AFX Endovascular AAA System BA25-100/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00818009010032), received between Apr 9, 2016 and Sep 28, 2023 — classified as 1 death, 37 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 41 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2023Off-Label Use; Material Puncture/Hole; Device-Device Incompatibility; Off-Label Use; Material Puncture/Hole; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A MEDTRONIC ENDURANT (NON-ENDOLOGIX) AORTIC CUFF TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DUE TO AORTIC NECK DIAMETER AND ANGULATION, THE ENDURANT CUFF WAS IMPLANTED FIRST PROXIMALLY FOLLOWED BY THE AFX BIFURCATED STENT GRAFT. APPROXIMATELY FIVE AND HALF (5.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT THE EMERGENCY ROOM COMPLAINING OF BACK PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED ON (B)(6) 2023 AND THE IMAGES CONFIRMED ANEURYSM RUPTURE. AN ENDOLEAK WAS NOT IDENTIFIED BY CT AND THE REASON FOR ANEURYSM ENLARGEMENT WAS UNKNOWN, THE PHYSICIAN DECIDED TO PERFORM AN OPEN SURGERY ON (B)(6) 2023. DURING THIS SURGERY, TWO PINHOLES ON THE FRONT, A HOLE ON THE LEFT AND ONE MORE ON THE BACK OF AFX BIFURCATED STENT GRAFT WERE CONFIRMED. THE AFX STENT GRAFT WAS EXPLANTED AND WILL BE RETURNED FOR EVALUATION. VASCULAR REPLACEMENT WAS PERFORMED. THE PATIENT WAS REPORTED AS STABLE POST THIS EXPLANT PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak; Pain; Ruptured Aneurysm

  MAUDE report 17840544 ↗
• InjuryJul 11, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) AND A RIGHT COMMON ILIAC ARTERY ANEURYSM ON (B)(6) 2017. A GORE (NON-ENDOLOGIX) EXCLUDER LEG WAS DEPLOYED THEN THE AFX2 BIFURCATED STENT GRAFT (BSG) AND AN UNKNOWN AFX VELA WERE IMPLANTED. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS FOR USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM. REPORTEDLY, THE AFX2 BSG WAS POSSIBLY FORCED INTO THE ANTERIOR AORTA WALL AND MIGRATED. THE DISTRIBUTOR DID NOT PROVIDE FURTHER DETAILS. AFTER THE INITIAL PROCEDURE, THE DISTRIBUTOR PROVIDED ADDITIONAL INFORMATION TO CLARIFY THE EVENT. THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) AND A RIGHT COMMON ILIAC ARTERY ANEURYSM ON (B)(6) 2017 WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT. REPORTEDLY, THE AFX2 BSG WAS POSSIBLY FORCED INTO THE ANTERIOR AORTA WALL AND MIGRATED. IN (B)(6) 2022, A COMPUTERIZED TOMOGRAPHY SCAN IDENTIFIED ANEURYSM ENLARGEMENT WITH A TYPE IA ENDOLEAK CAUSED BY THE MIGRATION. ON (B)(6) 2022, REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF A NON-ENDOLOGIX ENDURANT AUI STENT GRAFT AND FEM-FEM BYPASS WAS PERFORMED. THE PATIENT'S CURRENT CONDITION IS STABLE.

  Patient problems: Aneurysm; Clinical Endoleak; Insufficient Information

  MAUDE report 17302005 ↗
• InjuryDec 5, 2022Appropriate Device Problem Term/Code Not Available; Lack of Effect; Appropriate Device Problem Term/Code Not Available; Lack of Effect

  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 YEARS POST INITIAL PROCEDURE, PATIENT PRESENTED WITH A RUPTURED ANEURYSM AND A TYPE 3A ENDOLEAK. THE PATIENT WAS RELINED WITH NON- ENDOLGIX (GORE) DEVICE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Aneurysm; Clinical Endoleak; Failure of Implant; Rupture

  MAUDE report 15921183 ↗
• InjuryNov 28, 2022Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT. APPROXIMATELY (1) ONE YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH OCCLUSION OF THE LEFT LEG AND SEVERE STENOSIS OF THE RIGHT LEG. THE PATIENT UNDERWENT A RE-INTERVENTION WHERE THE PHYSICIAN IMPLANTED A SMART (NON-ENDOLOGIX) STENT. THE FINAL PATIENT STATUS REMAINS UNKNOWN. THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 15873856 ↗
• InjuryMar 3, 2022Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY SIX (6) AND A HALF YEARS POST INITIAL PROCEDURE, AT ROUTINE FOLLOW-UP A TYPE II ENDOLEAK (NON-DEVICE RELATED) FROM PATENT LUMBERS AND INFERIOR MESENTERIC ARTERY WAS IDENTIFIED WITH SUSPECT TYPE IIIB ENDOLEAK. DIAGNOSTIC ANGIOGRAM IS PLANNED BUT HAS NOT BEEN PERFORMED. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC.

  Patient problems: Aneurysm; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 13660774 ↗
• InjuryNov 17, 2021Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH AFX BIFURCATED STENT GRAFT, AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED IN STABLE CONDITION WITH AN EXPANDING AAA SAC IDENTIFIED VIA ULTRASOUND. ANGIOGRAPHY WAS PERFORMED IDENTIFYING A POSSIBLE TYPE IB ENDOLEAK WITH THE LIMB PULLING UP INTO THE SAC. THE PATIENT WAS TREATED WITH IMPLANT OF A MEDTRONIC (NON-ENDOLOGIX) ILIAC LIMB; HOWEVER, A SLIGHT BLUSH WAS STILL PRESENT. THE PATIENT WILL CONTINUE TO BE MONITORED. A TYPE 2 ENDOLEAKS OF THE LUMBAR ARTERIES (NON-DEVICE RELATED FAILURE), A POST-OPERATIVE THROMBOSIS AND THROMBECTOMY OF THE RIGHT COMMON FEMORAL ARTERY IMMEDIATELY POST INDEX PROCEDURE OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. (REPORTED UNDER MFR#: 2031527-2020-00177). APPROXIMATELY ONE AND A HALF (1.5) YEARS LATER, THE PATIENT PRESENTED TO A ROUTINE FOLLOW-UP WITH AN EXPANDING AAA FROM 6.1CM TO 7.2CM, A POSSIBLE TYPE 3A ENDOLEAK AND A POSSIBLE TYPE 3B ENDOLEAK. REINTERVENTION IS PLANNED; HOWEVER, HAS NOT YET BEEN SCHEDULED. THE PATIENT IS REPORTED TO BE STABLE. UPDATED INFORMATION: IT WAS REPORTED THAT D

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12830099 ↗
• MalfunctionOct 22, 2021Fracture; Fracture

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY THREE (3) YEARS LATER, ROUTINE FOLLOW-UP IDENTIFIED A STENT FRACTURE. REPORTEDLY, THE FOUR (4) YEAR FOLLOW-UP IDENTIFIED THAT THE FRACTURE IS PERSISTING. THERE HAS BEEN NO IMPACT TO THE PATIENT, AND THEY ARE BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 12685487 ↗
• InjuryJan 6, 2021Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH PAIN HOWEVER THE ROUTINE EXAMS WERE OKAY. A TYPE 3A ENDOLEAK WAS IDENTIFIED. THERE WAS DISCONNECTION BETWEEN THE BIFURCATED STENT GRAFT AND A VELA SUPRARENAL EXTENSION. THE PHYSICIAN ELECTED TO REOPEN THE PATIENT AND A VELA INFRARENAL WAS IMPLANTED BETWEEN THE PARTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT IS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 11127082 ↗
• InjuryAug 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 6 YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, COMPUTERIZED TOMOGRAPHY IDENTIFIED ANEURYSM ENLARGEMENT. AT RE-INTERVENTION, A SMALL TYPE IIIA ENDOLEAK WAS IDENTIFIED. THE LEAK WAS RESOLVED WITH AN AFX VELA INFRARENAL BRIDGING THE OVERLAP. THE PATIENT WAS RELEASED HOME.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10440200 ↗
• InjuryJul 24, 2020Insufficient 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. APPROXIMATELY FOUR (4) YEARS POST INITIAL IMPLANT DURING A ROUTINE FOLLOW UP CT (COMPUTED TOMOGRAPHY) IDENTIFIED SAC GROWTH OF 6.6CM AND A POSSIBLE TYPE 1B ENDOLEAK. PATIENT IS REPORTED AS DOING WELL AND HAS A FOLLOW-UP ANGIOGRAM PENDING AT A FUTURE UNDISCLOSED DATE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10322329 ↗
• InjuryJun 25, 2020Material Puncture/Hole; Insufficient Device Problem Information; Material Puncture/Hole; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AFX BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A POSSIBLE TYPE IIIB ENDOLEAK. PATIENT IS STABLE AND RE-INTERVENTION IS TO BE SCHEDULED.

  Patient problems: Aneurysm; Cardiopulmonary Arrest; Failure of Implant; Hemorrhage/Blood Loss/Bleeding; Respiratory Failure

  MAUDE report 10196425 ↗
• InjuryJun 23, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT WAS INITIALLY IMPLANTED WITH AFX BIFURCATED STENT GRAFT, AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4.5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED IN STABLE CONDITION WITH AN EXPANDING AAA SAC IDENTIFIED VIA ULTRASOUND. ANGIOGRAPHY WAS PERFORMED IDENTIFYING A POSSIBLE TYPE IB ENDOLEAK WITH THE LIMB PULLING UP INTO THE SAC. THE PATIENT WAS TREATED WITH IMPLANT OF A MEDTRONIC (NON-ENDOLOGIX) ILIAC LIMB; HOWEVER, A SLIGHT BLUSH WAS STILL PRESENT. THE PATIENT WILL CONTINUE TO BE MONITORED. ADDITIONAL INFORMATION: A TYPE 2 ENDOLEAKS OF THE LUMBAR ARTERIES (NON-DEVICE RELATED FAILURE), A POST-OPERATIVE THROMBOSIS AND THROMBECTOMY OF THE RIGHT COMMON FEMORAL ARTERY IMMEDIATELY POST INDEX PROCEDURE OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Aneurysm; Failure of Implant; Thrombosis

  MAUDE report 10187191 ↗
• InjuryMar 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A GROWING ANEURYSM (UNKNOWN DIAMETER) AND A POSSIBLE TYPE III ENDOLEAK. THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. THE PATIENT IS REPORTEDLY IN STABLE CONDITION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 9875925 ↗
• InjuryFeb 19, 2020Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method; 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. APPROXIMATELY 5 YEARS POST INITIAL PROCEDURE, A FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED A TYPE IIIA AND A IIIB ENDOLEAK. PATIENT IS DOING WELL AND IS PENDING RE-INTERVENTION. ADDITIONAL INFORMATION: A RE- INTERVENTION WAS COMPLETED ON (B)(6) 2020. THE PHYSICIAN ELECTED TO IMPLANTED AN AFX BIFURCATED STENT GRAFT AND A NON-ENDOLOGIX DEVICE (COOK THORACIC CUFF) TO RESOLVE THIS EVENT. THE FINAL PATIENT STATUS WAS REPORTED AS FINE.

  Patient problems: Failure of Implant

  MAUDE report 9730901 ↗
• DeathDec 23, 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, A TYPE 1 (ORIGIN UNKNOWN) ENDOLEAK WAS REPORTED. PATIENT WAS ADMITTED AND INTERVENTION WAS NOT RECOMMENDED DUE TO PATIENT'S POOR HEALTH CONDITION. THE PATIENT ELECTED PALLIATIVE CARE. THE PATIENT EXPIRED ON (B)(6) 2019.

  Patient problems: Aneurysm; Death; Rupture

  MAUDE report 9511886 ↗
• InjuryNov 1, 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, A POSSIBLE 3B ENDOLEAK WAS REPORTED. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH NON- ENDOLOGIX (GORE) STENTS TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING GREAT.

  Patient problems: Failure of Implant

  MAUDE report 9267695 ↗
• InjurySep 30, 2019Material Puncture/Hole; Insufficient Device Problem Information; Material Puncture/Hole; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ENLARGED ANEURYSM (50MM TO 70MM). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EXPLANTING THE AFX DEVICE ON (B)(6) 2019. DURING THE RE-INTERVENTION, A TYPE IIIB ENDOLEAK WAS ALSO FOUND. THE PATIENT IS REPORTEDLY DOING WELL POST OPEN CONVERSION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9136420 ↗
• InjuryApr 3, 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 THREE (3) YEARS POST INITIAL PROCEDURE, A POSSIBLE TYPE 1B ENDOLEAK (DISTAL LEAK) WAS REPORTED. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX ILIAC LIMB TO TREAT THE REPORTED TYPE 1B ENDOLEAK. A TYPE 2 ENDOLEAK (NON- DEVICE RELATED FAILURE) WAS ALSO REPORTED BUT UNKNOWN IF TREATED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8479941 ↗
• InjuryNov 9, 2018Leak/Splash; Leak/Splash

  AN AFX BIFURCATED STENT GRAFT WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. A TYPE 3B ENDOLEAK WAS IDENTIFIED DURING A ROUTINE FOLLOW UP VISIT. THE PATIENT WAS ASYMPTOMATIC. THE TYPE 3B ENDOLEAK WAS RELINED WITH AN AFX. PATIENT WAS STABLE POST RELINE AND DISCHARGED FROM THE HOSPITAL. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8057799 ↗
• InjurySep 13, 2018Leak/Splash; Material Puncture/Hole; Material Integrity Problem; Leak/Splash; Material Puncture/Hole; Material Integrity Problem

  ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A TYPE 3B ENDOLEAK. THE PATIENT IS SCHEDULED TO HAVE A SECONDARY PROCEDURE ON (B)(6) 2018. AS OF THE DATE OF THIS REPORT, THE PATIENT IS REPORTED TO BE STABLE AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7872858 ↗
• InjuryJul 24, 2018Leak/Splash; Material Puncture/Hole; Material Integrity Problem; Leak/Splash; Material Puncture/Hole; Material Integrity Problem

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, THE PATIENT WAS PRESENTED TO THE ER WITH A RUPTURED AAA. THE PHYSICIAN WAS ATTEMPTING TO RE-LINE THE STENT GRAFT WHICH HAD A TYPE 3B ENDOLEAK WHEN THE PATIENT'S CONDITION DETERIORATED AND THE PHYSICIAN FELT IT NECESSARY TO CONVERT TO AN OPEN REPAIR AND EXPLANT OF THE AFX GRAFT. THE PATIENT IS IN ICU WITH POOR PROGNOSIS.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 7717013 ↗
• InjuryJun 28, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT GRAFT AND AN INFRARENAL EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF AN INDETERMINATE ENDOLEAK (POSSIBLE TYPE 3A OR 3B). THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL STENT WITH A NON- ENDOLOGIX STENT THE RELINE WAS SUCCESSFULLY. THE PATIENT WAS REPORTED AS DOING WELL. AS OF THE DATE OF THIS REPORT, THE PATIENT IS REPORTED TO BE STABLE AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7646841 ↗
• InjuryApr 19, 2018Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  ON (B)(6) 2015, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, AND A VELA SUPRARENAL. ON (B)(6) 2016, A SECONDARY PROCEDURE WAS PERFORMED TO TREAT AN ENDOLEAK AT AN UNDETERMINED LOCATION. THE PATIENT WAS IMPLANTED WITH AN ADDITIONAL VELA SUPRARENAL. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 7444321 ↗
• InjuryApr 4, 2018Hole In Material; Leak/Splash; Material Integrity Problem; Hole In Material; Leak/Splash; Material Integrity Problem

  ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT AND A NON-ENDOLOGIX STENT. IT WAS NOTED THAT THERE WAS AN INTRAOPERATIVE TYPE 1A ENDOLEAK THAT WAS RESOLVED. IT WAS REPORTED THAT IN (B)(6) 2017 (6 MONTH FOLLOW UP) A CT SCAN SHOWED RESIDUAL OF AN ENDOLEAK (TYPE OF ENDOLEAK WAS NOT REPORT). ON (B)(6) 2018, (1 YEAR FOLLOW UP) SAC GROWTH WAS NOTED. ON (B)(6) 2018, THE PATIENT WAS ADMITTED TO THE HOSPITAL. ON (B)(6) 2018, A SECONDARY PROCEDURE WAS PERFORMED. A HOLE IN THE DISTAL EDGE OF THE BIFURCATED STENT (TYPE 3B ENDOLEAK) WAS DISCOVERED. TWO (2) NON- ENDOLOGIX STENTS WERE IMPLANTED TO RESOLVE THIS ENDOLEAK. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7397009 ↗
• InjuryFeb 27, 2018Failure To Adhere Or Bond; Leak/Splash; Off-Label Use; Inadequacy of Device Shape and/or Size; Stretched; Failure To Adhere Or Bond; Leak/Splash; Off-Label Use; Inadequacy of Device Shape and/or Size; Stretched

  AN AFX BIFURCATED AND A VELA SUPRARENAL EXTENSION WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 2 YEAR ROUTINE FOLLOW-UP SHOWED THE PRESENCE OF A POTENTIAL ENDOLEAK; HOWEVER, THE TYPE OF ENDOLEAK WAS NOT REPORTED. THE PATIENT IS REPORTED TO BE ASYMPTOMATIC AND STABLE, AND WILL BE SCHEDULED FOR A POSSIBLE RE-INTERVENTION TO TREAT THE ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 7299638 ↗

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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-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-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-0589-06 · 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

…and 1 more.