AFX2 Bifurcated Endograft System BEA25-110/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00818009014856), received between Mar 2, 2017 and Sep 4, 2025 — classified as 1 death, 19 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Off-Label Use; Material Puncture/Hole; Patient-Device Incompatibility; Migration; Off-Label Use; Material Puncture/Hole; Patient-Device Incompatibility; Migration

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA SUPRARENAL AORTIC EXTENSION, AND AN AFX ILIAC LIMB STENT GRAFT FOR THE TREATMENT OF A 58.8 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2020. THE SIX-MONTH FOLLOW-UP APPROXIMATELY ON (B)(6) 2020, POST INDEX PROCEDURE THE PATIENT HAD GOOD RESULTS. ON (B)(6) 2025, IT WAS REPORTED THAT A RECENT COMPUTED TOMOGRAPHY (CT) REVEALED THE PATIENT HAS ANEURYSM ENLARGEMENT FROM 58.8 MM IN DIAMETER TO CURRENTLY 83 MM IN DIAMETER, MIGRATION OF THE BSG RESULTING IN SEPARATION FROM THE AFX VELA SUPRARENAL AORTIC EXTENSION AND A TYPE IIIA ENDOLEAK. IT WAS REPORTED THAT ON (B)(6) 2025, THE PHYSICIAN INTENDED TO DO AN INTERVENTION HOWEVER DUE TO THE ANATOMY OF THE PATIENT, IT WAS NOT POSSIBLE TO GET THE INTRODUCER SHEATH (OR OTHER MATERIAL) TO THE INTENDED LOCATION. AS A RESULT, THE PROCEDURE WAS STOPPED. THE PATIENT¿S STATUS WAS NOT REPORTED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22968488 ↗
• InjuryAug 11, 2025Migration or Expulsion of Device; Off-Label Use; Material Twisted/Bent; Lack of Effect; Migration or Expulsion of Device; Off-Label Use; Material Twisted/Bent; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL ON (B)(6) 2016. ROUTINE FOLLOW-UP COMPUTED TOMOGRAPHY ON (B)(6) 2025 IDENTIFIED A POSSIBLE TYPE IIIA ENDOLEAK WITH ANEURYSM ENLARGEMENT. REINTERVENTION IS SCHEDULED FOR (B)(6) 2025. THE PATIENT IS STABLE. REINTERVENTION WAS COMPLETED ON (B)(6) 2025 WITH THE IMPLANT OF AN AFX VELA INFRARENAL AND AN AFX VELA SUPRARENAL. THE TYPE IIIA ENDOLEAK WAS SUCCESSFULLY SEALED AND TE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22771532 ↗
• InjuryMar 20, 2023Material 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, AN AFX VELA SUPRARENAL, AND AN AFX VELA INFRARENAL. APPROXIMATELY THREE (3) YEARS AFTER POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM (AAA) GROWTH. THE PATIENT UNDERWENT A RE-INTERVENTION, DURING WHICH AN ENDOLEAK TYPE 3B WAS IDENTIFIED. THE ATTENDING PHYSICIAN DECIDED TO ADDRESS THE ISSUE BY IMPLANTING AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT. THE INTERVENTION PROVED SUCCESSFUL IN RESOLVING THE ENDOLEAK, AND THE PATIENT'S POST-OPERATIVE RECOVERY WAS REPORTED TO BE DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16577863 ↗
• InjuryFeb 8, 2023Material 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 FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ENDOLEAK TYPE 3B. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ALTO MAIN BODY, TWO (2) OVATION IX ILIAC LIMB(S), AND OVATION PRIME FILL POLYMER. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16330345 ↗
• InjuryOct 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  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 FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH ANEURYSM SAC GROWTH (UNKNOWN DIAMETER) AND NO DEFINITIVE ENDOLEAK. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT WHO IS REPORTEDLY IN STABLE CONDITION.

  Patient problems: Aneurysm

  MAUDE report 15577708 ↗
• InjuryJul 16, 2021Device-Device Incompatibility; Insufficient Device Problem Information; Separation Problem; Device-Device Incompatibility; Insufficient Device Problem Information; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, TWO (2) SUPRARENAL AORTIC EXTENSIONS AND AN OVATION ILIAC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED A POSSIBLE TYPE 3 ENDOLEAK AND ANEURYSM ENLARGEMENT. THE PATIENT IS DOING FINE AND CURRENTLY BEING MONITORED AS AN INTERVENTION IS BEING PLANNED. ADDITIONAL INFORMATION: AN INTERNAL EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX SHOWS THAT THE REPORTED TYPE 3 ENDOLEAK IS CONFIRMED AS A TYPE 3A ENDOLEAK (WITH COMPONENT SEPARATION).

  Patient problems: Aneurysm

  MAUDE report 12181578 ↗
• DeathMay 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) DAYS POST INITIAL PROCEDURE THE PATIENT WAS FOUND TO HAVE PROGRESSIVE BOWEL ISCHEMIA AND PASSED AWAY ON DAY SIX (6) POST INITIAL PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant; Ischemia

  MAUDE report 11872742 ↗
• InjuryMar 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4.5 YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW-UP, A COMPUTED TOMOGRAPHY (CT) IDENTIFIED ANEURYSM ENLARGEMENT HOWEVER NO ENDOLEAK WAS IDENTIFIED. IT WAS NOTED THAT OVERLAP BETWEEN THE BIFURCATED STENT GRAFT AND THE SUPRARENAL AORTIC EXTENSION HAS DECREASED (STENT MOVEMENT). THE PHYSICIAN ELECTED TO IMPLANT A NON-ENDOLOGIX (MEDTRONIC CUFF) STENT TO COVER THE OVERLAP. THE PATIENT WAS REPORTED AS DOING FINE POST SECONDARY PROCEDURE. ADDITIONAL INFORMATION: THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A SECONDARY ENDOVASCULAR PROCEDURE (EMBOLIZATION OF A LUMBAR ARTERY DATE UNKNOWN) OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11489973 ↗
• InjuryApr 6, 2020Use of Device Problem; Patient-Device Incompatibility; Insufficient Device Problem Information; Use of Device Problem; Patient-Device Incompatibility; 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 2.5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. A TYPE 3A ENDOLEAK BETWEEN THE BIFURCATED DEVICES AND PROXIMAL EXTENSION WAS IDENTIFIED BY COMPUTED TOMOGRAPHY (CT) SCAN. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANTED A SUPRARENAL STENT GRAFT EXTENSION AND AN INFRARENAL STENT GRAFT EXTENSION TO RESOLVE TO EVENT. THE PATIENT WAS REPORTED AS STABLE POST- INTERVENTION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 9929752 ↗
• InjuryJan 7, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, AN INFRARENAL STENT GRAFT EXTENSION AND A LIMB STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 10 MONTHS POST INITIAL PROCEDURE, (EXACT DATE WAS NOT PROVIDED) A TYPE 3B ENDOLEAK WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9560846 ↗
• InjuryNov 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE (EXACT DATE WAS NOT PROVIDED), SAC GROWTH WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) OVATION IX EXTENDERS TO TREAT THIS PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: DURING THE INVESTIGATION, CLINICAL PERSONNEL IDENTIFIED A TYPE IB ENDOLEAK OF THE LEFT COMMON ILIAC ARTERY AND THE FINAL PATIENT STATUS WAS DISCHARGED ON THE SECOND POST-OPERATIVE DAY FOLLOWING A SECONDARY ENDOVASCULAR REPAIR.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9342867 ↗
• InjuryOct 15, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Separation Problem; Patient-Device Incompatibility; Insufficient Device Problem Information; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM. A TYPE 3A ENDOLEAK WAS SEPARATION BETWEEN THE BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION WAS IDENTIFIED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH A NON-ENDOLOGIX (GORE) DEVICE. THE RE-INTERVENTION WAS SUCCESSFUL. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Rupture

  MAUDE report 9195168 ↗
• InjuryAug 29, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; 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 2.5 YEARS POST INITIAL PROCEDURE, A COMPUTERIZED TOMOGRAPHY (CT) REVEALED A POSSIBLE TYPE 3 ENDOLEAK OF INDETERMINATE ORIGIN. AS TO DATE, NO INTERVENTION HAS BEEN SCHEDULED AND THE PATIENT IS BEING MONITORED. ADDITIONAL INFORMATION: THE PHYSICIAN COMPLETED A SUCCESSFUL REINTERVENTION AND TREATED THE PATIENT WITH A VELA SUPRARENAL STENT GRAFT EXTENSION. THE ENDOLEAK WAS RESOLVED AND PATIENT WAS REPORTEDLY STABLE POST REINTERVENTION. THE INDETERMINATE TYPE 3 ENDOLEAK IS REFUTED, RATHER IT IS A TYPE 3A (AORTIC) ENDOLEAK WITH THE LOSS OF OVERLAP.

  Patient problems: Failure of Implant

  MAUDE report 8947003 ↗
• InjuryAug 29, 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 THREE (3) MONTHS POST INITIAL PROCEDURE, THE PATIENT HAD SURGERY TO REMOVE THE PORTION OF THE JEJUNUM THAT WAS ADHERED TO THE DISTAL ANEURYSM SAC WHICH ERODED INTO THE GRAFT. A YEAR LATER, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN, A POSSIBLE RUPTURE, AND AN INFECTION (ACTIVE ECOLI BACTOREMIA). CTA (COMPUTED TOPOGRAPHY ANGIOGRAPHY) REVEALED ANEURYSM SAC GROWTH (UNKNOWN DIAMETER) AND A POSSIBLE TYPE IIIB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL BIFURCATED AFX2 DEVICE ON (B)(6) 2019. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED BUT THE PATIENT CONTINUES TO BE IN POOR CONDITION DUE TO THE INFECTION.

  Patient problems: Aneurysm; Pain; Rupture; Unspecified Infection

  MAUDE report 8946117 ↗
• InjuryAug 26, 2019Material Puncture/Hole; Separation Problem; Material Puncture/Hole; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE (THE EXACT DATE WAS NOT PROVIDED), A TYPE 3B ENDOLEAK WAS REPORTED. THE PATIENT IS ASYMPTOMATIC. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) INFRARENAL STENT GRAFT EXTENSIONS TO TREAT THIS REPORTED EVENT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: DURING THE INVESTIGATION, THE REPORTED TYPE 3B ENDOLEAK WAS REFUTED, RATHER IT WAS A TYPE 3A ENDOLEAK WITH COMPONENT SEPARATION.

  Patient problems: Failure of Implant

  MAUDE report 8933074 ↗
• InjuryNov 9, 2018Leak/Splash; Leak/Splash

  THE PATIENT WAS PREVIOUSLY IMPLANTED WITH A BIFURCATED STENT GRAFTS AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) MONTH POST INITIAL IMPLANT. A TYPE 3A ENDOLEAK WAS IDENTIFIED. THE PATIENT IS CURRENT BEING MONITORED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8056014 ↗
• InjuryNov 15, 2017Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  ON (B)(6) 2017, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL EXTENSION. ON THE ONE MONTH ROUTINE FOLLOW UP CT, A TYPE 1B ENDOLEAK WITH SAC GROWTH WAS DISCOVERED. THE PHYSICIAN ELECTED TO USE A NON- ENDOLOGIX STENT GRAFT TO RESOLVE THIS REPORTED EVENT. THE PATIENT WAS REPORTED AS DOING WELL AND NO ADDITIONAL PATIENT SEQUELAE HAVE BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7034143 ↗
• InjuryJun 23, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  AN AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED WITH A VELA SUPRARENAL CUFF TO TREAT AN ABDOMINAL AORTIC ANEURYSM. FOLLOWING COMPLETION OF THE ENDOVASCULAR REPAIR, THE PATIENT'S RIGHT PEDAL PULSE WAS NOTED TO BE DIMINISHED. THE PATIENT UNDERWENT EXPLORATION OF THE RIGHT FEMORAL ARTERY, WHICH REVEALED A DISSECTION FLAP WITHIN THE ARTERY, WHICH OBSTRUCTED ARTERIAL FLOW. A RE-INTERVENTION WAS PERFORMED ON THE DATE OF THE STENT GRAFT IMPLANTATION, WHERE A RIGHT FEMORAL ARTERY ENDARTERECTOMY WAS PERFORMED AND CLOSED USING A BOVINE PERICARDIAL PATCH. FOLLOWING THE RE-INTERVENTION, THE PATIENT'S RIGHT PEDAL PULSE WAS RESTORED TO NORMAL. THE PATIENT WAS DISCHARGED THE DAY FOLLOWING THE INDEX PROCEDURE. AS THE DATE OF THIS REPORT, THAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant; Ischemia

  MAUDE report 6665120 ↗
• InjuryApr 5, 2017Partial Blockage; Occlusion Within Device; Partial Blockage; Occlusion Within Device

  IT AS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE WITH A BIFURCATED STENT AND TWO SUPRARENAL AORTIC EXTENSIONS. THE PATIENT CAME IN EMERGENTLY TO THE EMERGENCY ROOM WITH A COLD RIGHT LEG. IT WAS REPORTED THE PATIENT WAS EXPERIENCING SYMPTOMS FOR THREE DAYS PRIOR TO COMING IN TO THE EMERGENCY ROOM. THE PHYSICIAN IDENTIFIED THROMBUS IN THE RIGHT LIMB OF THE MAIN BODY STENT, THE RIGHT COMMON ILIAC ARTERY (RCIA), THE RIGHT EXTERNAL ILIAC ARTERY (REIA), AND THE RIGHT COMMON FEMORAL ARTERY. THE PHYSICIAN INDICATED ALTHOUGH THE ORIGIN OF THE THROMBUS OCCLUSION IS UNKNOWN, A POTENTIAL COMPRESSION OF THE MAIN BODY RIGHT LIMB WAS OBSERVED. THE PHYSICIAN PERFORMED AN ENDOVASCULAR REVASCULARIZATION AND SUCCESSFULLY RESTORED FLOW. POST SECONDARY INTERVENTION IN RECOVERY THE RIGHT MAIN BODY LIMB AND ADDITIONAL STENTS RE-OCCLUDED. THE PHYSICIAN STATED THE LEG OF THE PATIENT WILL NOT BE SALVAGEABLE AND THE PATIENT WILL END UP WITH AN AMPUTATION.

  Patient problems: Aneurysm; Failure of Implant; Ischemia; Occlusion; Reocclusion

  MAUDE report 6461965 ↗
• InjuryMar 2, 2017Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE WITH A BIFURCATED STENT AND TWO SUPRARENAL AORTIC EXTENSIONS. THE PATIENT CAME IN EMERGENTLY WITH ABDOMINAL PAIN AND COMPUTED TOMOGRAPHY (CT) SHOWED A TYPE 1B ENDOLEAK COMING FROM THE RIGHT ILIAC LIMB. THE PHYSICIAN ELECTED TO IMPLANT AN OVATION LIMB EXTENSION TO SEAL THE LEAK. THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: Abdominal Pain; Failure of Implant

  MAUDE report 6374900 ↗

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-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-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-0592-06 · 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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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
• 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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL

…and 1 more.