AFX2 Bifurcated Endograft System BEA25-90/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00818009014863), received between Mar 8, 2017 and Jun 9, 2026 — classified as 1 death, 51 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (15 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 53 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Lack of Effect

  THE PATIENT PREVIOUSLY UNDERWENT IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT AS A TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2021. DURING A REGULAR FOLLOW-UP, IMAGING WAS PERFORMED USING COMPUTED TOMOGRAPHY (CT). THE REVIEW OF THESE IMAGES REVEALED THE PRESENCE OF A TYPE 1A ENDOLEAK. GIVEN THE FINDINGS, THE PROPOSED PLAN IS TO ADD AN AORTIC EXTENSION. SUFFICIENT AORTIC NECK REMAINS AVAILABLE, WHICH WILL ALLOW FOR RESTORATION OF PROPER SEALING WITH THE EXTENSION. AT PRESENT, THE PATIENT IS STABLE AND CONTINUES TO BE MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 25447561 ↗
• InjuryJun 4, 2026Separation Problem

  THE REPORTED INCIDENT WAS IDENTIFIED BY ENDOLOGIX THROUGH A RETROSPECTIVE REVIEW OF AN JOURNAL ARTICLE AND BY THE DISTRIBUTOR, JAPAN LIFELINE. DOI: 10.3400/AVD.CR.25-00129 A 76-YEAR-OLD MALE WAS REFERRED FOR TREATMENT OF AN INFRARENAL AAA IDENTIFIED DURING SCREENING COMPUTED TOMOGRAPHY (CT). THE ANEURYSM WAS FUSIFORM, WITH A MAXIMUM DIAMETER OF 65 MM AND A LONGITUDINAL LENGTH OF 85 MM. THE PROXIMAL NECK MEASURED 37 MM IN LENGTH WITH AN ANGULATION OF 55 DEGREES. THE DISTAL AORTA AT THE AORTIC BIFURCATION MEASURED 18 MM IN DIAMETER, WHICH PROMPTED THE SELECTION OF THE AFX ENDOGRAFT. ALTHOUGH THE LARGE ANEURYSM SIZE RAISED CONCERNS ABOUT SECURE FIXATION BETWEEN THE AFX2 MAIN BODY AND THE VELA EXTENSION, IT WAS ASSUMED THAT THE PRESENCE OF EXTENSIVE MURAL THROMBUS WOULD MITIGATE THE RISK OF MIGRATION. EVAR WAS PERFORMED USING A LONG AFX2 MAIN BODY (BEA25-90-116) AND A SUPRARENAL VELA EXTENSION (A28-28-C95-020V) ON 05 JANUARY 2022. INTRAOPERATIVE ANGIOGRAPHY AND POSTOPERATIVE CT REVEALED NO EVIDENCE OF AN ENDOLEAK. THE REQUIRED OVERLAP BASED ON THE MANUFACTURER'S RECOMMENDATION (ANEURYSM RADIUS +20MM) WAS CALCULATED TO BE 52.5 MM. THE OVERLAP WAS SHORTER ON THE OUTER CURVATURE SIDE THAN

  Patient problems: Clinical Endoleak

  MAUDE report 25395170 ↗
• InjuryMar 13, 2026Separation Problem

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH SAC DIAMETER OF 60MM WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA INFRARENAL, AND AN AFX VELA SUPRARENAL ON (B)(6) 2020. THE PROCEDURE WAS COMPLETED WITH NO CONFIRMED ENDOLEAKS. ON 11 DECEMBER 2020, CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) CONFIRMED THE ABSENCE OF ENDOLEAKS. ON (B)(6) 2021, CT CONFIRMED A STABLE SAC DIAMETER OF 62 MM. ON (B)(6) 2022, CT SHOWED SAC ENLARGEMENT, WITH THE DIAMETER INCREASING TO 69 MM. ON (B)(6) 2026, THE PATIENT WAS EMERGENTLY TRANSPORTED TO THE HOSPITAL DUE TO A RUPTURE OF THE AAA AND ARTIFICIAL VESSEL REPLACEMENT WAS PERFORMED. DURING THE OPEN SURGERY IT WAS REPORTED THAT THERE WAS HARDLY ANY OVERLAP BETWEEN THE AFX2 BSG AND THE AFX VELA INFRARENAL AND THE JUNCTION WAS EASILY SEPARATED. ON THE PROXIMAL SIDE, THE VELA SUPRARENAL WAS CUT, LEAVING APPROXIMATELY 3CM. A J-GRAFT SHIELD (NON-ENDOLOGIX) WAS USED TO ANASTOMOSE THE STENT GRAFT AND THE NATIVE VESSEL. ON THE DISTAL SIDE, THE AFX2 BSG AND THE VELA INFRARENAL WERE EXPLANTED. AN I-SHAPED ARTIFICIAL GRAFT (NON-ENDOLOGIX) WAS ANASTOMOSED JUST ABOVE THE AORTIC BIFURCATION AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Aneurysm; Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 24592304 ↗
• InjuryJan 15, 2026Fracture; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL EXTENSION, AND GORE EXCLUDER LEG (NON-ENDOLOGIX) FOR THE TREATMENT OF AN IMPEDING RUPTURE ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2020. THIS CASE IS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL) AS THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED. AT THE INDEX PROCEDURE THE PHYSICIAN ELECTED TO EMBOLIZE THE INFERIOR MESENTERIC ARTERY (IMA) PRIOR TO IMPLANTATION OF THE AFX2 BIFURCATED STENT GRAFT, AFX VELA SUPRARENAL AND GORE EXCLUDER LEG (NON-ENDOLOGIX). IT WAS REPORTED ON (B)(6) 2025; AN ADDITIONAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED AT THE HOSPITAL DUE TO ANEURYSM SAC ENLARGEMENT AND A SUSPECTED TYPE IIIB ENDOLEAK. THE INTRAOPERATIVE ANGIOGRAPHY CONFIRMED THERE WAS SEPARATION OF THE ENDOSKELETON STENT AND IT WAS PROTRUDING THROUGH THE FABRIC. THE PHYSICIAN ELECTED TO IMPLANT A MEDTRONIC ENDURANT AORTIC CUFF 25 BY 70MM (NON-ENDOLOGIX). THE TYPE IIIB ENDOLEAK WAS RESOLVED AND THE PROCEDURE WAS COMPLETED. THE PATIENT STATUS WAS NOT REPORTED. THE SECONDARY PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (O

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 24081624 ↗
• InjuryDec 4, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2017 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. THERE WAS A REINTERVENTION COMPLETED ON (B)(6) 2025 WITH THE IMPLANT OF AN AFX VELA INFRARENAL (REPORTED UNDER MFR# 3011063223-2025-00040). ON APPROXIMATELY (B)(6) 2025 THE FOLLOW UP COMPUTED TOMOGRAPHY (CT) REVEALED AN INDETERMINATE TYPE ENDOLEAK WITH ANEURYSM ENLARGEMENT. ON (B)(6) 2025 THE PHYSICIAN ELECTED TO TREAT THE PATIENT. TWO OVATION IX ILIAC LIMBS WERE IMPLANTED IN THE LEFT ILIAC LIMB, TWO OVATION IX ILIAC LIMBS WERE IMPLANTED IN THE RIGHT ILIAC LIMB, AND ONE AFX VELA EXTENSION WAS IMPLANTED PROXIMALLY. THE ENDOLEAK WAS NOT RESOLVED, THERE IS A TYPE IIIB ENDOLEAK. AN AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED TO RELINE THE PREVIOUSLY IMPLANTED DEVICE, BALLOONED AND THE TYPE IIIB ENDOLEAK WAS RESOLVED. THE PATIENT LEFT THE PROCEDURE ROOM IN STABLE CONDITION.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 23719512 ↗
• InjuryDec 1, 2025Off-Label Use; Obstruction of Flow; Off-Label Use; Obstruction of Flow

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT (BSG), AND AFX VELA SUPRARENAL AORTIC EXTENSION FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025. A FOLLOW-UP ON (B)(6) 2025 REVEALED OCCLUSION OF THE RIGHT CIA (COMMON ILIAC ARTERY). THE AFX2 BIFURCATED STENT GRAFT LEG SHOWED POOR EXPANSION, AND THE LUMEN OF THE RIGHT CIA WAS CONFIRMED TO BE NARROW (3.0 TO 5.0MM). ON (B)(6) 2025, THE PHYSICIAN ELECTED TO TREAT THE OCCLUSION WITH A BARE STENT EXPRESS LD:8.0MM/37MM LENGTH (NON-ENDOLOGIX) THAT WAS DEPLOYED AT THE PROXIMAL OCCLUSION OF THE AFX2 BSG RIGHT LEG. ANOTHER BARE STENT (NON-ENDOLOGIX) WAS ALSO DEPLOYED IN THE CONTRALATERAL LEG TO EQUALIZE THE EXPANSION FORCE. AS THE RIGHT CIA OCCLUSION IN THE AFX BSG DISTAL LEG WAS DEEMED TO BE STENOSED, A BARE STENT EPIC:7.0MM/40MM LENGTH (NON-ENDOLOGIX) WAS DEPLOYED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT REPORTED NO PAIN AFTER THE SURGERY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23687442 ↗
• InjurySep 5, 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) 2023. ON (B)(6) 2025, DURING A ROUTINE FOLLOW UP, A POTENTIAL TYPE IIIA ENDOLEAK WAS FOUND. THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 22986684 ↗
• InjuryApr 29, 2025Unintended Movement; Unintended Movement

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THERE WAS AN ANTEGRADE LEAK FROM THE LUMBAR ARTERY; HOWEVER, THE PROCEDURE WAS COMPLETED BECAUSE THE BLOOD FLOW WAS DELAYED. THE PATIENT WAS BEING MONITORED. NOW, APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, ANEURYSM ENLARGEMENT DUE TO AN ENDOLEAK WAS CONFIRMED. THE AFX2 BIFURCATED STENT GRAFT WAS NOTED TO BE LEANING TOWARD THE ANTERIOR WALL OF THE AORTA; THEREFORE, A TYPE IA OR TYPE 2 ENDOLEAK FROM INFERIOR MESENTERIC ARTERY (IMA) WAS SUSPECTED. ON (B)(6) 2025 THE PATIENT WAS BROUGHT BACK FOR REINTERVENTION; HOWEVER, THE ORIGIN OF THE ENDOLEAK WAS NOT IDENTIFIED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT AND IMPLANTED AN AFX VELA INFRARENAL FOLLOWED BY A GORE EXCLUDER (NON-ENDOLOGIX) CUFF TO SUCCESSFULLY RESOLVE THE ENDOLEAK.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21930572 ↗
• InjuryApr 17, 2025Off-Label Use; Off-Label Use

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA). ANGIOPLASTY WITH BARE METAL STENTS (NON-ENDOLOGIX) WAS PERFORMED IN BOTH ILIAC ARTERIES DUE TO SIGNIFICANT CALCIFICATION IN THE LEFT COMMON ILIAC ARTERY (LCIA) AND LUMINAL NARROWING IN THE RIGHT COMMON ILIAC ARTERY (RCIA). THE PHYSICIAN THEN IMPLANTED AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. 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. FINAL ANGIOGRAPHY CONFIRMED THE ABSENCE OF AN ENDOLEAK AND THE PROCEDURE WAS COMPLETED. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW-UP, ANEURYSM ENLARGEMENT WAS OBSERVED. A MONTH LATER A CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CECT) SCAN WAS PERFORMED TO INVESTIGATE THE ANEURYSM ENLARGEMENT. THE IMAGING RAISED SUSPICION FOR A TYPE III OR TYPE II ENDOLEAK. ANGIOGRAPHY WAS ALSO PERFORMED BUT FAILED TO IDENTIFY THE SPECIFIC TYPE OF THE ENDOLEAK. THE FINAL PATIENT STATUS IS UNKNOWN.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21858913 ↗
• InjuryFeb 26, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS TREATED TO REPAIR A SACCULAR AORTIC ANEURYSM WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG). THE PATIENT WAS MONITORED ANNUALLY. APPROXIMATELY SIX (6) YEARS POST PROCEDURE, INTERVENTION WAS PERFORMED DUE TO ANEURYSM ENLARGEMENT. DURING INTERVENTION A TYPE IIIB ENDOLEAK WAS OBSERVED AS A PINHOLE WAS FOUND APPROXIMATELY 1CM PROXIMAL TO THE JUNCTION BETWEEN THE AFX2 MAIN BODY AND THE LIMBS OF THE AFX2. THE AFX2 BSG WAS EXPLANTED, AND VASCULAR GRAFT SURGERY WAS PERFORMED TO COMPLETE THE PROCEDURE. THE PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21471091 ↗
• InjuryFeb 19, 2025Off-Label Use; Device-Device Incompatibility; Separation Problem; Off-Label Use; Device-Device Incompatibility; Separation Problem

  THE PATIENT WAS TREATED ON (B)(6) 2019, WITH AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) TO ADDRESS AN ABDOMINAL AORTIC ANEURYSM AND A RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIAA). A NON-ENDOLOGIX STENT WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY, FOLLOWED BY A NON-ENDOLOGIX EXCLUDER LEG TO REPAIR THE RCIAA. 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. AN AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED VIA THE LEFT FEMORAL APPROACH; HOWEVER, AN ATTEMPT TO INSERT THE AFX SHEATH THROUGH ITS LIMB FAILED DUE TO INTERFERENCE WITH THE NON-ENDOLOGIX EXCLUDER LEG. AS A RESULT, THE RIGHT FEMORAL APPROACH WAS UTILIZED, AND AN AFX VELA SUPRARENAL STENT WAS IMPLANTED BELOW THE RENAL ARTERIES. THE PROCEDURE WAS COMPLETED WITHOUT AN ENDOLEAK. ON (B)(6) 2025, AN INCREASE IN ANEURYSM DIAMETER WAS DETECTED. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A DISCONNECTION BETWEEN THE AFX2 BIFURCATED STENT GRAFT AND THE AFX VELA SUPRARENAL. ON (B)(6) 2025, AN ADDITIONAL AFX VELA INFRARENAL WAS IMPLANTED ONE SEGMENT BELOW THE PROXIMAL EDGE OF THE EXISTING AFX VELA SUPRARENAL. THE PROCEDURE WAS COMPLETED AFTER ENS

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21414005 ↗
• InjuryNov 22, 2024Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2019 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AFX VELA SUPRARENAL AND ENDURANT (NON-ENDOLOGIX) CUFF. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) AS THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED. APPROXIMATELY 5 YEARS POST INITIAL PROCEDURE, DURING ROUTINE FOLLOW-UP, COMPUTED TOMOGRAPHY (CT) SCAN SUSPECTED AN ENDOLEAK OF INDETERMINATE ORIGIN. REPORTEDLY THERE IS A POSSIBILITY OF TYPE II ENDOLEAK BECAUSE RETROGRADE BLOOD FLOW FROM THE LUMBER ARTERY WAS OBSERVED ON ANGIOGRAPHY. HOWEVER, IT WAS ALSO REPORTED THAT THERE IS THE POSSIBILITY OF A TYPE IIIB ENDOLEAK, SINCE THE INSIDE OF THE ANEURYSM COULD NOT BE SHOWN BY ANGIOGRAPHY. REINTERVENTION WAS COMPLETED ON (B)(6) 2024 WITH THE IMPLANTATION OF AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Clinical Endoleak

  MAUDE report 20760493 ↗
• InjuryNov 1, 2024Off-Label Use; Material Puncture/Hole; Migration; Separation Problem; Off-Label Use; Material Puncture/Hole; Migration; Separation Problem

  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) 2020. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE ON (B)(6) 2024, IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP THE COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) REVEALED ANEURYSM ENLARGEMENT, STENT GRAFT MIGRATION AND SEPARATION OF THE AFX2 MAIN BODY AND AFX VELA SUPRARENAL STENT GRAFTS LEADING TO A SUSPECTED TYPE IIIA ENDOLEAK, AND THE POSSIBLE PRESENCE OF A TYPE IIIB ENDOLEAK DUE TO THE MIGRATION OF THE AFX2 MAIN BODY TOWARDS THE AORTIC BIFURCATION AND THE OBSERVED REDUCTION IN THE SKELETON'S LENGTH. IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT HAD A SURGICAL INTERVENTION WITHOUT ANY COMPLICATIONS.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20586974 ↗
• InjuryOct 9, 2024Migration; Migration

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL. THE STENT GRAFTS WERE IMPLANTED THROUGH THE LEFT ACCESS SITE. IT WAS NOTED THAT THE LEFT COMMON ILIAC ARTERY (CIA) WAS LESS THAN 30 MM IN LENGTH. IT WAS ALSO NOTED THAT THE AFX WAS IMPLANTED FLOATING FROM THE AORTIC BIFURCATION. THE PROCEDURE WAS COMPLETED WITHOUT AN ENDOLEAK; HOWEVER, BECAUSE ONLY ONE STENT LENGTH OVERLAPPED THE AORTIC NECK, A SECOND VELA INFRARENAL WAS IMPLANTED SO THAT ONE STENT LENGTH COULD BE EXTENDED PROXIMALLY. AFTER BALLOON TOUCH-UP OF THE LIMB THE PROCEDURE WAS COMPLETED. APPROXIMATELY THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE STENT MIGRATION AND SHORTER OVERLAP BETWEEN THE STENT GRAFTS WERE SEEN. THERE WAS NO CONFIRMED ENDOLEAK. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Clinical Endoleak; Failure of Implant

  MAUDE report 20408633 ↗
• InjurySep 16, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2021. THE LEFT INTERNAL ILIAC ARTERY (IIA) WAS EMBOLIZED AND THE AFX2 BIFURCATED STENT, AFX VELA SUPRARENAL AND AFX LIMB EXTENSION WERE IMPLANTED VIA LEFT ACCESS. POST-DEPLOYMENT, THERE WAS A TYPE IIIA ENDOLEAK FROM THE RIGHT COMMON ILIAC ARTERY (CIA) WAS SUSPECTED. THE ENDOLEAK WAS RESOLVED INTRAOPERATIVELY BY PERFORMING BALLOON TOUCH-UP. THE PATIENT WAS TO BE KEPT UNDER OBSERVATION. THE PRE-DISCHARGE COMPUTED TOMOGRAPHY CONDUCTED POST PROCEDURE (APPROXIMATELY 08/17/2021) IDENTIFIED A SUSPECTED TYPE IIIB ENDOLEAK. AS THERE WAS NO CHANGE TO THE ANEURYSM DIAMETER AT THE TIME, THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE FOLLOW-UP IN MAY 2024, IDENTIFIED ANEURYSM ENLARGEMENT OF 5MM (54MM TO 59MM) COMPARED TO THE FOLLOW-UP SIX MONTHS PRIOR. ECHOCARDIOGRAPHY ALSO CONFIRMED THAT IT WAS MOST LIKELY TYPE IIIB ENDOLEAK. OPEN REPAIR WAS PERFORMED ON (B)(6) 2024. REPORTEDLY, THE PATIENT HAD NOT BEEN TAKING ANTICOAGULANTS AND THERE WAS NOT MUCH THROMBOSIS WITHIN THE ANEURYSM. PROXIMAL AORTA VESSEL DISSECTION OCCURRED DUE TO THE ADHESIONS BETWEEN THE VESSEL AND THE PROXIMAL BARE SEGMENT OF THE AFX VELA SUPR

  Patient problems: Aneurysm; Clinical Endoleak; Vascular Dissection

  MAUDE report 20232354 ↗
• InjuryApr 5, 2024Off-Label Use; Material Puncture/Hole; Malposition of Device; Device-Device Incompatibility; Off-Label Use; Material Puncture/Hole; Malposition of Device; Device-Device Incompatibility

  THE PATIENT WAS BEING TREATED FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2024. THE AFX2 BIFURCATED STENT GRAFT (BSG) AND AFX VELA SUPRARENAL WERE IMPLANTED FROM RIGHT ACCESS. ANGIOGRAPHY SHOWED A POSSIBLE TYPE IIIB ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A SECOND AFX2 BSG. THE SECOND AFX2 BSG WAS NOT TIGHTLY SIT ON THE TERMINAL AORTA, AND THE DISTAL EDGE OF AFX2 BSG LEFT LIMB APPEARED TO NOT BE COMPLETELY EXPANDED. ANGIOGRAPHY SHOWED A TYPE IIIB ENDOLEAK THROUGH THE FIRST AFX2. BALLOON TOUCH-UP DID NOT RESOLVE THIS PROBLEM. THE PHYSICIAN DECIDED TO ADD AN AFX LIMB ON THE LEFT COMMON ILIAC ARTERY. A BECTON DICKINSON E-LUMINEXX (NON-ENDOLOGIX) STENT WAS THEN ADDED INSIDE THE AFX LIMB; HOWEVER, THE TYPE IIIB ENDOLEAK WAS STILL SLIGHTLY OBSERVED. THE OPERATION WAS FINISHED. PATIENT STATUS WAS NOT PROVIDED. 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.

  Patient problems: Clinical Endoleak

  MAUDE report 19053714 ↗
• InjuryApr 3, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE ON (B)(6) 2023, DURING WHICH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL WERE IMPLANTED. APPROXIMATELY ONE (1) YEAR FOLLOWING THE INITIAL PROCEDURE, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED AN ENLARGEMENT OF AN ANEURYSM, MEASURING 63MM, ALONG WITH A SUSPECTED TYPE IIIB ENDOLEAK. MONITORING OF THE PATIENT WILL BE MAINTAINED, AND IN THE EVENT OF FURTHER GROWTH OF THE ANEURYSM, RE-INTERVENTION WILL BE CONSIDERED AND DISCUSSED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19030535 ↗
• InjuryMar 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT THE OVERLAP LENGTH BETWEEN THE STENT GRAFTS WAS APPROXIMATELY 40MM AT THE TIME OF IMPLANT. APPROXIMATELY FIVE AND HALF (5.5) YEARS POST INITIAL PROCEDURE, THE STENT GRAFTS WERE FOUND TO HAVE ALMOST SEPARATED. THERE WAS NO APPARENT ENDOLEAK OBSERVED; HOWEVER, THERE WAS ANEURYSM ENLARGEMENT. ON 4 MARCH 2024 THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO SUCCESSFULLY RESOLVE THIS EVENT.

  Patient problems: Aneurysm

  MAUDE report 18963544 ↗
• InjuryDec 14, 2023Insufficient Device Problem Information; 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 PROXIMAL EXTENSION. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT CONTACTED ENDOLOGIX AND STATED HIS STENT HAD FAILED AND THAT HE HAD JUST HAD MAJOR SURGERY APPROXIMATELY ONE MONTH AGO. ENDOLOGIX IS NOT AWARE OF AN ADDITIONAL SURGERY IN RELATION TO THIS PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18324119 ↗
• MalfunctionMay 8, 2023Difficult or Delayed Positioning; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Difficult or Delayed Positioning; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance

  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 CONTRALATERAL WIRE WAS NOTED TO BE TWISTING AROUND THE DELIVERY SYSTEM OF THE BIFURCATED STENT GRAFT. THE PHYSICIAN THEN ROTATED THE DELIVERY SYSTEM IN BOTH DIRECTIONS, HOWEVER THE STENT GRAFT DID NOT SEEM TO ROTATE WITH THE HANDLE ROTATION. THEREFORE, THE PHYSICIAN PULLED THE CONTRALATERAL WIRE, AFTER WHICH ITS ORIENTATION APPEARED AS RESOLVED. THE DELIVERY SYSTEM WAS THEN SEATED ON THE TERMINAL AORTA AND THE CONTROL CORD PULLED FOR STENT GRAFT DEPLOYMENT. A STRONG RESISTANCE WAS FELT, SO THE DELIVERY SYSTEM WAS ROTATED AGAIN AND THE CONTROL CORD PULLED A SECOND TIME. THE BIFURCATED STENT GRAFT THEN SUCCESSFULLY DEPLOYED. RESISTANCE WAS FELT AGAIN WHILE RETRIEVING THE CONTROL CORD AND MAIN BODY COVER, AND IT WAS DISCOVERED THAT THE DISTAL PORTION OF THE COVER WAS TORN AND DETACHED FROM THE CONTROL CORD. ONLY THE CORD WITH A METAL PART ORIGINALLY ATTACHED TO THE RED COVER WERE RETRIEVED FROM THE PATIENT'S BODY. THE OPERATION WAS CONTINUED AS PLANNED AND AN AFX VELA INFRARENAL IMPLANTED, FINAL ANGIOGRAPHY DID NOT VISUALIZE

  Patient problems: Failure of Implant

  MAUDE report 16892331 ↗
• InjuryApr 14, 2023Material Puncture/Hole; Separation Problem; Material Puncture/Hole; Separation Problem

  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 FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN INCREASING AAA (UNKNOWN DIAMETER), A TYPE II ENDOLEAK (ANATOMY-RELATED) FROM THE INFERIOR MESENTERIC ARTERY (IMA), AND A TYPE IIIA ENDOLEAK WITH COMPONENT SEPARATION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) AFX VELA INFRARENAL ON (B)(6) 2023 AND COILING THE IMA. THE ENDOLEAKS WERE CONFIRMED RESOLVED AND THE ANEURYSM SUCCESSFULLY EXCLUDED. PATIENT IS REPORTEDLY DOING WELL AND HAS BEEN DISCHARGED HOME. ADDITIONAL INFORMATION: CLINICAL ASSESSMENT IDENTIFIED THAT A TYPE IIIB ENDOLEAK (OF THE BIFURCATED STENT GRAFT) WAS ALSO PRESENT. DATE OF EVENT CONFIRMED AS 09 AUGUST 2022 PER CONSULTATION NOTE INDICATING A TYPE III ENDOLEAK WAS DIAGNOSED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16742614 ↗
• InjuryFeb 6, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE 3A ENDOLEAK AND ANEURYSM ENLARGEMENT OF 7CM WERE IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT A SUPRARENAL AORTIC EXTENSION AND AN INFRARENAL AORTIC EXTENSION TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS STABLE POST THIS SECONDARY INTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16308343 ↗
• InjuryOct 25, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY ONE YEAR POST-INITIAL PROCEDURE, A TYPE 3B ENDOLEAK WAS IDENTIFIED. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF A MEDTRONIC GRAFT (NON-ENDOLOGIX). THE TYPE 3B ENDOLEAK WAS RESOLVED. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 15670792 ↗
• InjuryAug 1, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 6 YEARS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. THE PHYSICIAN ELECTED TO RELINE THE PATIENT WITH AN ALTO ABDOMINAL STENT GRAFT SYSTEM. REPORTEDLY, THE PATIENT DID WELL.

  Patient problems: Failure of Implant

  MAUDE report 15142440 ↗
• InjuryDec 2, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 2.5 YEARS POST INITIAL PROCEDURE A CT (COMPUTED TOMOGRAPHY) SCAN WAS COMPLETED AND A TYPE 1A ENDOLEAK WAS REVEALED. REPORTEDLY, THE PHYSICIAN PLANS TO RE-INTERVENE, BUT SURGERY HAS NOT BEEN SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 12921430 ↗

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-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-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• Z-1054-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-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-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
• 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-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-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

…and 1 more.