AFX Endovascular AAA System BA28-90/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00818009010247), received between May 12, 2016 and Jan 9, 2024 — classified as 1 death, 30 injuries.

The most frequently reported specific device problem is “Leak/Splash” (9 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2024Lack of Effect; Lack of Effect

  THE PATIENT UNDERWENT THE IMPLANTATION OF AN AFX BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL TO ADDRESS AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST THE INITIAL PROCEDURE, A TYPE 2 ENDOLEAK (NON-DEVICE-RELATED FAILURE) AND A POSSIBLE TYPE 3B ENDOLEAK OF THE BIFURCATED STENT GRAFT WERE IDENTIFIED THROUGH A CONTRAST COMPUTED TOMOGRAPHY (CT) SCAN, SHOWING SAC GROWTH. THE PATIENT HAD AN ADDITIONAL ENDOVASCULAR PROCEDURE (COILING OF A LUMBAR), WHICH OCCURRED SOMETIME BETWEEN (B)(6) 2021, AND (B)(6) 2021. THE FINAL PATIENT STATUS WAS REPORTED AS STABLE (MANUFACTURER REPORT #2031527-2021-00175). APPROXIMATELY EIGHT (8) YEARS POST THE INITIAL PROCEDURE, THE PATIENT DEVELOPED AN ENDOLEAK OF INDETERMINATE ORIGIN. THE PATIENT IS SCHEDULED TO UNDERGO AN ADDITIONAL RE-INTERVENTION TO ADDRESS THE ENDOLEAK. IT HAS BEEN REPORTED THAT THE PATIENT WILL BE TREATED BY A DIFFERENT PHYSICIAN FROM THE ORIGINAL IMPLANTER AND WILL BE REPAIRED USING A COOK MEDICAL (NON-ENDOLOGIX) GRAFT.

  Patient problems: Clinical Endoleak

  MAUDE report 18475040 ↗
• InjuryJun 9, 2023Separation Problem; Separation Problem

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN AFX LIMB STENT GRAFT ON (B)(6) 2015. ON (B)(6) 2023, AN ENDOLEAK BETWEEN THE LIMB EXTENSION AND THE MAIN BODY LIMB WAS IDENTIFIED AT THE ROUTINE FOLLOW-UP. AS THE PATIENT WAS SYMPTOMATIC WITH A TYPE IIIA ENDOLEAK WITH COMPONENT SEPARATION AND THE ANEURYSM MEASURED 9.7CM, EMERGENCY REINTERVENTION WAS PERFORMED ON (B)(6) 2023, WITH THE IMPLANT OF TWO AFX VELA SUPRARENAL AND TWO AFX VELA INFRARENAL. REPORTEDLY DURING THE PROCEDURE, AN ATTEMPT TO DEPLOY AN AFX2 BIFURCATED STENT GRAFT WAS MADE; HOWEVER, THE PHYSICIAN WAS NOT TO SNARE THE DEVICE; THEREFORE, IT WAS NOT DEPLOYED. THE POST-ANGIOGRAM CONFIRMED THERE WAS NO LONGER AN ENDOLEAK. THE PATIENT DID WELL, AND WAS STABLE AND EXPECTED TO STAY IN THE HOSPITAL OVERNIGHT.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17099294 ↗
• InjuryMar 22, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY EIGHT (8) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH AN ENLARGED AAA AND AORTIC NECK, AND A TYPE IIIB ENDOLEAK AS DETECTED PER CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN PLANS TO RE-INTERVENE, BUT SURGERY HAS NOT BEEN SCHEDULED. PATIENT IS REPORTEDLY IN GOOD CONDITION.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16592242 ↗
• InjuryFeb 7, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN EXPANDING ANEURYSM SAC (UNKNOWN DIAMETER), THROMBUS IN BOTH ILIACS, AND A TYPE IIIB ENDOLEAK (AT THE BIFURCATION) AS DETECTED PER ANGIOGRAM. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) AFX2 BIFURCATED STENT GRAFT AND ONE (1) ADDITIONAL VELA SUPRARENAL ON (B)(6) 2023. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PATIENT REPORTEDLY STABLE POST RE-INTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak; Thrombosis/Thrombus

  MAUDE report 16311709 ↗
• InjuryDec 15, 2022Appropriate Device Problem Term/Code Not Available; Lack of Effect; Appropriate Device Problem Term/Code Not Available; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT. APPROXIMATELY SEVEN AND A HALF (7.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A MEDTRONIC (NON-ENDOLOGIX) 30MM PROXIMAL CUFF ON (B)(6) 2022. DURING THIS SECONDARY PROCEDURE, THE ILIAC ARTERY RUPTURED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED THREE (3) OVATION IX ILIAC LIMBS.

  Patient problems: Clinical Endoleak; Failure of Implant; Perforation of Vessels

  MAUDE report 15988760 ↗
• InjuryJun 13, 2022Separation Problem; Separation 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 PROXIMAL EXTENSION. APPROXIMATELY SIX AND A HALF (6.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE SURVEILLANCE WITH AN EXPANDING AAA SAC (UNKNOWN DIAMETER) AND A TYPE IIIA ENDOLEAK (WITH COMPONENT SEPARATION). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM AND A PALMAZ (NON-ENDOLOGIX) STENT ON (B)(6) 2022. HOWEVER, THE ENDOLEAK REMAINED UNRESOLVED. THIS SECONDARY PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM PER DEVICE IFU. THE PATIENT IS REPORTEDLY IN STABLE CONDITION, AND THE PHYSICIAN PLANS TO TREAT PATIENT FURTHER BUT ADDITIONAL SURGERY HAS NOT BEEN SCHEDULED. AFTER THE INITIAL REPORT, THE CLINICAL EVALUATION ALSO SHOWS REASONABLE EVIDENCE TO SUGGEST THAT THE REPORTED UNRESOLVED ENDOLEAK WAS DETERMINED TO BE AN INTRAOPERATIVE TYPE IA ENDOLEAK

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14681909 ↗
• InjuryOct 8, 2021Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND TWO (2) AFX VELA SUPRARENAL. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY AND UN-STABLE WITH EXPANDING AAA AND RUPTURE. COMPUTERIZED TOMOGRAPHY AND ANGIOGRAM IDENTIFIED A JUNCTIONAL TYPE 3A ENDOLEAK AND POSSIBLE TYPE 1A ENDOLEAK. REINTERVENTION WAS PERFORMED WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL AND AN OVATION IX ILIAC LIMB. THE RE-LINE WAS SUCCESSFUL. REPORTEDLY, THE PATIENT LEFT THE OPERATING ROOM STABLE AND BEING MONITORED OVERNIGHT.

  Patient problems: Aneurysm; Failure of Implant; Rupture

  MAUDE report 12600402 ↗
• InjuryAug 6, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND TWO (2) INFRARENAL AORTIC EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING ROUTINE FOLLOW-UP THERE WAS AN OBSERVED INCREASE OF THE ANEURYSM SAC (12.1MM TO 16.9MM) IN THE COMMON ILIAC ARTERY AND A TYPE 3A ENDOLEAK WAS SUSPECTED. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT REFUTING THE REPORTED 3A ENDOLEAK, AND RATHER CONFIRMING A 3B ENDOLEAK WAS PRESENT.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12288853 ↗
• InjuryAug 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL AORTIC EXTENSION AND AN ILIAC LIMB TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE ANEURYSM SAC GROWTH OF GREATER THAN 5MM WAS IDENTIFIED. THE PATIENT STATUS WAS NOT REPORTED. ADDITIONAL INFORMATION: DURING THE CLINICAL ASSESSMENT, IT WAS DETERMINED THAT THE REPORTED DANCE GROWTH WAS COMING FROM A TYPE II ENDOLEAK (NON- DEVICE RELATED) FROM THE LUMBAR ARTERY THEREFORE A COMPLAINT IS NOT WARRANTED SINCE THERE IS NO ALLEGED DEFICIENCY RELATED TO IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE.

  Patient problems: Aneurysm

  MAUDE report 12264438 ↗
• DeathApr 2, 2021Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX VELA SUPRARENAL, AFX LIMB STENT GRAFT, AND AN AFX BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM (AAA) RUPTURE LEADING TO THE PATIENT PASSING AWAY. THE PHYSICIAN REPORTED THAT THERE WAS A MIGRATION OF THE PROXIMAL EXTENSION. THE PATIENT EXPIRED BEFORE INTERVENTION COULD BE PERFORMED. THIS EVENT WAS REPORTED TO ENDOLOGIX BY A FORMER EMPLOYEE. THIS EVENT OCCURRED APPROXIMATELY 1.5 MONTHS AGO THEREFORE THE EVENT DATE OF (B)(6) 2021 IS BEING USED.

  Patient problems: Rupture

  MAUDE report 11608592 ↗
• InjuryMar 30, 2021Insufficient 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 FIVE (5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A DOPPLER ULTRASOUND SHOWED A TYPE 3A ENDOLEAK. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT AN INFRARENAL AND A SUPRARENAL AORTIC EXTENSIONS TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING FINE POST SECONDARY PROCEDURE. ADDITIONAL INFORMATION: THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST BUCKLING OF THE SUPRARENAL PROXIMAL EXTENSION OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE BUCKLING WAS DISCOVERED DURING A REVIEW OF THE 61 MONTH POST ANGIOGRAM.

  Patient problems: Failure of Implant

  MAUDE report 11590162 ↗
• InjuryJan 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW UP EXAM, AN ENDOLEAK OF INDETERMINATE ORIGIN (POSSIBLY A TYPE II OR TYPE III) WAS IDENTIFIED. THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 11165377 ↗
• InjuryMay 1, 2020Use 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 IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, A VELA SUPRARENAL STENT GRAFT, A LIMB STENT GRAFT EXTENSION AND A VIABAHN STENT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF- LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES (VIABAHN STENT) NOT COMPATIBLE WITH THE AFX SYSTEM PER THE IFU. APPROXIMATELY 4.5 YEARS POST INITIAL IMPLANT, A COMPUTED TOMOGRAPHY (CT) IDENTIFIED A FRACTURE AT THE DISTAL PORTION OF THE BIFURCATED STENT WITH SAC GROWTH (POSSIBLE ENDOLEAK). THE PHYSICIAN PERFORMED A RE-INTERVENTION AND ELECTED TO RE-LINE THE ORIGINAL IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA INFRARENAL STENT GRAFT AND A LIMB STENT GRAFT EXTENSION TO RESOLVE THIS EVENT. THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10018424 ↗
• InjuryApr 13, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Separation Problem; Patient-Device Incompatibility; Insufficient Device Problem Information; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WAS IDENTIFIED. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL, AND A VELA INFRARENAL STENT GRAFT EXTENSION TO RESOLVE THIS EVENT. THE PATIENT DID WELL. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THERE WAS EVIDENCE TO REASONABLY SUGGEST SAC GROWTH OF 20MM OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. ADDITIONALLY, THE TYPE 3A ENDOLEAK INCLUDED COMPLETE COMPONENT SEPARATION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9955714 ↗
• InjuryFeb 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 5 YEARS POST INITIAL PROCEDURE PATIENT PRESENTED WITH LEG PAIN AND THE PHYSICIAN IDENTIFIED COMPONENT SEPARATION OF THE GRAFTS. PHYSICIAN ELECTED TO TREAT THE PATIENT WITH NON-ENDOLOGIX (GORE) DEVICE AND THE PATIENT IS DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 9759410 ↗
• InjuryDec 22, 2019Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4 YEARS POST INITIAL PROCEDURE, A CTA IDENTIFIED A 3B ENDOLEAK (MIDGRAFT). THE PHYSICIAN ELECTED TO TREAT WITH A VELA, A NON-ENDOLOGIX (PALMAZ STENT) AND (GORE 36 CUFF). FINAL ANGIOGRAM DEMONSTRATED THAT THE TYPE 3B LEAK IS SEALED. ADDITIONAL INFORMATION: DURING THE INVESTIGATION, A TYPE IA ENDOLEAK, BUCKLING OF THE PROXIMAL EXTENSION, SAC GROWTH OF 7.2 MM AND A TYPE II ENDOLEAK OF THE LUMBAR WERE IDENTIFIED. CORRECTION TO THE INITIAL REPORT: THE PHYSICIAN ELECTED TO TREAT WITH AN AFX VELA INFRARENAL STENT GRAFT AND TWO (2) NON-ENDOLOGIX STENTS (PALMAZ AND GORE) TO RESOLVE THIS EVENT. THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9508917 ↗
• InjuryAug 24, 2019Use of Device Problem; Use of Device Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT AND MEDTRONIC ENDURANT (OUTSIDE INDICATIONS OF USE WITH NON-ENDOLOGIX DEVICE). APPROXIMATELY 1.5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A THORACIC ANEURYSM AND JUNCTION (TYPE IIIA ENDOLEAK) BETWEEN THE ENDURANT AND AFX DEVICES AS DETECTED PER CT (COMPUTED TOPOGRAPHY). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN AMPLATZER VASCULAR PLUG I (12MM) AND A GORE EXCLUDER (NON-ENDOLOGIX DEVICES) ON (B)(6) 2019. THE LEAK WAS CONFIRMED RESOLVED AT THE CONCLUSION OF THE RE-INTERVENTION AND THE PATIENT WAS DISCHARGED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8928736 ↗
• InjuryApr 3, 2019Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, AN INFRARENAL STENT GRAFT EXTENSION AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A TYPE 3B ENDOLEAK WAS IDENTIFIED. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER BIFURCATED STENT GRAFT AND AN INFRARENAL STENT GRAFT EXTENSION TO RESOLVE THE REPORTED EVENT. THE PATIENT WAS REPORTED AS DOING GREAT POST INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 8479900 ↗
• InjuryMay 10, 2018Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND VELA SUPRARENAL ON (B)(6) 2016. ENDOLOGIX BECAME AWARE OF A COMPLAINT AGAINST OUR DEVICE ON (B)(6) 2018 WHEN THE PATIENT PRESENTED AT (B)(6) WITH A CONTAINED RUPTURE. AFTER TRANSFER TO (B)(6), IT WAS DETERMINED THERE WAS NO RUPTURE BUT A TYPE 2 ENDOLEAK AND A POTENTIAL MYCOTIC ANEURYSM. ASPIRATION WAS DONE AND THE FLUID SENT IN FOR CULTURE, BUT THE RESULTS ARE STILL PENDING.

  Patient problems: Aneurysm; Inflammation; Pain; Unspecified Infection

  MAUDE report 7503605 ↗
• InjuryApr 19, 2018Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND VELA INFRARENAL ON (B)(6) 2014. ON A LATER DATE, THE PATIENT WAS IDENTIFIED TO HAVE DEVELOPED SAC GROWTH PER ANGIOGRAM IRREGULARITIES NOTED AT THE BIFURCATION WITH NO DEFINITIVE ENDOLEAK. THE SECONDARY CASE FOR THIS PATIENT WAS COMPLETED ON (B)(6) 2016 AND THE PHYSICIAN RELINED THE PATIENT BY IMPLANTING AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) VELA SUPRARENALS.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7445613 ↗
• InjuryApr 19, 2018Failure To Adhere Or Bond; Leak/Splash; Adverse Event Without Identified Device or Use Problem; Failure To Adhere Or Bond; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND 1 VELA INFRARENAL. ON (B)(6) 2017, A SECONDARY PROCEDURE, WAS PERFORMED FOR AN UNKNOWN REASON. DURING THE INTERVENTION, 2 ADDITIONAL VELA INFRARENALS AND 1 VELA SUPRARENAL WERE IMPLANTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm; Failure of Implant; No Information

  MAUDE report 7444247 ↗
• InjuryApr 4, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE BY A REP WHO WAS CALLED BY A PHYSICIAN TODAY TO REVIEW A CTA FOR A PATIENT THAT HAD AN INITIAL IMPLANT PROCEDURE DONE ON (B)(6) 2015. IT WAS REPORTED THAT PATIENT'S AAA WAS INCREASING IN SIZE AND PHYSICIAN WAS QUESTIONING IF THERE IS A TYPE 3. FROM LOOKING AT THE CTA, THE PATIENT ORIGINAL DEVICE HAD A SHORT PROXIMAL NECK. THE PROXIMAL NECK LOOKS TO HAVE DISEASE PROGRESSION WITH ENLARGEMENT OF THE AORTA AT THE LEVEL OF RIGHT RENAL MEASURING 3.9X3.5. NO OBVIOUS TYPE 1A SEEN, BUT SUSPECTED. OVERLAP OF COMPONENTS LOOKS GOOD AND STABLE. REP WILL DISCUSS CTA IN FURTHER DETAIL WITH PHYSICIAN AT A LATER TIME AND WHAT HE PLANS TO DO FOR PATIENT. PATIENT IS DOING WELL AND STABLE AND BEING MONITORED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7397942 ↗
• InjuryApr 3, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT ON 03/06/2018, THE SECONDARY PROCEDURE WAS PERFORMED. REPORTEDLY, IT WAS CONFIRMED, THERE WAS NO LEAK AND NO SAC GROWTH, JUST MINIMAL OVERLAP OF THE PREVIOUSLY IMPLANTED STENTS. THE PHYSICIAN ELECTED TO ADD A VELA SUPRARENAL CUFF AND A VELA INFRARENAL CUFF TO IMPROVE OVERLAP. THE PATIENT WAS DISCHARGED THE NEXT DAY AND WAS REPORTED TO BE PAIN FREE AND IN GOOD CONDITION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7392173 ↗
• InjuryJan 11, 2018Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  DURING THE CLINICAL EVALUATION OF EVENT (B)(4) FOR AN ENDOLEAK TYPE II, IT WAS DISCOVERED THAT THE PATIENT UNDERWENT A PREVIOUS INTERVENTION ON (B)(6) 2015 FOR A SUSPECTED ENDOLEAK TYPE IIIB. THE PATIENT WAS RELINED WITH A BIFURCATED DEVICE. NO OTHER INFORMATION WAS RECEIVED FOR THIS RELINE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7184288 ↗
• InjuryOct 26, 2017Hole In Material; Leak/Splash; Material Integrity Problem; Hole In Material; Leak/Splash; Material Integrity Problem

  AN AFX BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR A ROUTINE FOLLOW-UP WHERE THE PHYSICIAN NOTICED AN ANEURYSM SAC EXPANSION OF APPROXIMATELY 8CM DUE TO A SUSPECTED TYPE IIIB ENDOLEAK. THE PHYSICIAN ELECTED TO RE-LINE THE STENT GRAFT WITH AN AFX2 BIFURCATED STENT GRAFT. THE RE-LINE PROCEDURE WENT WELL AND SUCCESSFULLY RESOLVED THE TYPE IIIB ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6980469 ↗

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-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-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-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-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-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• Z-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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

…and 1 more.