AFX2 Bifurcated Endograft System BEA28-90/I20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00818009014559), received between Jan 18, 2017 and Mar 26, 2026 — classified as 3 deaths, 63 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (20 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 67 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026Off-Label Use; Improper or Incorrect Procedure or Method

  THE PATIENT WAS TREATED FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2026. A COOK THORACIC STENT GRAFT (NON-ENDOLOGIX) WAS IMPLANTED FIRST AND THEN THE AFX2 BIFURCATED STENT GRAFT (BSG) WAS IMPLANTED. THE RUPTURE WAS TREATED AND SEAL WAS OBTAINED WITH A MILD TYPE IA ENDOLEAK OF THE COOK THORACIC STENT GRAFT WAS PRESENT. THE TYPE IA ENDOLEAK WAS LEFT UNTREATED AS IT WAS EXPECTED TO RESOLVE ONCE OFF HEPARIN. THE DISCHARGE COMPUTED TOMOGRAPHY SCAN ON (B)(6) 2026, FOUND THE TYPE IA ENDOLEAK FROM THE COOK THORACIC STENT GRAFT AND A TYPE IB ENDOLEAK FROM THE RIGHT LIMB OF THE AFX2 BSG WAS OBSERVED. THE SAME DAY REINTERVENTION WAS PERFORMED WITH IMPLANT OF AN OVATION IX ILIAC LIMB RESOLVING THE TYPE IB ENDOLEAK. A GORE TAG GRAFT (NON-ENDOLOGIX) WAS IMPLANTED TO RESOLVE THE TYPE IA ENDOLEAK AS WELL AS A PALMAZ STENT (NON-ENDOLOGIX) TO PUSH THE AORTIC CUFFS OPEN WITH BETTER APPOSITION. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NOTE: THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED. ALSO, THIS PROCEDURE WAS OFF LABEL DUE TO THE AB

  Patient problems: Clinical Endoleak

  MAUDE report 24703350 ↗
• InjuryMar 23, 2026Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2018. ON (B)(6) 2026, DURING A ROUTINE FOLLOW UP A POTENTIAL TYPE IIIB ENDOLEAK WAS IDENTIFIED. AN ANGIOGRAPHY AND A POTENTIAL INTERVENTION IS PLANNED FOR (B)(6) 2026.

  Patient problems: Clinical Endoleak

  MAUDE report 24664074 ↗
• InjuryDec 9, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL ON (B)(6) 2016. ON (B)(6) 2022, AN INTERVENTION FOR AN EXPANDING ANEURYSM SAC THAT WAS NON-DEVICE RELATED OCCURRED. THE PHYSICIAN COILED THE LEFT HYPO AND EXTENDED WITH AN AFX LIMB EXTENSION. ON (B)(6) 2025, DURING A ROUTINE FOLLOW UP, A TYPE IB ENDOLEAK WAS IDENTIFIED. INTERVENTION OCCURRED ON (B)(6) 2025. TWO OVATION IX ILIAC LIMBS WERE PLACED INTO EXTERNAL ILIAC FROM PREVIOUSLY PLACED ALTO MAIN BODY AFTER THE PHYSICIAN COILED (NON-ENDOLOGIX) HYPOGASTRIC. THE TYPE IB ENDOLEAK WAS RESOLVED AND THE PATIENT WENT HOME THE NEXT DAY.

  Patient problems: Clinical Endoleak

  MAUDE report 23763926 ↗
• InjuryDec 9, 2025Off-Label Use; Separation Problem; Off-Label Use; Separation Problem

  IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY REFERRED FROM ANOTHER HOSPITAL WHERE THEY WERE UNDER OBSERVATION FOR A PARARENAL ABDOMINAL AORTIC ANEURYSM (PRAAA). A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A 51MM DIAMETER AAA AND SAC ENLARGEMENT. THE PATIENT WAS THEN IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, VELA SUPRARENAL AND A VELA INFRARENAL ON (B)(6) 2019. ALSO, A 6X50MM VIABAHN (NON-ENDOLOGIX) STENT GRAFT WAS DEPLOYED IN THE LEFT RENAL ARTERY (RA) VIA THE LEFT BRACHIAL APPROACH. IT WAS NOTED THAT THE VELA SUPRARENAL OVERLAP WITH THE AFX2 WAS SHORT, THEREFORE, THE VELA INFRARENAL WAS IMPLANTED. THE FINAL ANGIOGRAM CONFIRMED NO ENDOLEAKS AND THE PROCEDURE WAS COMPLETED. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, A DISPLACEMENT BETWEEN THE AFX2 BIFURCATED STENT GRAFT AND THE VELA SUPRARENAL WAS CONFIRMED. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL VELA INFRARENAL, A VELA SUPRARENAL, AND A 32MM (NON-ENDOLOGIX) GORE EXCLUDER CUFF TO RELINE THE ORIGINAL IMPLANTED STENT GRAFTS. THE EVENT WAS SUCCESSFULLY RESOLVED AND THERE WERE NO ENDOLEAKS OR PATIENT HARM NOTED. NOTE: THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STEN

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 23757636 ↗
• InjuryAug 6, 2025Off-Label Use; Material Puncture/Hole; Deformation Due to Compressive Stress; Separation Problem; Off-Label Use; Material Puncture/Hole; Deformation Due to Compressive Stress; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA INFRARENAL AND AN ENDURANT CUFF (NON-ENDOLOGIX). THE NECK LENGTH WAS SHORT AND TORTUOUS. THE ENDURANT CUFF WAS DEPLOYED FIRST JUST BELOW THE RENAL ARTERY VIA THE RIGHT ACCESS. THE AFX2 BSG WAS DEPLOYED BUT THE JUNCTION WAS SHORT, SO A VELA INFRARENAL WAS DEPLOYED TO PREVENT SEPARATION. AFTER TOUCH UP WAS COMPLETED A TYPE IA ENDOLEAK WAS OBSERVED SO THE PHYSICIAN PERFORMED TOUCH UP AGAIN, BUT IT DID NOT RESOLVE THE TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE WITH THE EXPECTATION THAT IT WOULD RESOLVE OVER TIME DUE TO THE LEAK VOLUME BEING SMALL. APPROXIMATELY ONE YEAR POST INITIAL PROCEDURE, ON (B)(6) 2025, A PLAIN COMPUTED TOMOGRAPHY SCAN REVEALED SUSPECTED DAMAGE TO THE STENT STRUCTURE. JUNCTION SEPARATION WAS CONFIRMED AND A TYPE IIIA ENDOLEAK WAS SUSPECTED. INTERVENTION WAS PERFORMED APPROXIMATELY ONE MONTH LATER ON (B)(6) 2025. THE PHYSICIAN ELECTED TO IMPLANT A GORE EXCLUDER (NON-ENDOLOGIX) AT THE CENTER OF THE JUNCTION VIA THE RIGHT APPROACH AS WELL AS ANOTHER GORE EXCLUDER (NON-ENDOLOGIX) PROXIMALLY. THE PHYSICIAN

  Patient problems: Clinical Endoleak

  MAUDE report 22731868 ↗
• InjuryApr 18, 2025Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS BEING TREATED FOR A RIGHT INTERNAL ILIAC ARTERY (IIA) ANEURYSM ON (B)(6) 2025 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AFTER COIL EMBOLIZATION OF THE RIGHT SUPERIOR AND INFERIOR GLUTEAL ARTERY. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO THE ABSENCE OF AN ABDOMINAL AORTIC ANEURYSM. A GORE (NON-ENDOLOGIX) EXCLUDER LEG WAS PLACED TO EXTEND THE RIGHT LEG OF THE AFX2 BSG AND THE JUNCTION BETWEEN THE AFX2 BSG AND THE EXCLUDER LEG WAS TOUCHED UP WITH A BALLOON. 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. WHEN ANGIOGRAPHY WAS PERFORMED INSIDE THE GRAFT, AN ENDOLEAK WAS OBSERVED. WHEN BOTH AFX LEGS WERE BLOCKED WITH BALLOONS AND ANOTHER ANGIOGRAPHY WAS PERFORMED FROM THE PROXIMAL SIDE, AN ENDOLEAK WAS OBSERVED NEAR THE TERMINAL AORTA, THEREFORE, IT WAS DETERMINED TO BE TYPE IIIB ENDOLEAK. A NEW AFX2 BSG WAS PLACED USING THE SAME PROCEDURE. REPORTEDLY, AN ANGIOGRAPHY CONFIRMED THAT THE FLOW OF THE TYPE IIIB ENDOLEAK HAD SLOWED DOWN HOWEVER, IT SUGGESTED A TYPE IB ENDOLEAK WAS OCCURRING CONCURRENTLY FROM THE LEFT LEG OF THE AFX2 BIFURCA

  Patient problems: Clinical Endoleak

  MAUDE report 21868489 ↗
• InjuryMar 17, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT A SACCULAR ABDOMINAL AORTIC ANEURYSM (AAA LOCATED IMMEDIATELY ABOVE THE AORTIC BIFURCATION. AFTER THE AFX2 (BIF) WAS IMPLANTED THE FINAL ANGIOGRAPHY DID NOT SHOW A LEAK AND THE PHYSICIAN COMPLETED THE OPERATION. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE AN ENDOLEAK WAS SHOWN NEAR THE BIFURCATED SECTION OF THE AFX2 STENT GRAFT AND IT WAS DETERMINED THAT THE ANEURYSM HAD RUPTURED. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT STENT GRAFT AND EXCLUDER LEGS (NON-ENDOLOGIX) STENTS TO REINFORCE BOTH LEGS. THE ENDOLEAK WAS RESOLVED, BUT THE PATIENT'S BLADDER PRESSURE WAS HIGH; THEREFORE, THE PHYSICIAN ELECTED TO PERFORM A LAPAROTOMY TO LOWER THE BLADDER PRESSURE. THE PATIENT REGAINED CONSCIOUSNESS AFTER THE OPERATION AND IS REPORTEDLY IN STABLE CONDITION.

  Patient problems: Aneurysm; Clinical Endoleak; Rupture

  MAUDE report 21621145 ↗
• InjuryDec 2, 2024Off-Label Use; Material Puncture/Hole; Device-Device Incompatibility; Off-Label Use; Material Puncture/Hole; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY TREATED FOR A FUSIFORM AORTIC ANEURYSM WITH SIGNIFICANT AORTIC NECK ANGULATION ON (B)(6) 2023, WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT, A (NON-ENDOLOGIX) MEDTRONIC ENDURANT CUFF, AND A (NON-ENDOLOGIX) MEDTRONIC ENDURANT ILIAC EXTENSION . THIS INITIAL PROCEDURE WAS OUTSIDE THE INDICATIONS FOR USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM, AS STATED IN THE IFU. AN ENDURANT CUFF AND ILIAC EXTENSION WERE PLACED, FOLLOWED BY THE AFX2 BIFURCATED STENT GRAFT. A TYPE II ENDOLEAK FROM THE LUMBAR ARTERY WAS DETECTED POST-PROCEDURE, AND THE PHYSICIAN OPTED FOR MONITORING. DURING A ROUTINE FOLLOW-UP ON (B)(6) 2024, AN ANGIOGRAPHY REVEALED AN ENDOLEAK, SUSPECTED TO BE TYPE IIIA, TYPE IIIB, OR TYPE II. ON (B)(6) 2024, A RE-INTERVENTION WAS PERFORMED. AN INTRAOPERATIVE ANGIOGRAPHY CONFIRMED A TYPE IIIB ENDOLEAK AT THE BIFURCATED SECTION OF THE AFX2. AN ADDITIONAL (NON-ENDOLOGIX) MEDTRONIC EXCLUDER STENT GRAFT WAS IMPLANTED BELOW THE RENAL ARTERIES, SUCCESSFULLY RESOLVING THE ENDOLEAK. THE PATIENT REMAINS HOSPITALIZED AND WILL BE CLOSELY MONITORED DURING FOLLOW-UP.

  Patient problems: Clinical Endoleak

  MAUDE report 20827076 ↗
• InjuryNov 19, 2024Lack of Effect; Lack of Effect

  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 ON (B)(6) 2023. IT WAS REPORTED ON (B)(6) 2024, THAT THE ROUTINE FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED A POSSIBLE ENDOLEAK OF INDETERMINATE ORIGIN. THE ANGIOGRAM PERFORMED ON (B)(6) 2024 WAS UNABLE TO POSITIVELY IDENTIFY ANY ENDOLEAKS; HOWEVER, THE ANEURYSM SAC WAS GROWING. THE PHYSICIAN ELECTED TO RELINE THE INITIALLY IMPLANTED GRAFTS WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. POST-SECONDARY PROCEDURE, THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20725985 ↗
• InjuryNov 5, 2024Material Puncture/Hole; Lack of Effect; Material Puncture/Hole; Lack of Effect

  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 ON (B)(6) 2023. IT WAS REPORTED ON (B)(6) 2024 THAT THE ROUTINE FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED A POSSIBLE ENDOLEAK OF INDETERMINATE ORIGIN. THE ANGIOGRAM PERFORMED ON (B)(6) 2024 WAS UNABLE TO POSITIVELY IDENTIFY ANY ENDOLEAKS; HOWEVER, THE ANEURYSM SAC WAS GROWING. THE PHYSICIAN ELECTED TO RELINE THE INITIALLY IMPLANTED GRAFTS WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. POST-SECONDARY PROCEDURE, THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20610403 ↗
• InjuryNov 1, 2024Material Puncture/Hole; Deformation Due to Compressive Stress; Separation Problem; Material Puncture/Hole; Deformation Due to Compressive Stress; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ACUTE RUPTURE OF THE ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL), SAFETY AND EFFECTIVENESS OF THE AFX2 SYSTEM HAS NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: LEAKING, PENDING RUPTURE OR RUPTURED ANEURYSMS. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE TYPE IIIA ENDOLEAK WITH JUNCTION SEPARATION WAS CONFIRMED. ON (B)(6) 2024 THE AFX2 BIFURCATED STENT GRAFT AND AFX VELA INFRARENAL WERE EXPLANTED, AND VESSEL REPLACEMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED AS PLANNED WITHOUT PROBLEMS ON (B)(6) 2024.

  Patient problems: Clinical Endoleak

  MAUDE report 20587889 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY TREATED ON (B)(6) 2024 WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT. APPROXIMATELY THREE (3) MONTHS POST INITIAL PROCEDURE, DUE TO AN INFECTION, THE PATIENT UNDERWENT EXPLANT OF ALL THEIR GRAFTS. THE EXPLANT WAS PERFORMED BUT THE PATIENT EXPIRED ON THE TABLE DURING OPEN SURGERY.

  Patient problems: Bacterial Infection

  MAUDE report 20417243 ↗
• InjuryMay 1, 2024Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2019, WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN OVATION IX ILIAC LIMB. THIS INITIAL PROCEDURE IS OUTSIDE OF THE INDICATIONS OF USE DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT HAD AN ENDOLEAK TYPE IB, AN ANEURYSM ENLARGEMENT, AND A POSSIBLE ENDOLEAK TYPE 3B. THE PATIENT IS SCHEDULED FOR A RE-INTERVENTION ON (B)(6) 2024. ADDITIONAL INFORMATION: ON (B)(6) 2024, THE PATIENT UNDERWENT A RE-INTERVENTION DURING WHICH THE PHYSICIAN CHOSE TO IMPLANT AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL DEVICE. THE FINAL STATUS OF THE PATIENT REMAINS UNKNOWN, AS THIS INFORMATION WAS NOT PROVIDED TO ENDOLOGIX.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19225716 ↗
• InjuryApr 3, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2022 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, TWO (2)EXCLUDER LEGS, AND A LIMINEXX STENT. THIS INITIAL PROCEDURE IS OUTSIDE OF THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM. APPROXIMATELY ONE YEAR POST INITIAL PROCEDURE THE ANEURYSM HAD GROWN FROM 51MM TO 56MM. APPROXIMATELY 1.5 YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW-UP WITH COMPUTED TOMOGRAPHY (CT) AND INTRAOPERATIVE ANGIOGRAPHY, THE ANEURYSM MEASURED 62MM WHICH THE PHYSICIAN SUSPECTS IS DUE TO A TYPE IIIB ENDOLEAK. REINTERVENTION IS SCHEDULED TO BE ON (B)(6) 2024.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19035163 ↗
• InjuryAug 10, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN AFX VELA INFRARENAL. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, A POSSIBLE TYPE 1B ENDOLEAK WAS IDENTIFIED FROM THE RIGHT COMMON ILIAC. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ALTO ABDOMINAL STENT GRAFT SYSTEM (ALTO MAIN BODY, OVATION PRIME FILL POLYMER, AND THREE (3) OVATION IX ILIAC LIMBS). THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Clinical Endoleak

  MAUDE report 17502918 ↗
• InjuryJul 25, 2023Material Puncture/Hole; Unintended Movement; Material Puncture/Hole; Unintended Movement

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS AFTER THE INITIAL PROCEDURE, IT WAS REPORTED THAT THE TWO COMPONENTS ARE MOVING AWAY FROM EACH OTHER. THE PATIENT UNDERWENT A RE-INTERVENTION WHERE THE PHYSICIAN OPTED TO PROCEED WITH AN IMPLANT OF AN AFX VELA INFRARENAL. THE FINAL PATIENT STATUS REMAINS UNKNOWN AS IT WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Clinical Endoleak; Failure of Implant

  MAUDE report 17393803 ↗
• InjuryJun 26, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT, TWO (2) ENDURANT CUFFS (NON-ENDOLOGIX DEVICE), AND ONE (1) EXCLUDER CUFF (NON-ENDOLOGIX DEVICE). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, AN ANGIOGRAPHY IDENTIFIED A TYPE 3B ENDOLEAK. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. IT WAS REPORTED THAT THE 3B ENDOLEAK WAS RESOLVED AFTER THE SECONDARY PROCEDURE. THE FINAL PATIENT STATUS REMAINS UNKNOWN. THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX. THIS EVENT WAS PREVIOUSLY REPORTED UNDER (MFR # 2031527-2021-00501). NOW, APPROXIMATELY ONE AND HALF (1.5) YEARS LATER DURING A ROUTINE FOLLOW UP, A TYPE 1B WAS IDENTIFIED AND IT WAS ORIGINATING FROM THE RECENTLY IMPLANTED AFX2 BIFURCATED STENT GRAFT VIA THE RIGHT COMMON ILIAC ARTERY (CIA). IT WAS ALSO NOTED THAT SAC ENLARGEMENT WAS NOT OBSERVED, AND THE PATIENT IS CURRENTLY ASYMPTOMATIC. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. NOTE: THE INITIAL PROCEDURE PERFORMED ON (B)(6) 2017, WAS OFF LABEL DUE TO THE CONCOMITANT USE WITH PRODUCTS OUTSIDE THE (IFU) INSTRUCTIONS FOR USE. ADDITIONAL

  Patient problems: Clinical Endoleak

  MAUDE report 17199930 ↗
• InjuryMay 12, 2023Material Puncture/Hole; Improper or Incorrect Procedure or Method; Lack of Effect; Material Puncture/Hole; Improper or Incorrect Procedure or Method; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2023. THE AFX2 BIFURCATED STENT GRAFT AND THE AFX VELA SUPRARENAL WERE IMPLANTED AS PLANNED. THE LEFT COMMON ILIAC ARTERY (CIA) MEASURED OVER 20MM; THEREFORE, AN OVATION IX EXTENSION WAS IMPLANTED. AFTER BALLOON TOUCH-UP, ANGIOGRAPHY SHOWED POSSIBLE TYPE IB, IIIB OR IIIA (JUNCTION OF AFX VELA SUPRARENAL AND OVATION IX EXTENSION) ENDOLEAK. A GORE (NON-ENDOLOGIX) STENT GRAFT WAS IMPLANTED ON THE LEFT SIDE FOR POSSIBLE TYPE IB AND IIIA ENDOLEAKS. BALLOON TOUCH-UP WAS PERFORMED, BUT THE ENDOLEAK WAS NOT RESOLVED. AS A TYPE IB ENDOLEAK FROM THE RIGHT SIDE WAS ALSO SUSPECTED. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL OVATION IX EXTENSION. DURING THE INSERTION OF THE OVATION IX EXTENSION DELIVERY SYSTEM, THE WIRE PASSED BEHIND ONE OF THE AFX2 BIFURCATED STENT GRAFT LIMB STENT STRUT AND THE EXTENSION WAS DEPLOYED AS IT WAS. THE PHYSICIAN IMPLANTED A GORE (NON-ENDOLOGIX) VIABAHN VBX 11MMTO PREVENT GRAFT STENOSIS. ANGIOGRAPHY WAS PERFORMED INSIDE THE STENT GRAFT AROUND LEFT CIA, SHOWING NO ENDOLEAK. ANGIOGRAPHY WAS PERFORMED FROM THE AFX2 BIFURCATED STENT GRAFT BIFURCATION WHILE THE RIGHT LEG WAS TEMPORALLY OCCLUDED BY T

  Patient problems: Clinical Endoleak

  MAUDE report 16925031 ↗
• InjuryMay 9, 2023Migration; Migration

  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 THREE (3) YEARS AFTER POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE 3A ENDOLEAK, VELA MIGRATION, AND AN ANEURYSM ENLARGEMENT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A NON-ENDOLOGIX DEVICE (MEDTRONIC/ ENDURANT II). THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16899846 ↗
• InjuryMay 4, 2023Lack of Effect; Lack of Effect

  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 THREE (3) YEARS AFTER POST-INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT, AFX VELA SUPRARENAL, AND AN AFX VELA INFRARENAL COMPLEMENTED BY A BALLOON TOUCH-UP. THE ULTIMATE DIAGNOSIS OF ENDOLEAK AFTER THE SECONDARY PROCEDURE WAS IDENTIFIED AS A COMBINATION OF TYPE 1A AND 3A BUT WAS ULTIMATELY RESOLVED THROUGH THE SECONDARY RE-INTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 16869580 ↗
• InjuryFeb 9, 2023Malposition of Device; Malposition of Device

  THE PATIENT WAS INITIALLY TREATED FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN AFX VELA INFRARENAL. THIS INITIAL PROCEDURE IS CONTRAINDICATIVE OF THE AFX2 BIFURCATED STENT GRAFT INDICATIONS FOR USE AS THE SAFETY AND EFFECTIVENESS OF THE SYSTEM HAVE NOT BEEN EVALUATED FOR PATIENTS WITH RUPTURED ANEURYSMS. REPORTEDLY, AT THE INDEX PROCEDURE, THE PATIENT HAD A VERY LONG RENAL TO AORTOILIAC BIFURCATION. DUE TO THE URGENT NATURE OF THE CASE IT IS UNKNOWN IF THE CORRECT SIZE DEVICES WERE AVAILABLE AT THE TIME. A COMPLETE SEAL WAS OBTAINED AT THE INITIAL PROCEDURE; HOWEVER, THE PHYSICIAN HAD TO COVER THE LEFT RENAL. THE MALPOSITION OF THE GRAFT OCCLUDED THE LEFT RENAL ARTERY AND RESULTED IN POST OPERATIVE RENAL FAILURE (DEVICE RELATED), ACUTE BLOOD LOSS, RESPIRATORY FAILURE, A LEFT UPPER EXTREMITY DEEP VEIN THROMBUS, ENCEPHALOPATHY AND ADDITIONAL SURGICAL PROCEDURES (ABDOMINAL COMPARTMENT SYNDROME). THE FINAL PATIENT STATUS WAS REPORTED TO BE DISCHARGED TO SUBACUTE REHABILITATION ON POSTOPERATIVE DAY FIFTEEN.

  Patient problems: Renal Failure

  MAUDE report 16342147 ↗
• InjuryJan 10, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A POSSIBLE TYPE 3A OR TYPE 1A ENDOLEAK WAS IDENTIFIED (EXACT DATE IS UNKNOWN). A COMPUTED TOMOGRAPHY (CT) ALSO SHOWED "BIRD BEAK" OF THE PROXIMAL PORTION OF THE STENT GRAFT CATEGORIZED AS BUCKED MATERIALS. THE PATIENT IS CURRENTLY STABLE AND BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. ADDITIONAL INFORMATION: AN INTERNAL CLINICAL ASSESSMENT DETERMINED THAT THERE WAS A TYPE 2 ENDOLEAK (NON-DEVICE RELATED) FROM THE LUMBAR ARTERY THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE TYPE 2 ENDOLEAK WAS DISCOVERED DURING A REVIEW OF THE POST INDEX CT SCAN.

  Patient problems: Clinical Endoleak

  MAUDE report 16135234 ↗
• 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 AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL, AN AFX VELA SUPRARENAL AND AN AFX LIMB STENT GRAFT. APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH BACK PAIN, AN EXPANDING ANEURYSM SAC (UNKNOWN DIAMETER) AND A SUSPECT TYPE IIIA ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) ADDITIONAL AFX VELA INFRARENALS ON (B)(6) 2022. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak; Failure of Implant

  MAUDE report 15992913 ↗
• InjuryDec 7, 2022Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN AFX VELA INFRARENAL. THIS INITIAL PROCEDURE IS CONTRAINDICATIVE OF THE AFX2 BIFURCATED STENT GRAFT INDICATIONS FOR USE AS THE SAFETY AND EFFECTIVENESS OF THE SYSTEM HAVE NOT BEEN EVALUATED FOR PATIENTS WITH RUPTURED ANEURYSMS. REPORTEDLY, AT THE INDEX PROCEDURE, THE PATIENT HAD A VERY LONG RENAL TO AORTOILIAC BIFURCATION. DUE TO THE URGENT NATURE OF THE CASE IT IS UNKNOWN IF THE CORRECT SIZE DEVICES WERE AVAILABLE AT THE TIME. A COMPLETE SEAL WAS OBTAINED AT THE INITIAL PROCEDURE; HOWEVER, THE PHYSICIAN HAD TO COVER THE LEFT RENAL. APPROXIMATELY FIVE (5) YEARS POST-INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL AND BACK PAIN. A TYPE IIIA ENDOLEAK WITH COMPONENT SEPARATION WAS IDENTIFIED. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM AND TWO (2) ADDITIONAL OVATION IX ILIAC LIMBS. THE TYPE IIIA ENDOLEAK WAS SUCCESSFULLY SEALED. THE PATIENT'S PAIN WAS GONE, AND THE PATIENT WAS EXPECTED TO BE DISCHARGED THE SAME DAY AS REINTERVENTION OR ONE-DAY POST-REINTERVENTION.

  Patient problems: Clinical Endoleak; Failure of Implant; Pain

  MAUDE report 15935739 ↗
• DeathSep 19, 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 AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED AAA IN UNSTABLE CONDITION. REVIEW OF THE SUBSEQUENT COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A TYPE IB ENDOLEAK. THE PATIENT DID NOT MAKE IT TO THE OPERATING ROOM (OR) AND PASSED AWAY.

  Patient problems: Failure of Implant; Ruptured Aneurysm

  MAUDE report 15452257 ↗

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-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-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-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-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-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-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.