AFX2 Bifurcated Endograft System BEA28-90/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00818009014597), received between Dec 28, 2016 and Apr 6, 2026 — classified as 7 deaths, 40 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2026Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2023. AFTER BILATERAL INTERNAL ILIAC ARTERY EMBOLIZATION, AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL WERE DEPLOYED VIA THE RIGHT ACCESS. THE PROCEDURE WAS COMPLETE AFTER CONFIRMING THE ABSENCE OF ENDOLEAKS ON THE FINAL ANGIOGRAPHY. IMMEDIATELY POST-PROCEDURE, THE PATIENT DEVELOPED ACUTE RENAL FAILURE THAT WAS COMPLICATED BY SYSTEMATIC THROMBOSIS. PARAPARESIS WAS NOTED. DUE TO THE PATIENT REFUSING DIALYSIS, NO ADDITIONAL TREATMENT WAS PERFORMED. THE PATIENT PASSED AWAY THE FOLLOWING DAY. REPORTEDLY, DUE TO THE PATIENT'S SIGNIFICANT SHAGGY AORTA, IT IS SUSPECTED THAT THROMBI WERE DISLODGED INTO THE RENAL ARTERIES DURING DEVICE MANEUVERS WHICH LED TO RENAL FAILURE. GIVEN THE PRESENCE OF A SHAGGY AORTA FROM THE DESCENDING TO THE ABDOMINAL AORTA, THIS EVENT COULD HAVE OCCURRED WITH ANY DEVICE DUE TO THE UNDERLYING VASCULAR CONDITION. WHILE THIS CASE SHOULD ORIGINALLY HAVE BEEN TREATED WITH SURGICAL GRAFT REPLACEMENT, A STENT GRAFT WAS SELECTED BECAUSE THE PATIENT REQUESTED ENDOVASCULAR ANEURYSM REPAIR.

  Patient problems: Renal Failure

  MAUDE report 24789901 ↗
• InjuryNov 18, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS IN THE HOSPITAL ON (B)(6) 2025 FOR AN UNRELATED REASON AND A TYPE 3B ENDOLEAK WAS DISCOVERED ON A COMPUTED TOMOGRAPHY (CT). ACCORDING TO THE PHYSICIAN THE PATIENT IS STABLE AND A PLAN FOR REINTERVENTION HAS NOT BEEN MADE AS OF YET.

  Patient problems: Clinical Endoleak

  MAUDE report 23583225 ↗
• InjurySep 11, 2025Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT ON (B)(6) 2021. ON (B)(6) 2022 IT WAS REPORTED THAT THERE WAS A TYPE IA ENDOLEAK, TYPE II ENDOLEAK (LUMBAR ARTERY), AND ANEURYSM ENLARGEMENT. ON (B)(6) 2023 THE PHYSICIAN PERFORMED AN INTERVENTION WITH IMPLANTATION OF ONE OVATION IX EXTENDER. 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. THIS EVENT WAS PREVIOUSLY REPORTED UNDER (MANUFACTURER REPORT NUMBER 2031527-2022-00277). IT WAS REPORTED THAT DURING A RECENT ROUTINE FOLLOW-UP ON (B)(60 2025, A TYPE IIIB ENDOLEAK WAS OBSERVED. IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT WAS TREATED WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT. PER THE ANGIOGRAM THERE WAS BALLOONING PERFORMED AND THE TYPE IIIB ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 23027108 ↗
• InjuryAug 27, 2025Off-Label Use; Deformation Due to Compressive Stress; Migration; Off-Label Use; Deformation Due to Compressive Stress; Migration

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA INFRARENAL AORTIC EXTENSION, AND TWO (2) GORE TAG THORACIC DEVICES (NON-ENDOLOGIX) FOR THE TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM (RAAA) ON (B)(6) 2021. 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, ON (B)(6) 2025 IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN AND THE COMPUTED TOMOGRAPHY (CT) SHOWED ENDOLEAK GOING INTO THE ANEURYSM SAC WITH ASSUMED ANEURYSM ENLARGEMENT RESULTING IS AN ASSUMED ANEURYSM RUPTURE. DURING THE INTERVENTION IT WAS REVEALED A TYPE IIIA ENDOLEAK THAT WAS BETWEEN THE AFX2 BSG AND THE GORE TAG DEVICE. THE AFX2 BIFURCATED STENT GRAFT APPEARED TO BE SCRUNCHED UP AND AN OUT POUCHING WAS OBSERVED. THE PHYSICIAN ELECTED TO FULLY RE-LINE THE IMPLANTED DEVICES WITH AN AFX2 MAIN BODY, AN AFX VELA SUPRARENAL AORTIC EXTENSION AND TWO (2) 40MM GORE TAG DEVICES (40X100 AND 40X150). THE TYPE IIIA ENDOLEAK WAS RESOLVED AND THE PATIENT IS STABLE.

  Patient problems: Aneurysm; Clinical Endoleak; Pain; Ruptured Aneurysm

  MAUDE report 22909199 ↗
• InjuryDec 27, 2024Off-Label Use; Material Puncture/Hole; Separation Problem; Lack of Effect; Off-Label Use; Material Puncture/Hole; Separation Problem; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL AORTIC EXTENSION FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2016. IT WAS REPORTED DURING A RECENT ROUTINE FOLLOW-UP, THE FILMS REVEALED AN INDETERMINATE ENDOLEAK. ON (B)(6) 2025 THE PATIENT WAS BROUGHT IN FOR AN INTERVENTION. IT WAS DISCOVERED THAT THERE IS A TYPE IIIB ENDOLEAK IN THE AFX2 BIFURCATED STENT GRAFT AND THERE IS ALSO A TYPE IIIA ENDOLEAK BETWEEN THE AFX2 BIFURCATED STENT GRAFT AND THE AFX VELA SUPRARENAL EXTENSION. THE PHYSICIAN RELINED THE STENT GRAFTS WITH AN AFX2 BIFURCATED STENT GRAFT AND THE TYPE IIIB ENDOLEAK AND THE TYPE IIIA ENDOLEAK WERE RESOLVED. THE PATIENT RECOVERED FINE AND WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Clinical Endoleak

  MAUDE report 21027187 ↗
• InjuryApr 16, 2024Material 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. APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, THE STENT GRAFTS WERE EXPLANTED ON (B)(6) 2024 DUE TO A TYPE IIIB ENDOLEAK AFTER WHICH VESSEL REPLACEMENT WAS PERFORMED. THE FINAL PATIENT STATUS IS UNKNOWN. THE EXPLANTED STENT GRAFT WILL BE RETURNED FOR EVALUATION.

  Patient problems: Clinical Endoleak

  MAUDE report 19121996 ↗
• InjuryDec 15, 2023Material Puncture/Hole; Lack of Effect; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2018 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. ON 28 NOVEMBER 2023, IT WAS REPORTED THAT A TYPE IIIA ENDOLEAK WAS IDENTIFIED. REINTERVENTION WAS COMPLETED THE SAME DAY WITH THE IMPLANT OF A GORE (NON-ENDOLOGIX) STENT.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18335616 ↗
• InjuryApr 27, 2023Off-Label Use; Device-Device Incompatibility; Separation Problem; Lack of Effect; Off-Label Use; Device-Device Incompatibility; Separation Problem; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, TWO (2) AFX ILIAC LIMBS AND TWO (2) OVATION IX AORTIC EXTENSIONS 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 HALF (3.5) YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK COMING FROM BETWEEN THE BIFURCATED STENT GRAFT AND ONE OF THE AORTIC EXTENSIONS WAS IDENTIFIED. THE PATIENT IS STABLE AND CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Clinical Endoleak

  MAUDE report 16828148 ↗
• InjuryApr 17, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE A TYPE IIIA ENDOLEAK AND A POSSIBLE TYPE IIIB ENDOLEAK WERE IDENTIFIED. REINTERVENTION IS BEING PLANNED. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 16758755 ↗
• InjuryMar 14, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL. APPROXIMATELY THREE AND A HALF (3.5) YEARS POST-INITIAL PROCEDURE, ON (B)(6) 2023, ANEURYSM ENLARGEMENT WITH AN UNKNOWN ENDOLEAK WERE IDENTIFIED. REINTERVENTION WAS COMPETED ON (B)(6) 2023, WITH THE SUCCESSFUL RELINE WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16538661 ↗
• InjuryMar 7, 2023Improper or Incorrect Procedure or Method; Separation Problem; Improper or Incorrect Procedure or Method; Separation Problem

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND A NON-ENDOLOGIX ENDURANT CUFF. REPORTEDLY, THE LEFT ACCESSORY RENAL ARTERY WAS OCCLUDED, AND THE ENDURANT CUFF WAS IMPLANTED FIRST, JUST BELOW THE RENAL ARTERY. THE INITIAL PROCEDURE WAS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL). THE PROCEDURE WAS COMPLETED WITH GOOD RESULTS. APPROXIMATELY TWO AND A HALF (2.5) YEARS POST INITIAL PROCEDURE, THE PATIENT EXPERIENCED PAIN DUE TO LOWER LIMB ISCHEMIA. ANEURYSM ENLARGEMENT, PARTIAL STENT SEPARATION WITH THROMBOSIS AT THE JUNCTION WITH A TYPE IIIA ENDOLEAK WAS IDENTIFIED. REINTERVENTION WAS COMPLETED ON (B)(6) 2023, WITH THE IMPLANT OF AN AFX VELA INFRARENAL JUST ABOVE THE TERMINAL AORTA. A SECOND AFX VELA INFRARENAL WAS IMPLANTED WITH ITS PROXIMAL EDGE AT THE PROXIMAL EDGE OF PREVIOUSLY IMPLANTED NON-ENDOLOGIX ENDURANT CUFF. THIS SECOND AFX VELA INFRARENAL MIGRATED DOWNWARD DURING THE DEPLOYMENT; THEREFORE, AN ADDITIONAL NON-ENDOLOGIX ENDURANT CUFF WAS DEPLOYED FOR FULL OVERLAP. REINTERVENTION SUCCESSFULLY SEALED THE TYPE IIIA ENDOLEAK. AFTER THE INITIAL REPORT THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO

  Patient problems: Aneurysm; Clinical Endoleak; Ischemia; Pain; Thrombosis/Thrombus

  MAUDE report 16499764 ↗
• InjuryDec 10, 2022Appropriate Device Problem Term/Code Not Available; Lack of Effect; Appropriate Device Problem Term/Code Not Available; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH ANEURYSM SAC GROWTH (UNKNOWN DIAMETER) AND A SUSPECTED TYPE IA ENDOLEAK. THE PHYSICIAN PLANS TO RE-INTERVENE AND THE PATIENT IS REPORTABLE IN STABLE CONDITION.

  Patient problems: Aneurysm; Clinical Endoleak; Failure of Implant

  MAUDE report 15956150 ↗
• DeathJun 15, 2022Off-Label Use; Migration; Separation Problem; Off-Label Use; Migration; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY (4) FOUR YEARS POST INITIAL PROCEDURE, THE PATIENT WAS EMITTED EMERGENTLY WITH A TYPE 3A ENDOLEAK AND RUPTURE AORTA. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT AN AFX VELA SUPRARENAL. UNFORTUNATELY THE FOLLOWING DAY THE PATIENT EXPIRED.

  Patient problems: Failure of Implant; Rupture; Stenosis

  MAUDE report 14704842 ↗
• InjuryMar 25, 2022Separation Problem; Separation Problem

  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. REPORTEDLY THE PROXIMAL NECK WAS TAPERED, AND THE ANEURYSM DIAMETER RANGED FROM 22 TO 34MM WITHIN THE LENGTH OF 15MM FROM THE MOST PROXIMAL LEVEL. POST-DEPLOYMENT BALLOON TOUCH-UP WAS NOT NEEDED, AND THERE WERE NO VISIBLE ENDOLEAKS. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE FOLLOW-UP COMPUTERIZED TOMOGRAPHY SCAN IDENTIFIED A TYPE IIIA ENDOLEAK WITH IMPLANT SEPARATION. ADDITIONAL ANGIOGRAPHY WAS PERFORMED, CONFIRMING THAT THERE WAS NO TYPE 3B ENDOLEAK. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF TWO (2) AFX VELA SUPRARENAL AND TWO (2) EXCLUDER (NON-ENDOLOGIX) AORTIC EXTENDER ENDOPROSTHESIS. THE PROCEDURE WAS COMPLETED AFTER THE FINAL ANGIOGRAM CONFIRMED THE ABSENCE OF ENDOLEAKS OR ISSUES ASSOCIATED WITH THE STENT-GRAFTS/BLOOD FLOW. THE ENDOLEAK WAS SEALED SUCCESSFULLY. THE PATIENT IS BELIEVED TO BE DOING WELL, AS THE RE-INTERVENTION WAS COMPLETED WITH NO REMAINING ENDOLEAKS.

  Patient problems: Failure of Implant

  MAUDE report 13904729 ↗
• InjuryMar 11, 2022Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  THE PATIENT WAS TREATED FOR ANASTOMOTIC ANEURYSMS AT BOTH PROXIMAL AND DISTAL SIDES OF A PREVIOUSLY IMPLANTED NON-ENDOLOGIX I-SHAPED AORTIC GRAFT WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL AND AN AFX VELA INFRARENAL VIA LEFT ACCESS. THE LEFT LEG OF THE AFX2 BIFURCATED STENT GRAFT DID NOT FULLY APPOSE TO THE VESSEL WALL; THEREFORE, A NON-ENDOLOGIX SMART STENT GRAFT (8MMX4CM) WAS DEPLOYED TO ADDRESS IT. THE PROCEDURE WAS COMPLETED WITHOUT ENDOLEAKS. 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. TWO (2) DAYS POST-PROCEDURE, WHILE THE PATIENT WAS STILL HOSPITALIZED, THE PATIENT COMPLAINED OF PAIN. IT WAS DETERMINED FROM A COMPUTED TOMOGRAPHY SCAN THAT A TYPE IB ENDOLEAK WAS OCCURRING. URGENT REINTERVENTION WAS PERFORMED ON THE SAME DAY TREATING THE TYPE IB ENDOLEAK FROM THE LEFT SIDE WITH IMPLANT OF A NON-ENDOLOGIX EXCLUDER LEG (10MM X 7CM) IN EACH ILIAC ARTERY. A COIL WAS ALSO DEPLOYED NEAR THE AORTIC BIFURCATION. THE PROCEDURE WAS COMPLETED WITH A SLIGHT LEVEL OF ENDOLEAK REMAINING. TWO (2) DAYS POST-REINTERVENTION ANGIOGRAPHY REVEALED THAT THE ENDOLEAK HAD BEEN

  Patient problems: Failure of Implant; Pain

  MAUDE report 13736747 ↗
• DeathFeb 2, 2022Off-Label Use; Separation Problem; Off-Label Use; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AN AFX INFRARENAL EXTENSION, AN EXPRESS SD (NON-ENDOLOGIX), AND AN ENDURANT (NON-ENDOLOGIX). 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. REPORTEDLY, DUE TO THE PATIENT'S SHORT PROXIMAL NECK THE SNORKEL TECHNIQUE WAS USED FOR THIS PROCEDURE. THE EXPRESS SD STENT WAS DEPLOYED, THEN THE ENDURANT CUFF WAS DEPLOYED ON THE PROXIMAL SIDE VIA LEFT ACCESS. THE AFX2 BIFURCATED STENT GRAFT WAS THEN DEPLOYED. POST DEPLOYMENT THERE WAS ALMOST NO OVERLAP BETWEEN THE ENDURANT CUFF AND THE AFX2 BIFURCATED STENT GRAFT. THE AFX INFRARENAL EXTENSION WAS DEPLOYED TO BRIDGE THE TWO DEVICES. BALLOON TOUCH UP WAS PERFORMED; HOWEVER, A RESIDUAL TYPE IIIA ENDOLEAK REMAINED. THE PHYSICIAN ELECTED TO END THE PROCEDURE AND ANTICIPATED THE TYPE IIIA ENDOLEAK WOULD CEASE WITH MEDICATION (PROTAMINE). THE PATIENT WAS REPORTED TO CONTINUE TO BE MONITORED. (REPORTED UNDER MFR# 2031527-2022-00024). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED EMERGENTLY DUE TO ANEURY

  Patient problems: Failure of Implant; Rupture

  MAUDE report 13423908 ↗
• InjuryFeb 1, 2022Off-Label Use; Off-Label Use

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AN AFX INFRARENAL EXTENSION, AN EXPRESS SD (NON-ENDOLOGIX), AND AN ENDURANT (NON-ENDOLOGIX). 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. REPORTEDLY, DUE TO THE PATIENT'S SHORT PROXIMAL NECK THE SNORKEL TECHNIQUE WAS USED FOR THIS PROCEDURE. THE EXPRESS SD STENT WAS DEPLOYED, THEN THE ENDURANT CUFF WAS DEPLOYED ON THE PROXIMAL SIDE VIA LEFT ACCESS. THE AFX2 BIFURCATED STENT GRAFT WAS THEN DEPLOYED. POST DEPLOYMENT THERE WAS ALMOST NO OVERLAP BETWEEN THE ENDURANT CUFF AND THE AFX2 BIFURCATED STENT GRAFT. THE AFX INFRARENAL EXTENSION WAS DEPLOYED TO BRIDGE THE TWO DEVICES. BALLOON TOUCH UP WAS PERFORMED; HOWEVER, A RESIDUAL TYPE IIIA ENDOLEAK REMAINED. THE PHYSICIAN ELECTED TO END THE PROCEDURE AND ANTICIPATED THE TYPE IIIA ENDOLEAK WOULD CEASE WITH MEDICATION (PROTAMINE). THE PATIENT WAS REPORTED TO CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 13416911 ↗
• InjuryDec 6, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL. APPROXIMATELY TWO AND A HALF (2.5) YEARS POST INITIAL PROCEDURE ROUTINE FOLLOW UP COMPUTED TOMOGRAPHY IDENTIFIED ANEURYSM ENLARGEMENT AND A TYPE 3B ENDOLEAK. REINTERVENTION IS SCHEDULED; HOWEVER, HAS NOT YET TAKEN PLACE. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12940624 ↗
• InjurySep 8, 2021Use of Device Problem; Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Insufficient Device Problem Information; Migration; Use of Device Problem; Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Insufficient Device Problem Information; Migration

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE THE PATIENT HAS BEEN IDENTIFIED WITH A 1B ENDOLEAK. THE PHYSICIAN IS PLANNING TO RE-INTERVENE. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED REPORTING REINTERVENTION WAS COMPLETED EXTENDING BOTH ILIAC LIMBS WITH IMPLANT OF AN OVATION IX EXTENDER ON EACH SIDE. THE ENDOLEAKS WERE BOTH SUCCESSFULLY SEALED. THE PATIENT WAS REPORTED TO DO WELL. ADDITIONALLY, CLINICAL ASSESSMENT DETERMINED THE REPORTED TYPE IB ENDOLEAK TO BE BILATERAL TYPE IB ENDOLEAKS AND THERE WAS CONCOMITANT PRODUCT USE (NON-ENDOLOGIX THORACIC STENT IMPLANTED WITH THE BIFURCATED STENT GRAFT) - OFF LABEL CONDITION. THERE WAS ALSO EVIDENCE TO REASONABLY SUGGEST MIGRATION OF THE ILIAC LIMBS OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE MIGRATION WAS DISCOVERED DURING A REVIEW OF THE 58-MONTH POST INDEX COMPUTED TOMOGRAPHY SCAN.

  Patient problems: Failure of Implant

  MAUDE report 12440185 ↗
• InjuryAug 11, 2021Insufficient Device Problem Information; Separation Problem; Insufficient Device Problem Information; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AFX VELA INFRARENAL. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL COMPLAINING OF LOWER ABDOMINAL PAIN. THE PATIENT SUFFERED FROM A CARDIAC ARREST DUE TO AN ANEURYSM RUPTURE. ONCE THE PATIENT¿S ABDOMEN WAS OPENED, A TYPE 3A ENDOLEAK WAS IDENTIFIED. THE PATIENT UNDERWENT A RE-INTERVENTION AND WAS SUCCESSFULLY TREATED BY THE ADDITION OF IMPLANTING A (NON-ENDOLOGIX DEVICE) EXCLUDER STENT-GRAFT. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL.

  Patient problems: Failure of Implant; Pain; Rupture

  MAUDE report 12308526 ↗
• InjuryJun 3, 2021Material Puncture/Hole; Use of Device Problem; Insufficient Device Problem Information; Material Puncture/Hole; Use of Device Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL, AND A VELA INFRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (4) FOUR YEARS POST INITIAL IMPLANT, THE PATIENT WAS IDENTIFIED WITH A TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO PLACE A VELA SUPRARENAL, AND A VELA INFRARENAL TO RESOLVE THIS LEAK. THE FINAL PATIENT STATUS WAS REPORTED AS DOING GREAT. ADDITIONAL INFORMATION: THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO SUGGEST A TYPE 3B ENDOLEAK OF THE SUPRARENAL EXTENSION HAD ALSO OCCURRED.

  Patient problems: Failure of Implant

  MAUDE report 11930646 ↗
• InjuryMay 27, 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 THREE (3) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN AND AN ENLARGED ANEURYSM. THE PHYSICIAN ELECTED TO BRING PATIENT INTO THE OPERATING ROOM AND A PRE-ANGIOGRAM WAS DONE TO TRY TO IDENTIFY A POSSIBLE ENDOLEAK. HOWEVER, NO CLEAR SIGNS OF A LEAK WERE IDENTIFIED. OUT OF AN ABUNDANCE OF CAUTION, THE PHYSICIAN ELECTED TO RE-LINE WITH ANOTHER BIFURCATED STENT GRAFT AND A PROXIMAL EXTENSION. FINAL ANGIOGRAM SHOWED GREAT PLACEMENT, AND NO SIGNS OF LEAK. PATIENT DID VERY WELL. ADDITIONAL INFORMATION: DURING THE INVESTIGATION THERE WAS EVIDENCE TO REASONABLY SUGGEST AN AORTIC RUPTURE AND RIGHT ACCESS SITE COMPLICATION (HEMATOMA) OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Aneurysm; Failure of Implant; Hematoma; Rupture

  MAUDE report 11896141 ↗
• InjuryMay 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE THERE WAS 50-74% STENOSIS IDENTIFIED. NO INTERVENTION WAS REPORTED. THE PATIENT'S STATUS WAS NOT REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 11810002 ↗
• InjuryMay 3, 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 FOUR (4) MONTHS POST INITIAL PROCEDURE, THERE WAS GREATER THAN 75% STENOSIS IN THE RIGHT ILIAC LIMB FOUND ON ULTRASOUND (NOT WITHIN THE STENT). THE PHYSICIAN ELECTED TO IMPLANT A MEDTRONIC ASSURANT COBALT 8X30 (NON- ENDOLOGIX) BARE METAL STENT TO RESOLVE THIS EVENT. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE A TYPE 1B ENDOLEAK WITH SAC GROWTH WAS IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT A NON-ENDOLOGIX ILLIAC LIMB TO RESOLVE THIS EVENT. ADDITIONALLY A TYPE 2 ENDOLEAK VIA RIGHT ILIOLUMBAR BRANCH WAS IDENTIFIED AND THE PHYSICIAN ELECTED TO EMBOLIZE IT TO RESOLVE THIS EVENT. THE PATIENT STATUS IS UNKNOWN AT THIS TIME.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11761170 ↗
• InjuryApr 29, 2021Use of Device Problem; Deformation Due to Compressive Stress; Use of Device Problem; Deformation Due to Compressive Stress

  ON (B)(6) 2021, AN EVAR PROCEDURE WAS PERFORMED. THE AFX INTRODUCER SYSTEM WAS INSERTED VIA RIGHT FEMORAL ACCESS AND A DRYSEAL SHEATH (12 FR) VIA LEFT FEMORAL ACCESS. THE AFX2 BIFURCATED STENT GRAFT WAS INSERTED INTO THE PATIENTS BODY AND SEATED ON THE BIFURCATION. THE CONTROL CORD WAS THEN PULLED. THE BIFURCATED STENT WAS SUCCESSFULLY DEPLOYED, BUT THE CORD COULD NOT BE PULLED ANYMORE. THE DOCTOR THEN PULLED THE CONTROL CORD WITH RELATIVELY A STRONG FORCE, WHICH RESULTED IN BREAKING THE CORD APART. THE DOCTOR THEN ATTEMPTED TO PULL THE WHOLE ASSEMBLY OF THE AFX2 DELIVERY SYSTEM AND THE SHEATH. WHEN PART OF THE AFX SHEATH WAS EXPOSED FROM THE BODY, THIS AREA WAS FOUND TO HAVE AN ACCORDION-LIKE DEFORMATION. SINCE THE AFX INTRODUCER SHEATH HAD ACCORDION-LIKE DEFORMATION, ITS USE WAS DISCONTINUED. A DIFFERENT AFX INTRODUCER SHEATH WAS INSERTED A VELA INFRARENAL ENDOGRAFT WAS DEPLOYED IN THE INFRARENAL AREA. SINCE THE STENT OF THE AFX2 MAIN BODY DID NOT SEEM TO BE FULLY EXPANDED, A PTA BALLOON CATHETER WAS USED FROM THE CONTRALATERAL SIDE TO TOUCH UP THE STENT. AFTER ONLY THE INNER CORE WAS CAREFULLY ADVANCED BY SEVERAL CENTIMETERS. THE WHOLE ASSEMBLY WAS ABLE TO BE REMOVED WITH THE R

  Patient problems: Failure of Implant; Perforation of Vessels

  MAUDE report 11749877 ↗

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-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-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-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-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-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-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-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
• 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.