AFX2 Bifurcated Endograft System BEA28-60/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00818009014474), received between Apr 25, 2018 and Jul 16, 2021 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2021Use of Device Problem; Device-Device Incompatibility; Separation Problem; Use of Device Problem; Device-Device Incompatibility; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND TWO (2) OVATION IX ILIAC LIMB STENT GRAFTS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP A TYPE 3A ENDOLEAK WITH COMPLETE COMPONENT SEPARATION AND LEFT ILIAC ANEURYSM ENLARGEMENT WERE IDENTIFIED. THE PATIENT IS DOING FINE AND IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. ADDITIONAL INFORMATION: A RE-INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) AFX VELA SUPRARENAL AND TWO (2) OVATION IX ILIAC LIMBS. THE FINAL PATIENT STATUS WAS REPORTED TO BE STABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12185726 ↗
• InjuryJan 9, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT WAS IMPLANTED WITH TWO (2) AFX2 BIFURCATED STENT GRAFTS, NON- ENDOLOGIX (COOK) PROXIMAL EXTENSION AND NON- ENDOLOGIX (COOK) LIMB EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE. THE NON- ENDOLOGIX (COOK) PROXIMAL EXTENSION WAS IMPLANTED FIRST. THEN THE FIRST AFX2 BIFURCATED STENT GRAFT WAS ATTEMPTED TO BE IMPLANTED HOWEVER DUE TO THE GUIDE WIRE BEING BEHIND THE GRAFT (INCORRECT LOCATION) THE STENT DEPLOYED PREMATURELY IN THE AORTA AND WAS UNABLE TO BE REMOVED. THE AFX2 BIFURCATED STENT GRAFT WAS PUSHED/ CRUSHED AGAINST THE AORTA WALLS AND RELINED WITH ANOTHER AFX2 BIFURCATED STENT GRAFT. THEN AN ADDITIONAL NON- ENDOLOGIX (COOK) LIMBS WERE IMPLANTED. THE PROCEDURE WAS PROLONGED AN ADDITIONAL 2.5 TO 3 HOURS. THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL EVENTS AND THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: No Code Available

  MAUDE report 9569773 ↗
• MalfunctionSep 24, 2019Use of Device Problem; Deformation Due to Compressive Stress; Use of Device Problem; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 AND OVATION IX ABDOMINAL AORTIC ANEURYSM STENTS (OUTSIDE INDICATIONS OF USE), AND THE INTERNAL ILIAC WAS COILED. APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE, A TYPE IIIA ENDOLEAK (BETWEEN THE BIFURCATION AND LIMB EXTENSION) WAS DETECTED AT ROUTINE FOLLOW-UP CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY). IN ADDITION, THE PROXIMAL PORTION OF THE BIFURCATED DEVICE APPEARED COMPRESSED. THE PATIENT WAS REPORTEDLY IN STABLE CONDITION. A RE-INTERVENTION WAS COMPLETED ON (B)(6) 2019, HOWEVER, THE DETAILS OF THE PROCEDURE WERE NOT PROVIDED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE RE-INTERVENTION WAS COMPLETED. THE PROXIMAL LIMB WAS DILATED WITH A NON-ENDOLOGIX HIGH PRESSURE NON-COMPLIANT BALLOON, A RELINE WAS PERFORMED WITH A NON-ENDOLOGIX (PALMAZ) BARE METAL STENT. THE ENDOLEAK WAS SUCCESSFULLY SEALED AND THE PATIENT WAS REPORTED TO BE WELL POST PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 9109717 ↗
• InjuryMay 16, 2019Break; Difficult or Delayed Positioning; Use of Device Problem; Improper or Incorrect Procedure or Method; Difficult to Advance; Positioning Problem; Break; Difficult or Delayed Positioning; Use of Device Problem; Improper or Incorrect Procedure or Method; Difficult to Advance; Positioning Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN ANUREX (NON-ENDOLOGIX) GRAFT SOMETIME IN 2004 (FIFTEEN (15) YEARS PRIOR). SINCE THEN THE GRAFT HAD MIGRATED AND THE PATIENT PRESENTED WITH A RUPTURED AAA. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH A BIFURCATED AFX2 AND ONE (1) ILIAC LIMB OVATION IX DEVICES, AND TWO (2) GORE (NON-ENDOLOGIX) THORACIC STENT GRAFTS (OFF-LABEL USE WITH ADJUNCTIVE DEVICES). DURING THE RE-INTERVENTION, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE AFX2 DEVICE THROUGH THE PREVIOUSLY IMPLANTED ANUREX DEVICE AND ALLEGEDLY DUE TO THE CHALLENGE TO SEE THE AFX2 MARKERS AND THE TORTUOSITY OF THE PATIENT'S ANATOMY. IT WAS ALSO DIFFICULT FOR THE PHYSICIAN TO WRAP THE CONTRALATERAL LIMB WIRE, ROTATE THE AFX2 DEVICE TO THE PROPER ORIENTATION, PULL THE CONTROL CORD, DEPLOY THE CONTRALATERAL LIMB, AND RETRACT THE LIMB COVER. DESPITE THE DIFFICULTY, ALL THE PREVIOUS STEPS WERE COMPLETED SUCCESSFULLY. HOWEVER, WHILE RETRACTING THE INNER CORE IT WAS NOTED THAT THE DISTAL PORTION OF ITS TIP BROKE OFF. THE AFX2 DELIVERY SHEATH AND THE BROKEN TIP WERE SUCCESSFULLY AND SAFELY REMOVED FROM THE PATIENT. THE STENT GRAFT SYSTE

  Patient problems: Failure of Implant

  MAUDE report 8617033 ↗
• InjuryJul 11, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. A NOTIFICATION WAS RECEIVED ON 06/14/2018 THAT A SECONDARY INTERVENTION OCCURRED ON (B)(6) 2018 WHERE A VELA SUPRARENAL EXTENSION WAS PLACED; HOWEVER, INFORMATION RELATED TO THE REASON FOR THE INTERVENTION AND THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7678348 ↗
• InjuryApr 25, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A TYPE 1A ENDOLEAK. A SECONDARY PROCEDURE HAS BEEN SCHEDULED FOR SOMETIME IN (B)(6) 2018. THERE IS NO OTHER INFORMATION AT THIS TIME. THE PATIENT WAS BEEN REPORTED AS DOING FINE AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7458802 ↗

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-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-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-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-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-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-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-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-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
• 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-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL

…and 1 more.