AFX2 Bifurcated Endograft System BEA22-40/I13-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00818009015075), received between Jun 3, 2016 and Apr 4, 2023 — classified as 5 deaths, 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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.

• DeathApr 4, 2023Off-Label Use; Insufficient Device Problem Information; Off-Label Use; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A GORE (NON-ENDOLOGIX) VBX STENT GRAFT TO TREAT A TOTAL OCCLUSION OF THE LCIA (LEFT COMMON ILIAC ARTERY) AND AIOD (AORTOILIAC OCCLUSIVE DISEASE) WITH BILATERAL ENDARTERECTOMY. APPROXIMATELY NINE (9) DAYS AFTER THE INITIAL PROCEDURE THE PATIENT PASSED AWAY DUE TO COMPLICATIONS ARISING FROM A PERFORATED BOWEL.

  Patient problems: Insufficient Information; Perforation of Vessels

  MAUDE report 16676285 ↗
• InjuryJul 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. APPROXIMATELY (2) TWO YEARS POST-OPERATIVE, THE PATIENT PRESENTED WITH CLAUDICATION. A REINTERVENTION WAS PERFORMED WHERE A BALLOON TOUCH-UP AND A (NON-ENDOLOGIX DEVICE) PALMAZ STENT WAS IMPLANTED TO FULLY APPROXIMATE PROXIMAL GRAFT TO THE AORTA. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL AND DISCHARGED TO GO HOME.

  Patient problems: Ischemia

  MAUDE report 15053878 ↗
• InjuryDec 18, 2020Complete Blockage; Adverse Event Without Identified Device or Use Problem; Complete Blockage

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A COLD LEG AND WAS IDENTIFIED WITH AN ACUTELY THROMBOSED GRAFT. THE PHYSICIAN IMPLANTED A VELA SUPRARENAL STENT GRAFT EXTENSION TO RESOLVE THIS EVENT. REPORTEDLY THE PATIENT IS DOING WELL.

  Patient problems: Occlusion; Thrombosis; Thrombus

  MAUDE report 11042111 ↗
• InjuryNov 4, 2020Device-Device Incompatibility; Insufficient Device Problem Information; Device-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT. APPROXIMATELY FOUR (4) MONTHS POST INITIAL PROCEDURE THE PATIENT PRESENTED WITH CLAUDICATION. COMPUTED TOMOGRAPHY IDENTIFIED AORTIC STENOSIS AND NARROWING OF THE LIMBS. RE-INTERVENTION WAS PERFORMED WITH KISSING BALLOON AND IMPLANT OF A NON-ENDOLOGIX (GORE) VBX BALLOON EXPANDABLE ENDOPROSTHESIS STENT IN THE LEFT COMMON ILIAC. THE PATIENT IS DOING WELL POST PROCEDURE.

  Patient problems: Claudication; Pain; Stenosis

  MAUDE report 10786868 ↗
• DeathOct 5, 2020Entrapment of Device; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Device-Device Incompatibility; Entrapment of Device; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Device-Device Incompatibility

  THE PHYSICIAN WAS IMPLANTING AN AFX2 BIFURCATED STENT GRAFT TO TREAT THE PATIENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, DURING THE PROCEDURE THE PULL THROUGH WIRE WAS WRAPPED AROUND THE GRAFT AND THE STENT BECAME CROSSED INSIDE THE AORTA AND PARTIALLY DEPLOYED. THE PHYSICIAN WAS UNABLE TO STRAIGHTEN THE WIRE TO SEE THE GRAFT IN THE BIFURCATION OF THE ILIACS. THE PHYSICIAN ELECTED TO ABORT THE STENT GRAFT PLACEMENT AND CONVERTED TO AN OPEN PROCEDURE TO EXPLANT THE GRAFT. THE STENT GRAFT WAS EXPLANTED SUCCESSFULLY, AND THE PHYSICIAN COMPLETED A REPAIR WITH A NON-ENDOLOGIX AORTO-BI-FEMORAL DACRON GRAFT. POST PROCEDURE, THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU), INTUBATED, AND LATER EXPIRED. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED OF BY THE FACILITY. DURING THE INVESTIGATION, IT WAS CONFIRMED THAT THE INITIAL PROCEDURE WAS OFF-LABEL DUE TO ABSENCE OF AN AORTIC ANEURYSM, CONCOMITANT USE WITH PRODUCTS OUTSIDE THE IFU, AND UNDER-SIZING OF THE ILIAC LIMBS AND AORTIC NECK ANATOMY. NOTE: ENDOLOGIX RECEIVED MEDWATCH REPORTS # MW5096848 AND MW5096936 FOR THIS REPORTED EVENT / PATIENT.

  Patient problems: Blood Loss; Cardiopulmonary Arrest; Death; Failure of Implant

  MAUDE report 10627797 ↗
• DeathSep 24, 2020Material Twisted/Bent

  PATIENT UNDERGOING ENDOVASCULAR AAA REPAIR. ENDOGRAFT WAS TWISTED UPON DEPLOYMENT. CASE WAS CONVERTED TO OPEN AAA REPAIR. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Death

  MAUDE report 10586007 ↗
• MalfunctionMay 28, 2020Improper or Incorrect Procedure or Method; Difficult to Advance; Improper or Incorrect Procedure or Method; Difficult to Advance

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF- LABEL) DUE TO THE PATIENT HAVING AORTOILIAC OCCLUSIVE DISEASE. DURING ADVANCEMENT OF THE AFX2 BIFURCATED STENT GRAFT, THERE WAS A HARD STOP AS CHALLENGING RESISTANCE WAS MET PREVENTING THE TRANSFER OF THE DEVICE. THE DEVICE WAS REMOVED, AND THE INTRODUCER SHEATH WAS EXCHANGED. A NEW AFX2 BIFURCATED STENT GRAFT ADVANCED AND IMPLANTED WITHOUT DIFFICULTY. FINAL ARTERIOGRAM SHOWED GOOD PLACEMENT AT THE BIFURCATION. SEGMENTED PRESSURES WERE CHECKED AND FOUND TO BE WITHOUT GRADIENT AFTER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF BILATERAL LIMBS. HOWEVER, THE PATIENT HAD DIMINISHED PULSES AT THE RIGHT EXTREMITY REQUIRING RIGHT FEMORAL EXPLORATION PATCH ANGIOPLASTY AND FEMORAL EMBOLECTOMY THAT YIELDED NO DEBRIS. IT WAS DETERMINED THAT THERE WAS INADEQUATE CLOSURE AT PERCLOSE (NON-ENDOLOGIX) LOCATION WITH A LOCALIZED DISSECTION REQUIRING SURGICAL REPAIR. PULSES REMAINED DIMINISHED AND FELT TO BE ARTIORIOSPASM AS PATIENTS FOOT FELT WARM TO TOUCH. PATIENT WAS SENT TO RECOVERY.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 10097003 ↗
• InjuryApr 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY TWO (2) MONTHS POST INITIAL IMPLANT THE PATIENT PRESENTED WITH STENT OCCLUSION. IT WAS STATED THAT THE PATIENT WOULD REQUIRE ABOVE THE KNEE AMPUTATION DUE TO THE OCCLUDED GRAFT. THE PATIENT WAS ALSO FOUND TO HAVE MULTIPLE ORGAN FAILURE (RENAL FAILURE AND RESPIRATORY FAILURE) BUT THE CAUSE COULD NOT BE DETERMINED DUE TO THE PATIENT BEING A CHRONIC DRUG USER. THE PATIENTS FAMILY HAS ELECTED NOT TO PERFORM ANY INTERVENTIONS BUT RATHER HAVE THE PATIENT PLACED IN PALLIATIVE CARE. NO FURTHER ADDITIONAL INFORMATION OR PATIENT SEQUALAE HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Occlusion

  MAUDE report 8494135 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 3 (THREE) MONTHS POST OP, THE PATIENT PRESENTED EMERGENTLY WITH BILATERAL LEG AND HIP PAIN. THROMBUS WAS IDENTIFIED THROUGHOUT THE AFX2 DEVICE. THROMBECTOMY WAS PERFORMED IN THE AORTA AND COMMON ILIACS (BILATERAL) AND THE PATIENT'S LEFT LEG WAS AMPUTATED BELOW THE KNEE DUE TO THE THROMBOSIS. THERE WAS NO FURTHER REPORT OF THE PATIENT'S CONDITION.

  Patient problems: Pain; Thrombus

  MAUDE report 8352461 ↗
• InjuryAug 13, 2018Obstruction of Flow; Infusion or Flow Problem; Material Deformation; Obstruction of Flow; Infusion or Flow Problem; Material Deformation

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH PAIN IN THE LEFT FOOT; THE CT SHOWED OCCLUSION IN THE LEFT LIMB OF THE DEVICE. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) BARE METAL BALLOON EXPANDABLE STENTS (NON-ENDOLOGIX) AND THE PROCEDURE CONCLUDED WITHOUT INCIDENT. THE PATIENT WAS DOING WELL POST PROCEDURE.

  Patient problems: Failure of Implant; Ischemia; Pain; Stenosis; Thrombus

  MAUDE report 7777049 ↗
• InjuryMay 25, 2018Partial Blockage; Occlusion Within Device; Partial Blockage; Occlusion Within Device

  PATIENT INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED AND OVATION LIMB ON (B)(6) 2018. APPROXIMATELY TWO WEEKS POST IMPLANT, PATIENT PRESENTED WITH CLAUDICATION, A DUPLEX SHOWED NARROWING IN THE LEFT LIMB OF THE AFX2. PATIENT WAS BROUGHT IN ON (B)(6) 2018 FOR INTERVENTIONS, WHICH WAS WHEN THE PHYSICIAN DISCOVERED THAT THE PATIENT HAD A COMPLETE OCCLUDED LEFT LIMB WITH THROMBUS AND A 50% STENOSIS IN THE RIGHT OVATION ILIAC LIMB (REPORTED IN A SEPARATE REPORT). THE PHYSICIAN ELECTED TO INTERVENED WITH ANGIOJET AND PLACED TWO NON-ENDOLOGIX STENTS IN BOTH ILIAC LIMBS OF THE PREVIOUSLY PLACED AFX GRAFT. THE ISSUES WERE RESOLVED. THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Failure of Implant; Occlusion; Thrombus

  MAUDE report 7545031 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY PROCEDURE WAS PERFORMED ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT AND AN OVATION ILIAC LIMB EXTENSION ON THE RIGHT SIDE. PATIENT PRESENTED AT PHYSICIAN'S OFFICE COMPLAINING OF LEFT LEG PAIN. AS THE PATIENT WAS REPORTED TO HAVE EXTENSIVE PERIPHERAL VASCULAR DISEASE. THE PHYSICIAN ELECTED TO TREAT THE CONTRA SIDE OF THE PREVIOUSLY IMPLANTED EDOLOGIX LIMB IN ORDER TO TREAT THE DISEASE PROGRESSION. THERE WAS NO REPORTED DEVICE ISSUE OF PREVIOUSLY IMPLANTED STENTS. ON (B)(6) 2016, AN ADDITIONAL OVATION ILIAC LIMB EXTENSION WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE PAIN FREE AND DOING GREAT. THERE HAS BEEN NO PATIENT SEQUELAE REPORTED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 7442294 ↗
• DeathFeb 21, 2018Failure To Adhere Or Bond; Leak/Splash; Material Integrity Problem; Failure To Adhere Or Bond; Leak/Splash; Material Integrity Problem

  AN AFX2 BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN PLACED TWO BARD LIFE STENTS IN THE COMMON ILIACS AND BALLOONED AT THE LEFT ILIAC, WHICH LED TO A RUPTURE OF THE MAIN BODY STENT AT THE BIFURCATION. ANOTHER AFX2 BIFURCATED STENT GRAFT WAS PLACED TO RESOLVE THE RUPTURE. UPON RETRACTION OF THE NOSE CONE OF THE MAIN BODY DELIVERY SYSTEM, THE LEFT COMMON ILIAC ARTERY WAS RUPTURED. PHYSICIAN ELECTED TO PLACE A VIABAHN GRAFT ACROSS THE RUPTURE TO RESOLVE IT. THE PHYSICIAN THEN PLACED AN 18X45 OVATION EXTENSION IN THE DISTAL PORTION OF THE AORTA DUE TO PLAQUE. THE GRAFT WAS BALLOONED, WHICH LED TO RUPTURE OF THE AORTA. A 22X45 OVATION EXTENSION WAS THEN PLACED AS A BRIDGE TO RESOLVE THE RUPTURE. THE PROCEDURE WAS CONCLUDED, HOWEVER, AN HOUR POST-PROCEDURE THE PATIENT'S BLOOD PRESSURE DROPPED AND THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death; Failure of Implant; Rupture; Shock

  MAUDE report 7285618 ↗
• InjuryJan 29, 2018Difficult or Delayed Positioning; Difficult to Remove; Activation, Positioning or Separation Problem; Difficult or Delayed Positioning; Difficult to Remove; Activation, Positioning or Separation Problem

  ON (B)(6) 2018, DURING THE INITIAL IMPLANT OF A BIFURCATED STENT, THE PHYSICIAN HAD DIFFICULTY WITH DEPLOYING STENT AND REMOVING THE DELIVERY SYSTEM. IT WAS REPORTED THAT THE YELLOW CONTRA LIMB WIRE WAS VERY DIFFICULT TO DEPLOY BUT WAS ABLE TO DEPLOY AFTER A LOT OF TUGGING AND TWISTING. ALSO THE INNER CORE WAS VERY DIFFICULT TO REMOVE. WITH A LOT OF MANIPULATION AND PULLING ON THE INNER CORE, THE GRAY PORTION DETACHED FROM THE METAL ROD AND IT WAS DISLODGED IN THE BIFURCATED GRAFT. THE PHYSICIAN CUT DOWN OVER THE RIGHT EXTERNAL ILIAC AND OPEN THE VESSELS TO PULL THE LIMB COVER OFF OF THE IPSILATERAL LIMB AND MANIPULATE THE INNER CORE OUT OF THE SHEATH IN THE GROIN. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS REPORTED AS DOING WELL. THE PATIENT IS CURRENTLY BEING MONITORED AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant; Occlusion

  MAUDE report 7226193 ↗
• InjuryJan 11, 2018Occlusion Within Device; Occlusion Within Device

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT TO TREAT OCCLUSIVE DISEASE. IT WAS REPORTED A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SHOWED THE PATIENT HAD AN OCCLUSION IN THE MAIN BODY STENT. THE PHYSICIAN ELECTED TO COMPLETE AN AUI FEM-FEM BYPASS TO RESTORE PATENCY. THE PATIENT IS REPORTED TO BE WELL POST PROCEDURE. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7184767 ↗
• InjuryJul 14, 2017Off-Label Use; Off-Label Use

  AN AFX2 BIFURCATED STENT GRAFT WAS USED IN COMBINATION WITH NON-ENDOLOGIX DEVICES IN AN OFF-LABEL AIOD CASE. AFTER EXTENDED DISTALLY IN BOTH ILIACS WITH UNCOVERED SELF EXPANDING STENTS, THE PATIENT'S PRESSURE DROPPED DUE TO RUPTURED ILIAC. AN BALLOON WAS INFLATED ON THE IPSI SIDE AND THE PHYSICIAN REPAIRED THE RUPTURE WITH A VIABAHN SELF EXPANDING STENT. AT THE COMPLETION OF THE CASE, THE PATIENT WAS REPORTED AS WELL.

  Patient problems: Calcium Deposits/Calcification; Occlusion; Rupture

  MAUDE report 6716354 ↗
• DeathJan 16, 2017Loss of or Failure to Bond; Break; Difficult or Delayed Positioning; Positioning Failure; Off-Label Use; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Break; Difficult or Delayed Positioning; Positioning Failure; Off-Label Use; Improper or Incorrect Procedure or Method

  DURING INITIAL IMPLANT OF AFX2 BIFURCATED DEVICE THE PHYSICIAN HAD DIFFICULTY DEPLOYING THE STENT. THE PATIENT WAS BEING TREATED FOR OCCLUSIVE DISEASE AND HAD NARROW ACCESS POINT. WHEN ATTEMPTING TO DEPLOY THE GRAFT THE STENT WOULD NOT OPEN, THE PHYSICIAN TRIED SEVERAL TECHNIQUES, INCLUDING THE USE OF A BALLOON AND WAS NOT ABLE TO DEPLOY THE GRAFT. IN AN EFFORT TO DEPLOY THE STENT AS THE PHYSICIAN WAS PULLING TO THE PHYSICIAN HEARD A SNAP AND THE INTRODUCER BROKE ADDITIONAL PULLING CAUSED THE GRAFT TO SLIP INTO THE COMMON ILIAC ARTERY. THE PATIENT HAD A DROP IN BLOOD PRESSURE AND 400CC LOSS OF BLOOD. THE PHYSICIAN MADE ONE FINAL ATTEMPT BY INTRODUCING AN OVATION LIMB AND THE PATIENT WENT INTO CARDIAC ARREST AND EXPIRED. THE PHYSICIAN INDICATED DEPLOYMENT WAS SUCCESSFUL, HOWEVER, THERE WAS RESISTANCE WHEN RETRACTING THE NOSE CONE. THE PHYSICIAN DOES NOT BELIEVE THE DEVICE WAS THE CAUSE OF THE PATIENT DEATH.

  Patient problems: Blood Loss; Cardiopulmonary Arrest; Death; Failure of Implant; Perforation of Vessels

  MAUDE report 6255067 ↗
• InjuryJun 3, 2016Difficult To Position; Activation, Positioning or Separation Problem; Device-Device Incompatibility; Difficult To Position; Activation, Positioning or Separation Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD INITIALLY BEEN IMPLANTED WITH A COMPETITOR DEVICE AT AN UNKNOWN DATE. SUBSEQUENTLY, DUE TO OCCLUSIVE DISEASE, THE PATIENT WAS SCHEDULED FOR AN IMPLANT OF A BIFURCATED DEVICE ON (B)(6) 2016. DURING IMPLANT, THE PHYSICIAN ENCOUNTERED DIFFICULTY WITH DEPLOYMENT DUE TO THE COMPETITOR STENT BECOMING TWISTED AND CAUSING A LEFT LIMB OCCLUSION OF THE BIFURCATED DEVICE. PHYSICIAN CORRECTED THE ISSUE BY PERFORMING AN AUI FEM-FEM BYPASS. THE PATIENT CAME OUT WITH SATISFACTORY RESULTS.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 5697877 ↗

Recalls under the same FDA submission

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

• Z-1049-2017 · Jan 4, 2017 · Terminated
  AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 B
• Z-1048-2017 · Jan 4, 2017 · Terminated
  AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C
• Z-1038-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (A
• Z-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• Z-1039-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-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-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-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0592-06 · 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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• Z-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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.