AFX Endovascular AAA System BA25-90/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00818009010230), received between Apr 20, 2016 and Mar 31, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Leak/Splash” (10 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2016 WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT BSG), AN AFX VELA SUPRARENAL STENT GRAFT, AN AFX LIMB EXTENSION, AND A GORE (NON-ENDOLOGIX) EXCLUDER CUFF. DURING THE INITIAL IMPLANTATION, FIRST THE INFERIOR MESENTERIC ARTERY WAS EMBOLIZED, THEN THE AFX BSG AND AFX VELA SUPRARENAL WERE DEPLOYED VIA LEFT ACCESS. SUBSEQUENTLY THE AFX ILIAC LIMB EXTENSION WAS DEPLOYED IN THE LEFT COMMON ILIAC ARTERY (CIA) AND THE GORE (NON-ENDOLOGIX) EXCLUDER CUFF WAS DEPLOYED IN THE RIGHT CA AFTER TOUCH-UP, IT WAS CONFIRMED THAT THERE WERE NO ENDOLEAKS, AND THE PROCEDURE WAS COMPLETED. REPORTEDLY ON (B)(6) 2026 THE DISTRIBUTOR WAS MADE AWARE OF A SUSPECTED TYPE IIIB ENDOLEAK APPROXIMATELY 12MM ABOVE THE AORTIC BIFURCATION. THE PATIENT IS CURRENTLY BEING MONITORED WHILE REINTERVENTION PLANS ARE BEING DISCUSSED.

  Patient problems: Clinical Endoleak

  MAUDE report 24743088 ↗
• InjuryMar 26, 2025Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2015 WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT (BSG) AND AFX VELA SUPRARENAL. ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2025 IDENTIFIED WHAT APPEARED TO BE A GRAFT SEPARATION AND POSSIBLE TYPE IIIA ENDOLEAK. REINTERVENTION WAS COMPLETED ON (B)(6) 2025 BY RELINING THE GRAFT WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL. PATIENT WAS REPORTED TO BE STABLE POST-SECONDARY PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21700622 ↗
• InjuryJun 27, 2023Insufficient Device Problem Information; Lack of Effect; Insufficient Device Problem Information; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND TWO AFX INFRARENAL AORTIC EXTENSION ON (B)(6) 2016. AT THE ONE-YEAR FOLLOW-UP THERE WAS NO ENDOLEAK OBSERVED, AND THE ANEURYSM MEASURED AT 53MM. AT THE REGULAR FOLLOW-UP ON (B)(6) 2023, THE ANEURYSM MEASURED AT 60MM WITH NO APPARENT ENDOLEAK PRESENT. ON (B)(6) 2023, THE DISTRIBUTOR RECEIVED INFORMATION THAT BASED ON THE COMPUTED TOMOGRAPHY THAT WITH NO FLOW INTO THE ANEURYSM, A TYPE V ENDOLEAK WAS SUSPECTED. ON (B)(6) 2023, OPEN SURGERY WAS PERFORMED AND THE DEVICE WAS EXPLANTED. AN ENDOLEAK WAS NOT CONFIRMED DURING THE PROCEDURE; THEREFORE, THE ANEURYSM ENLARGEMENT WAS CONSIDERED TO BE DUE TO A TYPE V ENDOLEAK (ENDOTENSION). THE VASCULAR REPLACEMENT WAS COMPLETED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17210597 ↗
• InjuryMar 17, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND A NON-ENDOLOGIX BARE STENT. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM PER DEVICE IFU. APPROXIMATELY FIVE (5) YEARS POST-INITIAL PROCEDURE, AN ENDOLEAK (INDETERMINATE ORIGIN) WAS SUSPECTED. A RE-INTERVENTION WAS DONE AND THE PHYSICIAN ELECTED TO IMPLANT AN AFX VELA SUPRARENAL. THE PROCEDURE WAS COMPLETED AND NO ENDOLEAK WAS OBSERVED. THE FINAL PATIENT STATUS REMAINS UNKNOWN. THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Clinical Endoleak

  MAUDE report 16566538 ↗
• InjuryApr 8, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, ROUTINE FOLLOW-UP COMPUTERIZED TOMOGRAPHY (CT) SCAN IDENTIFIED SAC EXPANSION AND A TYPE II ENDOLEAK (NON-DEVICE RELATED) THAT REPORTEDLY THE PHYSICIAN PLANNED TO EMBOLIZE. A SEPARATE REPORT WILL NOT BE FILED FOR THIS EVENT AS TYPE II ENDOLEAKS ARE ANATOMY RELATED AND NOT RELATED TO A FAILURE OF THE DEVICE. APPROXIMATELY THREE (3) YEARS POST POSSIBLE EMBOLIZATION, THE PATIENT PRESENTED WITH CHEST PAIN. A CT (COMPUTED TOMOGRAPHY) SCAN WAS PERFORMED AND IDENTIFIED A TYPE 3B ENDOLEAK. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF THE ALTO STENT GRAFT SYSTEM. THE TYPE 3B ENDOLEAK WAS SEALED SUCCESSFULLY. THE PATIENT WAS DISCHARGED HOME ONE-DAY POST-REINTERVENTION.

  Patient problems: Chest Pain; Failure of Implant

  MAUDE report 14056789 ↗
• InjurySep 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND AN INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT AT SOME POINT AFTER THE INITIAL PROCEDURE, A TYPE 2 ENDOLEAK (NON- DEVICE RELATED FAILURE) WAS IDENTIFIED AND THE LUMBAR ARTERY WAS EMBOLIZED WITH A COILS. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, AN ANGIOGRAM SHOWED A SUSPECT TYPE 3A ENDOLEAK. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS PROVIDED REPORTING THAT REINTERVENTION WAS PERFORMED WITH IMPLANT OF A GORE EXCLUDER (NON-ENDOLOGIX) SUCCESSFULLY SEALING THE SUSPECT TYPE 3A ENDOLEAK. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 12527136 ↗
• InjuryMar 1, 2021Insufficient Device Problem Information; Separation Problem; Insufficient Device Problem Information; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 5 YEARS POST INITIAL IMPLANT DURING A ROUTINE FOLLOW UP A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED A 3A ENDOLEAK WITH SEPARATION OF THE BIFURCATED STENT GRAFT AND PROXIMAL EXTENSION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ANOTHER SUPRARENAL STENT GRAFT EXTENSION AND AN INFRARENAL STENT GRAFT EXTENSION. REPORTEDLY, PATIENT IS DOING WELL POST RE-INTERVENTION. ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT INDICATING THAT A SIGNIFICANT ANEURYSM SAC GROWTH WAS ALSO PRESENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11393097 ↗
• InjuryFeb 17, 2021Material Puncture/Hole; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE AN ENDOLEAK OF INDETERMINATE ORIGIN WAS IDENTIFIED. A RE-INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT A SUPRARENAL STENT GRAFT TO RESOLVE THE ISSUE. THE PATIENT IS CURRENTLY STABLE AND BEING MONITORED. ADDITIONAL INFORMATION: THE ENDOLEAK OF INDETERMINATE ORIGIN WAS DETERMINED TO BE A TYPE 3B ENDOLEAK OF THE BIFURCATED STENT GRAFT.

  Patient problems: Failure of Implant

  MAUDE report 11338956 ↗
• InjuryJan 20, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE A COMPUTED TOMOGRAPHY (CT) REVEALED A 3A ENDOLEAK WITH ANEURYSM ENLARGEMENT. REPORTEDLY, PATIENT IS STABLE AND IS PENDING RE-INTERVENTION. ADDITIONAL INFORMATION: A RE-INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL. THE TYPE 3A ENDOLEAK WAS RESOLVED AND THE FINAL PATIENT STATUS WAS REPORTED AS DOING STABLE POST SECONDARY ENDOVASCULAR PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 11203224 ↗
• InjuryJan 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, NON-ENDOLOGIX (GORE EXCLUDER AORTIC EXTENDER) AND PROXIMAL STENT GRAFT (NON- ENDOLOGIX) 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 (3) THREE YEARS POST INITIAL PROCEDURE, AN INDETERMINATE ENDOLEAK (POSSIBLE TYPE 1B OR 3B) WAS IDENTIFIED FROM A 4D CT (COMPUTED TOMOGRAPHY). PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 11165477 ↗
• InjuryJan 11, 2021Insufficient Device Problem Information; Separation Problem; Insufficient Device Problem Information; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (6) SIX YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO TREAT THIS EVENT BY RELINING THE EXISTING STENT GRAFTS WITH A NON-ENDOLOGIX (GORE) DEVICE. THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 11149650 ↗
• InjuryFeb 25, 2020Material Puncture/Hole; Material Puncture/Hole

  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 WITH A TYPE IIIB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH A GORE (NON-ENDOLOGIX) EXCLUDER. THE PATIENT WAS REPORTEDLY IN GOOD CONDITION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9751731 ↗
• InjuryFeb 25, 2020Material Puncture/Hole; Material Puncture/Hole

  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 WITH A TYPE IIIB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH A GORE (NON-ENDOLOGIX) EXCLUDER. THE PATIENT WAS REPORTEDLY IN GOOD CONDITION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION RECEIVED PER CLINICAL EVALUATION CONFIRMING THAT THE INITIAL IMPLANT WAS AN EMERGENT USE OF THE AFX SYSTEM DUE TO A PRE-EXISTING RUPTURE, WHICH IS CAUTIONARY PRODUCT USE. A TYPE IIIA ENDOLEAK WAS ALSO CONFIRMED PRESENT AT THE TIME OF THE REPORTED EVENT PER CT (COMPUTED TOMOGRAPHY) SCAN FROM (B)(6) 2019; DATE OF EVENT THEREFORE UPDATED. ADDITIONALLY, THE RE-INTERVENTION WAS CONFIRMED TO HAVE BEEN PERFORMED ON (B)(6) 2019 IN WHICH THE PHYSICIAN IMPLANTED A MEDTRONIC (NON-ENDOLOGIX) AUI (AORTO-UNI-ILIAC) DEVICE WITH A RIGHT ILIAC EXTENSION (UNKNOWN MANUFACTURER), AND A RIGHT-TO-LEFT FEMORAL-FEMORAL LIA (LEFT ILIAC ARTERY) COIL, WHICH IS AN OFF-LABEL PROCEDURE DUE TO ADJUNCTIVE USE OF NON-ENDOLOGIX PRODUCTS.

  Patient problems: Failure of Implant

  MAUDE report 9751726 ↗
• InjuryNov 22, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY, 4.5 YEARS POST INITIAL PROCEDURE, THE PATIENT WAS TREATED FOR A SUSPECTED TYPE II ENDOLEAK (NON-DEVICE RELATED FAILURE). THE PHYSICIAN TREATED THE PATIENT BY COILING AND (ONYX) GLUING THE ANEURYSM SAC AND DURING THIS PROCEDURE THE PHYSICIAN DETECTED A POSSIBLE TYPE 1A ENDOLEAK. THE PHYSICIAN REFERRED THE PATIENT TO ANOTHER PHYSICIAN. THE REFERRED PHYSICIAN ELECTED TO EXPLANT THE GRAFT AND THE PATIENT IS DOING VERY WELL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9365522 ↗
• InjuryOct 23, 2019Material Puncture/Hole; Insufficient Device Problem Information; Material Puncture/Hole; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3 YEARS POST INITIAL IMPLANT, THE PATIENT WAS DIAGNOSED WITH A TYPE IIIA ENDOLEAK. AN ADDITIONAL SUPRARENAL STENT GRAFT WAS IMPLANTED TO RESOLVE THIS EVENT. THIS EVENT WAS PREVIOUSLY REPORTED UNDER 2031527-2018-00742. NOW, APPROXIMATELY 1 YEAR POST RE-INTERVENTION, A TYPE IIIB ENDOLEAK HAS BEEN IDENTIFIED AND A RE-INTERVENTION HAS BEEN SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 9227721 ↗
• InjuryAug 24, 2019Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; 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 PRESENTED WITH A TYPE IIIB ENDOLEAK PER CT (COMPUTED TOPOGRAPHY). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH MEDTRONIC (NON-ENDOLOGIX) DEVICES ON AN UNKNOWN DATE. THE FINAL ULTRASOUND CONFIRMED THE ENDOLEAK WAS RESOLVED, AND THE PATIENT IS REPORTEDLY IN STABLE CONDITION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8928735 ↗
• InjuryNov 28, 2018Partial Blockage; Partial Blockage

  AN AFX BIFURCATED AND SUPRARENAL WERE INITIALLY IMPLANTED. THE PATIENT PRESENTED EMERGENTLY FOUR (4) YEARS POST OP TO A DIFFERENT HOSPITAL WITH COLD LEFT LEG. THE CTA SHOWED A COMPLETE OCCLUSION OF THE LEFT GRAFT LIMB AND THROMBUS WITHIN THE MAIN BODY OF THE STENT GRAFT, WITH A SMALLER LUMINAL FLOW AND OUTFLOW OUT OF THE RIGHT LIMB. THE CTA ALSO SHOWED EVIDENCE OF TWISTING AND COMPRESSION OF THE LEFT AFX LIMB THAT LIKELY OCCURRED AT THE TIME OF IMPLANT, AND INSUFFICIENT OVERLAP BETWEEN THE TWO (2) NON-ELGX STENTS DISTAL TO THE AFX LIMB IN LCI / LEI WHICH ALSO NARROWED LUMINAL FLOW AND SUBSEQUENT LOSS OF PATENCY. A RE-INTERVENTION WAS PERFORMED WHERE TWO (2) SELF-EXPANDING STENTS WERE PLACED IN THE LEFT LIMB TO RESTORE FLOW. ANOTHER RE-INTERVENTION WAS COMPLETED TO RELINE THE ENTIRE STENT GRAFT TO COVER THE THROMBUS IN ORIGINALLY PLACED MAIN BODY AND TO ADDRESS THE DISTAL STENTS IN LEFT COMMON AND LEFT EXTERNAL ILIAC. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 8113802 ↗
• InjuryNov 14, 2018Leak/Splash; Material Puncture/Hole; Material Integrity Problem; Leak/Splash; Material Puncture/Hole; Material Integrity Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION. APPROXIMATELY FOUR (4) YEARS POST INITIAL IMPLANT, A TYPE 3B ENDOLEAK WAS DISCOVERED. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANT WITH THE OVATION SEALING SYSTEM. THE PATIENT WAS REPORTED A STABLE POST SECONDARY PROCEDURE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8072163 ↗
• InjurySep 24, 2018Leak/Splash; Leak/Splash

  AN AFX BIFURCATED AND SUPRARENAL WAS INITIALLY IMPLANTED. THE THREE (3) YEAR ROUTINE FOLLOW-UP SHOWED THE PRESENCE OF A TYPE IIIA ENDOLEAK. A RE-INTERVENTION WAS COMPLETED AT A DIFFERENT HOSPITAL WHERE AN ADDITIONAL SUPRARENAL STENT GRAFT WAS IMPLANTED TO BRIDGE THE COMPONENTS SUCCESSFULLY RESOLVING THE ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7904201 ↗
• InjurySep 18, 2018Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem

  PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED, ONE VELA SUPRARENAL, AND ONE OVATION LIMB. RECENTLY, IT WAS NOTED THAT THE PATIENT HAS A POSSIBLE ENDOLEAK TYPE IIIB WITH FABRIC BILLOWING/TEAR. PATIENT IS CURRENTLY BEING MONITORED, THERE HAS NOT BEEN ANY PLANS FOR INTERVENTION. AS OF THIS REPORT, THERE HAS NOT BEEN ANY ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7887201 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY PROCEDURE WAS PERFORMED ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH A AFX BIFURCATED STENT GRAFT AND A AFX INFRARENAL AORTIC EXTENSION. SECONDARY PROCEDURE WAS PERFORMED ON (B)(6) 2017, FOR AN UNKNOWN REASON. A AFX VELA SUPRARENAL AND AFX VELA INFRARENAL WERE IMPLANTED IN THE PATIENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 7443835 ↗
• InjuryMar 26, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  ON (B)(4) 2016, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL EXTENSION. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A TYPE 3A ENDOLEAK. ON (B)(6) 2018, THE PHYSICIAN ELECTED TO BRIDGE THE GAP BY IMPLANTING AN INFRARENAL EXTENSION. THE ENDOLEAK WAS RESOLVED. THE PATIENT WAS REPORTED AS DOING OK AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7370462 ↗
• InjuryFeb 15, 2018Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  AN AFX BIFURCATED AND A VELA SUPRARENAL EXTENSION WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM IN 2016. THE PATIENT WAS ADMITTED TO ER APPROXIMATELY TWO (2) YEARS POST-OP FOR A STROKE (ON APPROXIMATELY (B)(6) 2018) AND WAS TREATED WITH TPA (TISSUE PLASMINOGEN ACTIVATOR) AND SUBSEQUENTLY DEVELOPED A RETROPERITONEAL BLEED. PATIENT RECEIVED A CAT SCAN WHICH SHOWED AN INDETERMINATE ENDOLEAK. IT WAS REPORTED THAT THE PATIENT HAD TWO SELF-EXPANDING STENT PLACED DUE TO TORTUOSITY OF THE NATIVE VESSELS AN ANGIOGRAM WAS PERFORMED ON (B)(6) 2018 WHICH SHOWED THE PRESENCE OF A TYPE IIIB ENDOLEAK. A RE-INTERVENTION WAS PERFORMED WHERE THE STENT GRAFT WAS RELINED WITH ANOTHER MAIN BODY GRAFT SUCCESSFULLY RESOLVING THE LEAK. THE PATIENT DID WELL DURING THE RE-INTERVENTION AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7274112 ↗
• InjuryJan 5, 2018Difficult or Delayed Positioning; Deformation Due to Compressive Stress; Difficult or Delayed Positioning; Deformation Due to Compressive Stress

  ON (B)(6) 2017, AN EVAR WAS PERFORMED FOR A PATIENT WITH ABDOMINAL AORTIC ANEURYSM. A PIG CATHETER WAS INSERTED FROM THE RIGHT UPPER ARM AND ADVANCED TO THE DESCENDING AORTA. A NON - ENDOLOGIX STENT STENT GRAFT WAS IMPLANTED ON THE LEFT LIMB FIRST. THROUGH THE RIGHT FEMORAL APPROACH, AN ENDOLOGIX BIFURCATED STENT GRAFT WAS INSERTED NEXT. DURING THE BIFURCATED STENT GRAFT DEPLOYMENT, THERE WAS A DIFFICULTY ON RETRACTING THE CONTROL CORD AND IT WAS UNABLE TO BE COMPLETELY RETRACTED. THE NON - ENDOLOGIX STENT FROM THE PROXIMAL EDGE SEEMED NOT BE DEPLOYED AS A RESULT. WHEN THE TENSION WAS APPLIED AGAIN ON THE CONTROL CORD, THE TIP OF ENDOLOGIX BIFURCATED STENT GRAFT BENT (BUCKLED). THE BIFURCATED STENT GRAFT WAS FULLY DEPLOYED AT THAT TIME, HOWEVER THE TIP OF BIFURCATED STENT GRAFT STILL LOOKED TO BE CONTACTED TO THE AORTA WALL. A NON - ENDOLOGIX IPSILATERAL LIMB WAS DEPLOYED AND THEN A ENDOLOGIX PROXIMAL EXTENSION WAS IMPLANTED RIGHT AWAY IN ORDER TO COVER ENDOLOGIX BIFURCATED STENT GRAFT DEFORMATION. THEN A NON - ENDOLOGIX CONTRALATERAL LIMB WAS THEN DEPLOYED. AN ANGIOGRAM SHOWED NO ENDOLEAKS. THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 7167571 ↗
• InjuryAug 17, 2017Failure To Adhere Or Bond; Collapse; Leak/Splash; Stretched; Material Integrity Problem; Failure To Adhere Or Bond; Collapse; Leak/Splash; Stretched; Material Integrity Problem

  THE PATIENT WAS IMPLANTED WITH A BIFURCATED AND SUPRARENAL STENT GRAFT ON (B)(6) 2015. ON (B)(6) 2017 IT WAS REPORTED THAT THE PATIENT HAD A AAA RUPTURE. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICE AND NOTED THAT THE GRAFT HAD NO MATERIAL ON THE STRUTS. THE GRAFT IS NOT AVAILABLE FOR RETURN BECAUSE THE PHYSICIAN HAD SENT IT TO PATHOLOGY. THE PATIENT IS REPORTED TO HAVE TOLERATED THE PROCEDURE; NO ADDITIONAL PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: Aneurysm; Pain; Rupture

  MAUDE report 6802701 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040002. One submission often covers many models, so check the product and lot details in each record.

• Z-1048-2017 · Jan 4, 2017 · Terminated
  AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C
• Z-1049-2017 · Jan 4, 2017 · Terminated
  AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 B
• Z-1037-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-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-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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• Z-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• Z-0590-06 · 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
• 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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL

…and 1 more.