AFX2 Bifurcated Endograft System BEA28-80/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00818009014467), received between Oct 11, 2017 and Feb 20, 2026 — classified as 3 deaths, 33 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Difficult or Delayed Activation

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) ON (B)(6) 2026. DURING THE DEPLOYMENT OF THE AFX2 BSG THE PHYSICIAN ATTEMPTED TO PULL THE YELLOW KNOB, BUT IT ONLY PULLED OUT 3CM BEFORE IT STOPPED. MANY ATTEMPTS WERE TRIED TO UN-SLEEVE THE AFX2 BSG BUT THEY WERE UNSUCCESSFUL. AFTER TROUBLESHOOTING THE AFX2 BSG WAS FULLY DEPLOYED. THE PHYSICIAN HAD TO CUT DOWN TO CLOSE THE ARTERY ON THE RIGHT SIDE OF PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 24408144 ↗
• InjuryDec 10, 2025Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2025. BILATERAL COIL EMBOLIZATION OF THE INTERNAL ILIAC ARTERIES WAS PERFORMED. A NON-ENDOLOGIX GORE EXCLUDER LEG WAS IMPLANTED FROM THE ORIGIN OF THE RIGHT COMMON ILIAC ARTERY (RCIA) VIA A DRYSEAL 12FR SHEATH. THE SHEATH WAS REPLACED WITH AN AFX INTRODUCER SHEATH, WHICH WAS ADVANCED TO THE PROXIMAL PORTION OF THE EXCLUDER LEG. TO PREVENT DISTAL MIGRATION OF THE EXCLUDER LEG, THE AFX2 BIFURCATED STENT GRAFT (BIF) DELIVERY SYSTEM WAS CAUTIOUSLY ADVANCED BY SEATING IT ON THE AFX INTRODUCER SHEATH. SUBSEQUENTLY, THE AFX BIF WAS DEPLOYED WITHOUT ISSUES. AFTER CONFIRMING THE RENAL ARTERY BIFURCATION WITH ANGIOGRAPHY, A VELA AFX VELA SUPRARENAL WAS DEPLOYED TO ALIGN WITH THE LEFT RENAL ARTERY. THE PHYSICIAN OPTED TO PERFORM THE ANGIOGRAPHY WITHOUT TOUCH-UP AT THIS STAGE. ANGIOGRAPHY CONFIRMED BLOOD FLOW TO AN ANEURYSMAL SEGMENT OF THE RCIA. SUSPECTING A TYPE IIIA ENDOLEAK, TOUCH-UP OF THE RCIA, INCLUDING THE JUNCTION BETWEEN THE EXCLUDER LEG AND THE AFX2 BIF, WAS PERFORMED TWICE. HOWEVER, THE ENDOLEAK PERSISTED. SUSPECTING A TYPE IIIB ENDOLEAK, INTRA-GRAFT ANGIOGRAPHY WAS PERFORMED WHILE OCCLUDING THE DISTAL RCIA WITH A B

  Patient problems: Clinical Endoleak

  MAUDE report 23768486 ↗
• InjuryNov 8, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) A TYPE 3A ENDOLEAK AND ANEURYSM ENLARGEMENT WERE IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT A VELA SUPRARENAL AND A VELA INFRARENAL. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20640633 ↗
• InjuryJan 8, 2024Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST THE INITIAL PROCEDURE, DURING ROUTINE FOLLOW-UP, THE PATIENT PRESENTED WITH A 3A ENDOLEAK AND REPORTS OF SEPARATION OF THE VELA FROM THE MAIN BODY. THE INTERVENTION WAS COMPLETED, AND THE PHYSICIAN ELECTED TO IMPLANT TWO (2) AFX VELA SUPRARENALS TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS STABLE POST-REINTERVENTION AND DISCHARGED FROM THE HOSPITAL.

  Patient problems: Clinical Endoleak

  MAUDE report 18471033 ↗
• InjuryAug 30, 2023Fracture; Material Puncture/Hole; Fracture; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL PROXIMAL EXTENSION AND THREE (3) AFX LIMB STENT GRAFTS ON (B)(6) 2019. THE PATIENT PRESENTED EMERGENTLY. THE COMPUTED TOMOGRAPHY (CT) DETECTED A RUPTURED AAA AND A TYPE IB ENDOLEAK FROM THE RIGHT COMMON ILIAC ON (B)(6) 2020. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL AFX LIMB STENT GRAFT WITH TWO (2) OVATION IX EXTENDERS ON THE SAME DAY. CLINICAL ASSESSMENT OF THIS EVENT DETERMINED THE INITIAL PROCEDURE WAS OFF LABEL DUE TO THE RIGHT ILIAC ARTERY AS THE ANEURYSM EXTENDED INTO BILATERAL ILIACS AND THERE WAS NOT AN ADEQUATE DISTAL FIXATION LENGTH (AT 15MM ABOVE RIGHT INTERNAL ILIAC ARTERY THE VESSEL WAS ANEURYSMAL AT 23.8MM (SHOULD BE 10-23MM)). ADDITIONALLY, CLINICAL ASSESSMENT OF THIS EVENT DETERMINED THAT THE TYPE IB HAD BEEN IDENTIFIED AT THE ONE MONTH CT FOLLOW-UP AND THE DELAY IN TREATMENT LIKELY CONTRIBUTED TO THE RUPTURE (USER ERROR). THIS WAS REPORTED UNDER MFR#3008011247-2020-00046 (THE MDR WAS UNINTENTIONALLY REPORTED UNDER THE INCORRECT FEI# AND HAS BEEN RESUBMITTED AS A CORRECTION UNDER MFR# 2031527-2023-00207).

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

  MAUDE report 17654979 ↗
• InjuryJul 17, 2023Off-Label Use; Off-Label Use

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN OVATION ILIAC LIMB TO TREAT AN ILIAC AND A HYPOGASTRIC ANEURYSM. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU AND THE LACK OF AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT PRIOR TO THE STENT GRAFT IMPLANT THE HYPOGASTRIC ARTERY WAS COIL EMBOLIZED AND COVERED WITH THE OVATION LIMB FOLLOWED BY IMPLANT OF THE AFX2 BIFURCATED STENT GRAFT FOR PROXIMAL SEAL AND TO COVER THROMBUS IN AORTA. THE GRAFT WAS THEN BALLOONED WITH A Q50 BALLOON AND IT APPEARED TO BE BALLOONED TOO AGGRESSIVELY. IMAGING WAS PERFORMED WHICH SHOWED WHAT APPEARED TO BE A RUPTURE AT THE BIFURCATION OF THE AORTA AND THE JUNCTION OF THE AFX AND OVATION LIMB WITH A TYPE 3B ENDOLEAK APPEARANCE. THE RUPTURE WAS CONTAINED WITHIN THE ILIAC ANEURYSM SAC. THE PHYSICIAN ELECTED TO RELINE WITH ANOTHER AFX2 BIFURCATED STENT AND AN OVATION LIMB ON THE LEFT SIDE. THE EVENT WAS SUCCESSFULLY RESOLVED AND THERE WAS NO LONGER EVIDENCE OF A RUPTURE OR ENDOLEAK.

  Patient problems: Rupture

  MAUDE report 17336663 ↗
• DeathJun 16, 2023Material 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 IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH AN ANEURYSM ENLARGEMENT AND AN ENDOLEAK (AT INDETERMINATE ORIGIN). RE-INTERVENTION WAS COMPLETED WITH IMPLANT OF AN ADDITIONAL AFX VELA SUPRARENAL, AND THE ENDOLEAK WAS SUCCESSFULLY SEALED. THE PATIENT WAS REPORTED AS STABLE. REFERENCE MFR. REPORT # 2031527-2021-00280 FOR THIS PREVIOUS EVENT. APPROXIMATELY TWO (2) YEARS POST SECONDARY INTERVENTION, THE PATIENT PRESENTED WITH UNEXPLAINED ANEURYSM ENLARGEMENT (UNKNOWN DIAMETER). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EXPLANTING THE DEVICES ON (B)(6) 2023, AND A HYGROMA WAS DIAGNOSED DURING THE PROCEDURE. THE PATIENT PASSED AWAY A COUPLE OF DAYS LATER. ADDITIONAL INFORMATION: SAMPLE EVALUATION OF THE RETURNED EXPLANTED DEVICES IDENTIFIED PRESENCE OF HOLES IN THE AFX2 BIFURCATED STENT GRAFT.

  Patient problems: Aneurysm

  MAUDE report 17144834 ↗
• InjuryApr 19, 2023Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, TWO (2) AFX VELA SUPRARENAL AND TWO (2) OVATION IX EXTENDER(S). THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM PER DEVICE IFU. APPROXIMATELY THREE (3) YEARS AFTER THE POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ENDOLEAK TYPE 3B. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ALTO MAIN BODY, TWO (2) OVATION IX ILIAC LIMB(S), AND OVATION PRIME FILL POLYMER. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16773686 ↗
• InjuryDec 9, 2022Material Puncture/Hole; Failure to Unfold or Unwrap; Material Puncture/Hole; Failure to Unfold or Unwrap

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, THREE (3) AFX LIMB STENT GRAFTS AND ONE (1) AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE THE PHYSICIAN DETERMINED THERE IS A POSSIBLE TYPE 3B AND 3A ENDOLEAK. A RE-INTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN AFX LIMB STENT GRAFT, AN AFX VELA SUPRARENAL AND AN AFX2 BIFURCATED STENT GRAFT. REPORTEDLY, DURING THE PROCEDURE THE MAIN BODY WAS DEPLOYED WITH THE APPEARANCE THAT THERE WAS ZERO WIRE WRAP, BUT WHEN THE PHYSICIAN TRIED TO DEPLOY THE CONTRALATERAL LIMB, HE COULD SEE THAT THERE WAS IN FACT WIRE WRAP. THE PHYSICIAN WAS UNABLE TO CORRECT THIS ISSUE AND ELECTED TO PERFORM AN AORTO-UNI ILIAC (AUI) WITH A FEMORAL-FEMORAL BYPASS. THE PHYSICIAN THEN DEPLOYED THE SUPRARENAL EXTENSION AND THE RIGHT AFX LIMB EXTENSION WITHOUT FURTHER COMPLICATION. THE FINAL PATIENT STATUS WAS REPORTED AS DOING FINE AND RECOVERING WELL. ADDITIONAL INFORMATION : A CLINICAL EVALUATION SHOWED REASONABLE EVIDENCE TO SUGGEST AN ABDOMINAL ANEURYSM ENLARGEMENT OF 5 MM OCCURRED. THE CLINICAL ASSESSMENT ALSO DETERMINED THERE WAS A COMPLETE INABILITY TO CANNULATE THE

  Patient problems: Aneurysm; Failure of Implant; Thrombosis/Thrombus

  MAUDE report 15955622 ↗
• InjuryOct 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, THREE (3) AFX LIMB STENT GRAFTS AND ONE (1) AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE THE PHYSICIAN DETERMINED THERE IS A POSSIBLE TYPE 3B AND 3A ENDOLEAK. A RE-INTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN AFX LIMB STENT GRAFT, AN AFX VELA SUPRARENAL AND AN AFX2 BIFURCATED STENT GRAFT. REPORTEDLY, DURING THE PROCEDURE THE MAIN BODY WAS DEPLOYED WITH THE APPEARANCE THAT THERE WAS ZERO WIRE WRAP, BUT WHEN THE PHYSICIAN TRIED TO DEPLOY THE CONTRALATERAL LIMB, HE COULD SEE THAT THERE WAS IN FACT WIRE WRAP. THE PHYSICIAN WAS UNABLE TO CORRECT THIS ISSUE AND ELECTED TO PERFORM AN AORTO-UNI ILIAC (AUI) WITH A FEMORAL-FEMORAL BYPASS. THE PHYSICIAN THEN DEPLOYED THE SUPRARENAL EXTENSION AND THE RIGHT AFX LIMB EXTENSION WITHOUT FURTHER COMPLICATION. THE FINAL PATIENT STATUS WAS REPORTED AS DOING FINE AND RECOVERING WELL.

  Patient problems: Failure of Implant

  MAUDE report 15567780 ↗
• InjuryAug 25, 2022Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 4 YEARS POST INITIAL PROCEDURE THE PATIENT WAS IDENTIFIED WITH A TYPE 1B ENDOLEAK DURING A ROUTINE FOLLOW UP. THE PATIENT WAS REPORTED AS STABLE AND THE PHYSICIAN IS PLANNING A RE-INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 15297899 ↗
• InjuryJun 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS BEING 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, ROUTINE FOLLOW-UP NON-CONTRAST COMPUTERIZED TOMOGRAPHY (CT) IDENTIFIED ANEURYSM ENLARGEMENT WITH A POSSIBLE INDETERMINATE ENDOLEAK. REPORTEDLY, DUE TO THE HIGH TORTUOSITY IT IS DIFFICULT TO CONFIRM AN ENDOLEAK. AN ADDITIONAL CT SCAN IS TO BE SCHEDULED AS THE QUALITY OF THIS ONE WAS POOR. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14567041 ↗
• InjuryMay 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY ONE (1) YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW-UP AN ANEURYSM ENLARGEMENT AND A TYPE 1B ENDOLEAK WERE IDENTIFIED. THE PHYSICIAN IS PLANNING ON A RE-INTERVENTION IN THE FOLLOWING WEEKS. THE CURRENT STATUS OF THE PATIENT'S HEALTH IS STABLE. ADDITIONAL INFORMATION: A RE-INTERVENTION WAS DONE, AND THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX EXTENDER. THE ENDOLEAK WAS REPORTED TO BE RESOLVED. THE FINAL PATIENT STATUS WAS REPORTED AS BEING STABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14476316 ↗
• InjuryNov 29, 2021Complete Blockage; Complete Blockage

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFTS, TWO (2) VELA SUPRARENAL, AND A VELA INFRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) MONTH POST INITIAL IMPLANT, THE PATIENT WAS IDENTIFIED WITH A POSSIBLE TYPE 3A ENDOLEAK. AT THE REINTERVENTION IT WAS DETERMINED THAT THERE WAS A TYPE II ENDOLEAK (NON-DEVICE RELATED) AND NOT A TYPE 3A ENDOLEAK. THE TYPE II ENDOLEAK WAS RELINED WITH AN AFX2 BIFURCATED STENT GRAFT, AND TWO (2) AFX VELA SUPRARENAL; HOWEVER, THE TYPE II ENDOLEAK WAS STILL PRESENT AT THE END OF THE PROCEDURE. (POSSIBLE TYPE 3A ENDOLEAK REPORTED UNDER MFR# 2031527-2021-00313). APPROXIMATELY TWO AND A HALF (2.5) MONTHS POST-REINTERVENTION, LEFT LIMB OCCLUSION WAS IDENTIFIED. THE ISSUE APPEARS TO BE CRITICAL STENOSIS AT THE PROXIMAL EXTERNAL ILIAC (JUNCTION OF THE INTERNAL). SUCCESSFUL REINTERVENTION WAS COMPLETED OPENING THE LEFT COMMON ILIAC ARTERY. ENDARTERECTOMY WAS PERFORMED FIRST, CROSSED THE CRITICAL STENOSIS ON THE EXTERNAL ILIAC, BALLOONED THE STENOSIS WITH AN 8X4 PTA BALLOON, THEN DEPLOYED THE AFX LIMB STENT GRAFT ACROSS THE CLOT THAT FORMED THROUGH THE LIMB. THE PATIENT IS DOING WELL.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12888053 ↗
• InjuryAug 17, 2021Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL AND AN OVATION IX EXTENDER; THIS 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 FOUR (4) YEARS POST INITIAL PROCEDURE, IT WAS IDENTIFIED DURING A ROUTINE FOLLOW-UP THAT THE AFX HAD MIGRATED AND THAT THERE IS A POSSIBLE TYPE 3 ENDOLEAK. THE PATIENT IS REPORTED TO BE ASYMPTOMATIC AND IS IN GOOD HEALTH. THE PHYSICIAN PLANS TO RE-INTERVENE. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST THAT THE REPORTED TYPE 3 ENDOLEAK (AT INDETERMINATE ORIGIN) IS A TYPE II (NON-DEVICE-RELATED) AND TYPE IA ENDOLEAKS. THIS WAS DISCOVERED DURING REVIEW OF THE 42 MONTH POST INDEX IMPLANT CT SCAN.

  Patient problems: Failure of Implant

  MAUDE report 12334600 ↗
• InjuryJul 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY (5) FIVE YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH AN ANEURYSM ENLARGEMENT AND AN ENDOLEAK (INDETERMINATE ORIGIN). THE PATIENT IS CURRENTLY IN STABLE CONDITION WITH A RE-INTERVENTION PENDING.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12206600 ↗
• InjuryJul 20, 2021Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH COMPONENT SEPARATION (CLASSIFIED AS A TYPE IIIA ENDOLEAK). THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. THE PATENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12196750 ↗
• InjuryJun 25, 2021Improper or Incorrect Procedure or Method; Separation Problem; Improper or Incorrect Procedure or Method; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A NON-ENDOLOGIX AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED A TYPE 3A ENDOLEAK WITH SEPARATION BETWEEN THE IMPLANTED DEVICES. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. THE PHYSICIAN ELECTED TO IMPLANT AN INFRARENAL AORTIC EXTENSION TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS FINE POST SECONDARY PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 12068384 ↗
• InjuryMay 28, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND NON-ENDOLOGIX DEVICES TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) AND AN INTRAOPERATIVE 3A ENDOLEAK. APPROXIMATELY (3) THREE YEARS AFTER POST INITIAL PROCEDURE THE PATIENT WAS BROUGHT IN URGENTLY TO TREAT A 3A ENDOLEAK AND A SUSPECTED ANEURYSM RUPTURE. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER AFX2 BIFURCATED STENT GRAFT. ANGIOGRAPHY SHOWED AN INTRAOPERATIVE TYPE 1B ENDOLEAK SO THE PHYSICIAN IMPLANTED A NON-ENDOLOGIX VBX STENT GRAFT. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM PER THE IFU. THE ENDOLEAK WAS NOT RESOLVED SO THE PHYSICIAN ELECTED TO DO A FEMORAL-FEMORAL BYPASS AND THE PROCEDURE WAS COMPLETED. AN ANGIOGRAPHY SHOWED THE LEAK WAS RESOLVED. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL. CORRECTION: THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND NON-ENDOLOGIX DEVICES TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) AND AN INTRAOPERATIVE 3A ENDOLEAK. APPROXIMATELY (3) THREE YEARS AFTER POST INITIAL PROCEDURE THE PATIENT WAS BROUGHT IN URGENTLY TO TREAT

  Patient problems: Failure of Implant; Rupture

  MAUDE report 11904816 ↗
• InjuryApr 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL STENT GRAFT AND 3 LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4.5 YEARS POST INITIAL IMPLANT DURING ROUTINE FOLLOW UP, THE COMPUTED TOMOGRAPHY SCAN IDENTIFIED SAC GROWTH. REPORTEDLY, INTERVENTION HAS BEEN RECOMMENDED. PATIENT IS BEING MONITORED AND NO INTERVENTION HAS YET BEEN COMPLETED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11733226 ↗
• InjuryMar 31, 2021Premature Activation; Insufficient Device Problem Information; Premature Activation; Insufficient Device Problem Information

  DURING THE INITIAL IMPLANT OF A BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA), IT WAS REPORTED THAT THE BIFURCATED STENT GRAFT HAD PREMATURELY DEPLOYED IN THE RIGHT COMMON ILIAC DUE TO THE DEPLOYMENT WIRE/CORD BEING WRAPPED/STUCK. AN OPEN REPAIR WAS PERFORMED AND THE DEVICE WAS EXPLANTED WITHOUT FURTHER COMPLICATIONS. THE PATIENT WAS REPORTED AS DOING FINE POST SECONDARY PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 11596122 ↗
• DeathMar 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL IMPLANT, AN ENDOLEAK OF INDETERMINATE ORIGIN WAS REPORTED. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO RE-LINE THE ORIGINAL IMPLANTED STENT GRAFTS GRAFT WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. THE PATIENT WAS REPORTED AS DOING FINE POST INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 11572077 ↗
• InjuryFeb 18, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, SUPRARENAL AORTIC EXTENSION AND A LIMB EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) IDENTIFIED A TYPE 3B ENDOLEAK. PATIENT IS STABLE AND CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Failure of Implant

  MAUDE report 11346104 ↗
• InjurySep 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAS A TYPE 1 (UNKNOWN ORIGIN) ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) ADDITIONAL (1) SUPRARENAL STENT GRAFT EXTENSION ON (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 10609163 ↗
• InjuryAug 21, 2020Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem

  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 AT ROUTINE FOLLOW-UP WITH AN ENLARGED ANEURYSM SAC (UNKNOWN DIAMETER) AND AN ENDOLEAK (AT AN INDETERMINATE ORIGIN) PER CT (COMPUTED TOMOGRAPHY) SCAN FROM AN UNKNOWN DATE. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) LIMB STENT GRAFT IN THE RIGHT ILIAC AND ONE (1) VELA INFRARENAL ON (B)(6) 2020; THE INFRARENAL DEVICE SUCCESSFULLY RESOLVED THE CONFIRMED TYPE IIIB ENDOLEAK, AND THE LIMB WAS IMPLANTED TO PREVENT A FUTURE TYPE IB ENDOLEAK. THE PATIENT TOLERATED THE RE-INTERVENTION WELL. IN ADDITION, THE PHYSICIAN STATED THAT HE BELIEVES THE IIIB ENDOLEAK WAS CAUSED BY THE BRIDGE STENT (NON-ENDOLOGIX) THAT WAS IMPLANTED IN THE INITIAL CASE, WHICH IS OFF-LABEL DUE TO NONCOMITANT USE OF A NON-ENDOLOGIX STENT WITH AFX DEVICES. THIS PATIENT HAS A PREVIOUS ADVERSE EVENT FOR A TYPE IIIA ENDOLEAK THAT WAS RESOLVED WITH THE IMPLANTATION OF A VELA SUPRARENAL AND VELA INFRARENAL STENT GRAFTS ON (B)(6) 2019. THIS EVENT WAS REPORTED UNDER 2031527-2019-00540.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10437246 ↗

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-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-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-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-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-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• 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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• 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-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.