AFX2 Bifurcated Endograft System BEA28-120/I20-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00818009014399), received between Jul 14, 2016 and Oct 30, 2025 — classified as 3 deaths, 41 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (17 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 45 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2025Material Puncture/Hole; Deformation Due to Compressive Stress; Material Puncture/Hole; Deformation Due to Compressive Stress

  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) 2021. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE ER FOR CHEST PAIN UNRELATED TO AAA. A COMPUTED TOMOGRAPHY (CT) SCAN WAS TAKEN AND A TYPE IIIB ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2025, THE PATIENT DISCHARGED THEMSELVES AGAINST MEDICAL ADVICE. THE PATIENT WAS BEING MONITORED AND AN INTERVENTION WAS PLANNED FOR ON (B)(6) 2025 BUT IT HAS BEEN CANCELED.

  Patient problems: Aneurysm; Clinical Endoleak; Pain

  MAUDE report 23427052 ↗
• InjuryJul 22, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2018 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA SUPRARENAL. IT WAS REPORTED ON (B)(6) 2025 THAT A POSSIBLE TYPE IIIB ENDOLEAK OF THE AFX2 BSG WAS IDENTIFIED AT ROUTINE FOLLOW-UP. ANGIOGRAM AND POSSIBLE REINTERVENTION IS SCHEDULED FOR (B)(6) 2025.

  Patient problems: Clinical Endoleak

  MAUDE report 22567348 ↗
• InjuryJul 3, 2025Material Puncture/Hole; Lack of Effect; Material Puncture/Hole; 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) 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. NOW APPROXIMATELY THREE (3) MONTHS POST THIS EVENT, 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. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22394654 ↗
• InjuryOct 2, 2024Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL STENT GRAFT FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6), 2018. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP THE COMPUTED ANGIOGRAPHY (CT) SHOWS A TYPE IIIB ENDOLEAK. THE PATIENT IS STABLE AND IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Clinical Endoleak

  MAUDE report 20353070 ↗
• InjuryAug 8, 2024Material Puncture/Hole; Deformation Due to Compressive Stress; Lack of Effect; Material Puncture/Hole; Deformation Due to Compressive Stress; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED AN INDETERMINATE ENDOLEAK WITH ANEURYSM ENLARGEMENT. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19945550 ↗
• InjuryJul 18, 2024Off-Label Use; Off-Label Use

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2020, WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND TWO (2) OVATION IX EXTENDERS. 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. IT WAS NOTED THAT THE OVATION ILIAC EXTENDERS WERE IMPLANTED ON THE PATIENT'S LEFT SIDE. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW-UP, A TYPE IB ENDOLEAK WAS IDENTIFIED ORIGINATING FROM THE PATIENT'S RIGHT SIDE. RE-INTERVENTION IS SCHEDULED FOR (B)(6) 2024. THE PATIENT IS STABLE. ADDITIONAL INFORMATION: A CLINICAL EVALUATION OF THE ADVERSE EVENT WAS CONDUCTED, REVEALING A PROCEDURE-RELATED COMPLICATION: A SMALL, (ANATOMY RELATED) TYPE II ENDOLEAK ORIGINATING FROM THE RIGHT INTERNAL ILIAC ARTERY. A RE-INTERVENTION HAS BEEN SCHEDULED FOR (B)(6) 2024.

  Patient problems: Clinical Endoleak

  MAUDE report 19779545 ↗
• InjuryMar 21, 2024Fracture; Material Puncture/Hole; Fracture; Material Puncture/Hole

  THE PATIENT UNDERWENT INITIAL TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2020, WHICH INVOLVED THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT HAS DEVELOPED AN ENDOLEAK TYPE IIIB ATTRIBUTED TO A FRACTURE IN THE AFX2 BIFURCATED STENT. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE STENT IS IN CONTACT WITH THE EDGE OF THE ANEURYSM SAC, POSING A SIGNIFICANT RISK OF RUPTURE. ALTHOUGH THE PATIENT'S CURRENT CONDITION IS STABLE, URGENT INTERVENTION IS NECESSARY TO MITIGATE POTENTIAL COMPLICATIONS. THE PATIENT'S RE-INTERVENTION IS PENDING.

  Patient problems: Clinical Endoleak

  MAUDE report 18952432 ↗
• InjuryNov 6, 2023Material Puncture/Hole; Deformation Due to Compressive Stress; Lack of Effect; Material Puncture/Hole; Deformation Due to Compressive Stress; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2019 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. ROUTINE FOLLOW-UP COMPUTED TOMOGRAPHY PERFORMED ON (B)(6) 2023 IDENTIFIED A TYPE II ENDOLEAK (NON-DEVICE RELATED). THE PHYSICIAN ELECTED TO PERFORM AN ADDITIONAL ANGIOGRAM ON (B)(6) 2023 WHICH IDENTIFIED A TYPE IB ENDOLEAK IN THE LEFT LIMB. THIS WAS SUCCESSFULLY TREATED WITH THE IMPLANT OF AN OVATION IX EXTENDER. THE FINAL ANGIOGRAM LOOKED GREAT AND THE PATIENT DID WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 18074590 ↗
• InjuryAug 24, 2023Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT, TWO (2) AFX INFRARENAL AORTIC EXTENSIONS AND ONE (1) AFX VELA SUPRARENAL PROXIMAL EXTENSION ON (B)(6) 2014. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH SIGNIFICANT ANEURYSM ENLARGEMENT (6MM), SUPRARENAL MIGRATION (1.5CM) AND A DISTAL TYPE IIIB ENDOLEAK OF THE BIFURCATED STENT GRAFT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL AND ONE (1) ADDITIONAL AFX VELA SUPRARENAL ON (B)(6)2017. REFERENCE MFR. REPORT # 2031527-2017-00375 FOR THIS SECONDARY INTERVENTION EVENT. APPROXIMATELY ONE (1) YEAR POST SECONDARY INTERVENTION, THE PATIENT PRESENTED WITH A POTENTIAL ENDOLEAK (AT AN INDETERMINATE ORIGIN). THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. REFERENCE MFR. REPORT # 2031527-2018-00415. THEN APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST SECONDARY INTERVENTION, THE PHYSICIAN TREATED THE PATIENT FOR A TYPE IIIB ENDOLEAK AND AORTIC RUPTURE SOMETIME IN (B)(6)2022. THIS EVENT WAS DISCOVERED DURING CLINICAL ASSESSMENT TO PATIENT ID (B)(6) (MFR. REPORT # 2031527-202

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 17613364 ↗
• InjuryAug 3, 2023Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2019 WITH THE IMPLANT OF AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL AND AN OVATION IX EXTENDER. 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. ON (B)(6) 2023, ENDOLOGIX WAS NOTIFIED THAT THE RECENT COMPUTED TOMOGRAPHY SCAN IDENTIFIED ANEURYSM GROWTH OF 5CM THAT APPEARS STABLE AND A POSSIBLE TYPE IIIB ENDOLEAK NEAR THE BIFURCATION OF THE AFX2. REINTERVENTION IS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17452627 ↗
• InjuryJul 17, 2023Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL AORTIC EXTENSION, AN OVATION ILIAC LIMB, AND AN OVATION ILIAC EXTENSION 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 FIVE (5) YEARS POST INITIAL PROCEDURE, DURING A FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED EVIDENCE OF A TYPE 2 OR A TYPE 3B ENDOLEAK AND THE ANEURYSM SAC HAD GROWN TO 6CM. FIVE (DAYS) AFTER THE CT, THE PATIENT WAS BROUGHT BACK FOR INTERVENTION. AN ANGIOGRAM WAS TAKEN AND REVEALED A PUNCTURE IN THE STENT GRAFT (CATEGORIZED AS A TYPE 3B ENDOLEAK) THAT THE PHYSICIAN BELIEVES IS DUE TO AN UNRELATED HEART CATHETER PROCEDURE. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT AND AN OVATION EXTENDER. THE EVENT WAS SUCCESSFULLY RESOLVED AND THERE WAS NO LONGER EVIDENCE OF AN ENDOLEAK ON THE ANGIOGRAM.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17339556 ↗
• InjuryJun 20, 2023Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL, AND A LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE DURING ROUTINE FOLLOW UP, THE PATIENT PRESENTED WITH A 3A ENDOLEAK, 1B ENDOLEAK AND A TYPE 2 ENDOLEAK OF THE LUMBARS (NON-DEVICE FAILURE). INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINED THE ORIGINAL IMPLANTED DEVICES WITH A AFX2 BIFURCATED STENT GRAFT, AFX LIMB STENT GRAFT AND OVATION IX EXTENDER TO RESOLVE THIS EVENT. PATIENT WAS REPORTED AS STABLE POST REINTERVENTION. THIS EVENT WAS PREVIOUSLY REPORTED UNDER 2031527-2021-00147. NOW, APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE A TYPE 3A ENDOLEAK WAS IDENTIFIED COMING FROM BETWEEN THE BIFURCATED STENT GRAFT AND A THE VELA SUPRARENAL AORTIC EXTENSION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY PLACING ONE (1) OVATION EXTENDER AND FOUR (4) AFX VELA SUPRARENAL AORTIC EXTENSIONS TO RESOLVE THIS EVENT.

  Patient problems: Clinical Endoleak

  MAUDE report 17164317 ↗
• DeathMay 15, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN OVATION IX EXTENDER. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY THREE (3) YEARS POST-INITIAL PROCEDURE, THE PATIENT WAS IN A CAR ACCIDENT EXPERIENCING INTERNAL TRAUMA. A POSSIBLE TYPE 3B ENDOLEAK WAS IDENTIFIED. REINTERVENTION WAS COMPLETED WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL, AND TWO (2) OVATION IX EXTENDER. THE TYPE 3B ENDOLEAK WAS REPORTED TO BE SEALED. REFERENCE MFR. REPORT # 2031527-2022-00124. NOW, APPROXIMATELY ONE (1) YEAR POST-REINTERVENTION, THE PATIENT HAS BEEN IN A CAR ACCIDENT AND THERE IS A POSSIBLE TYPE 3B ENDOLEAK. REINTERVENTION HAS BEEN SCHEDULED. AFTER THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE REINTERVENTION WAS CANCELLED AS THE PATIENT PASSED AWAY ON AN UNKNOWN DATE DUE TO COMPLICATIONS FROM THE CAR ACCIDENT.

  Patient problems: Clinical Endoleak

  MAUDE report 16934924 ↗
• InjuryMay 8, 2023Migration; Lack of Effect; Migration; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT, TWO (2) AFX INFRARENAL AORTIC EXTENSIONS AND ONE (1) AFX VELA SUPRARENAL PROXIMAL EXTENSION ON (B)(6) 2014. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH SIGNIFICANT ANEURYSM ENLARGEMENT (6MM), SUPRARENAL MIGRATION (1.5CM) AND A DISTAL TYPE IIIB ENDOLEAK OF THE BIFURCATED STENT GRAFT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL AND ONE (1) ADDITIONAL AFX VELA SUPRARENAL ON 17 JULY 2017. REFERENCE MFR. REPORT # 2031527-2017-00375. APPROXIMATELY ONE (1) YEAR POST-SECONDARY INTERVENTION, THE PATIENT PRESENTED WITH A POTENTIAL ENDOLEAK (AT AN INDETERMINATE ORIGIN). THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. REFERENCE MFR. REPORT # 2031527-2018-00415. NOW APPROXIMATELY THREE AND A HALF (3.5) YEARS LATER, THE PATIENT PRESENTS WITH AN ENLARGED ANEURYSM SAC (UNKNOWN DIAMETER) PER CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN PLANS TO TREAT THE PATIENT VIA FEVAR (FENESTRATED ENDOVASCULAR AORTIC REPAIR), BUT SURGERY HAS NOT BEEN SCHEDULED. PATIENT IS REPORTEDLY IN G

  Patient problems: Aneurysm

  MAUDE report 16892053 ↗
• InjuryMar 7, 2023Lack 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 LIMB STENT GRAFT DISTAL EXTENSION. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK FROM THE LEFT COMMON ILIAC. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EXTENDING THE LEFT EXTERNAL ILIAC WITH ONE (1) ADDITIONAL AFX LIMB STENT GRAFT ON (B)(6) 2023. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: Clinical Endoleak

  MAUDE report 16499462 ↗
• InjuryMar 7, 2023Fracture; Migration or Expulsion of Device; Lack of Effect; Fracture; Migration or Expulsion of Device; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, TWO (2) SUPRARENAL AORTIC EXTENSIONS, AND ONE (1) INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEAR POST INITIAL PROCEDURE THE PATIENT PRESENTED WITH AN ENLARGING AAA TO 11.4CM IN DIAMETER WITHOUT A VISIBLE ENDOLEAK. THE ANEURYSM RUPTURED IN THE EMERGENCY ROOM. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER AFX2 BIFURCATED STENT GRAFT, A SUPRARENAL AORTIC EXTENSION AND AN OVATION IX ILIAC EXTENSION TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST SECONDARY PROCEDURE. ADDITIONAL INFORMATION: AN INTERNAL CLINICAL ASSESSMENT SHOWS REASONABLE EVIDENCE TO SUGGEST A DISTAL STENT FRACTURE AND MIGRATION OF THE PROXIMAL EXTENSION (AMOUNT UNKNOWN) OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE FRACTURE AND MIGRATION WERE DISCOVERED DURING A REVIEW OF THE OPERATIVE NOTES DATED 02/13/2023.

  Patient problems: Aneurysm; Ruptured Aneurysm

  MAUDE report 16496540 ↗
• InjuryMay 11, 2022Off-Label Use; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE PATIENT TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. A TYPE IB ENDOLEAK WAS IDENTIFIED THIRTY-SIX DAYS POST INITIAL PROCEDURE. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN AFX LIMB STENT GRAFT SUCCESSFULLY SEALING THE TYPE IB ENDOLEAK. THE PATIENT WAS REPORTED TO BE FINE.

  Patient problems: Failure of Implant

  MAUDE report 14360279 ↗
• InjuryApr 21, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3 YEARS POST INITIAL PROCEDURE, AN ANGIOGRAM IDENTIFIED A 3B ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE THE ORIGINALLY IMPLANTED DEVICES WITH THE ALTO ABDOMINAL STENT GRAFT SYSTEM. THE CASE WENT WELL AND THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 14178081 ↗
• InjuryMar 8, 2022Material 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 TWO (2) AFX VELA INFRARENAL PROXIMAL EXTENSIONS. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IIIB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT AND VELA INFRARENAL. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED, AND THE PATIENT WAS REPORTEDLY IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 13694203 ↗
• InjuryFeb 15, 2022Off-Label Use; Material Puncture/Hole; Insufficient Device Problem Information; Off-Label Use; Material Puncture/Hole; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA), WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AFX VELA INFRARENAL STENT GRAFT, AND AN AFX SUPRARENAL STENT GRAFT. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN WHERE AN ENDOLEAK (INDETERMINATE ORIGIN) WAS IDENTIFIED. THE PATIENT IS CURRENTLY IN STABLE CONDITION PENDING A RE-INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 13538638 ↗
• InjuryJan 13, 2022Off-Label Use; Unintended Movement; Insufficient Device Problem Information; Off-Label Use; Unintended Movement; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, TWO (2) VELA SUPRARENAL STENT GRAFTS AND A LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL IMPLANT DURING A ROUTINE FOLLOW UP, THE PATIENT WAS IDENTIFIED WITH A TYPE 3A ENDOLEAK WITH COMPONENT SEPARATION. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER SUPRARENAL STENT GRAFT AND AN INFRARENAL STENT GRAFT TO TREAT THIS EVENT. THE PATIENT WAS REPORTED AS STABLE POST RE-INTERVENTION. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 2031527-2021-00056. APPROXIMATELY THREE (3) MONTHS POST RE-INTERVENTION, AN UNKNOWN PROXIMAL ENDOLEAK, AN UNKNOWN DISTAL TYPE 3 ENDOLEAK (TYPE UNKNOWN) AND ANEURYSM SAC GROWTH WERE IDENTIFIED. NO FURTHER INFORMATION WAS PROVIDED, AND THE PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13256124 ↗
• InjuryJul 23, 2021Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, VELA SUPRARENAL, AND (2) TWO LIMB STENT GRAFT'S TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS BROUGHT INTO THE (ER) EMERGENCY ROOM WITH A RUPTURE AND A TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO DO A RE-INTERVENTION AND IMPLANTED AN AFX VELA INFRARENAL. THE PATIENT WAS REPORTED AS BEING STABLE POST-SECONDARY PROCEDURE. ADDITIONAL CLARIFICATION TO REPORTED EVENT: PATIENT ALSO PRESENTED WITH HYPOTENSION AT TIME OF REPORTED EVENT, AND THE TYPE IIIA ENDOLEAK WAS ACCOMPANIED BY COMPLETE COMPONENT SEPARATION.

  Patient problems: Failure of Implant; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 12218237 ↗
• InjuryApr 26, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) MONTHS POST INITIAL PROCEDURE, EXPANSION OF BOTH ILIAC ARTERIES FROM AN INDETERMINATE ENDOLEAK (POSSIBLE TYPE 1B OR 2 ENDOLEAK) WAS IDENTIFIED. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) LIMB STENT GRAFTS TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED IN GOOD CONDITION POST INTERVENTION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11727029 ↗
• DeathMar 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND TWO (2) LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ANEURYSM RUPTURE AND SENT TO THE EMERGENCY ROOM. THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Rupture

  MAUDE report 11486514 ↗
• InjuryMar 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND AN INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4 YEARS POST INITIAL IMPLANT, A TYPE 3B ENDOLEAK WAS IDENTIFIED AND THE ORIGINAL DEVICES WERE RELINED WITH ANOTHER BIFURCATED STENT GRAFT AND A SUPRARENAL EXTENSION. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 2031527-2018-00401. NOW, APPROXIMATELY 2.5 YEARS POST INTERVENTION A COMPUTED TOMOGRAPHY (CT) HAS REVEALED THAT THE ANEURYSM HAS INCREASED IN SIZE FROM 5.4CM TO 7.4CM. REPORTEDLY, PATIENTS CURRENT CONDITION IS GOOD AND IS PENDING RE-INTERVENTION. A RE-INTERVENTION WAS COMPLETED ON THIS PATIENT AND THE ORIGIN OF THE ENDOLEAK WAS DETERMINED TO BE A TYPE 2 ENDOLEAK. THE VESSEL THAT WAS FEEDING THE AAA WAS EMBOLIZED AND THE PATIENT IS DOING WELL. THIS EVENT IS NO LONGER A REPORTABLE EVENT AS A TYPE 2 ENDOLEAK IS ANATOMY RELATED AND THE FAILURE IS NOT RELATED TO THE DEVICE. PLEASE REMOVE FROM YOUR COMPLAINT SYSTEM A COMPLAINT IS NOT WARRANTED SINCE THERE IS NO ALLEGED DEFICIENCY RELATED TO IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE.

  Patient problems: Aneurysm

  MAUDE report 11416175 ↗

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-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-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-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-0592-06 · 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-0593-06 · 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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL

…and 1 more.