AFX Endovascular AAA System I20-13/C88F SARecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00818009011459), received between Oct 26, 2015 and Jun 7, 2024 — classified as 34 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (8 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT, TWO (2) AFX LIMB STENT GRAFTS, AN AFX VELA SUPRARENAL, AND AN OVATION IX ILIAC LIMB ON (B)(6) 2024. 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. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE HOSPITAL WITH A REPORTED KINK IN THE LEFT LIMB. THE PHYSICIAN OPTED TO ADDRESS THIS ISSUE BY PERFORMING BALLOON ANGIOPLASTY AND PLACING A BALLOON-EXPANDABLE STENT. THE PATIENT'S POST-OPERATIVE CONDITION WAS REPORTED AS "OK" POST-OP.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19484720 ↗
• InjuryMar 21, 2024Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AFX LIMB STENT GRAFT, AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION ON (B)(6) 2024. FOLLOWING THIS PROCEDURE, THE PATIENT WAS READMITTED TO THE HOSPITAL LATER THE SAME DAY FOR A GROIN REPAIR. COMPUTED TOMOGRAPHY SCAN IDENTIFIED PARTIAL OCCLUSION OF THE RIGHT ILIAC LIMB. REINTERVENTION PLANS WERE NOT PROVIDED. THE PATIENT WAS REPORTED TO BE ON A VENTILATOR. ADDITIONAL INFORMATION: THE CLINICAL EVALUATION OF THE ADVERSE EVENT REVEALED THAT THE INITIAL COMPLAINT OF RIGHT LIMB OCCLUSION WAS INCORRECT AND INSTEAD IDENTIFIED AN ACCESS SITE COMPLICATION. MEDICAL RECORDS AND IMAGING SHOWED NO EVIDENCE OF LIMB OCCLUSION BUT DID REVEAL A RETROPERITONEAL HEMATOMA FROM A COMPUTED TOMOGRAPHY (CT) SCAN DATED (B)(6) 2024. THE COMPLICATION AROSE DUE TO DIFFICULTIES IN ACCESSING THE RIGHT COMMON FEMORAL ARTERY, LEADING TO PERIODIC HYPOTENSION AND NECESSITATING ADDITIONAL SURGERY TO CONTROL BLEEDING. THE PATIENT RETURNED TO THE OPERATING ROOM AN HOUR POSTOPERATIVELY FOR RE-SUTURING AT THE RIGHT COMMON FEMORAL ARTERY. THE PATIENT EXPERIENCED SEVERAL PROCEDURE-RELATED COMPLICATIONS, INCLU

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion; Respiratory Failure

  MAUDE report 18954196 ↗
• InjuryJan 3, 2024Malposition of Device; Malposition of Device

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA). THE AFX2 BIFURCATED STENT GRAFT AND AN AFX LIMB STENT GRAFT WERE IMPLANTED. REPORTEDLY, UPON INSERTION OF A 16FR SHEATH FROM THE PATIENT¿S LEFT SIDE AND ATTEMPTING TO ACCESS THE DISTAL LEFT LIMB WITH A GUIDEWIRE AND CATHETER THE AFX LIMB STENT GRAFT WAS HIT AND PUSHED OVER THE BIFURCATION AND INTO THE IPSILATERAL LEG. THE BIFURCATION WAS VERY WIDE, AND THE DEVICE HAD NO APPOSITION WITH EITHER LIMB. A UNI-ILIAC WAS CREATED WITH ADDITIONAL AFX PIECES (TWO (2) AFX VELA INFRARENAL AND AN AFX VELA SUPRARENAL), AND A SURGICAL FEMORAL-TO-FEMORAL SURGICAL PROCEDURE WAS PERFORMED TO RESTORE THE FLOW TO THE LEFT SIDE. THE PATIENT IS BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 18438452 ↗
• InjuryDec 11, 2023Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION ON (B)(6) 2015. APPROXIMATELY SEVEN AND A HALF (7.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A POSSIBLE TYPE IB ENDOLEAK AND ANEURYSM ENLARGEMENT OF THE RIGHT COMMON ILIAC (MEASURING MORE THAN 25MM). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH AN AFX2 BIFURCATED STENT GRAFT, ONE (1) ADDITIONAL AFX VELA SUPRARENAL AND ONE (1) AFX LIMB STENT GRAFT ON (B)(6) 2023 (REPORTED UNDER MFR# 3011063223-2023-00014). THE CLINICAL ASSESSMENT OF THE PREVIOUSLY REPORTED EVENT DETERMINED THAT THERE WAS REASONABLE EVIDENCE TO SUGGEST A TYPE II ENDOLEAK (LUMBAR) OCCURRED (NON-DEVICE RELATED). ON (B)(6) 2023, THE PATIENT RETURNED TO THE OPERATING ROOM FOR AN ADDITIONAL ENDOVASCULAR PROCEDURE DUE TO POST-OPERATIVE RIGHT LIMB OCCLUSION. THROMBECTOMY OF LIMB WAS PERFORMED. ANGIOGRAM SHOWED SIGNIFICANT STENOSIS OF THE ILIAC LIMB. BALLOON DILATATION WAS PERFORMED. THE FINAL ANGIOGRAM SHOWED EXCELLENT RESULTS WITH WIDE PATENCY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18307732 ↗
• InjuryMar 8, 2023Separation Problem; Lack of Effect; Separation Problem; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR A COMMON ILIAC ANEURYSM WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL PROXIMAL EXTENSION AND AN AFX LIMB STENT GRAFT DISTAL EXTENSION. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE ABSENCE OF AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PHYSICIAN TREATED THE PATIENT FOR A TYPE IIIA ENDOLEAK (OF THE RIGHT ILIAC LIMB) BY IMPLANTING TWO (NON-ENDOLOGIX) STENTS IN THE RIGHT COMMON ILIAC ARTERY. THE FINAL PATIENT STATUS WAS NOT INDICATED. THIS SECONDARY INTERVENTION, COMPLETED ON 14 MARCH 2022, WAS DISCOVERED DURING CLINICAL ASSESSMENT TO PATIENT ID 60939 (REFERENCE MFR. REPORT # 2031527-2023-00016). ADDITIONAL INFORMATION: CLINICAL ASSESSMENT IDENTIFIED THAT COMPLETE COMPONENT SEPARATION OF THE BIFURCATED STENT GRAFT FROM THE LIMB STENT GRAFT WAS ALSO PRESENT.

  Patient problems: Clinical Endoleak

  MAUDE report 16502619 ↗
• InjuryAug 13, 2021Unintended Movement; Unintended Movement

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX BIFURCATED STENT GRAFT, AN AFX LIMB STENT GRAFT IN THE EXTERNAL ILIAC AND AN AFX VELA SUPRARENAL. APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, ANGIOGRAM REVEALED THAT DUE TO REMODELING, THE DISTAL ATTACHMENT SIDE OF THE EXTENSION PULLED BACK INTO THE COMMON ILIAC ARTERY ANEURYSM. TO RE-ACHIEVE A DISTAL SEAL, THE PHYSICIAN ELECTED TO EXTEND TO THE EXTERNAL ILIAC WITH IMPLANT OF AN OVATION IX ILIAC LIMB. IN ADDITION, AN AFX LIMB STENT GRAFT WAS PLACED ON TOP OF THE OVATION IX ILIAC LIMB, SEALING VERY WELL INSIDE THE PREVIOUSLY IMPLANTED AFX LIMB STENT GRAFT EXTENSION. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. FINAL ANGIOGRAM SHOWED A VERY GOOD PROXIMAL AND DISTAL SEAL, AND EXCLUSION OF THE COMMON ILIAC ARTERY ANEURYSM. PATIENT DID VERY WELL INTRA- AND POST-OPERATIVELY AND WAS DISCHARGED HOME THE FOLLOWING DAY. CORRECTED INFORMATION: THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX BIFURCATED STENT GRAFT, AN AFX LIMB STENT GRAFT IN THE EXTERNAL ILIAC AND AN AFX VELA SUPRARENAL. APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE

  Patient problems: Failure of Implant

  MAUDE report 12318417 ↗
• InjuryAug 3, 2021Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 5 YEARS POST INITIAL PROCEDURE, PATIENT PRESENTED EMERGENTLY WITH PAIN AND SHORTNESS OF BREATH. THE PHYSICIAN IDENTIFIED SEPARATION BETWEEN THE LIMB EXTENSION AND THE BIFURCATED STENT GRAFT (CLASSIFIED AS A 3A ENDOLEAK) WITH EXPANSION OF THE ILIAC ANEURYSM. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH A NON-ENDOLOGIX DEVICE (GORE). REPORTEDLY, PATIENT DID WELL. UPDATED INFORMATION: DURING THE CLINICAL ASSESSMENT IT WAS NOTED THAT THIS CASE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THERE WAS NO ABDOMINAL AORTIC ANEURYSM (AAA) PRESENT AT TIME OF THE INITIALLY IMPLANT. THIS INITIAL PROCEDURE WAS TO TREAT A RIGHT COMMON ILIAC ANEURYSM MEASURING 5.2CM WHICH IS ALSO OFF LABEL AS IT SHOULD MEASURE BETWEEN 10-23MM.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12267329 ↗
• InjuryFeb 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL AND TWO LIMB EXTENSION STENT GRAFTS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED WITH AN EXPANDING ILIAC ANEURYSM ON THE LEFT COMMON ILIAC ARTERY. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) AFX LIMB EXTENSIONS SEAL OFF THE ANEURYSM IN THE LEFT COMMON ILIAC ARTERY TO RESOLVE THE ISSUE. PATIENT IS STABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11314644 ↗
• InjuryOct 16, 2020Complete Blockage; Complete Blockage

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, A SUPRARENAL PROXIMAL STENT GRAFT AND A ILIAC LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, AN OCCLUSION OF RIGHT COMMON ILIAC ARTERY (RCIA) WAS IDENTIFIED DURING A ROUTINE ANGIOGRAM. AN RE- INTERVENTION IS BEING PLANNED. THE PATIENT WAS REPORTED AS FINE AND IS BEING MONITORED.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 10693791 ↗
• InjuryAug 10, 2020Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND TWO (2) AFX LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3.5 YEARS POST INITIAL PROCEDURE, THE PATIENT WAS PREVIOUSLY TREATED FOR A TYPE 1B ENDOLEAK COMING FROM THE RIGHT ILIAC LIMB WITH EXPANDING COMMON ILIAC ARTERY ANEURYSM. APPROXIMATELY 26 DAYS POST RE-INTERVENTION, THE PATIENT UNDERWENT A TERTIARY FOR A TYPE 1B ENDOLEAK OF THE PATIENT¿S LEFT COMMON ILIAC WITH IMPLANT OF AN ADDITIONAL AFX LIMB STENT GRAFT. SEAL WAS SUCCESSFUL. THE PREVIOUS INTERVENTION WAS REPORTED UNDER MFR# 2031527-2020-00212.

  Patient problems: Failure of Implant

  MAUDE report 10388617 ↗
• InjuryJul 20, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Insufficient Device Problem Information; Use of Device Problem; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL, AND THREE AFX LIMB STENT GRAFTS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY, 4 (FOUR) YEARS POST INITIAL PROCEDURE, A ROUTINE FOLLOW-UP IDENTIFIED ILIAC ANEURYSM ENLARGEMENT OF 5CM AND A TYPE IB ENDOLEAK. RE-INTERVENTION WAS SUCCESSFULLY COMPLETED WITH IMPLANT OF OVATION IX EXTENDER AND TWO OVATION IX ILIAC LIMBS OCCLUDING BOTH ILIAC ANEURYSMS.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10299703 ↗
• InjuryJun 10, 2020Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND (2) LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED SYMPTOMATIC WITH RIGHT LEG REST PAIN AND OCCLUSION OF THE LEFT ILIAC LIMB WAS IDENTIFIED. THE PHYSICIAN ELECTED TO PERFORM A FEM-FEM BYPASS AND PATIENT IS DOING WELL. ADDITIONAL INFORMATION: CLINICAL ASSESSMENT IDENTIFIED OCCLUSION OF THE RIGHT LIMB, NOT THE LEFT LIMB AS INITIALLY REPORTED, AND A TYPE 3A ENDOLEAK OF THE RIGHT COMMON ILIAC ARTERY.

  Patient problems: Failure of Implant; Occlusion; Pain

  MAUDE report 10139510 ↗
• InjuryFeb 20, 2020Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Device Dislodged or Dislocated

  DURING THE RE-INTERVENTION OF A PREVIOUSLY REPORTED EVENT (2031527-2020-00038) FOR A TYPE 3A ENDOLEAK, THE PHYSICIAN DISLODGED THE PREVIOUSLY IMPLANTED AFX LIMB STENT GRAFT EXTENSION. THE PHYSICIAN ELECTED TO TREAT THE PREVIOUSLY REPORTED EVENT BY RELINING THE ORIGINALLY IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT DEVICE AND A MEDTRONIC (NON-ENDOLOGIX) 40MM THORACIC GRAFT IN THE AORTA (OFF-LABEL SECONDARY PROCEDURE DUE TO NONCOMPATIBLE USE WITH A NON-ENDOLOGIX DEVICE). THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE MEDTRONIC (NON-ENDOLOGIX) DELIVERY SYSTEM AND WHILE DOING SO, THE TOP CAP OF THE MEDTRONIC (NON-ENDOLOGIX) DELIVERY SYSTEM DISLODGED THE AFX LIMB STENT GRAFT EXTENSION. THE DISLODGED LIMB EXTENSION SUBSEQUENTLY OCCLUDED THE COMMON FEMORAL ARTERY. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL BE TREATED BY ANOTHER PHYSICIAN. THE OTHER PHYSICIAN ELECTED TO EXPLANT THE DISLODGED LIMB EXTENSION. THEN IMPLANTED ANOTHER AFX LIMB STENT GRAFT EXTENSION AND AN OVATION IX EXTENDER DEVICE TO RESOLVE THE RIGHT ILIAC OCCLUSION. THE OTHER PHYSICIAN ALSO IMPLANTED A GORE (NON-ENDOLOGIX) 13MM VIAHBAN STENT TO REPAIR THE DAMAGED EXTERNAL ILIAC ARTERY (OFF-LABEL TERTIARY PR

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 9735123 ↗
• InjuryDec 22, 2019Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE INTUITRAK ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY 4 YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED WITH A 1B ENDOLEAK AND PHYSICIAN ELECTED TO TREAT WITH A LIMB EXTENSION. THIS EVENT WAS REPORTED UNDER MFR #2031527-2015-00424. NOW, APPROXIMATELY 4.5 YEARS POST INTERVENTION, THE PATIENT PRESENTED WITH ENLARGED ILIAC ANEURYSMS (UNKNOWN DIAMETER) DURING FOLLOW-UP AS DETECTED BY NON-CONTRAST CT (COMPUTED TOMOGRAPHY) . THE PHYSICIAN ELECTED TO RELINE WITH A BIFURCATED STENT GRAFT, A PROXIMAL EXTENSION AND A NON-ENDOLOGIX DEVICE (VBX 8X59). PATIENT IS DOING FINE.

  Patient problems: Aneurysm

  MAUDE report 9508909 ↗
• InjuryNov 7, 2019Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL, AND A LIMB STENT GRAFT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A SYMPTOMATIC RUPTURE AND TYPE IIIB ENDOLEAK OF THE PROXIMAL SEGMENT OF THE RIGHT COMMON ILIAC LIMB. HOWEVER, THE EXACT DATE OF EVENT IS UNKNOWN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL BIFURCATED AFX2 DEVICE ON (B)(6) 2019. THE PATIENT HAS BEEN DISCHARGED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 9292409 ↗
• InjuryNov 6, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Use of Device Problem; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, TWO (2) INFRARENAL STENT GRAFT EXTENSIONS AND (3) LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT AT THE INDEX PROCEDURE, THAT ONE OF THE INFRARENAL STENT GRAFT EXTENSIONS WAS USED IN THE ILIAC LIMB. THIS IS OUTSIDE THE INDICATIONS OF USE (OFF- LABEL). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WAS REPORTED AND RESOLVED BY IMPLANTING ANOTHER LIMB STENT GRAFT EXTENSION. THIS EVENT WAS PREVIOUSLY REPORTED UNDER 2031527-2016-00093. NOW, APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, A COMPRESSION OF THE RIGHT ILIAC STENT GRAFT WAS IDENTIFIED ON A COMPUTED TOMOGRAPHY (CT). AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT A NON - ENDOLOGIX WALL STENT TO RESOLVED THIS EVENT. THE PATIENT WAS REPORTED AS DOING GREAT.

  Patient problems: Failure of Implant

  MAUDE report 9286436 ↗
• InjuryAug 23, 2019Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT WAS INITIALLY TREATED FOR AN ILIAC ARTERY ANEURYSM (OUTSIDE INDICATIONS OF USE) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH LEG PAIN; AN OCCLUDED RIGHT COMMON ILIAC ARTERY (RCIA) DUE TO THROMBI WITH TWISTED LEGS OF THE BIFURCATED DEVICE WERE DETECTED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A BARE-METAL (NON-ENDOLOGIX) STENT IN THE LEFT COMMON ILIAC ARTERY (LCIA) ON (B)(6) 2019, WHICH SUCCESSFULLY RESOLVED THE REPORTED ADVERSE EVENTS. THE PATIENT REPORTEDLY TOLERATED THE RE-INTERVENTION WELL AND HAS BEEN DISCHARGED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion; Pain; Thrombus

  MAUDE report 8928624 ↗
• InjuryAug 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A SUPRARENAL STENT GRAFT EXTENSION, AN INFRARENAL STENT GRAFT EXTENSION, LIMB STENT GRAFT EXTENSION AND A NON - ENDOLOGIX SENT GRAFT TO COMPLETED A FEMORAL- FEMORAL BYPASS PROCEDURE. SINCE THE AUI DEVICE WAS NOT ABLE TO BE DELIVERED, THE PHYSICIAN ELECTED TO DO A REVERSE BUILD UP WITH ENDOLOGIX DEVICES AND NON- ENDOLOGIX DEVICE. THIS PROCEDURE WAS OUTSIDE THE INDICATIONS OF USE (OFF- LABEL). NOW, SEVEN (7) DAYS POST INITIAL PROCEDURE, SEPARATION OF THE LIMB STENT GRAFT EXTENSION AND THE NON - ENDOLOGIX SENT GRAFT (3A ENDOLEAK) WAS IDENTIFIED. THE PATIENT WAS REPORTED AS UNSTABLE. AN INTERVENTION WAS COMPLETED. AN OVATION IX LIMB EXTENDER AND ANOTHER LIMB STENT GRAFT EXTENSION WERE IMPLANTED TO RESOLVE THE SEPARATION (3A ENDOLEAK). THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 8855972 ↗
• InjuryFeb 26, 2019Improper or Incorrect Procedure or Method; Obstruction of Flow; Malposition of Device; Improper or Incorrect Procedure or Method; Obstruction of Flow; Malposition of Device

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND TWO AFX ILIAC LIMBS. ADDITIONALLY A NON-ENDOLOGIX DEVICE WAS IMPLANTED AT THE TIME OF THE INITIAL PROCEDURE. DURING THE CASE, THE PHYSICIAN ELECTED TO EXTEND AT THE LEFT ILIAC WITH AN ENDOLOGIX LIMB DUE TO DISTAL STENOSIS PRESENT. THE ILIAC DEPLOYMENT WAS AS EXPECTED HOWEVER, DURING RECAPTURE THE TIP ENGAGED WITH THE LIMB MOST LIKELY RELATED TO THE ANGULATION OF THE COMMON ILIAC (PATIENT ANATOMY). THE ILIAC LIMB WAS DISPLACED DISTALLY. A DECISION WAS MADE TO IMPLANT A NON-ENDOLOGIX GRAFT WHICH RESOLVED THE REPORTED DISPLACEMENT. A FINAL ANGIO CONTROL WAS COMPLETED WHICH DETECTED THROMBUS WITHIN THE MAIN BODY AND THE ILIAC LIMB. THE PATIENT WAS REPORTEDLY UNDER SYSTEMIC HEPARIN. THE PHYSICIAN ELECTED TO PERFORM AN ANGIOJET THROMBECTOMY ALTHOUGH THIS WAS UNSUCCESSFUL IN RESOLVING THE THROMBUS. THE PHYSICIAN ELECTED TO CONCLUDE THE CASE WITHOUT FURTHER TREATMENT. THE PATIENT CONDITION POST-OP WAS REPORTED AS OKAY. ADDITIONALLY DURING THE NIGHT THE PATIENT EXPERIENCED RENAL INFARCTION. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Thrombosis

  MAUDE report 8372566 ↗
• InjuryJan 21, 2019Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  ADDITIONAL INFORMATION: THE SCHEDULED INTERVENTION HAS BEEN CANCELLED. AS OF DATE THERE HAS BEEN NO INTERVENTION REPORTED. AT THE COMPLETION OF THE CLINICAL ASSESSMENT, A TYPE 3A ENDOLEAK BETWEEN THE BIFURCATED STENT GRAFT AND THE RIGHT LIMB EXTENSION WAS IDENTIFIED THAT WAS NOT PREVIOUSLY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8265465 ↗
• InjuryDec 17, 2018Loss of or Failure to Bond; Leak/Splash; Loss of or Failure to Bond; Leak/Splash

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, A TYPE IB ENDOLEAK WAS DETECTED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN EXTENDER OVATION IX DEVICE AND COILING THE HYPOGASTRIC ARTERY ON (B)(6) 2016. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8169906 ↗
• InjuryOct 12, 2018Partial Blockage; Partial Blockage

  THE PATIENT WAS PREVIOUSLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, AN AFX LIMB EXTENSION STENT AND AN OVATION IX LIMB EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THE TWO (2) YEAR FOLLOW-UP, AN OCCLUDED RIGHT ILIAC LIMB WAS IDENTIFIED. A SECONDARY PROCEDURE WAS PERFORMED. THE PATIENT UNDERWENT BALLOON EMBOLECTOMY / ANGIOPLASTY. THE PHYSICIAN ELECTED TO RELINE WITH OVATION IX; TWO (2) ILIAC LIMBS AND TWO (2) EXTENDER STENT GRAFTS WERE IMPLANTED. THE PATIENT TOLERATED PROCEDURE WELL AND ILIAC FLOW WAS RESTORED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7962949 ↗
• InjurySep 24, 2018Loss of or Failure to Bond; Leak/Splash; Loss of or Failure to Bond; Leak/Splash

  PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED AND ILIAC LIMB IN 2016. RECENTLY, ON A FOLLOW UP CT, IT WAS DISCOVERED THAT THE PATIENT HAD AN ENDOLEAK TYPE IB WHERE THE DISTAL END OF THE EXISTING LIMB EXTENSION WAS NO LONGER SEATED IN THE EXTERNAL ILIAC. PATIENT WAS TREATED ON (B)(6) 2018 WHERE THE PHYSICIAN ELECTED TO PLACE ANOTHER LIMB. AS OF THE DATE OF THIS REPORT THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. THE PATIENT'S STATUS IS THAT HE'S DONG WELL AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 7903072 ↗
• InjuryMay 22, 2018Occlusion Within Device; Occlusion Within Device

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A BIFURCATED, A LIMB STENT GRAFT AND A NON- ENDOLOGIX STENT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. VESSEL STENOSIS WAS NOTED ON BOTH ACCESS SITES SO THE PHYSICIAN ELECTED TO PERFORM THE LEFT SIDE FIRST. IT WAS ALSO NOTED THAT ANGIOPLASTY WAS PERFORMED ON BOTH SIDE AND BALLOON TOUCH UP WAS PERFORMED. THE PROCEDURE WAS SUCCESSFUL. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A SECONDARY PROCEDURE THAT WAS PERFORMED IN MID-APRIL (THE EXACT DATE IS UNKNOWN). A BYPASS SURGERY (FEMORAL-FEMORAL) WAS PERFORMED DUE TO THE RIGHT EIA (EXTERNAL ILIAC ARTERY) BEING OCCLUDED. ANGIOPLASTY AND NON- ENDOLOGIX BARE STENT WAS IMPLANTED TO RESOLVE THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Thrombosis

  MAUDE report 7535731 ↗
• InjuryMay 8, 2018Kinked; Occlusion Within Device; Kinked; Occlusion Within Device

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH AFX DEVICE TO TREAT AN ABDOMINAL AORTIC ANEURYSM AND AN ANEURYSM ON THE RIGHT COMMON ILIAC WITH NO DISTAL NECK. DURING THIS PROCEDURE, IT WAS NOTED THAT THE C-ARM STOPPED WORKING AND THE THE AFX INTRODUCER WAS PLACED IN THE RIGHT ACCESS FOR A LONGER PERIOD OF TIME. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE THAT THIS PATIENT HAD REPORTED PAIN OF THE LEG A FEW DAYS EARLIER. THE PHYSICIAN DECIDED TO PERFORM AN ANGIOGRAPHY AND DISCOVERED THAT THE RIGHT ILIAC EXTENSION WAS OCCLUDED AND KINKED. THE PHYSICIAN ELECTED TO DO ANGIOPLASTY AND IMPLANT A NON- ENDOLOGIX STENT IN ORDER TO OPEN THE KINKED PORTION OF THE ILIAC EXTENSION THRU BRACHIAL ACCESS. THE PROCEDURE WAS SUCCESSFUL. THE PATIENT WAS REPORTED AS OK AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7497190 ↗

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-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-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-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-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• 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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-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.