AFX2 Bifurcated Endograft System BEA25-70/I20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00818009014832), received between Apr 13, 2018 and Oct 16, 2025 — classified as 1 death, 17 injuries.

The most frequently reported specific device problem is “Off-Label Use” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2025Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component

  THE PATIENT WAS TREATED FOR A LEFT COMMON ILIAC ANEURYSM ON (B)(6) 2025. PERCLOSE HEMOSTATIC DEVICES (NON-ENDOLOGIX) WERE PREPLACED IN BOTH FEMORAL ARTERIES. THE LEFT INTERNAL ILIAC ARTERY (IIA) WAS THEN COIL EMBOLIZED. AN EXCLUDER LEG (NON-ENDOLOGIX) WAS PLACED FROM THE ORIGIN OF THE LEFT COMMON ILIAC ARTERY (CIA) THROUGH A DRYSEAL SHEATH (NON-ENDOLOGIX) VIA THE LEFT FEMORAL ARTERY. AN INDY SNARE (NON-ENDOLOGIX) WAS INSERTED VIA THE RIGHT FEMORAL ARTERY TO PREPARE FOR SNARING. THE DRYSEAL SHEATH (NON-ENDOLOGIX) VIA THE LEFT FEMORAL ARTERY WAS REPLACED WITH AN AFX INTRODUCER SHEATH. THE DELIVERY SYSTEM OF AN AFX2 BIFURCATED STENT GRAFT (BSG) WAS DOCKED TO THE AFX INTRODUCER SHEATH AND THE CONTRALATERAL LEG WAS DEPLOYED ACCORDING TO THE INSTRUCTIONS. WHEN THE CONTRALATERAL LEG WIRE WAS UNLOCKED WITH A MARKER EQUIPPED PIGTAIL CATHETER THE CONTRALATERAL LEG WIRE BROKE WITHOUT ANY RESISTANCE. THE PHYSICIAN ASSUMED THE BROKEN WIRE WOULD BE RETRIEVED INSIDE THE AFX INTRODUCER SHEATH DURING DEPLOYMENT OF THE IPSILATERAL LEG, SO THE PHYSICIAN ELECTED TO DEPLOY THE IPSILATERAL LEG AS IS. BALLOON TOUCH-UP OF THE PROXIMAL TO DISTAL SECTIONS OF THE AFX2 BSG VIA THE LEFT FEMORAL ARTERY WAS PERF

  Patient problems: Clinical Endoleak; Foreign Body In Patient

  MAUDE report 23312050 ↗
• InjuryApr 22, 2025Fracture; Material Separation; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Fracture; Material Separation; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL AORTIC EXTENSION TO TREAT A FUSIFORM ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED THAT THE LEFT AND RIGHT LEGS OF THE AFX2 BIFURCATED STENT GRAFT WERE BROKEN AND COLLAPSED TO THE LEFT SIDE. ALSO, THE VELA WAS DISLOCATED TO THE LEFT AND DISCONNECTED FROM THE AFX2 BIFURCATED STENT GRAFT. THE OVERLAP WAS ABOUT 43MM, AND THE ANEURYSM LUMEN WAS THROMBOSED WITHOUT SIGN OF ENLARGEMENT. INTERVENTION WAS SCHEDULED/PLANNED FOR (B)(6) 2025, HOWEVER IT WAS POSTPONED DUE TO THE PATIENT CONTRACTING THE CORONA VIRUS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885186 ↗
• InjurySep 30, 2024Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE OVATION PRIME STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY EIGHT AND HALF (8.5) YEARS POST INITIAL PROCEDURE, THE AAA WAS FOUND TO HAVE STILL BEEN GROWING. ONLY COMPUTED TOMOGRAPHY (CT) SCANS WERE PERFORMED TO DETECT THE ANEURYSM GROWTH AND NO ANGIOGRAM WAS DONE; HOWEVER, THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFTS IN (B)(6) 2024 (EXACT DATE IS UNKNOWN). THE GRAFT WAS FULLY INTACT WHEN EXPLANTED BUT IT WAS COVERED IN BILE AND PUS. THE PROXIMAL FIXATION STENT OF THE OVATION PRIME WAS NOT EXPLANTED AND REMAINED IN THE PATIENT. THE EXPLANTED STENT GRAFTS WERE NOT RETURNED AND THE FINAL PATIENT STATUS AT THE TIME WAS NOT REPORTED TO ENDOLOGIX. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 3008011247-2024-00104. IT WAS REPORTED THAT THE PATIENT CAME BACK EMERGENTLY FOR AN UNKNOWN REASON AND WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT ON (B)(6) 2024. ON 09/08/2024, IT WAS REPORTED THAT THERE WAS A DISTAL TUBE GRAFT LEAK WITH ENDOVASCULAR AORTIC REPAIR (EVAR) AT THE DISTAL ASPECT OF THE AAA TUBE GRAFT. THE FOLLOWING COMPLICATIONS WERE NOTED: COLECTOMY WITH ILEOSTOMY, OPEN BELLY THAT HAS GRANULATED, PIGTAIL IN

  Patient problems: Fistula; Ischemia; Unspecified Infection

  MAUDE report 20334377 ↗
• InjuryJul 22, 2024Off-Label Use; Off-Label Use

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2024. AN ENDURANT (NON-ENDOLOGIX) STENT WAS IMPLANTED FIRST JUST BELOW THE RENAL ARTERY. THE AFX2 BIFURCATED STENT GRAFT (BSG) WAS THEN IMPLANTED FROM THE RIGHT ACCESS. AFTER BALLOON TOUCH-UP OF THE RIGHT COMMON ILIAC ARTERY (CIA), ANOTHER ENDURANT (NON-ENDOLOGIX) STENT WAS IMPLANTED AT THE JUNCTION. THE ANGIOGRAM AFTER BALLOON TOUCH-UP SHOWED A TYPE IIIA ENDOLEAK AND TYPE IB ENDOLEAK ON THE RIGHT SIDE. THE RIGHT INTERNAL ILIAC ARTERY (IIA) WAS OCCLUDED AND AN AFX LIMB WAS IMPLANTED IN THE RIGHT SIDE. DURING BALLOON TOUCH-UP, THE RIGHT CIA RUPTURED, AND THE PATIENT¿S BLOOD PRESSURE DECREASED. ANGIOGRAM SHOWED A TYPE IIIA ENDOLEAK AT AFX2 BSG JUNCTION AS WELL AS AT THE AFX LIMB JUNCTION. BASED ON THE ANGIOGRAM OBSERVATION, GRAFT DAMAGE WAS SUSPECTED FOR THE AFX LIMB JUNCTION ENDOLEAK. A SECOND AFX2 BSG WAS IMPLANTED FROM THE RIGHT ACCESS. AS THE PROXIMAL AND LEFT LIMB PORTION OF SECOND AFX2 DID NOT FULLY EXPAND AN ADDITIONAL ENDURANT (NON-ENDOLOGIX) WAS IMPLANTED AT THE PROXIMAL PORTION. THE PHYSICIAN TRIED TO CANNULATE A GUIDE WIRE INTO THE LEFT LIMB, BUT IT FAILED. THE PHYSICIAN DECIDED TO CONVERT TO AN OPEN

  Patient problems: Clinical Endoleak; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 19797946 ↗
• InjuryOct 26, 2023Material Puncture/Hole; Improper or Incorrect Procedure or Method; Material Puncture/Hole; Improper or Incorrect Procedure or Method

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2019. THE LEFT INTERNAL ILIAC ARTERY (IIA) AND INFERIOR MESENTERIC ARTERY WERE OCCLUDED AND THEN A NON-ENDOLOGIX GORE EXCLUDER LEG (16/12-10) WAS IMPLANTED IN THE LEFT SIDE. AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL WERE THEN IMPLANTED. THE PROCEDURE WAS COMPLETED WITH NO ENDOLEAK. THIS INITIAL PROCEDURE IS OUTSIDE OF THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM. ON (B)(6) 2023, REINTERVENTION WAS PERFORMED TO TREAT ANEURYSM ENLARGEMENT AND AN INDETERMINATE ENDOLEAK (POSSIBLE TYPE IA, IIIA OR IB). THE RIGHT IIA WAS OCCLUDED, AND A NON-ENDOLOGIX BOSTON SCIENTIFIC WAS DEPLOYED IN THE SUPERIOR MESENTERIC ARTERY DUE TO A DISSECTION FROM AN UNKNOWN CAUSE. AN AFX VELA SUPRARENAL WAS DEPLOYED JUST BELOW THE RENAL ARTERY AND AN AFX LIMB EXTENSION WAS DEPLOYED ON THE RIGHT SIDE. BALLOON TOUCH-UP WAS PERFORMED AND THERE WAS NO APPARENT ENDOLEAK. THE REINTERVENTION WAS COMPLETED. PATIENT STATUS WAS NOT PROVIDED. (REPORTED UNDER MFR#: 3011063223-2023-00020). A FOLLOW-UP PERFORMED ON (B)(6) 2023, IDENTIFIED THAT ANEURYSM HAD OCCURRED AGAIN. THE

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18014358 ↗
• InjuryOct 26, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2019. THE LEFT INTERNAL ILIAC ARTERY (IIA) AND INFERIOR MESENTERIC ARTERY WERE OCCLUDED AND THEN A NON-ENDOLOGIX GORE EXCLUDER LEG (16/12-10) WAS IMPLANTED IN THE LEFT SIDE. AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL WERE THEN IMPLANTED. THE PROCEDURE WAS COMPLETED WITH NO ENDOLEAK. THIS INITIAL PROCEDURE IS OUTSIDE OF THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM. ON (B)(6) 2023 REINTERVENTION WAS PERFORMED TO TREAT ANEURYSM ENLARGEMENT AND AN INDETERMINATE ENDOLEAK (POSSIBLE TYPE IA, IIIA OR IB). THE RIGHT IIA WAS OCCLUDED, AND A NON-ENDOLOGIX BOSTON SCIENTIFIC WAS DEPLOYED IN THE SUPERIOR MESENTERIC ARTERY DUE TO A DISSECTION FROM AN UNKNOWN CAUSE. AN AFX VELA SUPRARENAL WAS DEPLOYED JUST BELOW THE RENAL ARTERY AND AN AFX LIMB EXTENSION WAS DEPLOYED ON THE RIGHT SIDE. BALLOON TOUCH-UP WAS PERFORMED AND THERE WAS NO APPARENT ENDOLEAK. THE REINTERVENTION WAS COMPLETED. PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18014148 ↗
• InjuryAug 16, 2023Material 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 PROXIMAL EXTENSION. VESSEL TORTUOSITY IN THE RIGHT COMMON INTERNAL ARTERY AND POOR WALL APPOSITION WAS NOTED AT INITIAL IMPLANT. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, ANEURYSM SAC ENLARGEMENT (UNKNOWN DIAMETER) WAS IDENTIFIED. THEN ANOTHER TWO (2) YEARS LATER, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN EXCLUDER (NON-ENDOLOGIX) LEG ON (B)(6) 2022. REFERENCE MFR. REPORT # 2031527-2022-00239 FOR THIS EVENT. APPROXIMATELY FIVE (5) MONTHS POST SECONDARY PROCEDURE, THE PHYSICIAN PERFORMED RE-INTERVENTION DUE TO A TYPE IIIB ENDOLEAK. AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED ON (B)(6) 2013. THIS REPORT IS TO ADDRESS THE TYPE IIIB ENDOLEAK EVENT WITH TERTIARY INTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 17561253 ↗
• InjurySep 29, 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 THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. REPORTEDLY, THE INFERIOR MESENTERIC ARTERY WAS OCCLUDED PRE-IMPLANT AND THERE WAS VESSEL TORTUOSITY ON THE RIGHT COMMON ILIAC ARTERY AND POOR WALL APPOSITION AT THE INITIAL PROCEDURE. APPROXIMATELY ONE (1) YEAR POST INITIAL ANEURYSM ENLARGEMENT WAS IDENTIFIED. NOW, APPROXIMATELY THREE (3) YEARS POST INITIAL A TYPE IB ENDOLEAK. REINTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15503419 ↗
• InjuryAug 8, 2022Off-Label Use; Material Puncture/Hole; Difficult to Remove; Device-Device Incompatibility; Off-Label Use; Material Puncture/Hole; Difficult to Remove; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL STENT GRAFT, AN AFX LIMB STENT GRAFT, AND AN EXCLUDER LEG STENT (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 AFX2 / AFX SYSTEM PER THE IFU. THE EXCLUDER LEG STENT (NON- ENDOLOGIX) WAS IMPLANTED FIRST, THEN THE AFX2 BIFURCATED STENT GRAFT. AN ANGIOGRAPHY SHOWED AN ENDOLEAK THEREFORE AN AFX VELA INFRARENAL STENT GRAFT WAS BEING IMPLANTED. DURING THE AFX VELA INFRARENAL STENT GRAFT DELIVERY SYSTEM BECAME SLIGHTLY GOT STUCK AT THE SKELETON; HOWEVER IT WAS RESOLVED AND THE DELIVERY SYSTEM WAS REMOVED FROM THE BODY. THE ANGIOGRAPHY WAS PERFORMED AGAIN FROM THE RENAL ARTERY AREA AFTER TOUCH-UP SHOWING ENDOLEAK AROUND NON- ENDOLOGIX EXCLUDER LEG STENT. THE ENDOLEAK WAS IDENTIFIED AS A TYPE 3 (INDETERMINATE ORIGIN). AN AFX LIMB STENT GRAFT WAS IMPLANTED AND ANOTHER ANGIOGRAPHY SHOWED THAT THERE WAS AA TYPE 3B ENDOLEAK PRESENT. THE PATIENT IS BEING MONITORED WITH MEDICATION, AND A RE-INTERVENTION IS BEING DISCUSSED IF THE TYPE 3B ENDOLEAK DOES NOT RESOLVED

  Patient problems: Failure of Implant

  MAUDE report 15184351 ↗
• InjuryMar 21, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND AN INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP THE OVERLAP BETWEEN THE BIFURCATED STENT GRAFT AND THE INFRARENAL AORTIC EXTENSION WAS FOUND TO HAVE DECREASED AND THE ANEURYSM HAD ENLARGED. THE PHYSICIAN DETERMINED THERE WAS A TYPE 3A ENDOLEAK. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT AN AFX INFRARENAL AORTIC EXTENSION IN THE JUNCTION BETWEEN THE ORIGINAL AFX2 BIFURCATED STENT GRAFT AND THE SUPRARENAL AORTIC EXTENSION AS WELL AS IMPLANT OF A NON-ENDOLOGIX 28.5MM X 3.3CM (EXCLUDER) AORTIC EXTENDER IN THE PROXIMAL NECK TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS STABLE POST SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13843050 ↗
• InjuryJan 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2, BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). ON (B)(6) 2020, A SECONDARY PROCEDURE WAS PREFORMED FOR AN UNKNOWN REASON. TWO (2) OVATION IX, LIMB STENT GRAFT EXTENDERS AND A NON - ENDOLOGIX (GORE VBX) STENT WERE IMPLANTED. THIS SECONDARY 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 SECONDARY PROCEDURE WAS IDENTIFIED DURING A REVIEW OF A RECENTLY REPORTED ADVERSE EVENT (REF 2031527-2021-00459). MEDICAL IMAGES AND RECORDS WERE REQUESTED. A CLINICAL ASSESSMENT OF THE MEDICAL RECORDS RECEIVED WAS COMPLETED ON (B)(6) 2021. A TYPE 1B ENDOLEAK AND A TYPE 2 ENDOLEAK (NON- DEVICE RELATED FAILURE) WERE IDENTIFIED. BOTH ENDOLEAKS WERE IDENTIFIED TO BE ANATOMY RELATED.

  Patient problems: Failure of Implant

  MAUDE report 13242367 ↗
• InjuryNov 3, 2021Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2, BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). ON (B)(6) 2020, A SECONDARY PROCEDURE WAS PREFORMED FOR AN UNKNOWN REASON. TWO (2) OVATION IX, LIMB STENT GRAFT EXTENDERS AND A NON - ENDOLOGIX (GORE VBX) STENT WERE IMPLANTED. THIS CASE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. NOW, APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A TYPE 3B AND TYPE 2 ENDOLEAKS WERE REPORTED. A THIRD PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINALLY IMPLANTED DEVICES WITH ANOTHER AFX2, BIFURCATED STENT GRAFT TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL AND HAD BEEN DISCHARGED.

  Patient problems: Failure of Implant

  MAUDE report 12749126 ↗
• InjuryMay 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 BIFURCATED STENT GRAFT AND EXCLUDER (NON-ENDOLOGIX) DEVICE; DUE TO CONCOMITANT USE OF AFX WITH A NON-ENDOLOGIX PRODUCT, THIS INITIAL IMPLANT WAS COMPLETED OUTSIDE THE INDICATIONS OF USE. APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ENLARGED ANEURYSM (UNKNOWN DIAMETER) AND A SUSPECT ENDOLEAK (AT AN INDETERMINATE ORIGIN). THE PATIENT IS REPORTEDLY ASYMPTOMATIC AND THE PHYSICIAN PLANS TO RE-INTERVENE. ADDITIONAL INFORMATION: IT IS UNKNOWN AT THE TIME IF THE PHYSICIAN IS PLANNING ON DOING A RE-INTERVENTION. THE PATIENT IS CURRENTLY BEING MONITORED AND HAS BEEN REPORTED TO NOT HAD ANY SYMPTOMS.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11894820 ↗
• DeathDec 9, 2020Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL STENT GRAFT, A VELA INFRARENAL STENT GRAFT, A NON-ENDOLOGIX EXCLUDER DEVICE, A NON-ENDOLOGIX GORE PROXIMAL EXTENSION AND A NON-ENDOLOGIX BARE STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO CONCOMITANT USE WITH PRODUCTS OUTSIDE THE IFU. APPROXIMATELY SIX (6) TO TWELVE (12) MONTHS POST INITIAL PROCEDURE, ANEURYSM ENLARGEMENT WAS IDENTIFIED AND A POSSIBLE ENDOLEAK WAS SUSPECTED. HOWEVER NO ADDITIONAL INTERVENTION WAS PERFORMED. NOW APPROXIMATELY ONE (1) YEAR LATER, A TYPE 3A ENDOLEAK WAS IDENTIFIED. AN INTERVENTION WAS PLANNED, HOWEVER, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH AN ANEURYSM RUPTURE AND CARDIAC ARREST. THE PHYSICIAN PERFORMED A REINTERVENTION, AND IMPLANTED A NON-ENDOLOGIX ENDURANT PROXIMAL EXTENSION DURING THIS EVENT. THE PATIENT'S CONDITION CONTINUED TO DECLINE AND THE PATIENT EXPIRED.

  Patient problems: Aneurysm; Cardiopulmonary Arrest; Death; Failure of Implant; Rupture

  MAUDE report 10977418 ↗
• InjuryJun 23, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA). THE PATIENT HAD A RIGHT COMMON ILIAC ARTERY (CIA) ANEURYSM AND A LEFT INTRARENAL ILIAC ARTERY ANEURYSM. AFTER OCCLUSION OF BOTH IIA ENDOLEAKS, ONE NON-ENDOLOGIX (GORE) EXCLUDER LEG WAS IMPLANTED FROM THE LEFT CIA TO THE EXTERNAL ILIAC ARTERY (EIA), ONE NON-ENDOLOGIX (GORE) EXCLUDER LEG WAS IMPLANTED FROM THE RIGHT CIA TO THE EIA, AND THEN THE AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED WITH ADDITIONAL BALLOONING. IT SHOULD BE NOTED THAT THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF LABEL) DUE TO IMPLANT WITH A NON-ENDOLOGIX SENT GRAFT. ANGIOGRAPHY IDENTIFIED AN INTRAOPERATIVE TYPE IIIA BETWEEN THE AFX2 AND EXCLUDER AT THE RIGHT CIA. ADDITIONAL BALLOONING WAS PERFORMED; HOWEVER, VIA ANGIOGRAPHY THE ENDOLEAK REMAINED AND AN INTRAOPERATIVE TYPE IIIB ENDOLEAK WAS FOUND. AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED WITHIN THE FIRST AFX2 RESOLVING THE INTRAOPERATIVE ENDOLEAKS.

  Patient problems: Failure of Implant

  MAUDE report 10182732 ↗
• InjuryDec 22, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY SEVEN (7) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IB ENDOLEAK FROM THE RIGHT COMMON ILIAC. HOWEVER, THE EXACT DATE OF EVENT IS UNKNOWN. THE PHYSICIAN PLANS TO RE-INTERVENE AND THE PATIENT IS REPORTEDLY STABLE. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A SECONDARY ENDOVASCULAR PROCEDURE ON (B)(6) 2020, WITH A LIMB STENT GRAFT. THE FINAL PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 9508915 ↗
• InjuryAug 2, 2019Misconnection; Misconnection

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY 1.5 YEARS POST INITIAL PROCEDURE, A TYPE IIIA ENDOLEAK WITH COMPONENT SEPARATION WAS DETECTED DURING ROUTINE FOLLOW-UP. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN INFRARENAL AFX DEVICE ON (B)(6) 2019. THE ENDOLEAK WAS CONFIRMED RESOLVED AND THE PATIENT REPORTEDLY IS DOING WELL. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: No Code Available

  MAUDE report 8857038 ↗
• InjuryApr 13, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  THE PATIENT WAS TREATED WITH AFX. DURING A ROUTINE FOLLOW-UP, A TYPE IA WAS IDENTIFIED. IN ADDITION, AAA SAC GROWTH WAS OBSERVED. THE PATIENT UNDERWENT TREATMENT ON (B)(6) 2018; COILS WHICH RESOLVED THE REPORTED TYPE IA ENDOLEAK. THE PATIENT CONDITION POST TREATMENT IS REPORTED AS STABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7428968 ↗

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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• Z-1038-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (A
• Z-1039-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-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-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-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• 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-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.