AFX Endovascular AAA System BA28-110/I20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00818009014214), received between Apr 8, 2016 and Apr 21, 2021 — classified as 2 deaths, 19 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2021Material Puncture/Hole; Material Puncture/Hole

  A BIFURCATED STENT GRAFT AND A SUPRARENAL EXTENSION WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, AN INTRAOPERATIVE TYPE 3B ENDOLEAK REMAINED AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT AND FOLLOW UP IN 30 DAYS WITH A COMPUTED TOMOGRAPHY SCAN. PATIENT IS DOING WELL, ASYMPTOMATIC AND DISCHARGED ON THE NEXT DAY. ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT REFUTING THE TYPE IIIB ENDOLEAK, AND INSTEAD CONFIRMING A TYPE II ENDOLEAK (NON-DEVICE-RELATED). THEREFORE, THIS EVENT IS NO LONGER REPORTABLE AS THERE IS NO ALLEGED DEFICIENCY RELATED TO IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 11704247 ↗
• InjuryMay 5, 2020Material Puncture/Hole; Insufficient Device Problem Information; Material Puncture/Hole; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, TWO (2) VELA SUPRARENAL STENT GRAFT EXTENSIONS AND A LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4.5 YEARS LATER, A COMPUTED TOMOGRAPHY ANGIOGRAM CONFIRMED A 1B ENDOLEAK (POSSIBLE 3B) WITH THROMBUS BURDEN WITHIN THE ENDOGRAFT. THE PHYSICIAN PERFORMED A RE-INTERVENTION AND ELECTED TO RE-LINE THE ORIGINAL IMPLANTED DEVICES WITH AN ENDURANT (GORE) DEVICE (NON-ENDOLOGIX). REPORTEDLY, THE ENDOLEAK WAS RESOLVED AND PATIENT TOLERATED THE PROCEDURE WELL. ADDITIONAL INFORMATION: DURING CLINICAL ASSESSMENT, IT WAS CONFIRMED THAT THE TYPE IB ENDOLEAK OF THE RIGHT ILIAC ARTERY AND THE TYPE IIIB ENDOLEAK OF THE DISTAL BIFURCATED STENT GRAFT HAD OCCURRED.

  Patient problems: Failure of Implant; Thrombus

  MAUDE report 10027168 ↗
• InjuryApr 13, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Separation Problem; Patient-Device Incompatibility; 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 4.5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT EMERGENCY ROOM WITH FLANK AND BACK PAIN. A TYPE IIIA ENDOLEAK WITH A RUPTURED AAA WAS IDENTIFIED. AN INTERVENTION WAS ATTEMPTED WITH NON-ENDOLOGIX (MEDTRONIC ENDURANT) STENTS BUT WAS NOT SUCCESSFUL. AN OPEN REPAIR WAS ATTEMPTED HOWEVER THE PATIENT EXPIRED DURING THE PROCEDURE. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THERE WAS EVIDENCE TO REASONABLY SUGGEST SAC GROWTH OF 30 MM OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. ADDITIONALLY, THE TYPE IIIA ENDOLEAK OF THE AORTIC COMPONENTS WAS WITH COMPLETE COMPONENT SEPARATION

  Patient problems: Aneurysm; Death; Rupture

  MAUDE report 9955748 ↗
• InjuryFeb 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP THE PATIENT WAS IDENTIFIED WITH A POSSIBLE TYPE 1B AND TYPE 3B ENDOLEAK IN TANDEM. PATIENT IS STABLE AND PENDING RE-INTERVENTION. ADDITIONAL INFORMATION: THE PHYSICIAN PERFORMED A RE-INTERVENTION BY IMPLANTING (2) OVATION IX EXTENDER TO RESOLVE THIS EVENT. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Failure of Implant; No Information

  MAUDE report 9714932 ↗
• DeathDec 31, 2019Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND A LIMB STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, PATIENT PRESENTED EMERGENTLY WITH BACK AND BELLY PAIN AND A TYPE 1B ENDOLEAK FROM THE LEFT COMMON ILIAC WAS DETECTED. REPORTEDLY, DURING RE-INTERVENTION PATIENT CODED BEFORE GAINING ACCESS, BUT WAS RECESITATED. PHYSICIAN THEN PLACED 2 OVATION LIMB EXTENSIONS AND AFTER PLACEMENT OF THE STENTS AN ANGIOGRAM WAS PERFORMED AND THE LEAK WAS STILL PRESENT. PHYSICIAN DETERMINED THAT THE PATIENT HAD A TYPE 3B ENDOLEAK AND WHILE THE PHYSICIAN WAS PREPARING TO RELINE THE GRAFT THE PATIENT CODED A SECOND TIME AND EXPIRED.

  Patient problems: Death; Pain

  MAUDE report 9535954 ↗
• InjuryDec 23, 2019Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, TWO (2) SUPRARENAL STENT GRAFT EXTENSIONS, AN INFRARENAL STENT GRAFT EXTENSION AND TWO (2) LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3.5 YEARS POST INITIAL PROCEDURE, A POSSIBLE TYPE 3B ENDOLEAK WAS IDENTIFIED ON A CT (COMPUTED TOMOGRAPHY) SCAN. THE PATIENT IS REPORTEDLY IN STABLE CONDITION. NO FURTHER INFORMATION HAS BEEN PROVIDED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: DURING REVIEW OF THE COMPUTED TOMOGRAPHY (CT) SCANS, CLINICAL PERSONNEL IDENTIFIED A TYPE IB ENDOLEAK OF THE RIGHT COMMON ILIAC ARTERY, A PERSISTENT TYPE IA ENDOLEAK, AORTIC SAC GROWTH OF 6.5 MM AND A NON-ENDOLOGIX STENT WAS PLACED PROXIMALLY DURING THE INDEX PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9508947 ↗
• InjuryNov 7, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED WITH AFX BIFURCATED STENT GRAFT AND (2) SUPRARENAL EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3 YEARS POST INITIAL IMPLANT, THE PHYSICIAN TREATED THE PATIENT FOR ANEURYSM GROWTH OF THE RCI (RIGHT COMMON ILIAC), THIS WAS A NON DEVICE RELATED EVENT. AN OVATION IX EXTENDER STENT GRAFT TO RESOLVE THIS EVENT. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL). NOW, APPROXIMATELY 4 YEAR POST INITIAL PROCEDURE, A TYPE 3B ENDOLEAK WITH SAC EXPANSION WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 9293778 ↗
• InjurySep 20, 2018Leak/Splash; Material Puncture/Hole; Material Integrity Problem; Leak/Splash; Material Puncture/Hole; Material Integrity Problem

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH AN BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY TWO (2) YEARS POST-OP, ENDOLOGIX WAS MADE AWARE OF A TYPE 2 ENDOLEAK AND AN INDETERMINATE ENDOLEAK (POSSIBLE 3B OF THE MAIN BODY). A SECONDARY PROCEDURE HAS BEEN SCHEDULED TO RELINE THE STENT GRAFT. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED, AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7896461 ↗
• InjuryMay 23, 2018Failure To Adhere Or Bond; Leak/Splash; Patient-Device Incompatibility; Failure To Adhere Or Bond; Leak/Splash; Patient-Device Incompatibility

  PATIENT INITIALLY IMPLANTED WITH AN AFX BIFURCATED AND VELA SUPRARENAL DEVICE IN 2016. RECENTLY, ENDOLOGIX WAS MADE AWARE OF AN UNKNOWN ENDOLEAK. THE ISSUE WAS FOUND DURING A RECENT FOLLOW UP CTA. PHYSICIAN WILL EVALUATE AND POTENTIALLY RELINE.

  Patient problems: Failure of Implant

  MAUDE report 7539160 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND VELA SUPRARENAL ON (B)(6) 2015. ON A LATER DATE, THE PHYSICIAN SCHEDULED AN ANGIOGRAM TO DIAGNOSE A POSSIBLE TYPE 1B ENDOLEAK WHICH WOULD REQUIRE A LIMB EXTENSION. THE PATIENT WAS ASYMPTOMATIC. THE COMPLETED ANGIOGRAM, HOWEVER, CONFIRMED A TYPE 2 ENDOLEAK WITH LUMBARS AND AN IRREGULAR DILATED AREA DISTAL TO THE INITIAL LANDING ZONE DURING THE INDEX PROCEDURE. THE PHYSICIAN DECIDED TO COIL THE INTERNS AND LAND DISTAL WITH THE LIMB FOR THE SECONDARY PROCEDURE. THIS SECONDARY CASE FOR THE PATIENT WAS COMPLETED ON (B)(6) 2017 AND THE PATIENT WAS IMPLANTED WITH AN AFX LIMB STENT GRAFT. THE PHYSICIAN DID NOT REPORT ANY COMPLAINTS OR FAILURE AGAINST AN ENDOLOGIX DEVICE. NO DEVICES WERE EXPLANTED DURING THE RE-INTERVENTION AND THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Not Applicable

  MAUDE report 7445883 ↗
• InjuryApr 19, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  A SECONDARY PROCEDURE WAS PERFORMED ON XX/XX/XXXX, FOR AN UNKNOWN REASON. A AFX2 BIFURCATED STENT GRAFT AND A AFX VELA SUPRARENAL WERE IMPLANTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7444216 ↗
• InjuryApr 4, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A POSSIBLE ENDOLEAK. DURING FEB (EXACT DATE UNKNOWN) CT SCAN, A POSSIBLE ENDOLEAK WAS DISCOVERED ON PATIENT. WITH THAT FINDING ADDED TO THE SAC EXPANSION OF ~ 2CM'S, MD PLANNED AN INTERVENTION FOR ASSESSMENT AND POSSIBLE TREATMENT. IT WAS AT THE INTERVENTION ON (B)(6) 2018 THAT THE "BULGE" WAS DISCOVERED, BUT VERY DISTAL TO WHERE THE POSSIBLE ENDOLEAK WAS IN THE FEB CT. AS THE MD WASN'T CERTAIN WHERE, OR IF, A TYPE 1 WAS THE CAUSE OF THE SAC EXPANSION, HE DECIDED TO RE-LINE ON (B)(6) 2018. THE RELINE PROCEDURE INCLUDED AN ADDITIONAL BIFURCATION. IT WAS REPORTED AT THE FINAL ANGIO THERE WAS NO "BULGE" AND NO EVIDENCE OF ENDOLEAK.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7397945 ↗
• InjuryMar 8, 2018Occlusion Within Device; Occlusion Within Device

  ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A PATIENT THAT HAD AN OCCLUDED GRAFT THAT NEEDED TO BE FIXED URGENTLY. THE GRAFT WAS ORIGINALLY PLACED BY DR DONALD AKERS FOR A RUPTURE. THE REINTERVENTION WAS PERFORMED TO DECLOT THE GRAFT IN AN OPEN FASHION ON (B)(6) 2018. PHYSICIAN FELT IT WAS AN OUTFLOW PROBLEM WITH THE PATIENT AND NOT THE GRAFT, PATIENT IS ALSO NON-AMBULATORY. PHYSICIAN WAS ABLE TO RESTORE FLOW AND TRAP MOST OF THE CLOT AND WAS VERY PLEASED WITH THE OUTCOME.

  Patient problems: Occlusion

  MAUDE report 7325921 ↗
• InjuryNov 15, 2017Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION: ON 01/23/2018, ENDOLOGIX WAS MADE AWARE THAT THE STENT HAS BEEN EXPLANTED AND THE PATIENT IS DOING WELL. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7035628 ↗
• InjuryMay 19, 2017Failure To Adhere Or Bond; Leak/Splash; Device Dislodged or Dislocated; Unintended Movement; Failure To Adhere Or Bond; Leak/Splash; Device Dislodged or Dislocated; Unintended Movement

  PATIENT IN INITIALLY IMPLANTED WITH A BIFURCATED STENT, TWO SUPRARENAL AORTIC EXTENSIONS, AN INFRARENAL AORTIC EXTENSION, AND TWO LIMB STENT GRAFTS. A FOLLOW UP SHOWED THE PATIENT HAD A TYPE 1B ENDOLEAK OF THE RIGHT LIMB EXTENSION. THE PHYSICIAN ADDITIONALLY OBSERVED LATERAL MOVEMENT OF THE STENT CAUSING THE DISPLACEMENT OF THE DEVICE, RESULTING IN THE STENT TO BE LOCATED OUTSIDE OF THE EXTERNAL ILIAC ARTERY. THE PHYSICIAN ELECTED TO SNORKEL THE HYPOGASTRIC IN LEFT LIMB AND IN THE RIGHT LIMB THE PHYSICIAN COILED AND IMPLANTED AN ADDITIONAL STENT TO EXTEND BACK INTO THE EXTERNAL ILIAC ARTERY. THE PATIENT IS REPORTED AS DOING WELL FOLLOWING THE SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6580141 ↗
• InjuryMay 19, 2017Hole In Material; Leak/Splash; Material Puncture/Hole; Hole In Material; Leak/Splash; Material Puncture/Hole

  ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN EXPLANTED THE DEVICES ON (B)(6) 2017. PATIENT IS REPORTED AS STABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6580087 ↗
• DeathMay 19, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT CAME IN EMERGENTLY WITH AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT HAD SEVERE AORTIC NECK ANGULATION AND DUE TO THE HEALTH OF THE PATIENT, AN OPEN REPAIR PROCEDURE WAS NOT AN OPTION. THE PHYSICIAN ELECTED TO COMPLETE AN ENDOVASCULAR REPAIR PROCEDURE WITH THE UNDERSTANDING OF USING THE AFX INTRODUCER SHEATHS AND LUNDERQUIST WIRES AS TOOLS TO STRAIGHTEN THE AORTA ENOUGH TO IMPLANT THE DEVICES. IN ATTEMPTING TO STRAIGHTEN THE AORTA THE PATIENT RUPTURED AND BECAME HYPOTENSIVE. THE PHYSICIAN WAS ABLE TO PLACE AN OCCLUSIVE BALLOON FOLLOWED BY THE BIFURCATED STENT AND TWO SUPRARENAL AORTIC EXTENSIONS. THE PHYSICIAN WAS NOT ABLE TO SUCCESSFULLY COVER THE AORTIC NECK WITH THE TWO PROXIMAL EXTENSIONS AND DETERMINED THE ANGLE REQUIRED THE PLACEMENT OF A THIRD SUPRARENAL DEVICE. DURING THE IMPLANT OF THE THIRD PROXIMAL EXTENSION THE DELIVERY SYSTEM DISLODGED ONE OF THE SUPRARENAL EXTENSIONS OUT OF THE PROXIMAL END OF THE BIFURCATED STENT. DUE TO THE SEVERITY OF THE PATIENT ANATOMY THE PHYSICIAN ABORTED THE COMPLETION OF THE INITIAL IMPLANT PROCEDURE. IT WAS REPORTED THE PATIENT EXPIRED ON (B)(6) 2017.

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

  MAUDE report 6579992 ↗
• InjuryMar 23, 2017Failure To Adhere Or Bond; Leak/Splash; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Failure To Adhere Or Bond; Leak/Splash; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE WITH A BIFURCATED STENT AND AN INFRARENAL AORTIC EXTENSION. AN IN-HOUSE CLINICAL REVIEW OF PATIENT IMAGING IDENTIFIED THE COMPLETION OF A SUBSEQUENT ENDOVASCULAR PROCEDURE WHERE THE PHYSICIAN IMPLANTED A SUPRARENAL AORTIC EXTENSION AS WELL AS A LIMB EXTENSION TO RESOLVE AN UNKNOWN ISSUE.

  Patient problems: Failure of Implant

  MAUDE report 6429553 ↗
• InjuryJan 4, 2017Hole In Material; Leak/Splash; Unintended Movement; Hole In Material; Leak/Splash; Unintended Movement

  IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2015 WITH A BIFURCATED STENT AND AN INFRARENAL AORTIC EXTENSION. ON (B)(6) 2016 A FOLLOW UP ULTRA SOUND SHOWED A TYPE 3B ENDOLEAK. ON (B)(6) 2016, THE PHYSICIAN RE-LINED WITH A BIFURCATED STENT TO SEAL THE ENDOLEAK. THE SUBSEQUENT ENDOVASCULAR PROCEDURE WAS COMPLETED AND THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 6221015 ↗
• InjurySep 15, 2016Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2015. ON (B)(6) 2016 A FOLLOW UP IDENTIFIED A TYPE 1B ENDOLEAK IN THE RIGHT COMMON ILIAC, THE PATIENT WAS ASYMPTOMATIC. ON (B)(6) 2016 THE PHYSICIAN ELECTED TO IMPLANT A LIMB STENT GRAFT TO SEAL THE ENDOLEAK. THE PATIENT IS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 5955104 ↗
• InjuryApr 8, 2016Occlusion Within Device; Occlusion Within Device

  PATIENT INITIALLY IMPLANTED WITH BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2016. UPON FOLLOW UP, ANGIOGRAM AND COMPUTED TOMOGRAPHY (CT) SHOWED LEFT LIMB OCCLUSION, PATIENT ALSO EXPERIENCING DISCOMFORT. PHYSICIAN ATTEMPTED TO IMPLANT A LIMB EXTENSION AND WAS UNABLE TO GAIN ACCESS. PHYSICIAN ELECTED TO COMPLETE A FEM-FEM BYPASS TO RESOLVE THE ISSUE. PATIENT IS IN STABLE CONDITION.

  Patient problems: Claudication; Ischemia; Occlusion; Thrombosis

  MAUDE report 5561292 ↗

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-1047-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoili
• Z-1039-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1038-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (A
• Z-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-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-0590-06 · 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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• Z-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• Z-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.