AFX2 Bifurcated Endograft System BEA28-110/I20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00818009014542), received between Dec 7, 2016 and Feb 19, 2026 — classified as 38 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (13 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Off-Label Use; Obstruction of Flow

  THE PATIENT WAS IMPLANTED WITH AN OVATION IX ILIAC LIMB, AFX2 BIFURCATED STENT GRAFT (BSG), AND AFX VELA SUPRARENAL AORTIC EXTENSION FOR THE TREATMENT OF A RIGHT INTERNAL ILIAC ARTERY ANEURYSM (RIIAA) AND AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2026. THE PATIENT WAS INITIALLY TREATED WITH COILS TO EMBOLIZE THE RIIAA AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED IN THE COMMON INTERNAL ILIAC ARTERY (CIA). THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX ILIAC LIMB IN THE RIGHT ILIAC ARTERY AND A VIABAHN 8MM-10MM STENT GRAFT (NON-ENDOLOGIX). THE AFX2 BIFURCATED STENT GRAFT WAS INSERTED VIA THE LEFT SIDE AND WAS DEPLOYED IN A WAY THAT INTERFERED WITH THE PROXIMAL PORTION OF THE ALREADY DEPLOYED OVATION IX ILIAC LIMB. IT WAS REPORTED THAT DURING DEPLOYMENT OF THE CONTRALATERAL LEG, THE AFX2 LEG INVERTED DUE TO THE OVATION IX ILIAC LIMB, CAUSING STENOSIS. ALTHOUGH PTA WAS PERFORMED, EXPANSION WAS NOT SUFFICIENT; THEREFORE, THE AREA WAS RELINED WITH A LUMINEXX 12MM-40MM BARE METAL STENT (NON-ENDOLOGIX), AND PTA WAS PERFORMED AGAIN. THE AFX VELA INFRARENAL STENT GRAFT WAS DEPLOYED JUST BELOW THE RENAL ARTERIES. A MINOR TYPE IA ENDOLEAK WAS OBSERVED BUT RESOLVED AFTER BAL

  Patient problems: Clinical Endoleak; Stenosis

  MAUDE report 24394522 ↗
• InjuryNov 10, 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, AN AFX VELA INFRARENAL AORTIC EXTENSION AND AN AFX VELA SUPRARENAL AORTIC EXTENSION. APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP THE PATIENT PRESENTED WITH AN EXPANDING ANEURYSM SAC ENLARGEMENT. THE PHYSICIAN ELECTED TO BRING THE PATIENT IN FOR A REINTERVENTION. THERE WAS NO OBVIOUS ENDOLEAK; HOWEVER, A TYPE 1B ENDOLEAK WAS SUSPECTED THEREFORE, THE RIGHT ILIAC LIMB WAS EXTENDED DISTALLY. ADDITIONALLY, THE PHYSICIAN ADDED A VELA PROXIMAL EXTENSION TO INCREASE DISTAL OVERLAP AS THE ANEURYSM HAD GROWN SO LARGE, IT WAS FELT THAT IT WAS NEEDED. THE PATIENT DID WELL DURING PROCEDURE AND EVERYTHING LOOKED SEALED BY ANGIOGRAM.

  Patient problems: Clinical Endoleak

  MAUDE report 23509323 ↗
• InjuryFeb 3, 2025Material Puncture/Hole; Lack of Effect; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE AND HALF (3.5) YEARS POST INITIAL PROCEDURE, DURING FOLLOW UP, THE PATIENT PRESENTED IN STABLE CONDITION WITH A SUSPECT TYPE 1B OR TYPE 3B ENDOLEAK. THE PATIENT IS STABLE AND CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT RETURNED FOR INTERVENTION AND BI-LATERAL TYPE 1B ENDOLEAKS WERE SEEN ON ANGIOGRAM AND THERE WAS NO TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO FULLY RELINE THE PREVIOUSLY IMPLANTED DEVICES WITH AN ALTO STENT GRAFT SYSTEM TO RESOLVE THE ENDOLEAKS.

  Patient problems: Clinical Endoleak

  MAUDE report 21293194 ↗
• InjuryAug 5, 2024Off-Label Use; Material Puncture/Hole; Separation Problem; Off-Label Use; Material Puncture/Hole; Separation Problem

  THE PATIENT WAS TREATED WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA SUPRARENAL, TWO (2) OVATION IX ILIAC LIMBS, AND AN OVATION IX EXTENDER ON (B)(6) 2022. APPROXIMATELY TWO (2) YEARS AFTER INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, IT WAS REPORTED THAT THERE WAS A TYPE IB ENDOLEAK AND A POSSIBLE TYPE III ENDOLEAK WAS IDENTIFIED. INTERVENTION OCCURRED ON (B)(6) 2024 WITH THE IMPLANTATION OF AN AFX2 BSG, AND AFX VELA INFRARENAL, AND AN OVATION IX ILIAC LIMB. DURING REINTERVENTION IT WAS DETERMINED THAT THERE WAS NO TYPE IA ENDOLEAK OBSERVED AND THE RIGHT OVATION IX ILIAC LIMB WAS NO LONGER CONNECTED TO THE INITIALLY IMPLANTED AFX2 BSG. THE ENDOLEAK ORIGIN WAS SUSPECTED TO BE COMING FROM THE RIGHT ILIAC OR A TEAR IN THE FABRIC OF THE AFX2 BSG BUT REMAINED UNDETERMINED. THE ENDOLEAK WAS RESOLVED. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL. 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: Aneurysm; Clinical Endoleak

  MAUDE report 19904537 ↗
• InjuryApr 13, 2023Insufficient Device Problem Information; 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 VELA SUPRARENAL ON (B)(6) 2020. THE ROUTINE FOLLOW-UP COMPUTERIZED TOMOGRAPHY (CT) SCAN PERFORMED ON (B)(6) 2022, IDENTIFIED A TYPE IIIA ENDOLEAK. REINTERVENTION WAS COMPLETED ON (B)(6) 2022. AN AFX VELA SUPRARENAL AND AN AFX VELA INFRARENAL WERE IMPLANTED SUCCESSFULLY SEALING THE TYPE IIIA ENDOLEAK. THE PATIENT WAS REPORTED TO BE STABLE POST-REINTERVENTION (REPORTED UNDER MFR# 2031527-2022-00070). NOW APPROXIMATELY ONE (1) YEAR POST-REINTERVENTION ON (B)(6) 2023, ROUTINE FOLLOW-UP CT SCAN IDENTIFIED ANEURYSM GROWTH OF 2CM. THERE WAS NO VISIBLE ENDOLEAK. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES AND PERFORM AN OPEN REPAIR. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Aneurysm

  MAUDE report 16735770 ↗
• InjuryFeb 6, 2023Unintended Movement; Unintended Movement

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, THE GRAFT APPEARS PUSHED PROXIMALLY AND IS NO LONGER ON ANATOMICAL BIFURCATION. ADDITIONALLY, A TYPE 1B ENDOLEAK IS IDENTIFIED. THE PATIENT IS CURRENTLY STABLE AND IS BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Clinical Endoleak

  MAUDE report 16308962 ↗
• InjuryJan 4, 2023Unintended Movement; Migration; Unintended Movement; Migration

  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 FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK, TYPE IB ENDOLEAK AND AFX GRAFT SLIPPAGE INTO THE ANEURYSM SAC (CLASSIFIED AS IMPLANT MOVEMENT). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM ON (B)(6) 2022. THE ANEURYSM WAS SUCCESSFULLY SEALED AND THE ENDOLEAKS RESOLVED. PATIENT HAS BEEN DISCHARGED HOME.

  Patient problems: Clinical Endoleak; Failure of Implant

  MAUDE report 16098918 ↗
• InjuryMar 31, 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 AND AN AFX VELA SUPRARENAL. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE ROUTINE FOLLOW-UP COMPUTERIZED TOMOGRAPHY SCAN IDENTIFIED A TYPE IIIA ENDOLEAK. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN AFX VELA SUPRARENAL AND AN AFX VELA INFRARENAL. THE TYPE IIIA ENDOLEAK WAS SUCCESSFULLY SEALED. THE PATIENT WAS REPORTED TO BE STABLE POST-REINTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 13969003 ↗
• InjuryMar 28, 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 AN AFXS BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE THE PHYSICIAN DETERMINED THERE IS A POSSIBLE TYPE 3B ENDOLEAK AND THE GRAFT APPEARS TWISTED. THE PATIENT CURRENTLY HAS OTHER MEDICAL COMPLICATIONS NOT RELATED TO THE AAA. THE PATIENT IS CURRENTLY BEING MONITORED AND ONCE THEY ARE HEALTHY, THE PHYSICIAN WILL SCHEDULE AN INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 13930319 ↗
• InjuryMar 8, 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 FOUR (4) AND A HALF YEARS POST INITIAL PROCEDURE ROUTINE FOLLOW-UP IDENTIFIED A POSSIBLE TYPE 3B ENDOLEAK. ANGIOGRAM WAS PERFORMED, AND REINTERVENTION IS PENDING. REPORTEDLY, THE PATIENT IS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 13694212 ↗
• InjuryFeb 1, 2022Off-Label Use; Off-Label Use

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL, AN AFX VELA SUPRARENAL, AND AN OVATION IX EXTENDER. THIS CASE IS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL) DUE THE USE OF AFX WITH OVATION DEVICES. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE A TYPE IB ENDOLEAK WAS IDENTIFIED. THE PATIENT WAS ASYMPTOMATIC. REINTERVENTION WAS COMPLETED WITH EMBOLIZATION OF THE HYPOGASTRIC AND EXTENSION OF THE LEFT ILIAC DOWN TO THE EXTERNAL ILIAC. FIRST AN OVATION IX ILIAC LIMB (14X100) WAS DEPLOYED AND THEN THE AFX LIMB WAS EXTENDED WITH DEPLOYMENT OF AN OVATION IX EXTENDER (22X45). THE TYPE IB ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PATIENT WAS REPORTED TO BE FINE POST-SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13417017 ↗
• InjuryJan 31, 2022Collapse; Material Puncture/Hole; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Appropriate Device Problem Term/Code Not Available; Collapse; Material Puncture/Hole; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT, (2) INFRARENAL AORTIC EXTENSIONS AND A VELA SUPRARENAL. APPROXIMATELY 2.5 YEARS POST INITIAL PROCEDURE, AN ENDOLEAK OF INDETERMINATE ORIGIN WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. PATIENT IS ASYMPTOMATIC AND PENDING A RE-INTERVENTION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13399209 ↗
• InjuryDec 20, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) AFX VELA SUPRARENAL STENT GRAFTS. APPROXIMATELY TWO (2) YEARS POST INITIAL IMPLANT, A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IDENTIFIED A TYPE 1B ENDOLEAK WITH ANEURYSM ENLARGEMENT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING (2) AFX LIMB STENT GRAFTS. THIS WAS REPORTED UNDER MDR#3008011247-2021-00008. APPROXIMATELY 1 YEAR POST INTERVENTION THE PATIENT WAS IDENTIFIED WITH AN ENLARGING SAC AND A 1B ENDOLEAK. THE PHYSICIAN ELECTED TO PERFORM A RE-INTERVENTION BY IMPLANTING AN AFX LIMB STENT GRAFT. THE FINAL PATIENT STATUS WAS REPORTED AS BEING STABLE FOLLOWING THE PROCEDURE. THIS WAS REPORTED UNDER MDR # 2031527-2021-00495. NOW, EIGHT (8) DAYS LATER THE PATIENT WAS IDENTIFIED WITH A TYPE 3B ENDOLEAK AND RUPTURE. THE PHYSICIAN ELECTED TO PERFORM A RE-INTERVENTION BY IMPLANTING AN AFX2 BIFURCATED STENT GRAFT, AFX LIMB STENT GRAFT, AND AN AFX VELA SUPRARENAL. THE FINAL PATIENT STATUS WAS REPORTED TO BE DISCHARGED ON THE THIRTEENTH POST OPERATIVE DAY TO A SUBACUTE REHABILITATION FACILITY. NOTE: RUPTURE AND TYPE 3B WERE IDENTIFIED ON A CT (COMPUTED TOMOGRAPH

  Patient problems: Failure of Implant; Rupture

  MAUDE report 13043538 ↗
• InjuryDec 13, 2021Appropriate 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 AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) AFX VELA SUPRARENAL STENT GRAFTS. APPROXIMATELY TWO (2) YEARS POST INITIAL IMPLANT, A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IDENTIFIED A TYPE 1B ENDOLEAK WITH ANEURYSM ENLARGEMENT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING (2) AFX LIMB STENT GRAFTS. THIS WAS REPORTED UNDER MDR#3008011247-2021-00008. NOW, APPROXIMATELY 1 YEAR POST INTERVENTION THE PATIENT WAS IDENTIFIED WITH AN ENLARGING SAC AND A 1B ENDOLEAK. THE PHYSICIAN ELECTED TO PERFORM A RE-INTERVENTION BY IMPLANTING AN AFX LIMB STENT GRAFT. THE FINAL PATIENT STATUS WAS REPORTED AS BEING STABLE FOLLOWING THE PROCEDURE. ADDITIONALLY, THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE IIIB ENDOLEAK OF THE DISTAL MAIN BODY WITH A RUPTURE WAS PRESENT ON A CT (COMPUTED TOMOGRAPHY) THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THIS EVENT WAS REPORTED UNDER MDR#2031527-2021-00504.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12984869 ↗
• InjurySep 30, 2021Material Puncture/Hole; Device-Device Incompatibility; Material Puncture/Hole; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL, A VELA INFRARENAL, A LIMB STENT GRAFT AND TWO (2) OVATION IX EXTENDERS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS CASE WAS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM PER DEVICE IFU. APPROXIMATELY 3.5 YEARS POST INITIAL PROCEDURE, PATIENT WAS IDENTIFIED WITH ANEURYSM ENLARGEMENT AND A POSSIBLE TYPE IIIB ENDOLEAK. THE PATIENT WAS TREATED AND THE ORIGINAL DEVICE WAS RELINED WITH ANOTHER BIFURCATED STENT GRAFT. THE PATIENT WAS REPORTED IN STABLE CONDITION POST INTERVENTION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12554906 ↗
• InjuryMay 6, 2021Material Puncture/Hole; Insufficient Device Problem Information; Material Puncture/Hole; 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 (7) SEVEN YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WITH DEVICE SEPARATION AND SAC GROWTH WAS REPORTED (MRN# 2031527-2019-00521). THE PATIENT WAS REPORTED IN STABLE CONDITION. IT WAS RECENTLY REPORTED THAT DURING A COMMERCIAL AFX EXPERIENCE STUDY THE PATIENT IN QUESTION HAD EXPERIENCED A RUPTURE. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION: DURING THE INTERNAL INVESTIGATION IT WAS DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE 3A ENDOLEAK AND TYPE 3B ENDOLEAK OCCURRED.

  Patient problems: Rupture

  MAUDE report 11784894 ↗
• InjuryApr 30, 2021Insufficient 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 SYSTEM. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A GRAFT INFECTION. THE PHYSICIAN ELECTED TO TREAT BY CONVERTING THE PATIENT TO OPEN REPAIR, EXPLANTING THE AFX DEVICES AND REPLACING WITH A DACRON TUBE GRAFT ON (B)(6) 2020. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 11755583 ↗
• InjuryMar 11, 2021Partial Blockage; Patient-Device Incompatibility; Insufficient Device Problem Information; Partial Blockage; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE COMPUTED TOMOGRAPHY (CT) THE PATIENT WAS IDENTIFIED WITH SIGNIFICANTLY THROMBUS WITHIN THE GRAFT. THE PATIENT IS CURRENTLY BEING MONITORED AND WAS REPORTED AS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 11467881 ↗
• InjuryJan 26, 2021Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX BIFURCATED STENT GRAFT, AND TWO (2) VELA SUPRARENAL STENT GRAFTS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL IMPLANT, A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IDENTIFIED A TYPE 1B ENDOLEAK WITH ANEURYSM ENLARGEMENT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING (2) LIMB STENT GRAFTS. REPORTEDLY, THE PATIENT IS DOING WELL AND LEAK WAS RESOLVED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 11233585 ↗
• InjuryOct 7, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL IMPLANT, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURE AND POSSIBLE TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE THE EXISTING STENT GRAFTS WITH A NON-ENDOLOGIX (MEDTRONIC) DEVICE. THE PATIENT REPORTEDLY IS DOING WELL.

  Patient problems: Aneurysm; Failure of Implant; Rupture

  MAUDE report 10645759 ↗
• InjurySep 12, 2020Patient-Device Incompatibility; Deformation Due to Compressive Stress; Insufficient Device Problem Information; Patient-Device Incompatibility; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND AN OVATION IX EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO CONCOMITANT USE WITH PRODUCTS OUTSIDE THE IFU. APPROXIMATELY 3.5 YEARS LATER DURING A ROUTINE FOLLOW-UP, A TYPE 1B ENDOLEAK ON THE LEFT ILIAC AND BUCKLING OF THE BIFURCATED STENT GRAFT DUE TO ANGULATION WAS IDENTIFIED. RE-INTERVENTION IS PLANNED BUT HAS NOT YET BEEN SCHEDULED. THE PATIENT IS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 10526059 ↗
• InjuryMar 3, 2020Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method; Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND AN OVATION IX LIMB EXTENDERS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS CASE IS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL) DUE THE USE OF AFX WITH OVATION DEVICES. APPROXIMATELY 3.5 YEARS POST INITIAL PROCEDURE, ABDOMINAL PAIN AND A TYPE 3B ENDOLEAK WITH SAC GROWTH WAS REPORTED. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT NON- ENDOLOGIX (GORE) STENT TO TREAT THIS REPORTED EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST INTERVENTION. ADDITIONAL INFORMATION: DURING CLINICAL INVESTIGATION IT WAS DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A RUPTURE.

  Patient problems: Aneurysm; Pain; Rupture

  MAUDE report 9783258 ↗
• InjuryNov 15, 2019Insufficient Device Problem Information; 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 3.5 YEARS POST INITIAL PROCEDURE (EXACT DATE WAS NOT PROVIDED), AN ENDOLEAK OF INDETERMINATE ORIGIN WAS REPORTED. THE PATIENT WAS REPORTED AS STABLE AND AN INTERVENTION HAS BEEN SCHEDULED. ADDITIONAL INFORMATION: THE PHYSICIAN PERFORMED A RE-INTERVENTION WITH A BIFURCATED STENT GRAFT AND (2) ILIAC LIMBS ON (B)(6) 2019. DURING THE CLINICAL INVESTIGATION, THE INDETERMINATE ENDOLEAK WAS DETERMINED TO BE A TYPE 1B ENDOLEAK OF THE LEFT ILIAC ARTERY.

  Patient problems: Failure of Implant

  MAUDE report 9329101 ↗
• InjurySep 24, 2019Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY 1.5 YEARS POST INITIAL PROCEDURE, A TYPE IIIB ENDOLEAK WITH AN INCREASED ANEURYSM SAC (UNKNOWN DIAMETER) WERE DETECTED DURING ROUTINE FOLLOW-UP. HOWEVER, THE EXACT DATE OF EVENT IS UNKNOWN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ADDITIONAL BIFURCATED AFX2 DEVICE ON (B)(6) 2019. THE ENDOLEAK WAS CONFIRMED RESOLVED AND THE PATIENT IS REPORTEDLY IN STABLE CONDITION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9109712 ↗
• InjuryApr 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT CONFIRMING THAT A TYPE IA ENDOLEAK WAS ALSO PRESENT AT THE TIME OF THE REPORTED EVENT. THE PHYSICIAN IS NOT CURRENTLY PLANNING TO RE-INTERVENE.

  Patient problems: Vascular Dissection

  MAUDE report 8501425 ↗

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-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-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-0593-06 · 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
• 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-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL

…and 1 more.