEVEN AND A HALF (7.5) YEARS POST INITIAL PROCEDURE, THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFTS FOR AN UNKNOWN REASON. THE EXPLANTED STENT GRAFT HAS NOT BEEN RETURNED TO ENDOLOGIX. THE PATIENT CONDITION AFTER THE EXPLANT WAS NOT REPORTED.

  Patient problems: Aneurysm; Clinical Endoleak; Failure of Implant; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19043433 ↗
• InjuryMay 3, 2023Material Puncture/Hole; Device-Device Incompatibility; Material Puncture/Hole; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) AND A RIGHT COMMON ILIAC ARTERY ANEURYSM. PRIOR TO IMPLANT OF THE ENDOLOGIX AFX2 BIFURCATED STENT GRAFT AND THE SUPRARENAL AORTIC EXTENSION, THE RIGHT INTERNAL ILIAC ARTERY WAS FIRST OCCLUDED WITH NON-ENDOLOGIX (AZUR COILS), FOLLOWED BY A NON-ENDOLOGIX (16X12X10 EXCLUDER LEG) WHICH WAS IMPLANTED IN THE PROXIMAL RIGHT COMMON ILIAC ARTERY. 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. AN ANGIOGRAM WAS PERFORMED AND SHOWED A TYPE 1A ENDOLEAK (WITH ANTEROGRADE FLOW TO THE LUMBAR ARTERY). BALLOON TOUCH-UP WAS PERFORMED AT SEVERAL POINTS, AND ANGIOGRAPHY WAS PERFORMED AGAIN. THE TYPE 1A ENDOLEAK WAS RESOLVED. HOWEVER, AN ENDOLEAK WAS OBSERVED AROUND THE PROXIMAL END OF THE RIGHT COMMON ILIAC ARTERY. ANOTHER ANGIOGRAM WAS PERFORMED, AND A TYPE 1B ENDOLEAK WAS EXCLUDED. AN ADDITIONAL ANGIOGRAM WAS PERFORMED FROM WITHIN THE STENT GRAFT AND IDENTIFIED A POSSIBLE TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER AFX2 BIFURCATED STENT

  Patient problems: Clinical Endoleak

  MAUDE report 16865474 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH AN EXPANDING ANEURYSM SAC (UNKNOWN DIAMETER) AND NO IDENTIFIABLE ENDOLEAK. THE PHYSICIAN PLANS TO RE-INTERVENE AND SURGERY HAS BEEN SCHEDULED. PATIENT IS REPORTEDLY IN STABLE CONDITION AND AT HOME. ADDITIONAL INFORMATION: CLINICAL ASSESSMENT IDENTIFIED THAT A TYPE II ENDOLEAK ALSO OCCURRED, WHICH IS AN ANATOMY-RELATED EVENT AND NOT ATTRIBUTABLE TO THE DEVICE. THEREFORE, THIS COMPLAINT IS NO LONGER REPORTABLE AS THERE IS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16414807 ↗
• InjurySep 2, 2022Material Puncture/Hole; Material Puncture/Hole

  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 TWO AND A HALF (2.5) YEARS POST-INITIAL PROCEDURE, ANEURYSM ENLARGEMENT WITH A SUSPECT TYPE 3B ENDOLEAK WAS IDENTIFIED. NINE (9) DAYS LATER AN ADDITIONAL COMPUTERIZED TOMOGRAPHY WAS PERFORMED AND THE ENDOLEAK WAS NOT OBSERVED; HOWEVER, REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF A GORE (NON-ENDOLOGIX) EXCLUDER CUFF AND A GORE (NON-ENDOLOGIX) EXCLUDER MAIN BODY WERE IMPLANTED INSIDE THE AFX2. THE FINAL PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15349293 ↗
• InjuryMay 27, 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 THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. APPROXIMATELY THREE AND A HALF YEARS POST-INITIAL PROCEDURE, A SUSPECTED TYPE IA ENDOLEAK WAS IDENTIFIED AT ROUTINE FOLLOW-UP. REINTERVENTION HAS NOT BEEN SCHEDULED. THE PATIENT IS REPORTED TO BE ASYMPTOMATIC.

  Patient problems: Failure of Implant

  MAUDE report 14523146 ↗
• InjuryMay 4, 2022Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX LIMB STENT GRAFT. APPROXIMATELY FOUR (4) AND A HALF YEARS POST INITIAL PROCEDURE ANEURYSM ENLARGEMENT FROM 26MM TO 36MM WAS IDENTIFIED. THE PHYSICIAN IS PLANNING TO DO A REINTERVENTION. CURRENTLY, THE PATIENT'S STATUS IS IN GOOD GENERAL CONDITION AND SUITABLE FOR SURGERY.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14274678 ↗
• InjuryOct 21, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT AND AN AFX VELA SUPRARENAL. APPROXIMATELY ONE (1) YEAR AND FIVE (5) MONTHS POST INITIAL PROCEDURE ANGIOGRAPHY IDENTIFIED A TYPE 3B ENDOLEAK. REINTERVENTION WAS COMPLETED WITH IMPLANT OF A GORE EXTRUDER (NON-ENDOLOGIX) STENT SUCCESSFULLY SEALING THE TYPE 3B ENDOLEAK. THE FINAL PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 12674715 ↗
• InjuryAug 30, 2021Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX2 BIFURCATED STENT GRAFT AND TWO (2) AFX LIMB STENT GRAFTS. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, A POSSIBLE TYPE II OR TYPE IIIA ENDOLEAK WAS OBSERVED. REINTERVENTION IS PLANNED. THE PATIENT IS REPORTEDLY STABLE. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS PROVIDED REPORTING THAT REINTERVENTION WAS COMPLETED WITH IMPLANT OF AN OVATION IX ILIAC LIMB AND AN OVATION IX EXTENDER. IT WAS DETERMINED AT REINTERVENTION THAT THERE WAS ONLY A TYPE IIIA ENDOLEAK ON THE LEFT COMMON ILIAC ARTERY DUE TO POOR OVERLAPPING OF THE ILIAC LIMBS DURING THE INDEX PROCEDURE. THIS WAS SUCCESSFULLY SEALED. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 12385187 ↗
• InjuryOct 23, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA); THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) AS THE AORTA IS UNDER SIZED PER THE IFU. APPROXIMATELY 1.5 YEARS POST-OPERATIVE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) REVEALED AN ENDOLEAK OF INDETERMINATE ORIGIN AND AORTIC ANEURYSM ENLARGEMENT OF 0.5 CM. ALSO IT WAS NOTED THAT GRAFT MATERIAL OF THE BIFURCATED STENT GRAFT HAD EXPANDED FROM 25MM TO +/-32MM. THIS IS KNOWN AS STENT DILATION AND IS NOT A DEVICE FAILURE. THE PATIENT CURRENTLY BEING MONITORED DUE TO THE TO THE MINIMAL ENLARGEMENT OF THE ANEURYSM AND IS REPORTEDLY DOING WELL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10731463 ↗
• InjuryDec 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE II ENDOLEAK AND A TYPE IB ENDOLEAK OF THE RIGHT-SIDE LIMB OF THE BIFURCATED DEVICE. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN AFX LIMB STENT GRAFT ON (B)(6) 2019. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9469647 ↗
• InjuryNov 7, 2019Material 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 AN AFX2 BIFURCATED STENT GRAFT, A GORE (NON-ENDOLOGIX) ILIAC EXTENDER, AND TWO (2) GORE (NON-ENDOLOGIX) EXCLUDER LEGS; INITIAL IMPLANT WAS OFF-LABEL DUE TO AFX2 USE WITH NON-ENDOLOGIX DEVICES. DURING THE INITIAL IMPLANT, A TYPE IIIB ENDOLEAK WAS SUSPECTED PER ANGIOGRAPHY WHICH REVEALED A LEAK INTO THE RIGHT COMMON ILIAC. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL GORE (NON-ENDOLOGIX) ILIAC EXTENDER AND AFX2 BIFURCATED STENT GRAFT, AFTER WHICH THE ENDOLEAK DISAPPEARED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9292418 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY FIVE (5) MONTHS POST INITIAL IMPLANT THE PHYSICIAN PERFORMED A SECONDARY PROCEDURE FOR AN UNKNOWN REASON. THE PHYSICIAN IMPLANTED TWO OVATION ILIAC LIMBS. NO FURTHER ADDITIONAL INFORMATION OR PATIENT SEQUELAE HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Failure of Implant; No Information

  MAUDE report 8453589 ↗
• InjuryAug 20, 2018Leak/Splash; Leak/Splash

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT. A POSSIBLE TYPE II OR IIIA ENDOLEAK WAS DISCOVERED. THE PHYSICIAN PERFORMED AN ANGIOGRAM BUT WAS NOT ABLE TO CONFIRM THE ENDOLEAK. THE PHYSICIAN ELECTED TO PERFORM SECONDARY PROCEDURE. UPON COMPLETION OF THE SECONDARY PROCEDURE AN ANGIOGRAM WAS PERFORMED WHERE AN OBLIQUE ANGLE TYPE II ENDOLEAK WAS IDENTIFIED. THERE HAS BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 7799686 ↗
• InjuryApr 4, 2018Difficult or Delayed Positioning; Malposition of Device; Difficult or Delayed Positioning; Malposition of Device

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX DEVICE TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING PROCEDURE, A LOSS OF WIRE ACCESS WAS PRESENTED ON THE IPSILATERAL SIDE AND THE RE-ADVANCED WIRE WENT THROUGH ONE OF THE STENT STRUTS IN THE MAIN BODY. THE PHYSICIAN BALLOONED SEVERAL TIMES TO ADDRESS THE ISSUE, FINAL ANGIO SHOWED GOOD SEAL AND NO ENDOLEAK PRESENT. THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7396436 ↗
• InjuryOct 5, 2017Loss of or Failure to Bond; Leak/Splash; Occlusion Within Device; Loss of or Failure to Bond; Leak/Splash; Occlusion Within Device

  AN AFX2 BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 3 WEEKS POST INDEX PROCEDURE, THE PATIENT RETURNED WITH INTERMITTENT FEELING OF NUMBNESS ON THE RIGHT LEG. A CT REVEALED THAT THERE WAS INFOLDING OF THE PROXIMAL EXTENSION AND A THROMBOEMBOLIC EVENT ON THE ENTIRE LENGTH OF THE RIGHT COMMON ILIAC. A RE-INTERVENTION WAS PERFORMED APPROXIMATELY ONE MONTH POST INDEX PROCEDURE WHERE PHYSICIAN IMPLANTED SIX EXCLUDER AORTIC EXTENSIONS FROM THE DISTAL PORTION OF THE INFRARENAL EXTENSION UP TO JUST BELOW THE RENAL ARTERY. THE THROMBUS IN THE RIGHT ILIAC ARTERY WAS REMOVED AND A STENT WAS IMPLANTED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Claudication; Occlusion; Stenosis; Thrombus

  MAUDE report 6914855 ↗

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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• Z-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL

…and 1 more.