AFX2 Bifurcated Endograft System BEA28-100/I20-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 00818009014405), received between Jun 23, 2016 and Feb 17, 2026 — classified as 4 deaths, 102 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (33 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 107 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA SUPRARENAL ON (B)(6) 2017. DURING THE INITIAL PROCEDURE, THE PATIENT¿S RIGHT ILIAC ARTERY WAS NOTED TO BE SLIGHTLY WIDE (ECTATIC); NO INTERVENTION WAS PERFORMED AT THE TIME, AND THE PHYSICIANS OPTED FOR ONGOING MONITORING. ON (B)(6) 2025 THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX AND AFX LIMB STENT GRAFT. APPROXIMATELY ON (B)(6) 2025 THE PHYSICIAN ELECTED TO IMPLANT A GORE IBE (NON-ENDOLOGIX) DUE TO SLOW SAC GROWTH FROM WHAT WAS THOUGHT TO BE FROM AN ECTATIC ILIAC THAT BECAME ANEURYSMAL. ON (B)(6) 2026, DURING A ROUTINE FOLLOW UP, IT WAS IDENTIFIED THAT THIS COULD BE A TYPE III ENDOLEAK. INTERVENTION OCCURRED ON (B)(6) 2026 WITH IMPLANT OF AN AFX2 BSG AND THE LEAK WAS RESOLVED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 24372854 ↗
• InjuryFeb 2, 2026Off-Label Use; Difficult to Remove; Difficult or Delayed Activation; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Difficult to Advance

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA SUPRARENAL, AND AFX ILIAC LIMB, AND AN OVATION IX ILIAC LIMB ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIANS WERE DEPLOYING THE AFX2 BSG PER THE INSTRUCTIONS FOR USE (IFU). WHEN THE PHYSICIAN PULLED THE STRING TO RELEASE THE AFX2 BSG THE CONTROL CORD PULLED BACK PARTIALLY, OPENING THE AFX2 BSG, BUT THE CONTROL CORD COULD NOT BE FULLY REMOVED. ONE OF THE AFX2 BARE METAL STRUTS AT THE VERY TOP WAS SLIGHTLY FOLDED OVER, INDICATING THAT THE CONTROL CORD MAY HAVE BEEN STUCK NEAR THE TOP. THE PHYSICIAN PROCEEDED WITH DEPLOYMENT AND CONTINUED DEPLOYING THE CONTRA LIMB DISCONNECTION STEP OF THE SNARED WIRE AND DEPLOYING IPSILATERAL LIMB PER IFU WHICH ALL APPEARED TO BE SUCCESSFUL WITHOUT INCIDENT. WHEN THE PHYSICIAN TRIED TO PULL ON THE CONTROL CORD, IT WAS BENDING/FOLDING THE AFX2 BSG OVER TO THE IPSILATERAL RIGHT SIDE DUE TO THE WIDE AORTIC BIFURCATION. THERE WAS ADDITIONAL PULLING OF THE STRING TO ATTEMPT TO REMOVE IT FROM THE PATIENT, BUT AT ONE POINT THE AFX2 BSG COMPLETELY BENT OVER WITH THE CONTRA LEG OF THE AFX2 BSG NO LONGER BEING IN THE LEFT IL

  Patient problems: Foreign Body In Patient

  MAUDE report 24240745 ↗
• InjuryNov 21, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT SYSTEM AND AN AFX VELA SUPRARENAL EXTENSION FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2019. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE PHYSICIAN¿S OFFICE AND THE ANGIOGRAM REVEALED THAT THERE WAS A TYPE IB ENDOLEAK (RIGHT COMMON ILIAC ARTERY), TYPE II ENDOLEAK, AND ANEURYSM ENLARGEMENT. THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX ILIAC LIMB AND AN AFX VELA SUPRARENAL AORTIC CUFF AND THE TYPE IB ENDOLEAK WAS RESOLVED, HOWEVER THE TYPE II ENDOLEAK REMAINED. THE PATIENT IS STABLE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 23619024 ↗
• InjuryNov 14, 2025Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AN AFX VELA SUPRARENAL AND AN OVATION IX ILIAC LIMB EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE 3B ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED STENT GRAFT WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT STATUS WAS REPORTED AS DOING WELL AND WAS DISCHARGED. NOTE: THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED.

  Patient problems: Clinical Endoleak

  MAUDE report 23556560 ↗
• MalfunctionOct 16, 2025Retraction Problem; Difficult or Delayed Activation; Malposition of Device; Deformation Due to Compressive Stress; Retraction Problem; Difficult or Delayed Activation; Malposition of Device; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2023. APPROXIMATELY TWO (2) YEARS AFTER THE INITIAL PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD AN ANEURYSM ENLARGEMENT AND AN ENDOLEAK OF INDETERMINATE ORIGIN, SUSPECTED TO BE EITHER A TYPE 1B OR TYPE 3A ENDOLEAK. THE PATIENT IS SCHEDULED TO UNDERGO A RE-INTERVENTION TO CORRECT THE ENDOLEAK. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 3011063223-2025-00116. NOW APPROXIMATELY THREE (3) MONTHS POST THIS EVEN, UPON IMAGING THE PATIENT WITH ANGIOGRAM THERE WAS CONCERN THAT THERE MAY BE A TYPE 3 ENDOLEAK; THEREFORE, THE DECISION WAS MADE TO DO A RE-LINE WITH A NEW AFX BIFURCATED STENT GRAFT. IT WAS NOTED THAT THE PHYSICIAN FIRST TESTED TO BE SURE THE NEW DEVICE WAS NOT GOING THROUGH A METAL STRUT OF THE ORIGINAL IMPLANTED STENT GRAFT; HOWEVER, UPON DEPLOYING THE GRAFT IT WAS DISCOVERED THAT THE DEVICE WAS STUCK ON A METAL STRUT AND IT WAS NOT POSSIBLE TO PULL THE BIFURCATED STENT GRAFT DOWN TO POSITION IT ON THE AORTIC BIFURCATION. THE PHYSICIAN ELECTED TO DEPLOY THE STENT GRAFT HIGHER UP AND THE LEFT ILIAC LIMB DID NOT OPEN AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310036 ↗
• InjuryJun 11, 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 THROUGH THE RIGHT ACCESS. AN ANGIOGRAM SHOWED A TYPE IIIA ENDOLEAK. THE PHYSICIAN PERFORMED BALLOON TOUCH-UP FROM THE PROXIMAL SIDE TO THE DISTAL SIDE OF THE VELA SUPRARENAL BUT THE ENDOLEAK DID NOT DISAPPEAR. THE PHYSICIAN THEN ELECTED TO ADD A 28.5MM GORE CUFF (NON-ENDOLOGIX) ON THE DISTAL END OF THE VELA SUPRARENAL. THE ENDOLEAK REMAINED, THE PHYSICIAN DECIDED TO MONITOR THE PATIENT UNDER FOLLOW UP AND COMPLETED THE PROCEDURE. THE PATIENT WILL BE MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 22186226 ↗
• DeathMay 21, 2025Off-Label Use; Material Puncture/Hole; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Material Puncture/Hole; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY TREATED WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AN AFX LIMB STENT GRAFT AND AN OVATION IX EXTENDER. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT EMERGENTLY PRESENTED WITH ABDOMINAL PAIN. THE PHYSICIAN IDENTIFIED A POTENTIAL ENDOLEAK (INDETERMINATE ORIGIN) DURING A COMPUTED TOMOGRAPHY (CT) SCAN. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR OPEN SURGERY TO REPAIR ENDOLEAK. THE PATIENT WAS HEMODYNAMICALLY STABLE AND EXPIRED DUE TO UNKNOWN REASON. 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.

  Patient problems: Cardiac Arrest; Clinical Endoleak; Embolism/Embolus; Ruptured Aneurysm

  MAUDE report 22063060 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2017 WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL. APPROXIMATELY SEVEN AND A HALF (7.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH PAIN AND THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES. THE FINAL PATIENT STATUS IS REPORTED AS OKAY.

  Patient problems: Abdominal Pain

  MAUDE report 22006892 ↗
• InjuryApr 25, 2025Off-Label Use; Off-Label Use

  THE PATIENT WAS TREATED FOR A 5.0 CM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2025. THE LEFT SIDE WAS ACCESSED AND 2 PROGLIDE (NON-ENDOLOGIX) SHEATHS WERE PLACED FOLLOWED BY AN AFX 17 FR SHEATH. THE CONTRALATERAL LEFT SIDE WAS ACCESSED AND HAD ONE PROGLIDE PLACED PRIOR TO ADVANCEMENT OF A 7FR 23 CM (NON-ENDOLOGIX) SHEATH. DURING THE FIRST ATTEMPT TO SNARE THE AFX2 BIFURCATED STENT GRAFT (BSG) CONTRALATERAL LIMB WIRE, THE PHYSICIAN MISSED THE CAPTURE WITH THE SNARE RESULTING IN THE LOSS OF ACCESS BELOW TORTUOUS/CALCIFIED PROXIMAL COMMON ILIAC ARTERY. AFTER MULTIPLE ATTEMPTS TO REGAIN ACCESS FAILED. THE PHYSICIAN INSERTED A RIM (NON-ENDOLOGIX) CATHETER THROUGH THE 17FR SHEATH AND GAINED ACCESS OVER THE BIFURCATION OF WHICH THE WIRE WAS THEN SNARED AND EXTERNALIZED. THE PHYSICIAN THEN PROCEEDED TO ADVANCE A 5 FR 90CM (NON-ENDOLOGIX) SHEATH INSIDE THE CONTRALATERAL 7FR SHEATH AND EXTERNALIZED IT OUT OF THE LEFT SIDE 17FR AFX SHEATH. THE CONTRALATERAL LIMB WIRE WAS THEN ADVANCED THROUGH THE 5FR 90 CM SHEATH AND PULLED OUT OF THE RIGHT SIDED 7FR SHEATH. AT THIS POINT, THE AFX2 BSG WAS ADVANCED AND DEPLOYED PER IFU STEP SEQUENCE. THE CONTRALATERAL LIMB ON THE LEFT SIDE WAS POST DILATED WITH A

  Patient problems: Clinical Endoleak; High Blood Pressure/ Hypertension; Ruptured Aneurysm

  MAUDE report 21909625 ↗
• InjuryApr 17, 2025Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR A FUSIFORM ANEURYSM WITH A LONG TREATMENT LENGTH AND SEVERE NECK FLEXION WITH IMPLANTATION OF AN ENDURANT CUFF TO MATCH THE LOWER RENAL ARTERY, AN ENDURANT ILIAC EXTENSION PLACED NEAR THE FLEXION APEX, AN AFX2 BIFURCATED STENT GRAFT, AND AN AFX VELA INFRARENAL PLACED NEAR THE FLEXION APEX. THE PROCEDURE WAS COMPLETED AFTER CONFIRMING NO ENDOLEAK IN THE FINAL ANGIOGRAM. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE OPEN SURGERY WAS PERFORMED FOR ANEURYSM ENLARGEMENT DUE TO A TYPE V ENDOLEAK. DURING THE OPEN SURGERY A LEAK DUE TO A SUTURE HOLE WAS CONFIRMED NEAR THE TERMINAL AORTA OF THE AFX2 BIFURCATED STENT GRAFT. THE TYPE IIIB ENDOLEAK WAS DETERMINED TO BE THE CAUSE OF THE ANEURYSM ENLARGEMENT. THE PHYSICIAN ELECTED TO EXPLANT THE ENDURANT ILIAC EXTENSION, AFX2 BIFURCATED STENT GRAFT, AND THE AFX VELA INFRARENAL. AN ABDOMINAL ARTIFICIAL VESSEL REPLACEMENT SURGERY WAS PERFORMED TO COMPLETE THE PROCEDURE. THE FINAL PATIENT STATUS IS UNKNOWN. IT SHOULD BE NOTED THAT THIS PROCEDURE IS OFF LABEL AS PER THE INDICATIONS FOR USE THE AFX2 ENDOVASCULAR AAA SYSTEM (AFX2 SYSTEM) IS A FAMILY OF ABDOMINAL ANEURYSM ENDOGRAFTS AND DELIVERY SYSTEMS INTENDED FOR THE

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21854144 ↗
• InjuryMar 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT (BSG), AFX VELA SUPRARENAL EXTENSION, AFX VELA INFRARENAL EXTENSION FOR THE TREATMENT OF A 51 MM X 60 MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2024. PRIOR TO THE INITIAL IMPLANTATION OF STENT GRAFTS THERE WAS EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY (IMA) PERFORMED, THE AFX BSG AND AFX VELA SUPRARENAL EXTENSION WERE IMPLANTED THROUGH THE RIGHT FEMORAL APPROACH. THEN, AN ADDITIONAL AFX VELA INFRARENAL EXTENSION WAS IMPLANTED IN THE LOCATION CLOSE TO THE AORTIC BIFURCATION. AFTER TOUCH-UP WAS PERFORMED, IT WAS ENSURED THAT THERE WAS NO ENDOLEAK, AND THEN THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT ON (B)(6) 2025, STENT GRAFT INFECTION WAS DIAGNOSED, AND OPEN ABDOMINAL SURGERY WAS PERFORMED. THE AFX BGS AND AFX VELA EXTENSIONS WERE SURGICALLY REMOVED, AND A PROSTHETIC GRAFT REPLACEMENT WAS PERFORMED BY USING A RIFAMPICIN-SOAKED PROSTHETIC GRAFT (GELSOFT PLUS), AND THE OPERATION WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 21700941 ↗
• InjuryMar 26, 2025Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AFX VELA INFRARENAL, AND AN OVATION IX ILIAC LIMB. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A TYPE IB ENDOLEAK WAS IDENTIFIED AND THE PHYSICIAN ELECTED TO ADD A 28X45 OVATION CUFF IN THE RIGHT COMMON ILIAC TO EXTEND THE AFX2 MAIN BODY LIMB. THERE WAS NO ENDOLEAK OBSERVED ON POST ANGIOGRAM PICTURE. THE PATIENT WAS REPORTED AS STABLE. 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.

  Patient problems: Abdominal Pain; Clinical Endoleak; Rupture

  MAUDE report 21698131 ↗
• InjuryJan 27, 2025Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AN AFX LIMB STENT GRAFT, AND AN OVATION IX EXTENDER FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2016. THIS INITIAL PROCEDURE WAS OUTSIDE THE INDICATIONS FOR USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM AS SPECIFIED IN THE IFU. APPROXIMATELY EIGHT (8) YEARS AFTER THE INITIAL PROCEDURE, IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, ANEURYSM ENLARGEMENT AND A POSSIBLE TYPE 3B ENDOLEAK WERE IDENTIFIED. THE PATIENT IS CURRENTLY IN STABLE CONDITION AND AWAITING RE-INTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21246455 ↗
• InjuryJan 13, 2025Off-Label Use; Off-Label Use

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT A SUPRARENAL AORTIC EXTENSION AND TWO (2) OVATION IX ILIAC EXTENDERS 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 NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) SCAN REVIEWED BY THE RADIOLOGIST IDENTIFIED A SUSPECTED TYPE 3 ENDOLEAK (INDETERMINATE TYPE); HOWEVER, THE PHYSICIAN WAS NOT ABLE TO CONFIRM THE TYPE 3 ENDOLEAK AND AT THE SAME TIME COULD NOT RULE OUT A TYPE 2 ENDOLEAK. THE ANEURYSM HAS DECREASED FROM 65MM TO 53MM SINCE THE IMPLANT. THE PATIENT IS ASYMPTOMATIC AND CURRENTLY BEING MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 21138060 ↗
• InjuryJan 9, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR YEARS AFTER THE INITIAL PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SAC ENLARGEMENT OF 2¿3 MM EVERY SIX MONTHS. ON (B)(6) 2024, THE PHYSICIAN REVIEWED A COMPUTED TOMOGRAPHY (CT) SCAN AND PERFORMED AN ANGIOGRAM, IDENTIFYING A TYPE 2 ENDOLEAK FROM THE INFERIOR MESENTERIC ARTERY (IMA), A POSSIBLE TYPE 1B ENDOLEAK OF THE RIGHT LIMB, AND A SUSPECTED TYPE 3B ENDOLEAK PINHOLE DEFECT IN THE ANTERIOR PORTION OF THE GRAFT. THE PHYSICIAN ELECTED TO COIL THE IMA VIA THE SMA/ARC AND RELINED THE GRAFT WITH AN ALTO STENT GRAFT SYSTEM. POST-PROCEDURE ANGIOGRAPHY SHOWED NO REMAINING LEAKS. THE PATIENT IS EXPECTED TO BE DISCHARGED THE FOLLOWING DAY.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21119108 ↗
• InjuryNov 22, 2024Migration; Migration

  THE PATIENT INITIALLY RECEIVED AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2018. DURING AN OUTPATIENT FOLLOW-UP, THE PHYSICIAN NOTED AN INCREASE IN ANEURYSM DIAMETER AND AN IRREGULAR SHAPE OF THE IMPLANTED AFX2 BIFURCATED STENT GRAFT. A COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED A TYPE 1B ENDOLEAK AND PROXIMAL MIGRATION OF THE STENT GRAFT LIMB. AN INTERVENTION IS SCHEDULED FOR LATER THIS MONTH.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20765430 ↗
• InjuryNov 22, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN AFX VELA INFRARENAL. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, IT WAS IDENTIFIED THAT THERE WAS A PROXIMAL SEAL FAILURE OF THE AFX GRAFT RESULTING IN A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO FIX WITH THE IMPLANTATION OF A PMEG DEVICE (NON-ENDOLOGIX) AS WELL AS EXTENDING THE ILIAC LIMBS WITH TWO OVATION IX EXTENDERS TO GAIN MORE COVERAGE IN THE ILIACS. EXCLUSION OF THE ENDOLEAK WAS CONFIRMED ON ANGIOGRAM. THE PATIENT WAS TREATED SUCCESSFULLY AND IS STABLE CONDITION.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20759814 ↗
• InjuryNov 5, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT DURING THIS INITIAL PROCEDURE A TYPE IA ENDOLEAK WAS OBSERVED AND THE DECISION WAS MADE TO IMPLANT A VELA SUPRARENAL. AFTER BALLOON TOUCH-UP, IT WAS CONFIRMED THAT THERE WAS NO ENDOLEAK, AND THE PROCEDURE WAS COMPLETED. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE DURING ROUTINE FOLLOW-UP A SUSPECTED TYPE 1B ENDOLEAK WAS OBSERVED. SIX (6) DAYS LATER THE DECISION WAS MADE TO IMPLANT VIABAHN (NON-ENDOLOGIX) STENTS IN THE LIMBS BILATERALLY; HOWEVER, THE ENDOLEAK DID NOT RESOLVE, THEREFORE THE TYPE 1B ENDOLEAK WAS RULED OUT. AN ENDURANT (NON-ENDOLOGIX) CUFF WAS PLACED PROXIMALLY, BUT THE ENDOLEAK DID NOT RESOLVE, THEREFORE THE PHYSICIAN DETERMINED THE ENDOLEAK TO BE TYPE 3B. ADDITIONALLY, THE PATIENT HAD PREVIOUSLY UNDERGONE OPEN SURGERY FOR INTESTINAL OBSTRUCTION TWICE. IT IS THOUGHT THAT THE INTESTINAL OBSTRUCTION MAY HAVE BEEN CAUSED BY THE INTESTINES BEING COMPRESSED BY THE ANEURYSM ENLARGEMENT DUE TO THE ENDOLEAK. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20608771 ↗
• InjuryAug 28, 2024Lack of Effect; Lack of Effect

  ON (B)(6) 2015, THE PATIENT UNDERWENT THE IMPLANTATION OF AN AFX BIFURCATED STENT GRAFT, AN AFX INFRARENAL AORTIC EXTENSION, TWO (2) AFX VELA SUPRARENALS, AND AN AFX LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS AFTER THE INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH FLANK PAIN AND SUSPECTED GASTROINTESTINAL BLEEDING. A TYPE 3B ENDOLEAK WAS IDENTIFIED. IT WAS NOTED THAT A WEEK PRIOR, THE PATIENT HAD UNDERGONE COILING FOR A TYPE 2 ENDOLEAK, WHICH WAS UNRELATED TO THE DEVICE. TO ADDRESS THE TYPE 3B ENDOLEAK, THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT. THE INTERVENTION WAS REPORTED TO BE SUCCESSFUL. THE TYPE 3B ENDOLEAK WAS ATTRIBUTED PRIMARILY TO MANIPULATION DURING THE REPAIR AND THE RECENT COILING FOR THE TYPE 2 ENDOLEAK. MORE THAN 50 COILS WERE IMPLANTED (MFR# 2031527-2019-00234). THIS PATIENT HAD A PREVIOUSLY REPORTED EVENT ON OCTOBER 5, 2015, INVOLVING A TYPE 3A ENDOLEAK, DOCUMENTED UNDER MFR# 2031527-2015-00440, WHICH WAS TREATED WITH AN INFRARENAL AORTIC EXTENSION. ON (B)(6) 2024, IT WAS REPORTED THAT THE ANEURYSM HAD GROWN SINCE THE PREVIOUS COMPUTED TOMOGRAPHY (CT)

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20092573 ↗
• InjuryJul 26, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2022. IT WAS REPORTED THAT THE OVERLAP BETWEEN THE AFX2 AND THE AFX VELA SUPRARENAL WAS SHORTER THAN PLANNED; THEREFORE, AN AFX VELA INFRARENAL WAS IMPLANTED BETWEEN THE TWO DEVICES. THE FINAL ANGIOGRAM SHOWED A POSSIBLE TYPE 1B ENDOLEAK FROM THE LEFT COMMON ILIAC ARTERY (CIA); THEREFORE, AN AFX LIMB WAS IMPLANTED IN THE LEFT CIA. ON (B)(6) 2024, DURING ROUTINE FOLLOW-UP, ANEURYSM ENLARGEMENT WAS OBSERVED AND A TYPE IB ENDOLEAK WAS SUSPECTED. THE PHYSICIAN PERFORMED COIL OCCLUSION AS AN ENDOLEAK FROM THE LUMBAR ARTERY AND INFERIOR MESENTERIC ARTERY (IMA) WAS ALSO SUSPECTED. THE COIL OCCLUSION WAS PERFORMED TO PREVENT A TYPE 2 (NON-DEVICE RELATED) ENDOLEAK. THE PHYSICIAN ALSO ELECTED TO PERFORM A SECONDARY ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE ON (B)(6) 2024 AND IMPLANTED AN AFX ILIAC LIMB STENT GRAFT IN THE RIGHT CIA TO TREAT THE TYPE 1B ENDOLEAK. THE FINAL ANGIOGRAM AFTER BALLOON TOUCH-UP SHOWED NO ENDOLEAK. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19841052 ↗
• InjuryJul 11, 2024Off-Label Use; Material Puncture/Hole; Separation Problem; Off-Label Use; Material Puncture/Hole; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2017 WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL AND TWO (2) OVATION IX ILIAC LIMB EXTENSIONS. 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 PATIENT PRESENTED EMERGENTLY ON (B)(6) 2024 WITH A TYPE IIIB ENDOLEAK AND WAS ADMITTED TO THE HOSPITAL. REINTERVENTION OCCURRED ON 03 JULY 2024 DURING WHICH THE SURGEON RE-LINED THE AAA WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, VELA SUPRARENAL AND OVATION IX EXTENDER. THIS SECONDARY PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. PATIENT DID WELL AND WAS DISCHARGED.

  Patient problems: Clinical Endoleak

  MAUDE report 19725852 ↗
• InjuryJun 12, 2024Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, TWO (2) AFX VELA INFRARENAL STENTS, AND AN OVATION IX EXTENDER ON (B)(6) 2022, 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 NOT COMPATIBLE WITH THE AFX SYSTEM PER THE IFU. ON (B)(6) 2024, DURING A ROUTINE COMPUTED TOMOGRAPHY (CT) SCAN, A TYPE 1A ENDOLEAK WAS IDENTIFIED. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC. ADDITIONAL INFORMATION: THE PATIENT REPORTEDLY UNDERWENT A RE-INTERVENTION, DURING WHICH A GORE TAMBE DEVICE AND A GORE CONFORMABLE DEVICE (BOTH NON-ENDOLOGIX) WERE IMPLANTED. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED.

  Patient problems: Clinical Endoleak

  MAUDE report 19521514 ↗
• InjuryMay 23, 2024Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AN AFX VELA INFRARENAL, AND AN OVATION IX EXTENDER ON (B)(6) 2017. 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. IT WAS REPORTED ON 24 APRIL 2024, THAT THE ROUTINE FOLLOW-UP IDENTIFIED A TYPE IIIB ENDOLEAK. ON (B)(6) 2024 INTERVENTION OCCURRED AND PHYSICIAN ELECTED TO RELINE WITH AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND TWO (2) AFX VELA INFRARENAL. THE TYPE IIIB ENDOLEAK AND A TYPE IIIA ENDOLEAK IN THE APEX OF THE BEND WERE RESOLVED. REPORTEDLY, THE PATIENT HAS BAD SCOLIOSIS. THE PATIENT WAS REPORTED AS DOING WELL, POST-SECONDARY PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 19381699 ↗
• InjuryMay 2, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED ON (B)(6) 2018 FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA SUPRARENAL. ROUTINE FOLLOW-UP CONDUCTED ON 18 APRIL 2024 IDENTIFIED A POSSIBLE TYPE IB AND/OR TYPE IIIB ENDOLEAK. REINTERVENTION COMPLETED ON 25 APRIL 2024. THE INITIALLY IMPLANTED AFX2 BSG WAS RELINED WITH A NEW AFX2 BSG DUE TO THE INCREASING SIZE OF THE ANEURYSM, EVEN THOUGH THERE WAS NO OBVIOUS TYPE IIIB ENDOLEAK. THE SURGEON ALSO EMBOLIZED THE RIGHT INTERNAL ILIAC AND IMPLANTED AN AFX LIMB STENT GRAFT TO COVER THE POTENTIAL CAUSE OF THE POSSIBLE TYPE IB ENDOLEAK AND EXTENDED THE SEAL TO THE RIGHT EXTERNAL ILIAC ARTERY. NO EVIDENCE OF ANY ENDOLEAKS WERE PRESENT AFTER THE COMPLETION OF THE IMPLANT.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19235444 ↗
• InjuryApr 30, 2024Fracture; Off-Label Use; Material Puncture/Hole; Deformation Due to Compressive Stress; Fracture; Off-Label Use; Material Puncture/Hole; Deformation Due to Compressive Stress

  THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE ON (B)(6) 2018, DURING WHICH AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND TWO (2) OVATION IX EXTENDERS WERE IMPLANTED. 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 THE INSTRUCTIONS FOR USE (IFU). ON (B)(6) 2024, THE PHYSICIAN REPORTED SUSPICION OF AN ENDOLEAK TYPE IIIB. REINTERVENTION IS SCHEDULED FOR ON (B)(6) 2024.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19216408 ↗

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-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-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-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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL

…and 1 more.