AFX Endovascular AAA System BA28-100/I20-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00818009014207), received between Apr 14, 2016 and Aug 18, 2025 — classified as 3 deaths, 39 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (21 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 43 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR A RIGHT ILIAC ANEURYSM ON (B)(6) 2015 WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX LIMB STENT GRAFT. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO THE ABSENCE OF AN ABDOMINAL AORTIC ANEURYSM. ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2025 IDENTIFIED THAT ALTHOUGH THE ILIAC IS STABLE, THE AORTA HAS GROWN ENOUGH TO THE POINT THAT THERE IS A SLIGHT FILLING AROUND THE INITIAL MAIN BODY CREATING A ABDOMINAL AORTIC ANEURYSM BUT NOT INTO THE RIGHT ILIAC ARTERY. REINTERVENTION WAS COMPLETED ON (B)(6) 2025. IT WAS LATER REPORTED THAT THE "SLIGHT FILLING" WAS COMING FROM A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN AFX VELA SUPRARENAL AND AN OVATION IX EXTENDER TO RESOLVE THE LEAK. THE FINAL PATIENT STATUS WAS REPORTED TO BE DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22829640 ↗
• InjuryJan 7, 2025Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2017 WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT, AFX VELA SUPRARENAL, AND AFX VELA INFRARENAL. SECONDARY REINTERVENTION TREATED A TYPE II ENDOLEAK THAT WAS CAUSING ANEURYSM ENLARGEMENT BY COILING THE SAC ON (B)(6) 2021. REPORTEDLY A TYPE II ENDOLEAK HAS BEEN MONITORED SINCE 2022. ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2024 IDENTIFIED A TYPE IIIB ENDOLEAK. REINTERVENTION PLANS ARE TO TREAT THE TYPE IIIB ENDOLEAK WITH A NON-ENDOLOGIX DEVICE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 21091341 ↗
• InjuryDec 21, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY EIGHT (8) YEARS AFTER THE INITIAL PROCEDURE, A REVIEW OF THE PATIENT'S COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A POTENTIAL TYPE 3B OR TYPE 1B ENDOLEAK. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Clinical Endoleak

  MAUDE report 18380363 ↗
• InjuryJun 8, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, ANEURYSM ENLARGEMENT FROM 6.1CM TO 7.5CM SINCE IMPLANTATION AND A POSSIBLE TYPE 3B ENDOLEAK WERE IDENTIFIED AT ROUTINE FOLLOW-UP. REINTERVENTION HAS NOT YET BEEN SCHEDULED; HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN PLANS TO TREAT THE TYPE 3B ENDOLEAK WITH A GORE (NON-ENDOLOGIX) DEVICE. THE PATIENT IS REPORTED TO BE GOOD.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14634424 ↗
• InjuryOct 20, 2021Collapse; Material Puncture/Hole; Insufficient Device Problem Information; Collapse; Material Puncture/Hole; Insufficient Device Problem Information

  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) YEARS AND FIVE (5) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH RIGHT FLANK PAIN. ANEURYSM ENLARGEMENT AND A POSSIBLE TYPE IIIA ENDOLEAK WERE IDENTIFIED. PATIENT IS CURRENTLY IN THE HOSPITAL FOR A GASTROINTESTINAL (GI) BLEED. AFTER THE GI BLEED HAS BEEN FIXED A REINTERVENTION WILL BE PERFORMED TO RE-LINE ANEURYSM ENLARGEMENT AND A POSSIBLE TYPE IIIA ENDOLEAK. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS PROVIDED REPORTING THAT THE PATIENT UNDERWENT COILING TO TREAT THE TYPE II ENDOLEAK. ADDITIONALLY, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST BUCKLING OF THE DISTAL BIFURCATED STENT GRAFT OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE BUCKLING WAS DISCOVERED DURING REVIEW OF THE 78 MONTH POST-IMPLANT CT SCAN.

  Patient problems: Aneurysm; Failure of Implant; Pain

  MAUDE report 12668840 ↗
• DeathMay 11, 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). FOLLOWING THE INITIAL IMPLANT THE PATIENT HAD A TYPE 2 ENDOLEAK, A SECONDARY ENDOVASCULAR PROCEDURE WAS NOT COMPLETED, AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE A FOLLOW UP SHOWED ANEURYSM SAC GROWTH AND A POTENTIAL TYPE 1B ENDOLEAK. THE PHYSICIAN ELECTED TO EXTEND THE RIGHT ILIAC ARTERY AND IMPLANTED AN INFRARENAL AORTIC EXTENSION INTO THE RIGHT COMMON ILIAC TO SEAL THE ENDOLEAK. THE PATIENT IS STABLE. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 2031527-2016-00536. ENDOLOGIX THEN BECAME AWARE OF AN INCREASED ABDOMINAL AORTIC ANEURYSM SAC AND SUSPICIOUS ENDOLEAK BASED ON THE DIAGNOSING COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) SCAN. THE PATIENT WAS ASYMPTOMATIC. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 2031527-2018-00548. NOW, APPROXIMATELY FOUR AND HALF (4.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A RUPTURED ANEURYSM DUE TO AN INDETERMINATE ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER BIFURCATED STENT GRAFT AND TWO (2) OVATION ILIAC EXTENDERS TO RESOLVE T

  Patient problems: Failure of Implant

  MAUDE report 11809275 ↗
• InjuryJan 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT AND A LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, AN ENDOLEAK OF INDETERMINATE ORIGIN AND A STENT FRACTURE WERE DETECTED DURING A ROUTINE FOLLOW-UP. REPORTEDLY, THE ANEURYSM AND RIGHT COMMON ILIAC ARTERY (RCIA) HAD SHRUNK IN DIAMETER SINCE THE INITIAL IMPLANT PROCEDURE AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THIS EVENT WAS REPORTED UNDER MDR# 2031527-2019-00309. NOW, APPROXIMATELY ONE (1) YEAR POST MONITORING, A 3A ENDOLEAK AND A 1B ENDOLEAK WERE IDENTIFIED AND THE PATIENT IS PENDING RE-INTERVENTION. ADDITIONAL INFORMATION: DURING THE INVESTIGATION IT WAS DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST THAT ON POST-OPERATIVE DAY ONE ((B)(6) 2021) OF THE RE-INTERVENTION THE PATIENT DEVELOPED RIGHT LOWER LEG ISCHEMIA AND OCCLUSION. THE POST-OPERATIVE RIGHT LOWER LEG ISCHEMIA AND OCCLUSION ARE LOCATED OUTSIDE THE STENT (NON-DEVICE-RELATED). CORRECTION: INITIAL REPORT MDR# 2031527-2019-00309 WHICH WAS INITIALLY REPORTED AS AN ENDOLEAK OF INDETERMINATE ORIGIN AND A STENT FRACTURE WAS IDENTIFIED AS A TYPE 3A

  Patient problems: Failure of Implant

  MAUDE report 11156398 ↗
• InjurySep 15, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; 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 FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 1A ENDOLEAK WAS DISCOVERED DURING A ROUTINE FOLLOW UP. THIS EVENT WAS RESOLVED BY IMPLANTING A SUPRARENAL STENT GRAFT EXTENSION AND AN INFRARENAL STENT GRAFT EXTENSION THIS EVENT WAS PREVIOUSLY REPORTED UNDER 2031527-2019-00254. ALSO APPROXIMATELY THREE (3) MONTHS POST RE- INTERVENTION, A TYPE 2 ENDOLEAK WAS DISCOVERED DURING A ROUTINE FOLLOW UP. A TYPE 2 ENDOLEAK IS NOT A DEVICE-RELATED FAILURE THEREFORE NO FURTHER DETAILS WERE PROVIDED. NOW, APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, A TYPE 1 (INDETERMINATE ORIGIN) WAS REPORTED. THE PATIENT IS CURRENTLY STABLE AND INTERVENTION HAS BEE SCHEDULED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10535450 ↗
• InjuryJul 8, 2019Fracture; Patient-Device Incompatibility; Fracture; Patient-Device Incompatibility

  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, AN ENDOLEAK AT AN INDETERMINATE ORIGIN AND A STENT FRACTURE WERE DETECTED DURING ROUTINE FOLLOW-UP. THE PATIENT'S AAA AND RIGHT COMMON ILIAC ARTERY (RCIA) HAVE SHRUNK IN DIAMETER SINCE THE INITIAL IMPLANT PROCEDURE, AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT REFUTED THE TYPE 1A, 1B, IIIB ENDOLEAK, AND STENT FRACTURE COMPLAINT. HOWEVER, EVIDENCE OF TYPE IIIA ENDOLEAK AND LOSS OF OVERLAP AT THE MID AORTA WAS IDENTIFIED, WITH DETERMINATION THAT THIS WAS ANATOMY RELATED (AORTA REMODELING). ADDITIONALLY, THERE WAS EVIDENCE TO REASONABLY SUGGEST RIGHT COMMON ILIAC ARTERY OCCLUSION AORTIC OCCURRED THREE DAYS POST THE INITIAL IMPLANT.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 8769087 ↗
• InjuryJun 17, 2019Misconnection; Material Puncture/Hole; Material Integrity Problem; Misconnection; Material Puncture/Hole; Material Integrity Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A TYPE IIIA ENDOLEAK WITH COMPONENT SEPARATION BETWEEN THE BIFURCATED AND LIMB DEVICES WERE DETECTED BY CT (COMPUTED TOMOGRAPHY) DURING ROUTINE FOLLOW-UP. THE PHYSICIAN PLANS TO RE-INTERVENE AND THE PATIENT IS REPORTEDLY STABLE. ADDITIONAL INFORMATION RECEIVED REPORTING THAT A TYPE IIIB AND IB ENDOLEAKS WERE ALSO PRESENT AT THE TIME OF THE REPORTED EVENT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL AFX LIMB STENT GRAFT AND ONE (1) OVATION IX ILIAC LIMB DEVICE ON (B)(6) 2019. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL AND THE TYPE IB ENDOLEAK WAS CONFIRMED RESOLVED. DUE TO THE NO SURGICAL BACK-UP, THE PHYSICIAN ELECTED TO TREAT THE TYPE IIIB ENDOLEAK ON A LATER DATE, BUT THIS ADDITIONAL RE-INTERVENTION HAS NOT BEEN SCHEDULED. SUBSEQUENT TO THE SECONDARY INTERVENTION PERFORMED ON (B)(6) 2019, TREATMENT OF THE TYPE IIIB ENDOLEAK WAS COMPLETED ON (B)(6) 2019. AN AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED AND THE PATIENT WAS RELEASED HOME ONE DAY POST PROCEDURE. NO ADDITIONAL PATIEN

  Patient problems: Failure of Implant

  MAUDE report 8705743 ↗
• InjuryMay 24, 2019Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN CONFIRMING THAT A TYPE IA ENDOLEAK WAS PRESENT, NOT A TYPE IIIA ENDOLEAK AS ORIGINALLY REPORTED. CLINICAL ASSESSMENT ALSO IDENTIFIED THE PRESENCE OF ANEURYSM ENLARGEMENT (TO 12MM) AND STENT MIGRATION (BY 12.7MM) OF THE PROXIMAL EXTENSION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8642100 ↗
• InjuryMay 8, 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 2.5 YEARS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH PAIN. A RUPTURE WAS IDENTIFIED AND THE DEVICES WERE EXPLANTED. THE PATIENT WAS REPORTED TO BE DOING WELL POST EXPLANT. THE EXACT DATE OF EVENT AND EXPLANT WERE NOT PROVIDED BUT WERE REPORTED TO HAVE OCCURRED IN (B)(6) 2019.

  Patient problems: Pain; Rupture

  MAUDE report 8593334 ↗
• InjuryApr 2, 2019Material Puncture/Hole; Product Quality Problem; Use of Device Problem; Material Integrity Problem; Material Puncture/Hole; Product Quality Problem; Use of Device Problem; Material Integrity Problem

  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 TYPE IIIB ENDOLEAK (HOLE IN GRAFT) WAS DETECTED DURING ROUTINE FOLLOW-UP. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH A GORE (NON-ENDOLOGIX) GRAFT ON (B)(6) 2019. THE PATIENT WAS REPORTEDLY IN GOOD CONDITION PRE- AND POST-SECONDARY PROCEDURE. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8474044 ↗
• InjuryJan 19, 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. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ABDOMINAL PAIN AND SHORTNESS OF BREATH, AND A RETROPERITONEAL BLEED. A RUPTURE OF THE ILIAC ANEURYSM WAS IDENTIFIED (INDETERMINATE ENDOLEAK). THE PHYSICIAN ELECTED TO EMBOLIZING THE RIGHT HYPOGASTRIC ARTERY AND IMPLANT ANOTHER BIFURCATED STENT GRAFT (AFX2), A LIMB STENT GRAFT EXTENSION (AFX) AND A ILIAC LIMB GRAFT EXTENSION (OVATION IX) TO RESOLVE THIS REPORTED EVENT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 8263083 ↗
• InjuryDec 27, 2018Leak/Splash; Material Puncture/Hole; Use of Device Problem; Material Integrity Problem; Leak/Splash; Material Puncture/Hole; Use of Device Problem; Material Integrity Problem

  ADDITIONAL INFORMATION: AT THE COMPLETION OF THE CLINICAL ASSESSMENT, CLINICAL IDENTIFIED THAT BOTH THE 1A ENDOLEAK AND THE 3B ENDOLEAK WERE FROM THE BIFURCATED STENT GRAFT AND NOT THE INFRARENAL AORTIC EXTENSION AS PREVIOUSLY REPORTED UNDER 2031527-2018-00967. THE INVESTIGATION SUMMARY FOR THIS EVENT WILL BE RECORDED AND DOCUMENTED UNDER THIS REPORT. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) A SUPRARENAL STENT GRAFT EXTENSION TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING FINE POST INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 8201488 ↗
• InjuryNov 27, 2018Leak/Splash; Material Puncture/Hole; Product Quality Problem; Material Integrity Problem; Leak/Splash; Material Puncture/Hole; Product Quality Problem; Material Integrity Problem

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH SEVERE ABDOMINAL PAIN AND A TYPE 3B ENDOLEAK WITH ANEURYSM EXPANSION WERE DETECTED BY CT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING NON-ENDOLOGIX DEVICES ON (B)(6) 2018. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Abdominal Pain; Aneurysm; Failure of Implant; Pain

  MAUDE report 8107419 ↗
• InjuryJun 28, 2018Leak/Splash; Material Puncture/Hole; Deformation Due to Compressive Stress; Material Integrity Problem; Leak/Splash; Material Puncture/Hole; Deformation Due to Compressive Stress; Material Integrity Problem

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH A BIFURCATED AND A SUPRARENAL EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF UNKNOWN ENDOLEAK (POSSIBLE 3A OR/AND 3B). ON (B)(6) 2018, THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH OVATION MAIN BODY, EXTENDER AND TWO (2) LIMBS STENT GRAFTS. DURING THE SECONDARY PROCEDURE, THE PHYSICIAN MENTIONED THAT THE PATIENT HAD A PERIPHERAL INTERVENTION AT SOME POINT WITH STENTS PLACED IN THE RIGHT ILIAC ARTERY. HE NOTED THE MAIN BODY WAS CONSIDERABLY FORESHORTENED, AND FELT THAT DURING THE PERIPHERAL INTERVENTION, THAT "SOMETHING" HAD HAPPENED TO THE GRAFT". POSSIBLY WIRE ENTRAPMENT WITH AGGRESSIVE REMOVAL COULD HAVE POSSIBLY CAUSED THE FORESHORTENING. THE PATIENT WAS REPORTED IN GOOD CONDITION POST SECONDARY PROCEDURE. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7646820 ↗
• InjuryJun 18, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  ENDOLOGIX BECAME AWARE OF AN INCREASED ABDOMINAL AORTIC ANEURYSM SAC AND SUSPICIOUS ENDOLEAK ON (B)(6) 2018 AS REPORTED BY (B)(6). THE DATE OF EVENT IS (B)(6) 2018 BASED ON THE DIAGNOSING CTA SCAN. THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL ON (B)(6) 2015 BY PHYSICIAN (B)(6) AT (B)(6) CENTER. THE PATIENT IS ASYMPTOMATIC. IT IS ALSO UNKNOWN IF RE-INTERVENTION IS PLANNED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7609361 ↗
• InjuryJun 4, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  ENDOLOGIX BECAME AWARE OF A RIGHT INTERNAL ANEURYSM THAT GREW TO 5CM ON (B)(6) 2018 AS REPORTED BY PHYSICIAN (B)(6) AT (B)(6) MEDICAL CENTER. THE REPORTED ANEURYSM SAC GROWTH WAS DISCOVERED BY ANGIOGRAM ON (B)(6) 2018. THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT ON (B)(6) 2015 BY THE REPORTING PHYSICIAN. DURING RE-INTERVENTION, THE PATIENT WAS TREATED BY IMPLANTING AN AFX ILIAC LIMB AND EXTENDER ON (B)(6) 2018 BY PHYSICIAN (B)(6). THE PATIENT WAS ASYMPTOMATIC PRIOR TO RE-INTERVENTION. POST-SECONDARY PROCEDURE THE PATIENT IS IN STABLE CONDITION AND IS PLANNED TO BE RELEASED ON (B)(6) 2018. NO ENDOLEAK WAS NOTED PRIOR AND POST SECONDARY PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7566000 ↗
• InjuryMay 27, 2018Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash; Unintended Movement; Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash; Unintended Movement

  PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT, ONE LIMB STENT, AND A VELA SUPRARENAL STENT. SECONDARY PROCEDURE WAS PERFORMED ON (B)(6) 2018, SUCCESSFULLY TREATING AN ENDOLEAK 1B IN THE LEFT COMMON ILIAC ARTERY (LCIA). THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2018, WITH POST-SURGICAL PAIN AT THE LEFT ACCESS SITE. COMPUTERIZED TOMOGRAPHY PERFORMED ON THE SAME DAY REVEALED AN ENDOLEAK 3A OF THE RIGHT COMMON ILIAC ARTERY (RCIA), COMPLETE COMPONENT SEPARATION OF THE AFX BIFURCATED STENT AND LIMB STENT, AS WELL AS SAC GROWTH. AT THIS TIME, NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm; Failure of Implant; Pain

  MAUDE report 7547278 ↗
• InjuryMay 22, 2018Fracture; Fracture

  AT THE COMPLETION OF THE CLINICAL ASSESSMENT ON 04/23/2018 FOR A PERVIOUS REPORT EVENT, CLINICAL WAS ABLE TO FIND SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING ADDITIONAL FINDING OF STRUT FRACTURE OF THE BIFURCATED STENT GRAFT (MAIN BODY). PREVIOUS REPORTED EVENT DETAIL- (2031527-2018-00139). ON (B)(6) 2015, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT, TWO (2) SUPRARENAL EXTENSION AND THREE (3) LIMB EXTENSIONS. ON (B)(4) 2018, ENDOLOGIX WAS MADE AWARE OF A TYPE 3A ENDOLEAK WITH LIMB SEPARATION. ON (B)(6) 2018, THE PHYSICIAN ELECTED TO IMPLANT THREE (3) 22X45 OVATION EXTENSION TO SUCCESSFULLY BRIDGE THE SEPARATION. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7535730 ↗
• InjuryMay 18, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH A BIFURCATED, A SUPRARENAL EXTENSION, AND A LIMB STENT GRAFT. ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH ADDITIONAL BIFURCATED STENT TO TREAT A REPORTED 3B ENDOLEAK. ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH ADDITIONAL SUPRARENAL EXTENSION TO TREAT A REPORTED 1A ENDOLEAK. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF ENDOLEAK (INDETERMINATE ORIGIN). THE PHYSICIAN PLANS TO COMPLETE AN ANGIOGRAM TO CONFIRM THE ENDOLEAK AND DETERMINE TREATMENT OPTIONS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7527925 ↗
• InjuryApr 27, 2018Failure To Adhere Or Bond; Hole In Material; Leak/Splash; Malposition of Device; Failure To Adhere Or Bond; Hole In Material; Leak/Splash; Malposition of Device

  PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED, ONE VELA SUPRARENAL, AND TWO VELA INFRARENAL. ENDOLOGIX BECAME AWARE OF A CASE FROM A TWEET BY THE PHYSICIAN THAT PERFORMED THE SECONDARY CASE. IT WAS REPORTED THAT THE PHYSICIAN NOTED THAT IT WAS NOT A FAULTY GRAFTS, BUT THE IMPLANTING PHYSICIAN MISPLACED THE DEVICE BY NOT COVERING MORE OF THE RIGHT COMMON ILIAC. THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. PATIENT REPORTED TO BE DOING WELL POST PROCEDURE AND IS SCHEDULED FOR A ONE MONTH FOLLOW UP.

  Patient problems: Aneurysm; Failure of Implant; Pain

  MAUDE report 7468265 ↗
• InjuryApr 19, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND VELA SUPRARENAL ON (B)(6) 2015. AT A LATER UNKNOWN DATE, THE AFX CUFF POSSIBLY SLIPPED OR AN AORTA LENGTHENED AND THE PHYSICIAN RELINED THE AFX WITH AN OVATION ON (B)(6) 2017.

  Patient problems: Not Applicable

  MAUDE report 7445922 ↗
• InjuryMar 26, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL EXTENSION. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A TYPE 3A ENDOLEAK, A LEAK BETWEEN THE SUPRARENAL EXTENSION AND THE BIFURCATED STENT. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM ON (B)(6) 2018 FOR A RUPTURED ANEURYSM. THE PATIENT WAS RELINED WITH A NON- ENDOLOGIX STENT AND THE REPAIR WENT WELL. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 7370467 ↗

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-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-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-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL

…and 1 more.