AFX2 Bifurcated Endograft System BEA25-80/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00818009014733), received between Apr 6, 2017 and Feb 12, 2026 — classified as 2 deaths, 33 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Off-Label Use; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) ON (B)(6) 2021. THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND SLIGHT ANEURYSM SAC GROWTH ON (B)(6) 2026. ON (B)(6) 2026, THE PHYSICIAN ELECTED TO RELINE THE AFX2 BSG WITH AN ALTO STENT GRAFT SYSTEM. THE PATIENT IS STABLE ON TELEMETRY FLOOR AND EXPECTED TO BE RELEASED THE FOLLOWING DAY.

  Patient problems: Abdominal Pain; Aneurysm; Clinical Endoleak

  MAUDE report 24328439 ↗
• InjuryAug 28, 2024Migration or Expulsion of Device; Deformation Due to Compressive Stress; Migration or Expulsion of Device; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2017, WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. DURING A FOLLOW-UP VISIT, A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED SIGNS OF AN ENLARGING ANEURYSM. THE PHYSICIAN DECIDED TO BRING THE PATIENT TO THE OPERATING ROOM FOR AN ANGIOGRAM AND POSSIBLE TREATMENT. ON (B)(6) 2024, DURING THE ANGIOGRAM, NO ENDOLEAK WAS FOUND, BUT THE DEVICE WAS NOTED TO BE ANGULATED AND LACKING SUFFICIENT OVERLAP. THE PHYSICIAN OPTED TO PERFORM A RE-INTERVENTION WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT RECOVERED WELL, STAYED OVERNIGHT IN THE HOSPITAL WITHOUT ANY ISSUES, AND WAS DISCHARGED THE NEXT DAY.

  Patient problems: Aneurysm

  MAUDE report 20086319 ↗
• InjuryAug 5, 2024Off-Label Use; Unintended Movement; Separation Problem; Off-Label Use; Unintended Movement; Separation Problem

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2022 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA SUPRARENAL. THE AFX VELA SUPRARENAL MIGRATED DOWN, AND AN EXCLUDER (NON-ENDOLOGIX) STENT WAS ADDED JUST BELOW THE LOWER RENAL ARTERY. THE AFX2 BSG AND AFX VELA SUPRARENAL OVERLAP LENGTH WAS ABOUT THREE SEGMENTS (AROUND 55MM). THERE WAS NO IMPACT TO PATIENT REPORTED. THE PATIENT ATTENDED A REGULAR FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN EVERY YEAR AND ECHOCARDIOGRAPHY WITH NO ENDOLEAKS DETECTED. ON (B)(6) 2024, THE PATIENT VISITED A DIFFERENT HOSPITAL DUE TO STOMACHACHE. A SIMPLE CT SCAN SHOWED RETROPERITONEAL HEMATOMA, THE PATIENT RETURNED TO THE IMPLANTING HOSPITAL. A CONTRAST CT SHOWED ANEURYSM RUPTURE DUE TO A TYPE IIIA ENDOLEAK WITH SEPARATION OF AFX2 BSG AND THE AFX VELA SUPRARENAL. AN EMERGENT REINTERVENTION WAS PERFORMED WITH THE IMPLANT OF AN EXCLUDER AORTA EXTENSION AT THE JUNCTION. IN ADDITION, A GORE (NON-ENDOLOGIX) IPSILATERAL LEG, GORE (NON-ENDOLOGIX) CONTRALATERAL LEG, GORE (NON-ENDOLOGIX) ILIAC EXTENDER, AND A GORE (NON-ENDOLOGIX) CONTRALATERAL LEG WERE IMPLANTED UNDER THE RENAL ARTERIES. THE FINAL PATIENT STATUS WAS NOT PRO

  Patient problems: Clinical Endoleak; Hematoma; Ruptured Aneurysm

  MAUDE report 19913609 ↗
• InjuryJul 1, 2024Material 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 IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY EIGHT (8) MONTHS POST INITIAL PROCEDURE, DURING ROUTINE FOLLOW UP SAC ENLARGEMENT WAS IDENTIFIED WHERE THE AAA MEASURED 43X54MM. THE AAA MEASURED 40X50MM PRIOR TO THE ENDOVASCULAR AORTIC REPAIR (EVAR). NO ENDOLEAK WAS FOUND DURING EARLY PHASE COMPUTED TOMOGRAPHY (CT) SCANS; HOWEVER A RECENT CT REVEALED A POSSIBLE TYPE IIIB ENDOLEAK AROUND THE MIDDLE OF ANEURYSM WITH DELAYED PHASE. THE PATIENT HAS NOT COMPLAINED ABOUT ANY SYMPTOMS. THE PATIENT IS CURRENTLY BEING MONITORED AS AN INTERVENTION IS BEING PLANNED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19644666 ↗
• InjuryAug 16, 2023Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE AN ANGIOGRAM IDENTIFIED A TYPE 3B ENDOLEAK. THE PATIENT IS STABLE AND CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17561062 ↗
• InjuryJul 11, 2023Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX LIMB STENT GRAFT DISTAL EXTENSION AND AN OVATION IX ILIAC LIMB. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM PER DEVICE IFU. APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH THE AFX GRAFT HAVING INADEQUATE APPOSITION TO THE ARTERIAL WALL IN THE AORTIC NECK AND THE LEFT ILIAC. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY BALLOONING WITH Q50 BALLOONS ON (B)(6) 2023. THE SUBSEQUENT ANGIOGRAM REVEALED THAT THE GRAFT WAS BETTER APPOSED, AND THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ADDITIONAL INFORMATION: CLINICAL ASSESSMENT IDENTIFIED THAT THE PATIENT LACKED AN ABDOMINAL AORTIC ANEURYSM AT INITIAL IMPLANT (OFF-LABEL CONDITION). IN ADDITION, A TYPE IB ENDOLEAK (OF THE LEFT COMMON ILIAC ARTERY), BILATERAL ILIAC LIMB STENOSIS AND BILATERAL LOWER LEG ISCHEMIA ALSO OCCURRED. DURING THE SECONDARY INTERVENTION ON (B)(6) 2023, BILATERAL NON-ENDOLOGIX STENTS WERE ALSO IMPL

  Patient problems: Clinical Endoleak; Insufficient Information; Ischemia; Stenosis

  MAUDE report 17298721 ↗
• InjuryMay 9, 2023Lack of Effect; Lack of Effect

  AN EMERGENCY EVAR (ENDOVASCULAR ANEURYSM REPAIR) PROCEDURE WAS PERFORMED. THE PATIENT RECEIVED AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) AFX VELA SUPRARENALS. A POSSIBLE TYPE 1B ENDOLEAK WAS OBSERVED DURING THE ANGIOGRAPHY, AND ADDITIONAL DEVICES WERE ADDED, GORE CUFF (NON-ENDOLOGIX) AND A GORE VIABAHN VBX (NON-ENDOLOGIX) BUT THE ISSUE PERSISTED. AN ANGIOGRAPHY WAS PERFORMED AGAIN, REVEALING A POSSIBLE TYPE 3B ENDOLEAK. DURING THE POST-OPERATION CHECK, THE INTRAOPERATIVE TYPE 3B ENDOLEAK WAS RESOLVED, BUT A NEW TYPE 2 OR 3A ENDOLEAK WAS OBSERVED AT THE JUNCTION BETWEEN AFX2 AND VELA. THE PHYSICIAN SCHEDULED A COMPUTERIZED TOMOGRAPHY (CT) SCAN AND A RE-INTERVENTION WILL BE CONSIDERED BASED ON THE RESULT.

  Patient problems: Clinical Endoleak

  MAUDE report 16899847 ↗
• InjuryApr 26, 2023Malposition of Device; Malposition of Device

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. DURING THE INITIAL IMPLANT PROCEDURE, THE MAIN BODY WAS LANDED SEVERAL CENTIMETERS BELOW THE LOWEST RENAL, THUS A TYPE IA ENDOLEAK WAS SUSPECTED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) AFX VELA INFRARENAL ON (B)(6) 2023. A GOOD FINAL RESULT WAS REPORTED, AND PATIENT WAS IN GOOD CONDITION.

  Patient problems: Clinical Endoleak

  MAUDE report 16817983 ↗
• InjuryJan 31, 2023Separation Problem; Lack of Effect; Separation Problem; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR A COMMON ILIAC ANEURYSM WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL PROXIMAL EXTENSION AND AN AFX LIMB STENT GRAFT DISTAL EXTENSION. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE ABSENCE OF AN ABDOMINAL AORTIC ANEURYSM (AAA). THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IIIA ENDOLEAK AND COMPONENT SEPARATION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM ON (B)(6) 2023. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED. PATIENT IS REPORTEDLY STABLE AND WAS DISCHARGED HOME. ADDITIONAL INFORMATION: CLINICAL ASSESSMENT IDENTIFIED AN ADDITIONAL ENDOVASCULAR PROCEDURE WAS COMPLETED ON (B)(6) 2022; THE PHYSICIAN TREATED THE PATIENT FOR A TYPE IIIA ENDOLEAK (OF THE RIGHT ILIAC LIMB) BY IMPLANTING TWO (NON-ENDOLOGIX) STENTS IN THE RIGHT COMMON ILIAC ARTERY. THIS SECONDARY INTERVENTION EVENT IS CAPTURED PER MFR. REF. #2031527-2023-00041.

  Patient problems: Clinical Endoleak

  MAUDE report 16271990 ↗
• InjuryOct 18, 2022Collapse; Insufficient Device Problem Information; Collapse; 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 TWO (2) YEARS POST INITIAL PROCEDURE AN INDETERMINATE ORIGIN ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER AFX2 BIFURCATED STENT GRAFT TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING FINE POST SECONDARY PROCEDURE AND WAS DISCHARGED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15629479 ↗
• DeathSep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE STENT GRAFTS WERE PLACED WITH NO COMPLICATIONS DURING THE PROCEDURE; HOWEVER, THE PATIENT HAD A LOW EJECTION FRACTION RATE AND MIGHT HAVE GONE INTO CARDIOGENETIC SHOCK AND PASSED AWAY TWO (2) HOURS POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 15503069 ↗
• InjuryAug 24, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST-INITIAL PROCEDURE, A SMALL PIN HOLE AT THE BIFURCATION OF THE AFX2 BIFURCATED STENT GRAFT (TYPE 3B ENDOLEAK) WAS IDENTIFIED. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. THE POST ANGIOGRAM SHOWED THAT THE TYPE 3B ENDOLEAK WAS SUCCESSFULLY SEALED. IT WAS REPORTED THAT THE PATIENT DID WELL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15284673 ↗
• InjuryMar 2, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, AT ROUTINE FOLLOW-UP AAA ENLARGEMENT WITH A TYPE IA ENDOLEAK, AND A TYPE 3B ENDOLEAK WERE IDENTIFIED. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES. REPORTEDLY, THE PATIENT IS IN GOOD CONDITION POST EXPLANT.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13653911 ↗
• InjuryJan 21, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE THE PHYSICIAN BELIEVES THERE MAY BE A TYPE 3B ENDOLEAK AS WELL AS AN ANEURYSM ENLARGEMENT BASED ON A COMPUTED TOMOGRAPHY (CT) SCAN THAT SHOWED A DECREASING THEN AN EXPANDING ABDOMINAL AORTIC ANEURYSM (AAA) IN LATER FOLLOW-UPS. AN ANGIOGRAM WILL BE DONE TO DETERMINE IF A RE-INTERVENTION WILL BE NEEDED. THE PATIENT IS CURRENTLY IN STABLE CONDITION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13320670 ↗
• InjuryJan 14, 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 IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN AFX VELA INFRARENAL. APPROXIMATELY SEVEN (7) MONTHS POST INITIAL PROCEDURE A TYPE IIIA ENDOLEAK WAS IDENTIFIED AT ROUTINE FOLLOW-UP. REINTERVENTION WAS COMPLETED WITH IMPLANT OF AN AFX VELA INFRARENAL. PROCEDURE WENT GREAT, THE TYPE IIIA ENDOLEAK WAS RESOLVED PER POST ANGIOGRAM. PATIENT DID WELL POST PROCEDURE AND WAS REPORTED TO BE DISCHARGED HOME.

  Patient problems: Failure of Implant

  MAUDE report 13258862 ↗
• InjuryDec 2, 2021Off-Label Use; Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (4) FOUR YEARS AFTER THE POST-INITIAL IMPLANT, THE PATIENT WAS IDENTIFIED DURING A ROUTINE FOLLOW-UP WITH AN ANEURYSM ENLARGEMENT AND A TYPE 1A ENDOLEAK. A RE-INTERVENTION WAS DONE AND THE PHYSICIAN ELECTED TO IMPLANT AN AFX VELA INFRARENAL AND A (NON-ENDOLOGIX DEVICE) PALMAZ STENT. IT APPEARED THAT THE ENDOLEAK WAS RESOLVED. THE FINAL PATIENT STATUS WAS REPORTED AS BEING STABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12918384 ↗
• InjuryAug 30, 2021Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  THE PATIENT WAS INITIALLY TREATED FOR A FUSIFORM ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL. THE AFX VELA INFRARENAL STENT-GRAFT MIGRATED UPON BALLOON TOUCH-UP; THEREFORE, A GORE (NON-ENDOLOGIX) STENT GRAFT WAS DEPLOYED PROXIMALLY. THEREFORE, THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM PER DEVICE IFU. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE ANGIOGRAPHY IDENTIFIED ANEURYSM ENLARGEMENT AND THAT THE BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL WERE ALMOST SEPARATED (CLASSIFIED AS A TYPE IIIA ENDOLEAK). THE PATIENT IS BEING MONITORED AND REINTERVENTION PLANS HAVE NOT YET BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED INDICATING THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) ADDITIONAL AFX VELA INFRARENALS ON (B)(6) 2021. REPORTEDLY, THE PATIENT IS IN GOOD CONDITION AND THE ENDOLEAK WAS SUCCESSFULLY RESOLVED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12384974 ↗
• InjuryAug 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (4) FOUR YEARS AFTER THE POST-INITIAL IMPLANT, THE PATIENT WAS IDENTIFIED WITH ANEURYSM ENLARGEMENT WITH NO VISIBLE ENDOLEAK DURING A ROUTINE FOLLOW-UP. A REINTERVENTION WAS DONE AND THE PHYSICIAN ELECTED TO IMPLANT AN AFX VELA SUPRARENAL. THE FINAL PATIENT STATUS WAS REPORTED AS DOING GOOD. ADDITIONAL INFORMATION: THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE IA ENDOLEAK OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE TYPE IA ENDOLEAK WAS DISCOVERED DURING A REVIEW OF THE 45 MONTH POST INDEX CT SCAN.

  Patient problems: Aneurysm

  MAUDE report 12324463 ↗
• InjuryJan 5, 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 THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE DURING THE 48 MONTHS COMPUTED TOMOGRAPHY (CT) EXAM AAA GROWTH (OF 6.1MM) WAS IDENTIFIED.

  Patient problems: Aneurysm

  MAUDE report 11117385 ↗
• InjuryDec 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA INFRARENAL ENDOGRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) MONTHS POST INITIAL PROCEDURE AN ENDOLEAK WAS IDENTIFIED DURING A ROUTINE COMPUTED TOMOGRAPHY (CT) SCAN. WITH THE OVERLAP HAVING DECREASED TO APPROXIMATELY 4 CM, A TYPE 3A ENDOLEAK WAS SUSPECTED. ADDITIONAL INFORMATION: THE REPORTED SUSPECTED TYPE 3A ENDOLEAK WAS REFUTED, RATHER THERE WERE MULTIPLE TYPE 2 ENDOLEAKS FROM THE LUMBAR ARTERY. AS A TYPE II ENDOLEAK IS A NON DEVICE RELATED FAILURE AND ANATOMY-RELATED, THIS EVENT IS NO LONGER REPORTABLE TO THE FDA AS THERE IS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF AN ENDOLOGIX DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 11052089 ↗
• InjuryDec 16, 2020Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWENTY-SIX (26) DAYS POST INITIAL PROCEDURE AN OCCLUSION OF THE STENT-GRAFT WAS CONFIRMED ON BOTH LEGS OF THE BIFURCATED STENT GRAFT. A RE-INTERVENTION WAS DONE, AND AN AXILLARY FEMORAL ARTERY BYPASS WAS PERFORMED. THE PHYSICIAN NOTED THAT DURING THE INITIAL PROCEDURE THE PATIENT¿S NATIVE COMMON ILIAC ARTERIES WERE NARROW (APPROXIMATELY 8 TO 10 MM IN DIAMETER) AND HAD CALCIFICATION.

  Patient problems: Occlusion

  MAUDE report 11021453 ↗
• InjuryNov 23, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A TYPE 3B ENDOLEAK WAS IDENTIFIED AND AN AFX2 BIFURCATED STENT GRAFT AND AN OVATION IX EXTENDER LIMB WERE IMPLANTED TO RESOLVE THIS EVENT. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 2031527-2017-00225. NOW, APPROXIMATELY 3.5 YEARS POST-RE-INTERVENTION, A POSSIBLE 3B ENDOLEAK OF THE AFX2 BIFURCATED STENT GRAFT STENT WAS IDENTIFIED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY PLACING A VELA INFRARENAL STENT GRAFT EXTENSION AND PERFORM BALLOONING TO RESOLVE THIS EVENT. THE PATIENT STATUS IS UNKNOWN AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 10886193 ↗
• InjuryOct 23, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA INFRARENAL STENT GRAFT EXTENSION AND AN OVATION IX EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY FOUR (4) MONTHS POST-OP, A COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) REVEALED A POSSIBLE INDETERMINATE ENDOLEAK. THE PHYSICIAN HAS SCHEDULED A REINTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 10731371 ↗
• InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK AT ROUTINE FOLLOW-UP AS DETECTED BY CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY). HOWEVER, THE EXACT DATE OF EVENT IS UNKNOWN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN OVATION IX EXTENDER DEVICE ON (B)(6) 2019. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: IT WAS REPORTED THAT A TYPE 1B ENDOLEAK WAS PRESENT IN THE RIGHT COMMON ILIAC AND WAS SUCCESSFULLY RESOLVED DURING THE PROCEDURE. THE PATIENT DID WELL DURING AND AFTER THE ENDOVASCULAR PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 9353674 ↗
• InjuryOct 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A VELA SUPRARENAL EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (2) YEARS POST IMPLANT (EXACT DATE WAS NOT PROVIDED), A TYPE 3A ENDOLEAK WAS IDENTIFIED DURING A ROUTINE FOLLOW UP ON A COMPUTERIZED TOMOGRAPHY (CT). PATIENT IS REPORTEDLY DOING WELL AND IS CURRENTLY BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 9174957 ↗

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-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-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-1037-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• Z-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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• 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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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
• 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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL

…and 1 more.