AFX2 Bifurcated Endograft System BEA25-100/I20-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00818009014672), received between Dec 20, 2017 and Jan 2, 2026 — classified as 3 deaths, 47 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (14 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 50 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Off-Label Use

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2021 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA SUPRARENAL GRAFT, AND AN AFX INFRARENAL GRAFT. DURING THE INITIAL PROCEDURE COIL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY (IMA) WAS PERFORMED BEFORE THE AFX2 BSG WAS DEPLOYED. SUBSEQUENTLY, AN AFX VELA SUPRARENAL WAS DEPLOYED JUST BELOW THE RENAL ARTERY AND AN AFX VELA INFRARENAL WAS DEPLOYED DISTALLY FOR RELINING DUE TO SHORT OVERLAP LENGTH. COMPLETE BALLOON TOUCH UP WAS PERFORMED AND THE PROCEDURE WAS CONCLUDED WITHOUT ANY ENDOLEAKS. THE PATIENT WAS HOSPITALIZED EMERGENTLY ON (B)(6) 2025 DUE TO IMPENDING RUPTURE FOLLOWING AN OUTPATIENT VISIT WHERE THE ANGIOGRAPHY REVEALED A SUSPECTED TYPE IIIA ENDOLEAK. REINTERVENTION WAS COMPLETED ON (B)(6) 2025 AFTER THE PHYSICIAN CONDUCTED ANOTHER ANGIOGRAPHY THAT CONFIRMED THE TYPE IIIA ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) GORE (NON-ENDOLOGIX) EXCLUDER CUFFS AND ONE (1) ENDURANT (NON-ENDOLOGIX) CUFF. THE SECONDARY PROCEDURE WAS COMPLETED AND THE TYPE IIIA ENDOLEAK WAS RESOLVED. THE FINAL PATIENT STATUS WAS NOT REPORTED. THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX CO

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 23945420 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL. INTERVENTION OCCURRED ON (B)(6) 2025 FOR AN UNKNOWN EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23785455 ↗
• InjuryDec 2, 2025Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH A LEFT COMMON ILIAC ARTERY ANEURYSM (LCIAA) ON (B)(6) 2019 BY IMPLANTING A GORE (NON-ENDOLOGIX) EXCLUDER LEG FIRST TO TREAT THE LCIAA, AND THEN AN AFX2 BIFURCATED STENT GRAFT (BSG) WAS DEPLOYED OVER THE PROXIMAL NECK AND AN AFX VELA SUPRARENAL WAS DEPLOYED JUST BELOW THE RENAL ARTERY. AFTER A COMPLETE TOUCH-UP, FINAL ANGIOGRAPHY CONFIRMED NO ENDOLEAKS AND THE PROCEDURE WAS COMPLETED. DURING A SIX-MONTH FOLLOW-UP, THE ANEURYSM SAC SIZE HAD SHRUNK. HOWEVER, A TENDENCY FOR GRADUAL ANEURYSM ENLARGEMENT WAS NOTED STARTING APPROXIMATELY FOUR YEARS PRIOR (IN 2021). IN (B)(6) 2025, A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED AS THE ANEURYSM DIAMETER HAD INCREASED TO APPROXIMATELY 60MM. THE RESULTS CONFIRMED AN APPARENT ENDOLEAK ORIGINATING FROM THE SUTURE LINE OF THE AFX2 BSG LEG. REPORTEDLY, THE LCIAA WAS ASSESSED AND FOUND TO BE IN GOOD CONDITION UNDER OBSERVATION. THE ENDOLEAK WAS DETERMINED TO BE A TYPE IIIB ENDOLEAK ORIGINATING FROM THE GRAFT OF THE AFX2 BSG LEG. REINTERVENTION WAS COMPLETED ON (B)(6) 2025 WHERE THE PHYSICIAN PLACED A GORE (NON-ENDOLOGIX) EXCLUDER AND A PROXIMAL GORE (NON-ENDOLOGIX) CUFF. THE S

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 23697041 ↗
• InjuryNov 10, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL AORTIC EXTENSION. APPROXIMATELY NINE (9) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE DEVELOPED A TYPE IB ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT, ONE (1) OVATION IX ILIAC LIMB AND ONE (1) OVATION IX EXTENDER INTO THE EXTERNAL ILIAC ARTERY. ADDITIONALLY, AN AFX INFRARENAL WAS ALSO IMPLANTED. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 23509267 ↗
• InjuryAug 18, 2025Migration; Lack of Effect; Migration; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA SUPRARENAL AORTIC EXTENSION, AND AN AFX ILIAC EXTENSION FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2016. ON (B)(6) 2023, AN OVATION IX EXTENDER AND AN AFX LIMB STENT GRAFT WERE IMPLANTED TO TREAT ILIAC ANEURYSM DISTAL TO THE AFX2 STENT GRAFT ON RIGHT SIDE. ON JULY 22, 2025, IT WAS REPORTED THAT A RECENT ROUTINE FOLLOW-UP ANGIOGRAM REVEALED A TYPE IB ENDOLEAK IN THE LEFT COMMON ILIAC TO THE DISTAL AORTA AND A POSSIBLE ANEURYSM ENLARGEMENT. THE PATIENT IS STABLE AND WILL BE MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Clinical Endoleak; Exsanguination; Ischemia

  MAUDE report 22827534 ↗
• InjuryMay 16, 2025Off-Label Use; Material Puncture/Hole; Lack of Effect; Off-Label Use; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS BEING TREATED FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON APRIL 23, 2025, WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL. AN INTRAOPERATIVE ANGIOGRAPHY CONFIRMED A TYPE 1B ENDOLEAK ORIGINATING FROM THE DISTAL PORTION OF THE LEFT LEG OF THE AFX2. TO ADDRESS THIS THE PHYSICIAN ELECTED TO IMPLANT A (NON-ENDOLOGIX) GORE CUFF AT THE DISTAL LEFT LEG OF THE AFX2 BIFURCATED STENT GRAFT IN THE LEFT COMMON ILIAC ARTERY (CIA). A BALLOON CATHETER WAS INTRODUCED, AND MULTIPLE TOUCH-UP DILATIONS WERE PERFORMED SEQUENTIALLY AT THE PROXIMAL END OF THE AFX VELA SUPRARENAL. 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. FOLLOW-UP ANGIOGRAPHY REVEALED A CONFIRMED TYPE 3B ENDOLEAK, ALONG WITH SUSPECTED TYPE 3A AND PERSISTENT TYPE 1B ENDOLEAKS. TO REINFORCE THE PREVIOUSLY IMPLANTED GRAFT, AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED WITHIN THE ORIGINAL DEVICE. THE FINAL ANGIOGRAPHY SHOWED SUCCESSFUL RESOLUTION OF THE TYPE 3B ENDOLEAK. THE SUSPECTED TYPE 3A AND TYPE 1B ENDOLEAKS FROM THE LEFT LEG PERSISTED. IT WAS CONFIRMED THAT THERE WAS NO BLOO

  Patient problems: Clinical Endoleak

  MAUDE report 22036183 ↗
• DeathMay 1, 2025Failure to Advance; Difficult or Delayed Activation; Failure to Advance; Difficult or Delayed Activation

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT ON (B)(6) 2025. IT WAS REPORTED THAT (NON-ENDOLOGIX) 8 FR SHEATH WAS USED IN THE RIGHT SIDE AND A DRYSEAL 20 FR ON THE LEFT SIDE. A LUNDERQUIST (NON-ENDOLOGIX) EXTRA STIFF GUIDEWIRE WAS USED AND AN INDY (NON-ENDOLOGIX) OVER THE WIRE (OTW) VASCULAR RETRIEVER WAS USED AS A SNARE CATHETER. THE DELIVERY SYSTEM OF THE AFX2 BIFURCATED STENT GRAFT WAS INSERTED THROUGH THE LEFT ACCESS. THE CONTRALATERAL WIRE WAS CAUGHT BY THE SNARE CATHETER ON THE AORTIC BIFURCATION, THEN THE INNER CORE WAS ADVANCED TO THE POINT WHERE THE TIP CAME OUT FROM THE TOP OF THE DRYSEAL SHEATH. WHEN THE PHYSICIAN WAS REMOVING THE TRANSFER STOP AND TRYING TO ADVANCE THE INNER CORE FURTHER, THE GUIDEWIRE GOT WARPED ON THE SIDE OF THE GREATER CURVE OF THE ANEURYSM, CAUSING THE AFX2 BIFURCATED STENT GRAFT TO DROP DOWN TOWARD THE ANEURYSM AND TO BE STUCK. SUBSEQUENTLY, DEPLOYMENT WAS ATTEMPTED BY ADVANCING THE SHEATH PROXIMALLY IN THE ANEURYSM AND THEN PULLING THE SHEATH. THE INNER CORE WAS PULLED BACK TO MINIMIZE THE GAP BETWEEN THE TOP OF THE SHEATH AND THE TIP AND THE PHYSICIAN ADVANCED THE SHEATH. HOW

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ruptured Aneurysm; Shock

  MAUDE report 21942673 ↗
• InjuryApr 25, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL AORTIC EXTENSION. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, DURING ROUTINE FOLLOW UP A TYPE 3B ENDOLEAK WAS SUSPECTED. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Clinical Endoleak; Rupture

  MAUDE report 21910375 ↗
• InjuryApr 23, 2025Off-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 AND AN AFX VELA SUPRARENAL AORTIC EXTENSION ON (B)(6) 2020. ON AN UNKNOWN DATE IN 2022, A TYPE 1B ENDOLEAK COMING FROM THE RIGHT ILIAC ARTERY WAS DETECTED. THE PHYSICIAN ELECTED TO IMPLANT AN AFX ILIAC EXTENSION IN THE RIGHT ILIAC ON (B)(6) 2022. ADDITIONALLY, EMBOLIZATION OF A LUMBAR ARTERY DUE TO A TYPE 2 (NON-DEVICE RELATED) ENDOLEAK WAS PERFORMED ON AN UNKNOWN DATE IN 2024. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3011063223-2025-00049. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, AT THE LAST COMPUTED TOMOGRAPHY (CT) SCAN IN (B)(6) 2025, THE ANEURYSM DIAMETER MEASURED 103MM, WHILE IN 2024 THE DIAMETER IT WAS 102MM. THE PHYSICIAN SUSPECTED THERE IS A TYPE 1B ENDOLEAK FROM THE LEFT ILIAC AND ELECTED TO TREAT THE PATIENT. ON (B)(6) 2025 TWO (2) AFX ILIAC LIMBS WERE IMPLANTED. IT WAS REPORTED THAT IT WAS DIFFICULT TO PASS THE LUNDERQUIST (NON-ENDOLOGIX) WIRE THROUGH THE ILIAC LIMB; THEREFORE, CANNULATION WAS DONE THROUGH THE BRACHIAL BRANCH TO GO THROUGH THE PROTHESIS AND IT WAS SUCCESSFUL. THE TWO AFX LIMBS WERE IMPLANTED AND AT THE END OF THE

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21895141 ↗
• InjuryApr 23, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL AORTIC EXTENSION ON (B)(6) 2020. ON AN UNKNOWN DATE IN 2022, A TYPE 1B ENDOLEAK COMING FROM THE RIGHT ILIAC ARTERY WAS DETECTED. THE PHYSICIAN ELECTED TO IMPLANT AN AFX ILIAC EXTENSION IN THE RIGHT ILIAC ON (B)(6) 2022. ADDITIONALLY, EMBOLIZATION OF A LUMBAR ARTERY DUE TO A TYPE 2 (NON-DEVICE RELATED) ENDOLEAK WAS PERFORMED ON AN UNKNOWN DATE IN 2024.

  Patient problems: Clinical Endoleak

  MAUDE report 21892377 ↗
• InjuryNov 27, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE II ENDOLEAK WAS IDENTIFIED FROM THE LUMBARS WHICH PROGRESSED THE LEFT COMMON ILIAC DISEASE CREATING A TYPE 1B ENDOLEAK. THE ENDOLEAK WAS IDENTIFIED WITH AN ANGIOGRAM. THE PHYSICIAN ELECTED TO COIL EMBOLIZE THE LEFT HYPOGASTRIC AND THEN PLACED AN ILIAC LIMB EXTENDING TO THE EXTERNAL. THE ENDOLEAK WAS RESOLVED AND THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 20791578 ↗
• InjuryOct 29, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2016. APPROXIMATELY EIGHT (8) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW-UP STENT GRAFT SEPARATION WITH ANEURYSM ENLARGEMENT WAS NOTED. ON (B)(6) 2024 AFTER SOME DIAGNOSTIC IMAGING, IT WAS APPARENT THAT THERE WAS A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH IMPLANTATION OF AN AFX VELA SUPRARENAL STENT GRAFT. THE TYPE 1A ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PATIENT WAS REPORTED AS STABLE AND BEING DISCHARGED. CORRECTION/UPDATE: THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2016. APPROXIMATELY EIGHT (8) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW-UP THERE WAS ANEURYSM ENLARGEMENT NOTED. ON (B)(6) 2024 AFTER SOME DIAGNOSTIC IMAGING, IT WAS APPARENT THAT THERE WAS A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH IMPLANTATION OF AN AFX VELA SUPRARENAL STENT GRAFT. THE TYPE 1A ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PATIENT WAS REPORTED AS STABLE AND BEING DISCHARGED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20560077 ↗
• InjuryJun 27, 2024Lack of Effect; 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, AND AN AFX VELA SUPRARENAL. APPROXIMATELY SIX AND A HALF (6.5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE IIIA ENDOLEAK AND AN EXPANDING ANEURYSM WAS OBSERVED. ON (B)(6) 2024 THE PHYSICIAN COMPLETED THE INTERVENTION WITH THE IMPLANTATION OF AN AFX VELA INFRARENAL, AFX VELA SUPRARENAL, AND AN OVATION IX EXTENDER. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19628977 ↗
• InjuryDec 27, 2023Off-Label Use; Off-Label Use

  THE PATIENT UNDERWENT AN INITIAL PROCEDURE INVOLVING THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT, TWO AFX VELA INFRARENAL AORTIC EXTENSIONS, AN AFX VELA SUPRARENAL AORTIC EXTENSION, TWO GORE (NON-ENDOLOGIX) VBX STENTS, AND A GORE (NON-ENDOLOGIX) CUFF FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THIS INITIAL PROCEDURE, AN ENDOLEAK TYPE 3A WAS IDENTIFIED. 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. APPROXIMATELY ONE AND A HALF (1.5) YEARS POST THE INITIAL PROCEDURE, THE PATIENT PRESENTED AT THE HOSPITAL WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. A REVIEW OF THE PATIENT'S COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE PRESENCE OF A TYPE 3B ENDOLEAK. AN EMERGENCY RE-INTERVENTION PROCEDURE WAS PERFORMED. THE PHYSICIAN OPTED TO IMPLANT A GORE (NON-ENDOLOGIX) EXCLUDER DEVICE DURING THIS INTERVENTION. (MRN 3011063223-2023-00051).

  Patient problems: Clinical Endoleak

  MAUDE report 18400622 ↗
• InjuryDec 18, 2023Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT UNDERWENT AN INITIAL PROCEDURE INVOLVING THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT, TWO AFX VELA INFRARENAL AORTIC EXTENSIONS, AN AFX VELA SUPRARENAL AORTIC EXTENSION, TWO GORE (NON-ENDOLOGIX) VBX STENTS, AND A GORE (NON-ENDOLOGIX) CUFF FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THIS INITIAL PROCEDURE, AN ENDOLEAK TYPE 3A WAS IDENTIFIED. 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. APPROXIMATELY ONE AND A HALF (1.5) YEARS POST THE INITIAL PROCEDURE, THE PATIENT PRESENTED AT THE HOSPITAL WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. A REVIEW OF THE PATIENT'S COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE PRESENCE OF A TYPE 3B ENDOLEAK. AN EMERGENCY RE-INTERVENTION PROCEDURE WAS PERFORMED. THE PHYSICIAN OPTED TO IMPLANT A GORE (NON-ENDOLOGIX) EXCLUDER DEVICE DURING THIS INTERVENTION. ADDITIONAL INFORMATION: THE CLINICAL EVALUATION INDICATED EVIDENCE THAT THE OCCURRENCE OF A TYPE II ENDOLEAK (ANATOMY-RELATED), SPECIFICALLY LUMBAR, WHICH WAS NOT REPORTED DURING THE INITIAL REPORT. THIS TYPE II ENDOLEAK WAS IDENTIFIED ON JANUARY 13, 2024, UPON R

  Patient problems: Clinical Endoleak; Rupture

  MAUDE report 18352003 ↗
• InjurySep 12, 2023Separation Problem; Separation Problem

  ON (B)(6) 2016 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 AN AFX LIMB STENT GRAFT. REPORTEDLY, THE PATIENT WAS LOST TO FOLLOW-UP. ON (B)(6) 2023 THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. THE COMPUTED TOMOGRAPHY ANGIOGRAPHY IDENTIFIED SEPARATION OF THE AFX2 BSG AND THE AFX VELA SUPRARENAL. REINTERVENTION WAS COMPLETED ON (B)(6) 2023 WITH THE IMPLANT OF TWO (2) AFX VELA INFRARENAL, AND AFX VELA SUPRARENAL AND AN AFX LIMB STENT GRAFT. REPORTEDLY, THE PATIENT DID WELL WAS DISCHARGED THE NEXT DAY. AFTER THE INITIAL REPORT, THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLE SUGGEST ANEURYSM ENLARGEMENT OF 44.6MM OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE ANEURYSM ENLARGEMENT WAS DISCOVERED DURING REVIEW OF THE COMPUTED TOMOGRAPHY SCAN DATED (B)(6) 2023.

  Patient problems: Aneurysm; Clinical Endoleak; Pain

  MAUDE report 17730421 ↗
• InjuryMay 12, 2023Difficult to Advance; Activation Failure; Difficult to Advance; Activation Failure

  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 PHYSICIAN ENCOUNTERED DIFFICULTY DEPLOYING THE CONTRALATERAL LIMB OF THE AFX2 DEVICE. VARIOUS METHODS WERE ATTEMPTED, BUT NONE WERE SUCCESSFUL. THE PHYSICIAN ULTIMATELY DECIDED TO LEAVE THE AFX2 AS AN AUI (AORTO-UNI-ILIAC) FORM AND PERFORM AN F-F (FEMORAL-FEMORAL) BYPASS. THE CONTRALATERAL LIMB COVER WAS CUT OFF AND LEFT INSIDE THE BODY WITH THE UNDEPLOYED LIMB. THE PROCEDURE WAS COMPLETED, AND BLOOD FLOW TO THE CONTRALATERAL LEG WAS CHECKED.

  Patient problems: Failure of Implant

  MAUDE report 16923301 ↗
• InjuryMay 3, 2023Collapse; Material Puncture/Hole; Collapse; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL ON (B)(6) 2016. THE ROUTINE FOLLOW-UP PERFORMED ON (B)(6) 2023, IDENTIFIED A POSSIBLE TYPE IIIA ENDOLEAK OR A POSSIBLE TYPE IIIB ENDOLEAK. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2023. IT WAS DETERMINED THAT THE ENDOLEAK WAS A TYPE IIIB. THE FINAL OUTCOME WAS SUCCESSFUL. AFTER THE INITIAL REPORT, THE CLINICAL EVALUATION ALSO SHOWS REASONABLE EVIDENCE TO SUGGEST ANEURYSM ENLARGEMENT OF 17MM AND BUCKLING OF THE LEFT ILIAC STENT OCCURRED THAT WAS NOT INCLUDED IN THE REPORTED EVENT AS REPORTED. THE ANEURYSM ENLARGEMENT AND BUCKLING WERE DISCOVERED DURING REVIEW OF THE COMPUTED TOMOGRAPHY SCAN REPORT DATED (B)(6) 2023.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16865617 ↗
• InjuryJan 3, 2023Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A SUPRARENAL AORTIC EXTENSION AND A GORE (NON-ENDOLOGIX) ILIAC LIMB 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. IT WAS NOTED THAT THE PATIENT WAS LOST TO FOLLOW UP DUE TO A CEREBRAL INFARCTION (UNRELATED TO THE AAA). APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE THE PATIENT WAS BEING TRANSPORTED TO THE HOSPITAL (THE EXACT DATE IS UNKNOWN) COMPLAINING OF STOMACHACHE. A COMPUTED TOMOGRAPHY (CT) WAS DONE AND SHOWED AAA RUPTURE. THERE WAS ALSO A TYPE 1B ENDOLEAK FROM THE RIGHT COMMON ILIAC ARTERY (CIA) OR A SUSPECTED TYPE 3B ENDOLEAK FROM THE AFX2 BIFURCATED STENT GRAFT. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER AFX2 BIFURCATED STENT GRAFT AND AN ILIAC EXTENSION ON THE RIGHT SIDE (EXACT DATE IS UNKNOWN). A TYPE 2 ENDOLEAK (NON-DEVICE RELATED) WAS CONFIRMED AFTER THIS INTERVENTION. NO OTHER ENDOLEAKS WERE OBSERVED. THE PATIENT WAS TRANSFERRED TO A REHABILITATION HOSPITAL.

  Patient problems: Abdominal Pain; Clinical Endoleak; Failure of Implant; Rupture

  MAUDE report 16091689 ↗
• InjurySep 14, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX2 BIFURCATED STENT GRAFT AND A NON-ENDOLOGIX E-LUMINEXX® BARD STENT. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX2 SYSTEM PER THE IFU. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH ABDOMINAL PAIN. COMPUTERIZED TOMOGRAPHY IDENTIFIED A POSSIBLE TYPE 3B ENDOLEAK AROUND THE ANEURYSM. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF NON-ENDOLOGIX GORE EXCLUDER STENTS (MAIN BODY, RIGHT AND LEFT LEG). THE TYPE 3B ENDOLEAK WAS RESOLVED. THE FINAL PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Abdominal Pain; Failure of Implant

  MAUDE report 15419824 ↗
• InjuryJul 19, 2022Material Puncture/Hole; Deformation Due to Compressive Stress; Device-Device Incompatibility; Material Puncture/Hole; Deformation Due to Compressive Stress; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AND TWO (2) GORE (NON-ENDOLOGIX) EXCLUDER ILIAC BRANCH ENDOPROSTHESIS STENTS. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX2 SYSTEM PER THE IFU. THREE (3) DAYS POST-INITIAL PROCEDURE, A TYPE IA ENDOLEAK WAS IDENTIFIED. REINTERVENTION WAS PERFORMED WITH THE IMPLANT OF AN AFX VELA SUPRARENAL. ADDITIONALLY, THERE WAS STENOSIS IN RIGHT LIMB OF THE AFX2 BIFURCATED STENT GRAFT NEAR THE COMMON ILIAC ARTERY DUE TO THE VESSEL MORPHOLOGY. A 14MM CORDIS (NON-ENDOLOGIX) S.M.A.R.T. STENT WAS IMPLANTED TO TREAT THE STENOSIS. THE TYPE IA ENDOLEAK WAS RESOLVED. THE FINAL PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 15056126 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA). AN ENDO KNOT OCCURRED DURING PLACEMENT OF THE AFX2 BIFURCATED STENT GRAFT. THE PHYSICIAN WAS UNABLE TO RESOLVE THE ISSUE; THEREFORE, THE AFX2 BIFURCATED STENT GRAFT SYSTEM WAS REMOVED FROM THE PATIENT. WHILE WITHDRAWING THE SYSTEM THE COMMON FEMORAL ARTERY WAS TORN. A NEW AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL WERE IMPLANTED SUCCESSFULLY EXCLUDING THE AAA. THE COMMON FEMORAL ARTERY WAS REPAIRED WITH A CUT-DOWN AND SEVERAL COVERED STENTS AS WELL AS A FEMORAL RECONSTRUCTION. THE PATIENT WAS REPORTED TO BE STABLE POST PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 13113004 ↗
• InjuryOct 4, 2021Insufficient Device Problem Information; 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 THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT THE HOSPITAL WITH ABDOMINAL PAIN. ANEURYSM ENLARGEMENT WAS IDENTIFIED AND AN INDETERMINATE ORIGIN ENDOLEAK WAS CONFIRMED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY PLACING NON-ENDOLOGIX STENT GRAFTS TO SUCCESSFULLY RESOLVE THIS EVENT. IT WAS REPORTED THAT DURING THE INTERVENTION PROCEDURE THE TYPE OF ENDOLEAK WAS UNABLE TO BE DETERMINED. THE PROCEDURE WAS COMPLETED WITHOUT ENDOLEAKS.

  Patient problems: Aneurysm; Failure of Implant; Pain

  MAUDE report 12573718 ↗
• InjuryJun 23, 2021Complete Blockage; Insufficient Device Problem Information; Complete Blockage; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (4) FOUR YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW-UP, AN OCCLUSION OF THE RIGHT LIMB WAS IDENTIFIED. THE PATIENT IS BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 12053610 ↗
• InjuryMay 22, 2021Fracture; Material Puncture/Hole; Insufficient Device Problem Information; Fracture; Material Puncture/Hole; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND (2) TWO VELA SUPRARENAL'S TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THE PROCEDURE, A TYPE 1A ENDOLEAK WAS CONFIRMED ON THE ANGIOGRAPHY, SO ANOTHER VELA SUPRARENAL WAS IMPLANTED. APPROXIMATELY (2) YEARS POST INITIAL IMPLANT PROCEDURE THE PATIENT WAS IDENTIFIED WITH TYPE 1B ENDOLEAK. THE PATIENT STATUS IS UNKNOWN AT THIS TIME.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11868164 ↗

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-1054-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1037-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1039-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• 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-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-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL

…and 1 more.