Vela Proximal Endograft System A34-34/C80 VRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00818009013545), received between Jun 3, 2017 and Apr 19, 2022 — classified as 1 death, 6 injuries.

The most frequently reported specific device problem is “Leak/Splash” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2022Off-Label Use; Malposition of Device; Off-Label Use; Malposition of Device

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) AFX VELA INFRARENAL. IT SHOULD BE NOTED THAT THIS PROCEDURE WAS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE SHORT AORTIC NECK. AFTER THE DEPLOYMENT OF THE FIRST AFX VELA INFRARENAL, THE NOSE CONE WAS RETRACTED, AND THE DEVICE SLIPPED DOWN INTO THE ANEURYSM SAC BECAUSE THERE WAS NO NECK TO OPPOSE IT AGAINST. THE PHYSICIAN ELECTED TO USE THE SECOND AFX VELA INFRARENAL WITH HIGH DEPLOYMENT. A FINAL ANGIOGRAM SHOWED A TYPE IA ENDOLEAK. ADDITIONAL BALLOONING OF THE ILIACS' WAS PERFORMED TO ENSURE GOOD OUTFLOW THROUGH THE ILIACS'. THE PHYSICIAN WILL MONITOR THE PATIENT AND PERFORM A 30 DAY COMPUTERIZED TOMOGRAPHY SCAN. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 14145762 ↗
• InjuryJun 4, 2021Migration; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE PATIENT WAS REPORTED TO PREVIOUSLY HAVE A PROXIMAL IMPLANT MIGRATION (MRN# (B)(4)) AS WELL AS A TYPE 3B ENDOLEAK (MRN# (B)(4)). NOW APPROXIMATELY (7) SEVEN MONTHS POST-SECONDARY PROCEDURE ANOTHER PROXIMAL IMPLANT MIGRATION WAS IDENTIFIED. THE FINAL PATIENT STATUS REMAINS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11943053 ↗
• InjuryDec 29, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, AN INFRARENAL AORTIC EXTENSION AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 6.5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL IN STABLE CONDITION AS THE PATIENT WAS THERE FOR A CARDIAC PROCEDURE. PATIENT HAS AN APPARENT TYPE 1A ENDOLEAK AND AAA GROWTH OF APPROXIMATELY 1CM. THE PATIENT IS CURRENTLY BEING MONITORED AS AN INTERVENTION IS BEING PLANNED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11091187 ↗
• InjuryJul 2, 2018Failure To Adhere Or Bond; Leak/Splash; Migration or Expulsion of Device; Failure To Adhere Or Bond; Leak/Splash; Migration or Expulsion of Device

  AN AFX BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT PRESENTED TO THE ER WITH ABDOMINAL PAIN APPROXIMATELY 3.5 YEARS POST INDEX PROCEDURE. A CT WAS PERFORMED ON (B)(6) 2018, WHERE A POTENTIAL TYPE IIIA ENDOLEAK WAS OBSERVED. ON (B)(6) 2018, THE SECONDARY PROCEDURE WAS PERFORMED. REPORTEDLY, IT WAS CONFIRMED, THERE WAS NO LEAK AND NO SAC GROWTH, JUST MINIMAL OVERLAP OF THE PREVIOUSLY IMPLANTED STENTS. THE PHYSICIAN ELECTED TO ADD A VELA SUPRARENAL CUFF AND A VELA INFRARENAL CUFF TO IMPROVE OVERLAP. THE PATIENT WAS DISCHARGED THE NEXT DAY AND WAS REPORTED TO BE PAIN FREE AND IN GOOD CONDITION. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7655259 ↗
• InjuryMar 6, 2018Detachment Of Device Component; Migration or Expulsion of Device; Stretched; Detachment Of Device Component; Migration or Expulsion of Device; Stretched

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION. A ROUTINE FOLLOW UP SHOWED THE PATIENT HAD A TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A NON-ENDOLOGIX COOK DEVICE TO SEAL THE ENDOLEAK. PATIENT WAS DISCHARGE HOME IN STABLE CONDITION.UPON CLINICAL EVALUATION, PATIENT WAS ALSO NOTED FOR A COMPLETE COMPONENT SEPARATION; A CUFF MIGRATION AND MAIN BODY BUCKLING; IIIB OF THE CUFF; AND SUPERIOR STENT CAGE DILATION. NO FURTHER INFORMATION WAS PROVIDED

  Patient problems: Failure of Implant

  MAUDE report 7318135 ↗
• InjuryJan 5, 2018Leak/Splash; Migration or Expulsion of Device; Unintended Movement; Leak/Splash; Migration or Expulsion of Device; Unintended Movement

  ON (B)(6) 2016, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND AN INFRARENAL EXTENSION. ON (B)(6) 2017, ENDOLOGIX WAS MADE AWARE OF MIGRATION OF THE INFRARENAL EXTENSION WITH NO ENDOLEAK OR SAC GROWTH. THE PATIENT WAS REPORTED AS STABLE AND IS BEING MONITORED. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7167611 ↗
• DeathJun 3, 2017Failure To Adhere Or Bond; Hole In Material; Leak/Splash; Unintended Movement; Failure To Adhere Or Bond; Hole In Material; Leak/Splash; Unintended Movement

  AN AFX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. INITIAL IMPLANT OCCURRED 3 YEARS AGO. PATIENT RETURNED EMERGENTLY APPROXIMATELY ONE MONTH AGO WITH ABDOMINAL PAIN. A CT WAS DONE WHICH SHOWED A TYPE 3A ENDOLEAK WITH COMPLETE COMPONENT SEPARATION. THE PHYSICIAN ELECTED TO IMPLANT TWO INFRARENAL AORTIC EXTENSIONS AND SUCCESSFULLY RESOLVED THE ENDOLEAK. ONE DAY POST-OP THE PATIENT EXPERIENCED A RUPTURED ANEURYSM DUE TO AN UNDETECTED TYPE 1A ENDOLEAK AND SUBSEQUENTLY EXPIRED.

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

  MAUDE report 6610340 ↗

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-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-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-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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-0592-06 · 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-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

…and 1 more.