AFX Endovascular AAA System BA28-120/I20-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00818009011992), received between Jul 21, 2016 and Apr 7, 2021 — classified as 27 injuries.

The most frequently reported specific device problem is “Leak/Splash” (14 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2021Unintended Movement; Insufficient Device Problem Information; Unintended Movement; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 1A AND 1B ENDOLEAK WAS IDENTIFIED. A RE-INTERVENTION WAS PERFORMED. THE PHYSICIAN ELECTED TO IMPLANTED AN ADDITIONAL AFX SUPRARENAL GRAFT EXTENSION AND AN OVATION IX LIMB EXTENDER TO TREAT THE LEAKS. REPORTEDLY, THE PATIENT IS STABLE. ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT INDICATING THAT MOVEMENT OF THE PROXIMAL STENT ALSO OCCURRED.

  Patient problems: Failure of Implant

  MAUDE report 11628425 ↗
• InjuryMar 17, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 2.5 YEARS POST INITIAL PROCEDURE, A TYPE 3A AND 3B ENDOLEAK WERE REPORTED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION. THIS EVENT WAS PREVIOUSLY REPORTED UNDER 2031527-2016-00049. APPROXIMATELY 3.5 YEARS POST RE-INTERVENTION, THE PATIENT PRESENTED EMERGENTLY WITH AN AORTIC RUPTURE AND PROXIMAL EXTENSION MIGRATION OF 22MM. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER SUPRARENAL AORTIC EXTENSION TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS STABLE. THIS EVENT WAS PREVIOUSLY REPORTED UNDER 2031527-2019-00456. NOW, APPROXIMATELY 1.5 YEARS POST THE SECOND RE-INTERVENTION, THE PATIENT PRESENTED WITH ABDOMINAL PAIN. A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN SHOWED SAC EXPANSION AND A TYPE 3B ENDOLEAK. RE-INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING FINE POST SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant; Pain

  MAUDE report 11507398 ↗
• InjuryMar 12, 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 FIVE (5) YEARS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK WAS IDENTIFIED. PATIENT IS CURRENTLY BEING MONITORED. THIS PATIENT IS PART OF A CLINICAL STUDY CASE.

  Patient problems: Failure of Implant

  MAUDE report 11478215 ↗
• InjuryNov 3, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE AND HALF (5.5) YEARS POST INITIAL IMPLANT THE PATIENT PRESENTED WITH CLAUDICATION. THE PHYSICIAN PERFORMED A CT (COMPUTED TOMOGRAPHY) SCAN AND OBSERVED A TYPE 3B ENDOLEAK AT THE BIFURCATION SECTION OF THE STENT. THE PHYSICIAN ELECTED TO TREAT WITH A GORE GRAFT STENT (NON-ENDOLOGIX). PATIENT IS DOING WELL AND IS HOME.

  Patient problems: Claudication; Failure of Implant

  MAUDE report 10782648 ↗
• InjuryDec 22, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY, 3 YEARS POST INITIAL PATIENT PRESENTED WITH A TYPE IIIA ENDOLEAK AND WAS TREATED WITH AN AORTIC EXTENSION. THIS EVENT WAS REPORTED UNDER MFR#: 2031527-2018-0079. NOW, APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ENDOLEAK (OF INDETERMINATE ORIGIN) AND AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: DURING THE INVESTIGATION, THE REPORTED INDETERMINATE ENDOLEAK WAS IDENTIFIED TO BE A TYPE IIIA ENDOLEAK OF THE RIGHT COMMON ILIAC ARTERY. RUPTURE AND SAC GROWTH OF APPROXIMATELY 23MM WERE ALSO IDENTIFIED.

  Patient problems: Aneurysm; Failure of Implant; Rupture

  MAUDE report 9508918 ↗
• InjuryOct 30, 2019Insufficient 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 FOUR (4) YEARS POST INITIAL PROCEDURE, A POSSIBLE TYPE IIIA OR IIIB ENDOLEAK WAS DETECTED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH GORE (NON-ENDOLOGIX) DEVICE(S) ON (B)(6) 2019. THE RE-INTERVENTION WAS SUCCESSFUL AND THE PATIENT IS REPORTEDLY IN STABLE CONDITION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9258448 ↗
• InjuryOct 11, 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 3.5 YEARS POST INITIAL PROCEDURE, AN ENDOLEAK OF INDETERMINATE ORIGIN WITH SAC GROWTH WAS REPORTED. AN INTERVENTION IS BEING DISCUSSED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: THE PHYSICIAN COMPLETED A SUCCESSFUL REINTERVENTION AND ELECTED TO RE-LINE THE EXISTING GRAFTS WITH A NON-ENDOLOGIX (GORE) DEVICE. NO VISIBLE ENDOLEAK WAS OBSERVED ON THE ANGIOGRAM. THE PATIENT WAS STABLE POST REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 9181371 ↗
• InjuryOct 11, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Migration; Patient-Device Incompatibility; Insufficient Device Problem Information; Migration

  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 TYPE 3A AND 3B ENDOLEAK WAS REPORTED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION.THIS EVENT WAS PREVIOUSLY REPORTED UNDER 2031527-2016-00049. NOW, APPROXIMATELY 3.5 YEARS POST RE-INTERVENTION, THE PATIENT PRESENTED EMERGENTLY WITH AN UNSPECIFIED DEVICE FAILURE. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER SUPRARENAL STENT GRAFT EXTENSION TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS STABLE. ADDITIONAL INFORMATION: AN ANGIOGRAM IDENTIFIED AN AORTIC RUPTURE AND PROXIMAL EXTENSION MIGRATION OF 22MM OCCURRED. THE FINAL PATIENT STATUS WAS DISCHARGED ON POST OPERATIVE DAY FOUR (4) TO A SKILLED NURSING FACILITY.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 9181342 ↗
• InjuryAug 29, 2019Insufficient 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 3.5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IA, II, OR III ENDOLEAK (AT INDETERMINATE ORIGIN); ENDOLOGIX SALES REPRESENTATIVE BECAME AWARE OF THE EVENT AT A CONFERENCE AND THEREFORE, THE EXACT DATE OF EVENT IS UNKNOWN. THE PHYSICIAN PLANS TO CONVERT THE PATIENT TO OPEN SURGICAL REPAIR BUT RE-INTERVENTION HAS NOT BEEN SCHEDULED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONALLY, CLINICAL ASSESSMENT DETERMINED THAT THE PATIENT UNDERWENT SURGICAL CONVERSION. THE FINAL PATIENT STATUS WAS REPORTED DISCHARGED ON POST OPERATIVE DAY 14 HOME STABLE WITH HOME HEALTH.

  Patient problems: Failure of Implant

  MAUDE report 8946823 ↗
• InjuryAug 5, 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 1.5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH ANEURYSM SAC EXPANSION (UNKNOWN DIAMETER) DURING ROUTINE FOLLOW-UP. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EXPLANTING THE DEVICES ABOUT A MONTH AGO; AS THE EXACT EXPLANT DATE IS UNKNOWN, THE BEST ESTIMATE WAS USED, WHICH IS THE (B)(6) 2019. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. NOTE; THIS PATIENT HAS A SECONDARY PROCEDURE FOR AN UNKNOWN REASON ON (B)(6) 2017. AN AFX BIFURCATED STENT GRAFT AND AFX, VELA SUPRARENAL STENT GRAFT EXTENSION WERE IMPLANTED. THIS EVENT WAS PREVIOUSLY REPORTED UNDER 20131527-2018-00255

  Patient problems: Aneurysm

  MAUDE report 8861783 ↗
• InjuryMay 28, 2019Material Puncture/Hole; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Material Integrity Problem; Migration; Material Puncture/Hole; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Material Integrity Problem; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION, AN INFRARENAL STENT GRAFT EXTENSION AND A LIMB STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 3B ENDOLEAK WITH SAC GROWTH WAS REPORTED. AN INTERVENTION IS BEING DISCUSSED. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: AN INTERVENTION WAS BEING DISCUSSED HOWEVER NO FURTHER INFORMATION WAS PROVIDED. DURING THE INVESTIGATION OF THIS EVENT, THE FOLLOWING ADDITIONAL EVENTS WERE IDENTIFIED: RIGHT HYPOGASTRIC ARTERY COILING AT THE INDEX PROCEDURE (OFF-LABEL), RIGHT LIMB STENT BUCKLING OCCURRED 1-MONTH POST INDEX PROCEDURE, FOLLOWED BY A SECONDARY ENDOVASCULAR PROCEDURE AT 2 MONTHS POST INDEX, MIGRATION OF THE SUPRARENAL STENT OF 19MM, MIGRATION OF THE INFRARENAL STENT OF 40MM AT THE REPORTED EVENT, TYPE 1A ENDOLEAK AT THE REPORTED EVENT, AND STENT BUCKLING OF THE BIFURCATED STENT GRAFT.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8648163 ↗
• InjuryMay 9, 2019Material Puncture/Hole; Patient-Device Incompatibility; Material Integrity Problem; Material Puncture/Hole; Patient-Device Incompatibility; Material Integrity Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, AN INFRARENAL STENT GRAFT EXTENSION, TWO (2) SUPRARENAL STENT GRAFT EXTENSIONS AND A LIMB GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH FLANK PAIN AND POSSIBLE GI BLEED. A TYPE 3B ENDOLEAK WAS IDENTIFIED. IT WAS REPORTED THAT THE PATIENT WAS COILED FOR A TYPE 2 ENDOLEAK (NON DEVICE RELATED) A WEEK PRIOR. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER BIFURCATED STENT GRAFT. THE INTERVENTION WAS SUCCESSFULLY AND THE PATIENT IS DOING WELL. IT WAS REPORTED THAT THE 3B ENDOLEAK WAS MOSTLY CAUSED FROM MANIPULATION DURING THE REPAIR AND THE RECENT COILING FOR THE TYPE 2 ENDOLEAK. MORE THEN 50 COILS WERE IMPLANTED. NOTE: THIS PATIENT HAD A PREVIOUSLY REPORTED EVENT UNDER 2031527-2015-00440 ON (B)(6) 2015 FOR A TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH AN INFRARENAL AORTIC EXTENSION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8595937 ↗
• InjuryOct 19, 2018Leak/Splash; Material Separation; Leak/Splash; Material Separation

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX DEVICE TO TREAT AN ANEURYSM. APPROXIMATELY 3 YEARS LATER THE PATIENT WAS PRESENTED WITH A POTENTIAL ENDOLEAK DUE TO SEPARATION OF THE ILIAC LIMB FROM THE AFX MAIN BODY. A REINTERVENTION IS PLANNED FOR A LATER DATE TO TREAT THE ENDOLEAK. AS OF THE DATE OF THIS REPORT THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7987270 ↗
• InjurySep 1, 2018Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX DEVICE TO TREAT AN ANEURYSM. ON (B)(6) 2018 THE PATIENT WAS PRESENTED WITH AN TYPE 3A AND 3B ENDOLEAK, AND AN AORTIC RUPTURE. THE PHYSICIAN ELECTED TO CONVERT THE PATIENT TO OPEN SURGICAL REPAIR AND THE STENT GRAFT WAS EXPLANTED AND A SURGICAL GRAFT WAS PLACED. THE ISSUE WAS RESOLVED AND AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT IS DOING WELL.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 7840467 ↗
• InjuryAug 24, 2018Leak/Splash; Leak/Splash

  PATIENT WAS INITIALLY IMPLANTED WITH A AFX BIFURCATED STENT AND TWO AFX VELA SUPRARENAL ON (B)(6) 2016. THE PRIMARY PROCEDURE WAS PERFORMED BY DR. (B)(6) AND DR. (B)(6) AT THE COMMUNITY HOSPITAL OF (B)(6) . ON (B)(6) 2018, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH UNKNOWN SYMPTOMS. A COMPUTERIZED TOMOGRAPHY WAS PERFORMED. DR. (B)(6) HAS NOT YET DECIDED ON TREATMENT. AT THE TIME OF THE REPORTED EVENT THE PATIENT WAS STABLE AND DOING WELL. NO ADDITIONAL EVENT OD PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 7814560 ↗
• InjuryAug 20, 2018Leak/Splash; Material Puncture/Hole; Material Integrity Problem; Leak/Splash; Material Puncture/Hole; Material Integrity Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT. APPROXIMATELY THREE (3) YEARS POST INITIAL IMPLANT ON A FOLLOW-UP CT SCAN THERE WAS A POSSIBLE TYPE IIIB ENDOLEAK OBSERVED. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THERE HAS BEEN NO ADDITIONAL PATIENT SEQUALAE REPORTED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 7799691 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT , VELA SUPRARENAL, AND LIMB STENT GRAFT ON (B)(6) 2015. DURING FOLLOW-UP ON (B)(6) 2017 AND PER ANGIOGRAPHY, IT WAS CONFIRMED THAT THE PATIENT DEVELOPED AN ILIAC ANEURYSM DISTAL TO THE PREVIOUSLY IMPLANTED LIMB STENT GRAFT. THE PATIENT WAS ASYMPTOMATIC DURING THIS FOLLOW-UP. THE SECONDARY CASE FOR THIS PATIENT WAS COMPLETED ON THE SAME DATE (B)(6) 2017 AND THE PATIENT WAS IMPLANTED WITH A NEW AFX LIMB STENT GRAFT. NO DEVICES WERE EXPLANTED DURING THIS SECONDARY PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7445887 ↗
• InjuryApr 19, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND VELA SUPRARENAL ON (B)(6) 2015. DURING FOLLOW-UP, BILATERAL TYPE 1B ENDOLEAKS WERE OBSERVED AND THE PATIENT WAS ASYMPTOMATIC. THE SECONDARY CASE FOR THIS PATIENT WAS COMPLETED ON (B)(6) 2016 AND THE PATIENT WAS IMPLANTED WITH AN AFX EXTENDER AND LIMB STENT GRAFT. NO DEVICES WERE EXPLANTED AND THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Failure of Implant

  MAUDE report 7445709 ↗
• InjuryMar 30, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED AND VELA INFRARENAL DEVICE IN 2015. RECENTLY IT WAS DISCOVERED THAT THE PATIENT HAD A INDETERMINATE ENDOLEAK AND SAC GROWTH. PATIENT IS REPORTED TO BE DOING FINE, THE PHYSICIAN PLANS TO EXPLANT THE DEVICE, PROCEDURE DATE HAS NOT BEEN SCHEDULED. THERE HAS BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AT THIS TIME.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7386752 ↗
• InjuryJan 19, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  THE PATIENT WAS INITIALLY IMPLANTED WITH A TWO SUPRARENAL AORTIC EXTENSIONS, AN INFRARENAL AORTIC EXTENSION, A BIFURCATED STENT, AND A LIMB STENT. THE INITIAL IMPLANT PROCEDURE INCLUDED THE PLACEMENT OF ONE OF THE SUPRARENAL AORTIC EXTENSIONS IN THE INFERIOR VENA CAVA (IVC). ON (B)(6) 2016 THE PATIENT HAD A TYPE 2 ENDOLEAK THAT WAS MONITORED BY THE PHYSICIAN WITH THE POSSIBILITY OF A COIL EMBOLIZATION PROCEDURE. A SECONDARY PROCEDURE WAS NOT REPORTED TO ENDOLOGIX. ON (B)(6) 2017 IT WAS REPORTED THE PATIENT HAD A TYPE 1B ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL LIMB EXTENSION IN THE RIGHT ILIAC ARTERY TO SEAL THE ENDOLEAK. DURING THE PROCEDURE THE WIRE MANIPULATION DURING THE DELIVERY OF THE LIMB EXTENSION CAUSED AN INTRAOPERATIVE UNKNOWN ENDOLEAK IN THE DISTAL AORTA BETWEEN THE LEFT ILIAC LIMB OF THE MAIN BODY AND THE INITIAL LEFT ILIAC LIMB EXTENSION. THE PHYSICIAN IMPLANTED AN ADDITIONAL BIFURCATED STENT, A NON-ENDOLOGIX PALMAZ STENT INSIDE THE NEWLY PLACED BIFURCATED STENT AND AN ADDITIONAL LIMB EXTENSION IN THE LEFT ILIAC ARTERY. AT THE COMPLETION OF THE SECONDARY PROCEDURE THERE WERE NO ENDOLEAKS OBSERVED. THE PATIENT IS REPORTED AS DOING WELL POST PROCEDURE. T

  Patient problems: Failure of Implant

  MAUDE report 7208607 ↗
• InjuryNov 21, 2017Leak/Splash; Leak/Splash

  AN AFX BIFURCATED AND A VELA SUPRARENAL EXTENSION WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT PRESENTED EMERGENTLY TO THE ER WITH BACK PAIN AND THEN CODED WITH A RUPTURED AAA. THE PHYSICIAN ELECTED TO EXPLANT THE AFX DEVICE, AND THE PATIENT WAS REPORTED TO HAVE EXPIRED FOLLOWING THE EXPLANT PROCEDURE. IT WAS NOTED THAT A CT WAS NOT PERFORMED PRIOR TO TAKING THE PATIENT INTO SURGERY.

  Patient problems: Death; Failure of Implant; Pain; Rupture

  MAUDE report 7051132 ↗
• InjuryOct 5, 2017Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash; Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash

  AT THE COMPLETION OF THE CLINICAL ASSESSMENT, THE REPORTED TYPE 1B ENDOLEAK WAS REFUTED. IT WAS CONFIRMED TO BE A TYPE 3A ILIAC ENDOLEAK WITH COMPLETE COMPONENT SEPARATION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6915318 ↗
• InjurySep 12, 2017Failure To Adhere Or Bond; Leak/Splash; Off-Label Use; Failure To Adhere Or Bond; Leak/Splash; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED DEVICE UNDER OFF LABEL CONDITION ON (B)(6) 2017. APPROXIMATELY 3 MONTHS LATER, THE PATIENT WAS BROUGHT IN AND A VELA INFRARENAL, AN OVATION EXTENDER, A COOK THORACIC STENT, AND TWO RENAL SNORKELS WERE PLACED. AT THE END OF THE PROCEDURE, A LEAK WAS STILL PRESENT. THE PATIENT WAS BROUGHT BACK IN ON (B)(6) 2017 AND AN AORTIC CUFF WAS PLACED BETWEEN THE AFX BIFURCATED STENT AND THE COOK THORACIC STENT. PATIENT IS REPORTED AS BEING STABLE AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6860683 ↗
• InjuryAug 24, 2017Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  AN AFX BIFURCATED AND SUPRARENAL CUFF WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 2 YEARS POST-OP, THE PATIENT PRESENTED WITH A POTENTIAL TYPE IIIB ENDOLEAK AND RUPTURE OF THE AORTA. A RE-INTERVENTION WAS PERFORMED TO SUCCESSFULLY RE-LINE THE AFX DEVICE WITH AN ENDURANT STENT GRAFT. THERE WAS NO EVIDENCE OF ENDOLEAKS FOLLOWING THE RE-INTERVENTION AND THE PATIENT WAS REPORTED AS WELL. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant; Rupture

  MAUDE report 6819107 ↗
• InjuryOct 7, 2016Failure To Adhere Or Bond; Hole In Material; Leak/Splash; Migration or Expulsion of Device; Failure To Adhere Or Bond; Hole In Material; Leak/Splash; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2015 WITH A BIFURCATED STENT, AND SUPRARENAL AORTIC EXTENSION. SUBSEQUENTLY, ON (B)(6) 2016 PHYSICIAN IDENTIFIED A POTENTIAL TYPE 3B WITH ANEURYSM SAC GROWTH. PATIENT WAS ASYMPTOMATIC. ON (B)(6) 2016 THE PHYSICIAN ELECTED TO RELINE THE DEVICES BY IMPLANTING AN ADDITIONAL BIFURCATED STENT, AN INFRARENAL AORTIC EXTENSION, AND A LIMB STENT GRAFT. PATIENT IS IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 6010146 ↗

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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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-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-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL

…and 1 more.