AFX Endovascular AAA System BA25-80/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00818009010018), received between Mar 8, 2016 and Sep 11, 2024 — classified as 4 deaths, 35 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (12 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 40 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2015 WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND VELA SUPRARENAL. DURING ROUTINE FOLLOW-UP THE PATIENT PRESENTED WITH SOME SIGNIFICANT ANGULATION OF THE AORTA WHICH SEEMED TO RESULT IN MINIMAL OVERLAP. ANGIOGRAM CONDUCTED ON (B)(6) 2024 CONFIRMED NO IDENTIFIABLE ENDOLEAK, HOWEVER EVIDENCE DID APPEAR AS THOUGH THE OVERLAP WAS LESS THAN IDEAL. OUT OF PRECAUTION, THE PHYSICIAN DECIDED TO PLACE TWO BRIDGE STENTS IN ORDER TO ACHIEVE MAXIMUM OVERLAP AND PREVENT THE POSSIBILITY OF FUTURE DISCONNECTION. REINTERVENTION WAS SUCCESSFULLY COMPLETED ON (B)(6) 2024 WITH THE IMPLANT OF A VELA SUPRARENAL AND VELA INFRARENAL WITHOUT INCIDENT. PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY.

  Patient problems: Insufficient Information

  MAUDE report 20196813 ↗
• InjurySep 10, 2024Off-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, ONE (1) ENDURANT (NON-ENDOLOGIX) ILIAC LIMB AND TWO (2) ENDURANT (NON-ENDOLOGIX) EXTENSIONS. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM PER DEVICE IFU. A TYPE II ENDOLEAK (NON-DEVICE-RELATED) FROM THE LUMBAR ARTERY WAS NOTED AT INITIAL IMPLANT. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH ANEURYSM ENLARGEMENT (ABOUT 5MM). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY CONVERTING TO OPEN SURGERY ON (B)(6) 2023. DURING THE RE-INTERVENTION, THE PHYSICIAN SLIGHTLY MOVED THE AFX BIFURCATED STENT GRAFT TO CHECK FOR OTHER ENDOLEAKS AND BLOOD LEAKED FROM MULTIPLE HOLES OF THE AFX DEVICE (CLASSIFIED AS TYPE IIIB ENDOLEAKS). AS THE BLOOD ONLY LEAKED FROM THESE HOLES IF THE PHYSICIAN PUSHED ON THE GRAFT, THE PHYSICIAN CHOSE TO NOT PERFORM ADDITIONAL TREATMENT AND CONCLUDED THE OPERATION. IT IS BELIEVED THAT THE FULLY EXPANDED ENDURANT STENT GRAFTS WERE SEALING THE HOLES. THE PATIENT IS REPORTEDLY DISCHARGED. THIS EVENT WAS REPORTED UNDER MFR# 2031527-2023-00203. ON

  Patient problems: Clinical Endoleak

  MAUDE report 20182862 ↗
• InjuryJan 11, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, POST INITIAL PROCEDURE ON AN UNKNOWN DATE THE PATIENT WAS IDENTIFIED WITH ANEURYSM ENLARGEMENT AND A SUSPECTED A TYPE II ENDOLEAK AND A RE-INTERVENTION WAS COMPLETED. NOW, APPROXIMATELY 4.5 YEARS POST INITIAL PROCEDURE ANOTHER RE-INTERVENTION FOR TYPE II ENDOLEAK WAS PERFORMED. EMBOLIZATION ON THE LUMBAR ARTERY VIA INTERNAL ILIAC ARTERY WAS COMPLETED. A TYPE IIIB ENDOLEAK WAS IDENTIFIED WITH A COMPUTED TOMOGRAPHY ANGIOGRAM (CTA). THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MFR # 2031527-2022-00018. ON (B)(6) 2023 THE PATIENT WAS FOUND TO HAVE A FISTULA BETWEEN THE DUODENUM AND SMALL INTESTINES. THE PHYSICIAN ELECTED TO EXPLANT ALL THE AFX STENT GRAFTS AND REPLACED THE ABDOMINAL AORTA WITH A "Y" SHAPED ARTIFICIAL GRAFT. DURING THE EXPLANT PROCEDURE, THE PHYSICIAN FOUND A HOLE (CLASSIFIED AS A TYPE 3B ENDOLEAK) IN THE ORI

  Patient problems: Clinical Endoleak; Fistula

  MAUDE report 18491296 ↗
• InjuryAug 17, 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, ONE (1) ENDURANT (NON-ENDOLOGIX) ILIAC LIMB AND TWO (2) ENDURANT (NON-ENDOLOGIX) EXTENSIONS. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM PER DEVICE IFU. A TYPE II ENDOLEAK (NON-DEVICE-RELATED) FROM THE LUMBAR ARTERY WAS NOTED AT INITIAL IMPLANT. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH ANEURYSM ENLARGEMENT (ABOUT 5MM). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY CONVERTING TO OPEN SURGERY ON (B)(6) 2023. DURING THE RE-INTERVENTION, THE PHYSICIAN SLIGHTLY MOVED THE AFX BIFURCATED STENT GRAFT TO CHECK FOR OTHER ENDOLEAKS AND BLOOD LEAKED FROM MULTIPLE HOLES OF THE AFX DEVICE (CLASSIFIED AS TYPE IIIB ENDOLEAKS). AS THE BLOOD ONLY LEAKED FROM THESE HOLES IF THE PHYSICIAN PUSHED ON THE GRAFT, THE PHYSICIAN CHOSE TO NOT PERFORM ADDITIONAL TREATMENT AND CONCLUDED THE OPERATION. IT IS BELIEVED THAT THE FULLY EXPANDED ENDURANT STENT GRAFTS WERE SEALING THE HOLES. THE PATIENT IS REPORTEDLY DISCHARGED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17564712 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL AORTIC EXTENSION AND AN ILIAC LIMB TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, AN OVATION IX ILIAC LIMB STENT GRAFT WAS REQUIRED TO BE IMPLANTED TO EXTEND INTO LEFT EXTERNAL ILIAC ARTERY DUE TO A LEFT COMMON ILIAC ANEURYSM. THE PATIENT WAS REPORTED AS DOING WELL POST THIS SECONDARY PROCEDURE. ADDITIONAL INFORMATION: AN INTERNAL CLINICAL ASSESSMENT DETERMINED THERE WAS EVIDENCE TO SUGGEST A TYPE 2 ENDOLEAK OF THE LUMBAR ARTERY OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE TYPE 2 ENDOLEAK WAS DISCOVERED DURING REVIEW OF THE COMPUTED TOMOGRAPHY (CT) STUDY DATED (B)(6) 2023. TYPE II ENDOLEAKS ARE ANATOMY RELATED EVENTS AND ARE NOT CAUSED OR CONTRIBUTED BY THE DEVICE. 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 16738254 ↗
• InjuryAug 18, 2022Material Puncture/Hole; Lack of Effect; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 8 YEARS POST INITIAL PROCEDURE, A TYPE 3B ENDOLEAK WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. THE PATIENT WAS REPORTED AS STABLE AND THE PHYSICIAN IS PLANNING A RE-INTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak; Failure of Implant

  MAUDE report 15255693 ↗
• InjuryMay 26, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 6.5 YEARS POST INITIAL PROCEDURE A TYPE IIIB ENDOLEAK WITH SAC GROWTH WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN ALTO ABDOMINAL STENT GRAFT SYSTEM. THE RE-INTERVENTION WAS SUCCESSFUL AND PATIENT IS WELL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14504778 ↗
• InjuryFeb 15, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AN AFX INFRARENAL AORTIC EXTENSION. CONTINUED ANEURYSM ENLARGEMENT WAS IDENTIFIED AT THE PATIENT¿S ROUTINE FOLLOW-UPS. THE ONE (1) MONTH CT IMAGING MEASURED THE ANEURYSM DIAMETER AT 55MM. THE FOUR (4) YEAR CT IMAGING MEASURED THE ANEURYSM DIAMETER AT 63.5MM. THE FIVE (5) YEAR CT IMAGING MEASURED THE ANEURYSM DIAMETER AT 68MM. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE A POSSIBLE TYPE II ENDOLEAK (NON-DEVICE RELATED) OR TYPE IIIA ENDOLEAK WAS SUSPECTED. THE PHYSICIAN ELECTED TO PERFORM COIL EMBOLIZATION ON THE INFERIOR MESENTERIC ARTERY AND MONITOR THE PATIENT. THE SCHEDULING OF ADDITIONAL REINTERVENTION IS UNDECIDED AND WILL NOT BE DONE IN THE NEAR FUTURE. THE PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13538250 ↗
• InjuryJan 26, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, POST INITIAL PROCEDURE ON AN UNKNOWN DATE THE PATIENT WAS IDENTIFIED WITH ANEURYSM ENLARGEMENT AND A SUSPECTED A TYPE II ENDOLEAK AND A RE-INTERVENTION WAS COMPLETED. NOW, APPROXIMATELY 4.5 YEARS POST INITIAL PROCEDURE ANOTHER RE-INTERVENTION FOR TYPE II ENDOLEAK WAS PERFORMED. EMBOLIZATION ON THE LUMBAR ARTERY VIA INTERNAL ILIAC ARTERY WAS COMPLETED. A TYPE IIIB ENDOLEAK WAS IDENTIFIED WITH A COMPUTED TOMOGRAPHY ANGIOGRAM (CTA). THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 13361236 ↗
• DeathDec 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWENTY (20) MONTHS ((B)(6) 2020) POST INITIAL PROCEDURE, THE ANEURYSM DIAMETER WAS FOUND TO HAVE INCREASED TO 78MM AFTER SERIOUS ANEMIA WAS CONFIRMED. UPON EXAMINATION IT WAS DETERMINED THERE WAS GASTROINTESTINAL BLEEDING RESULTING FROM A FISTULA BETWEEN THE DUODENUM AND THE AAA WHICH REQUIRED AN URGENT OPEN ABDOMINAL SURGERY. AN ADDITIONAL GASTROINTESTINAL SURGERY WAS PERFORMED. AFTER THIS PROCEDURE, THE PATIENT DID NOT SHOW SIGNS OF INFECTION OR ENLARGEMENT OF THE SUTURED PART OF THE AAA; HOWEVER, EIGHT (8) MONTHS ((B)(6) 2021) AFTER THIS SURGERY, THE PATIENT EXPIRED DUE TO MULTI-ORGAN FAILURE. EXACT DATE OF DEATH IS UNKNOWN, THEREFORE, BEST ESTIMATED DATE WAS SELECTED. NOTE: THIS PATIENT HAS ANOTHER REPORTED EVENT FOR A TYPE 1A ENDOLEAK, A TYPE 2 ENDOLEAK (NON-DEVICE RELATED) AND AAA ENLARGEMENT THAT WAS REPORTED UNDER 20031527-2021-00484.

  Patient problems: Fistula

  MAUDE report 12993445 ↗
• InjuryDec 8, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR A SACCULAR ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT. AT THE END OF THE PROCEDURE A TYPE II ENDOLEAK (NON-DEVICE RELATED) REMAINED. APPROXIMATELY SIX (6) MONTHS POST INITIAL PROCEDURE REINTERVENTION WAS BEING PERFORMED TO TREAT THE TYPE II ENDOLEAK; HOWEVER, ANEURYSM ENLARGEMENT OF 56MM WITH A TYPE IA ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO TREAT THE TYPE IA ENDOLEAK WITH IMPLANT OF AN AFX VELA SUPRARENAL EXTENSION. THE TYPE II ENDOLEAK FROM THE IMA WAS MILD AND REMAINING. PATIENT STATUS POST-REINTERVENTION WAS NOT PROVIDED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12962821 ↗
• InjurySep 21, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX BIFURCATED STENT GRAFT, A VELA SUPRARENAL PROXIMAL EXTENSION AND TWO (2) LIMB STENT GRAFTS. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. THE SUBSEQUENT CT (COMPUTED TOMOGRAPHY) SCAN REVEALED A TYPE IIIB ENDOLEAK AT THE BIFURCATION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL ON 14 SEPTEMBER 2021. THE PATIENT IS REPORTEDLY IN GOOD CONDITION POST SECONDARY ENDOVASCULAR PROCEDURE. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST SAC GROWTH OF 10MM OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE SAC GROWTH WAS DISCOVERED DURING REVIEW OF THE 73 MONTH POST IMPLANT CT SCAN.

  Patient problems: Aneurysm; Failure of Implant; Pain

  MAUDE report 12509033 ↗
• InjuryMar 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE, AFTER THE SUCCESSFUL RELEASE OF THE BIFURCATED BODY AND LATERAL (RIGHT) LIMB, THE SURE-PASS WIRE DID NOT RELEASE THE CONTRALATERAL LIMB. AFTER EXCESSIVE FORCE FROM THE PHYSICIAN, THE LIMB OPENED BUT THE SURE-PASS WIRE DID NOT PASS THROUGH THE INTRODUCER, TEARING THE ARTERY. AN INTERVENTION WAS PERFORMED WITH A POSITRON EMISSION TOMOGRAPHY (PET) (BOVINE PERICARDIUM GRAFT). THE ARTERY REPAIR WAS SUCCESSFUL, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Perforation of Vessels

  MAUDE report 11405631 ↗
• InjuryFeb 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST IMPLANT, THE PATIENT WAS IDENTIFIED WITH A TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS FINE.

  Patient problems: Failure of Implant

  MAUDE report 11279739 ↗
• InjuryDec 5, 2020Off-Label Use

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO TREAT THIS EVENT BY RE-LINING THE EXISTING STENT GRAFTS WITH A NON-ENDOLOGIX (31MM GORE TAG) DEVICE. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO CONCOMITANT USE WITH PRODUCTS OUTSIDE THE IFU. THIS EVENT WAS REPORTED UNDER MDR# 2031527-2019-00250. NOW, APPROXIMATELY ONE AND A HALF (1.5) YEARS POST SECONDARY INTERVENTION, AN INDETERMINATE ENDOLEAK WAS IDENTIFIED. THE PATIENT IS BEING MONITORED PENDING RE-INTERVENTION ADDITIONAL INFORMATION: THE REPORTED INDETERMINATE ENDOLEAK WAS IDENTIFIED TO BE A TYPE 3A ENDOLEAK BETWEEN THE NON ENDOLOGIX AND ENDOLOGIX PROXIMAL EXTENSION. CLINICAL EVALUATION SHOWS REASONABLE EVIDENCE TO SUGGEST SAC GROWTH. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT A SUPRARENAL AORTIC EXTENSION AND AN OVATION IX ILIAC EXTENDER TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS BEING STABLE POST SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10953795 ↗
• InjuryOct 23, 2020Material Puncture/Hole; Material Puncture/Hole

  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 IMPLANT, THE PATIENT PRESENTED TO THE HOSPITAL WITH AN ENLARGING SAC DUE TO A TYPE 3B ENDOLEAK. A RE-INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINALLY IMPLANTED DEVICES WITH ANOTHER BIFURCATED STENT GRAFT AND THE SUPRARENAL STENT GRAFT EXTENSION TO RESOLVE THIS EVENT. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10731462 ↗
• InjurySep 22, 2020Material Puncture/Hole; Improper or Incorrect Procedure or Method; Material Puncture/Hole; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, A VELA INFRARENAL STENT GRAFT EXTENSION AND TWO (2) LIMB STENT GRAFTS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS LATER, A TYPE 3B ENDOLEAK AT THE DISTAL END OF THE BIFURCATED STENT GRAFT WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. THE PHYSICIAN ELECTED TO RELINE THE EXISTING GRAFTS WITH A NON-ENDOLOGIX (GORE) DEVICE. THE PATIENT REPORTEDLY DID WELL AND WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Failure of Implant

  MAUDE report 10570594 ↗
• DeathSep 21, 2020Patient-Device Incompatibility; Device-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Device-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, A TYPE 1A ENDOLEAK WAS REVEALED BY A COMPUTED TOMOGRAPHY (CT) SCAN, AN ENDURANT (NON- ENDOLOGIX) AORTIC CUFF WAS IMPLANTED TO RESOLVE THIS EVENT. 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. THIS EVENT WAS REPORTED UNDER 2031527-2020-00265. NOW, APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A TYPE 3A ENDOLEAK WITH SEPARATION BETWEEN THE AFX BIFURCATED STENT GRAFT AND AFX INFRARENAL EXTENSION. A RE-INTERVENTION WAS SCHEDULED HOWEVER THE AORTA RUPTURED (2) TWO HOURS BEFORE THE SCHEDULED TIME. THE PHYSICIAN ELECTED TO IMPLANTED (2) TWO EXCLUDER (NON- ENDOLOGIX) CUFFS. AN INTRAOPERATIVE TYPE 1A ENDOLEAK WAS IDENTIFIED FROM THE NON- ENDOLOGIX STENT. ANOTHER EXCLUDER (NON- ENDOLOGIX) WAS IMPLANTED. THE PROCEDURE ENDED WITH NO ENDOLEAKS PRESENT. IT WAS REPORTED THAT THE PATIENT EXPIRED WHILE IN THE ICU POST INTERVENTION ON THE SAME DAY. THE PHYSIC

  Patient problems: Death; Failure of Implant; Rupture

  MAUDE report 10560245 ↗
• InjurySep 16, 2020Collapse; Insufficient Device Problem Information; Collapse; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 2 1/2 YEARS LATER, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THIS EVENT WITH A NON-ENDOLOGIX DEVICE (ENDURANT AORTIC PROXIMAL EXTENSION).

  Patient problems: Failure of Implant

  MAUDE report 10544241 ↗
• InjuryMar 2, 2020Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method; Material Puncture/Hole; Use of Device Problem; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IIIB ENDOLEAK AS DETECTED BY CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT WHO IS REPORTEDLY IN GOOD CONDITION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: DURING THE CLINICAL INVESTIGATION, SAC GROWTH OF 23.5MM WAS IDENTIFIED. ALSO THE OFF-LABEL USE OF NON-ENDOLOGIX ILIAC STENTS WERE PRESENT IN THE BILATERAL ILIAC ARTERIES.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9775141 ↗
• InjuryJan 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE (EXACT DATE WAS NOT PROVIDED), THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH ANEURYSM SAC GROWTH (10MM) AND AN ENDOLEAK OF INDETERMINATE ORIGIN. THE PHYSICIAN PLANS TO RE-INTERVENE AND WILL CONTINUE TO MONITOR THE PATIENT. THE PATIENT IS REPORTEDLY ASYMPTOMATIC. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9613342 ↗
• MalfunctionJul 31, 2019Material Integrity Problem; Material Integrity Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT HAD A CONTRAST-CT (COMPUTED TOPOGRAPHY) PERFORMED AND A TYPE IIIB ENDOLEAK WAS FOUND. THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. NO FURTHER ADDITIONAL INFORMATION OR PATIENT SEQUALAE HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 8845696 ↗
• InjuryJul 16, 2019Material Puncture/Hole; Product Quality Problem; Improper or Incorrect Procedure or Method; Material Puncture/Hole; Product Quality Problem; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT, GORE (NON-ENDOLOGIX) LEG DEVICE, AND BARE (NON-ENDOLOGIX) STENT (OFF-LABEL USE WITH NON-CONCOMITANT DEVICES). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, AN ANEURYSM EXPANSION (UNKNOWN DIAMETER) WAS OBSERVED DURING ROUTINE FOLLOW-UP. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY OPEN SURGERY ON (B)(6) 2019, DURING WHICH A TYPE IIIB ENDOLEAK WAS OBSERVED AT THE AFX BIFURCATION. A Y-GRAFT REPLACEMENT WAS THEN SUCCESSFULLY PERFORMED AND THE PATIENT WAS REPORTEDLY RECOVERING IN THE HOSPITAL. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8795288 ↗
• InjuryMay 17, 2019Misconnection; Improper or Incorrect Procedure or Method; Misconnection; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH AN IMPLANT DISCONNECT (TYPE IIIA ENDOLEAK). HOWEVER, THE EXACT DATE OF EVENT IS UNKNOWN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY SUCCESSFULLY RELINING WITH A 31MM GORE (NON-ENDOLOGIX) TAG DEVICE. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8621853 ↗
• InjuryMay 2, 2019Insufficient 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, A COMPUTERIZED TOMOGRAPHY (CT) SCAN IDENTIFIED MILD DISTAL STENOSIS OF THE ABDOMINAL PORTION OF THE BIFURCATED STENT GRAFT. THE PATIENT IS BEING MONITORED AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Stenosis

  MAUDE report 8574219 ↗

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-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-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-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-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-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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• 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.