AFX2 Bifurcated Endograft System BEA28-100/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00818009014450), received between Jul 14, 2016 and Dec 30, 2025 — classified as 3 deaths, 46 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 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 50 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR A 68.4 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL EXTENSION ON (B)(6) 2021. IT WAS REPORTED IN (B)(6) 2025 THE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE AAA WAS 63 MM IN DIAMETER. CURRENTLY THE CT SCAN REVEALED THAT THE AAA IS 66 MM IN DIAMETER. THERE IS AN INCREASE IN THE AORTIC NECK ANGULATION TO 75 DEGREES. THERE IS SEPARATION OF THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT AND THE AFX VELA SUPRARENAL EXTENSION AND A TYPE IIIA ENDOLEAK. THE PATIENT IS ASYMPTOMATIC. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 23928783 ↗
• InjuryNov 14, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE 3B ENDOLEAK WAS IDENTIFIED. THE PATIENT IS FINE AND CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. ADDITIONAL INFORMATION WAS RECEIVED THAT INTERVENTION WAS PERFORMED ON (B)(6) 2025 WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL. THE TYPE 3B ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PATIENT IS DOING WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 23555466 ↗
• DeathJun 5, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. REPORTEDLY THERE WAS AN AORTIC ARCH ANEURYSM AS WELL AS THE AAA. THE CONDITION OF THE AORTA WAS POOR AND SHAGGY. ALSO, THERE WAS A THROMBUS FROM ABOVE THE RENAL ARTERIES NEAR THE SUPERIOR MESENTERIC ARTERY (SMA). THE AFX2 MAIN BODY AND AFX VELA SUPRARENAL WERE IMPLANTED THROUGH THE AFX SHEATH AS USUAL. HOWEVER, WHEN THE AFX VELA SUPRARENAL WAS ATTEMPTED TO BE PLACED AFTER THE AFX MAIN BODY, AN ANGIOGRAPHY DID NOT SHOW THE RENAL ARTERIES. THEREFORE, CANNULATION TO THE RENAL ARTERIES WAS PERFORMED VIA AN ARM. THE FOLLOWING ANGIOGRAPHY SHOWED THE RENAL ARTERIES, SO THE AFX VELA SUPRARENAL WAS IMPLANTED. SINCE THE JUNCTION OF THE AFX2 MAIN BODY AND THE AFX VELA SUPRARENAL, AND LT-COMMON ILIAC ARTERY (CIA) WERE NARROWED, BALLOON TOUCH-UP WAS PERFORMED. THE FINAL ANGIOGRAPHY SHOWED NO ENDOLEAKS, SO THE PROCEDURE WAS COMPLETED. UNFORTUNATELY, THE PATIENT HAD PARAPLEGIA AFTER THE SURGERY AND DIED FROM MESENTERIC ISCHEMIA AFTERWARDS. REPORTEDLY THE POST-OPERATIVE COMPUTED TOMOGRAPHY SCAN SHOWED A TYPE 1A ENDOLEAK AND A CONTRAST AGENT FL

  Patient problems: Clinical Endoleak; Ischemia; Paraplegia; Thrombosis/Thrombus

  MAUDE report 22152723 ↗
• InjuryJan 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 ILIAC LIMB, TWO (2) AFX VELA SUPRARENAL¿S, AND A VELA INFRARENAL. APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK. THE PHYSICIAN PLANS TO PLACE A LIMB EXTENSION. THE PATIENT IS STABLE AND IS CURRENTLY BEING MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 21125139 ↗
• InjuryNov 20, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN OVATION IX EXTENDER. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM, AS PER THE INSTRUCTIONS FOR USE (IFU). APPROXIMATELY FOUR AND A HALF (4.5) YEARS AFTER THE INITIAL PROCEDURE, A FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED AN ANEURYSM ENLARGEMENT AND THE PRESENCE OF AN ENDOLEAK TYPE IB. IN RESPONSE TO THESE FINDINGS, THE PATIENT UNDERWENT A RE-INTERVENTION, DURING WHICH THE ATTENDING PHYSICIAN IMPLANTED AN OVATION IX EXTENDER AS WELL AS AN AFX LIMB STENT GRAFT. THE FINAL PATIENT STATUS REMAINS UNKNOWN. THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX. ADDITIONAL INFORMATION: THE FINAL PATIENT STATUS WAS REPORTED AS BEING RECOVERED AND DISCHARGED ON THE FIRST POST OPERATIVE DAY.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18177757 ↗
• InjuryOct 12, 2023Off-Label Use; Material Puncture/Hole; Lack of Effect; Off-Label Use; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND A MEDTRONIC (NON-ENDOLOGIX) 44X100 THORACIC DEVICE. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM PER DEVICE IFU. APPROXIMATELY THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A POSSIBLE TYPE IIIB OR IB ENDOLEAK. THE PHYSICIAN PLANS TO RELINE THE MAIN BODY AND POSSIBLY PLACE A LIMB EXTENSION IN THE RIGHT COMMON ILIAC. SURGERY HAS BEEN SCHEDULED FOR THE PATIENT. ADDITIONAL INFORMATION: THE PHYSICIAN ELECTED TO RELINE THE ORIGINALLY IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA INFRARENAL AORTIC EXTENSION AND AN OVATION IX EXTENDER ON (B)(6) 2023 TO SUCCESSFULLY SOLVE THE TYPE 3B ENDOLEAK. THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 17924931 ↗
• InjuryAug 25, 2023Material Puncture/Hole; Lack of Effect; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (1) ONE-YEAR POST INITIAL IMPLANT, THE PATIENT WAS IDENTIFIED WITH A POSSIBLE TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO PLACE A PROXIMAL EXTENSION TO RESOLVE THIS LEAK. THE FINAL PATIENT STATUS WAS REPORTED AS DOING GREAT. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 2031527-2021-00204. NOW, APPROXIMATELY TWO (2) YEARS POST SECONDARY PROCEDURE, DURING A ROUTINE FOLLOW UP A TYPE 3 ENDOLEAK (INDETERMINATE TYPE) WAS IDENTIFIED. THE PATIENT IS ASYMPTOMATIC AND CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. ADDITIONAL INFORMATION: THE ELECTED TO RELINE THE PREVIOUSLY IMPLANTED DEVICES WITH AN ALTO STENT GRAFT SYSTEM ON (B)(6) 2023. THE TERITARY PROCEDURE WAS UNEVENTFUL AND THE FINAL ANGIOGRAM SHOWED THERE WERE NO ENDOLEAKS. THE PATIENT WAS REPORTED AS DOING WELL AND WAS DISCHARGED THE NEXT DAY.

  Patient problems: Clinical Endoleak

  MAUDE report 17627155 ↗
• InjuryMay 24, 2023Material Puncture/Hole; Lack of Effect; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW-UP, A TYPE 3A ENDOLEAK AND ANEURYSM ENLARGEMENT OF 1CM WAS IDENTIFIED. THE PHYSICIAN PLANS TO DO A RELINE. ADDITIONAL INFORMATION: A COMPREHENSIVE CLINICAL ASSESSMENT HAS YIELDED SUBSTANTIAL EVIDENCE POINTING TOWARD THE PRESENCE OF A TYPE IIIB ENDOLEAK WITHIN THE DISTAL MAIN BODY. THE IDENTIFICATION OF THIS ENDOLEAK OCCURRED ON JULY 17, 2023, AS PART OF A METICULOUS REVIEW OF A COMPUTERIZED TOMOGRAPHY (CT) SCAN DATED ON (B)(6) 2023. FOLLOWING AN ANGIOGRAM, A COMPREHENSIVE EXAMINATION WAS CONDUCTED ON THE PATIENT, WHICH DID NOT YIELD ANY EVIDENCE OF THE PRESENCE OF THE LEAK. AS A RESULT, IT HAS BEEN DETERMINED THAT A RE-INTERVENTION WILL NOT BE NECESSARY AT THIS TIME.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16992491 ↗
• InjuryMay 12, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2021 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. ON (B)(6) 2023, THE DISTRIBUTOR WAS NOTIFIED BY THE DOCTOR THAT THE DEVICE HAD A SUSPECT TYPE IIIB ENDOLEAK. ON (B)(6) 2023, AN ADDITIONAL ANGIOGRAPHY WAS PERFORMED INSIDE THE STENT GRAFT, BUT THE ENDOLEAK WAS NOT DETERMINED. REINTERVENTION WAS COMPLETED WITH THE IMPLANTATION OF AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT. BALLOON TOUCH WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Clinical Endoleak

  MAUDE report 16924142 ↗
• InjuryFeb 28, 2023Material Puncture/Hole; Lack of Effect; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL AND AN AFX LIMB STENT GRAFT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A TYPE I OR TYPE 3 ENDOLEAK WAS IDENTIFIED AT A ROUTINE FOLLOW UP. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN AFX VELA SUPRARENAL AND AN AFX VELA INFRARENAL (REPORTED UNDER MFR#3008011247-2020-00057). NOW, APPROXIMATELY THREE (3) YEARS POST-SECONDARY, A POSSIBLE TYPE 3B ENDOLEAK WITH ANEURYSM ENLARGEMENT HAS BEEN IDENTIFIED. A TERTIARY HAS BEEN SCHEDULED FOR (B)(6) 2023. PATIENT IS REPORTEDLY STABLE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16454267 ↗
• InjuryDec 5, 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. APPROXIMATELY THREE (3) YEARS POST-INITIAL PROCEDURE, DURING A ROUTINE FOLLOW-UP, THE PATIENT WAS IDENTIFIED WITH AN ENDOLEAK TYPE 3B AND AN ANEURYSM ENLARGEMENT. THE PATIENT IS SCHEDULED FOR A RE-INTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak; Failure of Implant

  MAUDE report 15921306 ↗
• InjuryJul 11, 2022Fracture; Device-Device Incompatibility; Separation Problem; Fracture; Device-Device Incompatibility; Separation Problem

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN ENDURANT (NON-ENDOLOGIX) STENT GRAFT. THIS 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 INTRAOPERATIVE TYPE IA ENDOLEAK WAS IDENTIFIED AT THE GAP BETWEEN THE ENDURANT (NON-ENDOLOGIX) PROXIMAL EDGE AND ARTERY WALL. THIS WAS TREATED WITH COILS. APPROXIMATELY FOUR (4) YEARS POST-INITIAL PROCEDURE, A JUNCTION SEPARATION WITH POSSIBLE AND PARTIAL STENT FRACTURE OF THE AFX2 BIFURCATED STENT GRAFT AND THE ENDURANT (NON-ENDOLOGIX) STENT GRAFT WERE IDENTIFIED. A ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT (NON-ENDOLOGIX) WAS DEPLOYED INSIDE THE AFX2 BIFURCATED STENT GRAFT AND ENDURANT CUFF. AN EXCLUDER (NON-ENDOLOGIX) WAS THEN ADDED INSIDE THE ZENITH ALPHA. THE SECONDARY PROCEDURE WAS COMPLETED WITHOUT PROBLEMS AND THE PATIENT¿S POST STATUS IS GOOD.

  Patient problems: Failure of Implant

  MAUDE report 14978089 ↗
• InjuryMar 19, 2022Fracture; Material Puncture/Hole; Fracture; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL PROXIMAL EXTENSION AND ONE (1) AFX LIMB STENT GRAFT. APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A SUSPECTED TYPE IIIB ENDOLEAK AND A POSSIBLY FRACTURED STRUT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) AFX VELA INFRARENAL PROXIMAL EXTENSION AND AN ADDITIONAL AFX LIMB STENT GRAFT ON 02 MARCH 2022. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 13827660 ↗
• InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; 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. REPORTEDLY, THE PROCEDURE WENT WELL; HOWEVER, THE AORTIC NECK WAS CHALLENGING AND THERE WAS AN EXISTING SMALL DISSECTION IN THE LCIA (LEFT COMMON ILIAC ARTERY). FINAL ANGIOGRAM IDENTIFIED AN INDETERMINATE ENDOLEAK. THE PHYSICIAN HAS ELECTED TO MONITOR THE PATIENT AND DO A 30 DAY OR 60 FOLLOW-UP CT (COMPUTED TOMOGRAPHY) SCAN. THE PATIENT WAS REPORTED TO BE DISCHARGED ONE DAY POST PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 13240041 ↗
• InjuryDec 13, 2021Material Puncture/Hole; Deformation Due to Compressive Stress; Material Puncture/Hole; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED DURING A ROUTINE FOLLOW-UP WITH A TYPE 3B ENDOLEAK. A RE-INTERVENTION WAS DONE AND THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH A (NON ENDOLOGIX DEVICE) AORTO UNI-ILIAC STENT GRAFT AND PERFORMING A FEM-FEM BYPASS. THE FINAL PATIENT STATUS WAS REPORTED AS BEING GOOD. ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT INDICATING BUCKLING OF THE BIFURCATED STENT GRAFT AND SIGNIFICANT ANEURYSM SAC GROWTH ALSO OCCURRED AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12990932 ↗
• InjuryDec 13, 2021Material Puncture/Hole; Material Puncture/Hole

  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 THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE ROUTINE FOLLOW UP IDENTIFIED ANEURYSM ENLARGEMENT FROM 5.2CM TO 5.8CM AND A POSSIBLE PIN HOLE TYPE 3B ENDOLEAK NEAR THE BIFURCATION. REINTERVENTION WAS COMPLETED WITH IMPLANT OF AN AFX VELA INFRARENAL. THE PATIENT WAS REPORTED TO BE STABLE AND DOING WELL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12984632 ↗
• InjurySep 7, 2021Material Puncture/Hole; Patient-Device Incompatibility; Deformation Due to Compressive Stress; Material Puncture/Hole; Patient-Device Incompatibility; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A DISTORTED GRAFT AT ITS DISTAL END, BUT NO ACTIVE ENDOLEAK WAS DETECTED. THE PHYSICIAN PLANS TO RE-INTERVENE, AND THE PATIENT IS REPORTEDLY IN STABLE CONDITION. SUBSEQUENT TO THE INITIAL REPORT REINTERVENTION WAS COMPLETED WITH IMPLANT OF AN AFX VELA INFRARENAL. ADDITIONALLY, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE 3B ENDOLEAK OF THE DISTAL BIFURCATED STENT GRAFT OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE TYPE 3B ENDOLEAK WAS DISCOVERED DURING REVIEW OF THE 44 MONTH POST IMPLANT COMPUTERIZED TOMOGRAPHY (CT) SCAN.

  Patient problems: Failure of Implant

  MAUDE report 12433326 ↗
• InjuryAug 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITION INFORMATION WAS RECEIVED. DURING THE INTERVENTION IT WAS DETERMINED THAT THE REPORTED TYPE 3A ENDOLEAK WAS A TYPE 2 ENDOLEAK. THE TYPE II ENDOLEAK WAS RELINED WITH AN AFX2 BIFURCATED STENT GRAFT, AND TWO (2) AFX VELA SUPRARENAL.; HOWEVER, THE TYPE II ENDOLEAK WAS STILL PRESENT AT THE END OF THE PROCEDURE. PATIENT IS REPORTEDLY DOING FINE. A TYPE 2 ENDOLEAK IS A NON- DEVICE RELATED FAILURE AND IS AN ANATOMY RELATED EVENT THEREFORE THIS IS NO LONGER A REPORTABLE EVENT. A COMPLAINT IS NOT WARRANTED SINCE THERE IS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 12338582 ↗
• InjuryJul 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL PROXIMAL EXTENSION, AND A LIMB STENT GRAFT. APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IIIA ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN AFX VELA INFRARENAL PROXIMAL EXTENSION ON (B)(6) 2021. THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 12150632 ↗
• InjuryMay 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (1) ONE-YEAR POST INITIAL IMPLANT, THE PATIENT WAS IDENTIFIED WITH A POSSIBLE TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO PLACE A PROXIMAL EXTENSION TO RESOLVE THIS LEAK. THE FINAL PATIENT STATUS WAS REPORTED AS DOING GREAT.

  Patient problems: Failure of Implant

  MAUDE report 11822269 ↗
• InjuryJan 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL STENT GRAFT EXTENSION, A (NON-ENDOLOGIX) VBX STENT GRAFT, A (NON-ENDOLOGIX) EXPRESS SD STENT GRAFT AND A (NON-ENDOLOGIX) EXPRESS LD 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 THE AFX2 SYSTEM PER THE IFU. NOW APPROXIMATELY (7) SEVEN MONTHS LATER A TYPE IIIA ENDOLEAK WAS CONFIRMED ON A REGULAR FOLLOW-UP WITH THE PATIENT. A RE-INTERVENTION IS CURRENTLY SCHEDULED AND THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11116740 ↗
• InjuryDec 7, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, TWO (2) VELA (AFX) SUPRARENAL AORTIC EXTENSIONS, A VELA (AFX) INFRARENAL AORTIC EXTENSION AND TWO (2) OVATION IX ILIAC LIMB EXTENDER STENT GRAFTS 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 AFX2 SYSTEM PER THE IFU. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. AN INTERVENTION WAS PERFORMED. THE PHYSICIAN IMPLANTED TWO (2) VELA (AFX) SUPRARENAL STENT GRAFTS AND PERFORMED BALLOONING. THIS DID NOT RESOLVE THE RUPTURE THEREFORE THE PHYSICIAN ELECTED TO CONVERT TO AN OPEN REPAIR TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS STABLE POST INTERVENTION. ADDITIONAL INFORMATION: THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE 1A ENDOLEAK WITH MIGRATION OCCURRED. THE TYPE 1A ENDOLEAK WITH MIGRATION WAS DISCOVERED DURING REVIEW OF THE TWENTY-THREE (23) MONTH POST IMPLANT (COMPUTED TOMOGRAPHY) CT SCAN.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 10962754 ↗
• InjuryDec 7, 2020Material Puncture/Hole; Migration; Material Puncture/Hole; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AND TWO (2) VELA SUPRARENAL STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE AND HALF (3.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH FLANK PAIN. A TYPE 3B ENDOLEAK WAS IDENTIFIED. AN INTERVENTION WAS PERFORMED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT. THE INTERVENTION WAS SUCCESSFUL.

  Patient problems: Failure of Implant; Pain

  MAUDE report 10959997 ↗
• InjuryNov 23, 2020Material Puncture/Hole; Unintended Movement; Material Puncture/Hole; Unintended Movement

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 3B ENDOLEAK, A TYPE IA ENDOLEAK AND MOVEMENT OF THE AFX VELA SUPRARENAL WERE IDENTIFIED DURING ROUTINE FOLLOW-UP. DUE TO THE HOSTILE NECK ANATOMY THE PHYSICIAN ELECTED TO EXPLANT THE DEVICE. THE FINAL PATIENT STATUS WAS TO BE RECOVERING WELL. THE FINAL PATIENT STATUS WAS REPORTED TO BE DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 10885439 ↗
• InjuryOct 28, 2020Improper 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 AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 6 DAYS POST INITIAL PROCEDURE PATIENT WAS RE-ADMITTED TO THE HOSPITAL DUE TO COMPLICATIONS AFTER SURGERY ON (B)(6) 2020 OCCLUSION (COLD LEG). THE PHYSICIAN ELECTED TO PLACE A VBX (NON-ENDOLOGIX) GRAFT INSIDE RIGHT AFX LIMB AND 2 VABAHNS (NON-ENDOLOGIX) WERE IMPLANTED IN THE RIGHT EXTERNAL ILIAC. THE PATIENT IS DOING WELL. ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT INDICATING THAT THE REPORTED OCCLUSION IS DUE TO THE NON-ENDOLOGIX STENT IN THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY. ALSO, A TYPE IA ENDOLEAK IS OBSERVED PER CT COMPUTED TOMOGRAPHY) SCAN DATED (B)(6) 2020 AND ORIGINATES FROM THE THORACIC (NON-ENDOLOGIX) STENT. THEREFORE, THIS IS NO LONGER A REPORTABLE EVENT AS THERE IS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF AN ENDOLOGIX DEVICE.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 10752782 ↗

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-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-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-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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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-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-0593-06 · 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

…and 1 more.