Vela Proximal Endograft System A28-28/C75 VRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00818009013514), received between May 4, 2017 and Dec 7, 2021 — classified as 1 death, 13 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2021Material Puncture/Hole; Improper or Incorrect Procedure or Method; Material Puncture/Hole; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT, TWO (2) AFX VELA INFRARENAL AND AN AFX LIMB STENT GRAFT. APPROXIMATELY SIX AND A HALF (6.5) YEARS POST INITIAL PROCEDURE THE ANEURYSM GREW FROM 5.5CM TO 9.8CM IN APPROXIMATELY THE LAST TWELVE (12) MONTHS AND RUPTURED. ADDITIONALLY, THERE WAS A POSSIBLE TYPE 3B ENDOLEAK. REINTERVENTION WAS COMPLETED WITH IMPLANT OF A GORE 34X100MM (NON-ENDOLOGIX) STENT. THE PATIENT WAS REPORTED TO BE STABLE POST-REINTERVENTION.

  Patient problems: Failure of Implant; Ruptured Aneurysm

  MAUDE report 12946196 ↗
• InjurySep 9, 2021Migration; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 STENT GRAFT A TWO (2) VELA INFRARENAL EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 2.5 YEARS POST INITIAL PROCEDURE A NON-CONTRAST CT IMAGE REVEALED MIGRATION OF THE INFRARENAL EXTENSION. REPORTEDLY, THE PATIENT HAS NO SYMPTOMS AND NO NOTABLE ANEURYSM ENLARGEMENT WAS CONFIRMED. THE PHYSICIAN PLANS TO RE-INTERVENE, BUT SURGERY HAS NOT BEEN SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 12451245 ↗
• InjuryMay 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND TWO (2) INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING FOLLOW UP A TYPE 1A ENDOLEAK AND SAC GROWTH WERE IDENTIFIED. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11838711 ↗
• InjuryMay 10, 2021Migration or Expulsion of Device; Malposition of Device; Migration or Expulsion of Device; Malposition of Device

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW UP THE PATIENT PRESENTED WITH INCREASED AAA DIAMETER. AN ANGIOGRAM REVEALED THE INFRARENAL STENT GRAFT HAS MIGRATED AND THE PROXIMAL SUPRARENAL EXTENSION HAD ORIGINALLY BEEN PLACED LOW. A RE-INTERVENTION WAS COMPLETED AND THE PHYSICIAN ELECTED TO EXTEND WITH AN ADDITIONAL SUPRARENAL STENT GRAFT EXTENSION BACK TO THE RENALS, AND THE RIGHT ILIAC LIMB OF THE BIFURCATED STENT GRAFT WAS EXTENDED TO THE RIGHT HYPOGASTRIC WITH AN OVATION EXTENDER. PATIENT'S CURRENT STATUS IS DOING WELL POST RE-INTERVENTION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11803472 ↗
• InjuryOct 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS BEING IMPLANTED WITH A BIFURCATED STENT GRAFT (MAIN BODY) AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE MAIN BODY WAS IMPLANTED AS EXPECTED BUT DURING THE IMPLANTATION OF THE INFRARENAL PROXIMAL EXTENSION, THE DEVICE WAS IMPLANTED IN A FALSE LUMEN OF A DISSECTION THE WAS NOT VISIBLE IN THE PRE-OPERATION COMPUTED TOMOGRAPHY (CT). THE PHYSICIAN ELECTED TO IMPLANT A FREE-FLOW THORACIC (NON-ENDOLOGIX) DEVICE (TERUMO AORTIC) BETWEEN THE MAIN BODY AND THE INFRARENAL PROXIMAL EXTENSION. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF- LABEL). THE PROXIMAL LANDING ZONE WAS THE SMA (SUPERIOR MESENTERIC ARTERY) BECAUSE THE PATIENT WAS A DIALYSIS PATIENT. THE THORACIC DEVICE WAS THEN BALLOONED. THE FINAL ANGIOGRAM REVEALED THE RESTORATION OF THE FLOW THROUGH THE TRUE LUMEN AND A SMALL UNRESOLVED INTRAOPERATIVE ENDOLEAK (INDETERMINATE ORIGIN) IN THE AAA. THE PATIENT IS BEING MONITORED AND WAS REPORTED AS OK.

  Patient problems: Aortic Dissection

  MAUDE report 9168766 ↗
• InjurySep 10, 2019Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) AND INFECTED AORTA EMERGENTLY (OUTSIDE INDICATIONS OF USE) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FOUR (4) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A CRUMPLED PROXIMAL EXTENSION AND TYPE IA AND IIIA ENDOLEAKS. HOWEVER, THE EXACT DATE OF EVENT IS UNKNOWN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EXPLANTING THE DEVICES ON AN UNKNOWN DATE, AT WHICH TIME THROMBUS BETWEEN THE COMPONENTS WAS NOTED. THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Failure of Implant

  MAUDE report 8983395 ↗
• InjuryJul 26, 2019Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT HAD AN ENDOVASCULAR ANEURYSM SEALING (EVAS) TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). EXTENSIVE MURAL THROMBOSIS WAS PRESENT PRIOR TO THE EVAS. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF- LABEL). A BIFURCATED STENT GRAFT (MAIN BODY) AND INFRARENAL STENT GRAFT WERE IMPLANTED. AN INTRAOPERATIVE TYPE 1A WAS REPORTED BUT WAS RESOLVED BY BALLOONING. THE ENDOLEAK DISAPPEARED AND THE OPERATION WAS COMPLETED. 6.5 HOURS POST IMPLANT, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. THE SUPERIOR MESENTERIC ARTERY (SMA) WAS OCCLUDED BY THROMBOSIS. AN EMERGENCY OPERATION WAS PERFORMED, AND THE OCCLUSION WAS REMOVED. ON (B)(6) 2019, ONE DAY POST IMPLANT, THE PATIENT WAS CONFIRMED TO HAVE BOWEL NECROSIS AND A PART OF BOWEL WAS REMOVED BY A SURGICAL OPERATION. THE PATIENT IS MAKING A RECOVERING AND BEING MONITORED.

  Patient problems: Necrosis; Occlusion; Pain; Thrombosis

  MAUDE report 8833586 ↗
• DeathJan 19, 2019Partial Blockage; Device Dislodged or Dislocated; Partial Blockage; Device Dislodged or Dislocated

  THE PATIENT WAS TREATED FOR ABDOMINAL AORTIC ANEURYSM (AAA). A BIFURCATED STENT GRAFT, AN INFRARENAL STENT GRAFT EXTENSION AND A NON- ENDOLOGIX (SMART STENT) WERE IMPLANTED (OFF- LABEL). IT WAS REPORTED THAT THE GUIDEWIRE WAS INSERTED FROM THE RIGHT FEMORAL ARTERY WAS SLIGHTLY COMING OUT FROM THE ACCESS DURING BALLOON TOUCH-UP OF BIFURCATED STENT GRAFT (AROUND LEFT COMMON LILAC ARTERY), SO THE PHYSICIAN PUSHED IT BACK INTO THE VESSEL. DURING THIS GUIDEWIRE ADVANCEMENT, THE GUIDEWIRE GOT STUCK TO THE STENT STRUCTURE OF AN INFRARENAL STENT GRAFT EXTENSION AND WAS ACCIDENTALLY MIGRATED UPWARDS AS A RESULT. AS BOTH RENAL ARTERIES WERE COVERED BY THE INFRARENAL STENT GRAFT EXTENSION, THE PHYSICIAN TRIED TO PULL IT DOWN WITH A BALLOON, AND THE BLOOD FLOW INTO THE RIGHT RENAL ARTERY WAS RECOVERED. AS THE LEFT RENAL ARTERY WAS STILL COVERED, A STENT WAS IMPLANTED FROM THE RIGHT BRACHIOCEPHALIC ARTERY. BLOOD FLOW INTO THE LEFT RENAL ARTERY WAS THEN RECOVERED. THIS EVENT WAS REPORTED AS PROCEDURE-RELATED AND NOT DEVICE RELATED. APPROXIMATELY FOUR (4) DAYS POST INITIAL PROCEDURE, THE PATIENT HAD EXPIRED. IT WAS REPORTED AS POSSIBLY RESULTED FROM SHOWER EMBOLISM. IT IS UNKNOWN WHAT KIND OF PRO

  Patient problems: Death; Failure of Implant; Thrombosis

  MAUDE report 8263082 ↗
• InjuryNov 8, 2018Loss of or Failure to Bond; Leak/Splash; Material Puncture/Hole; Loss of or Failure to Bond; Leak/Splash; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX DEVICE TO TREAT AN ANEURYSM. RECENTLY THE PATENT WAS PRESENTED WITH STRATA AND A TYPE 3 ENDOLEAK (INDETERMINATE ORIGIN). AS OF THE DATE OF THIS REPORT THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND SECONDARY PLANNED PROCEDURE IS UNKNOWN. THE PATIENT STATUS AS UNKNOWN AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 8053823 ↗
• InjuryJun 21, 2018Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AT THE COMPLETION OF THE CLINICAL ASSESSMENT ON (B)(6) 2018 FOR A PERVIOUS REPORT EVENT (2031527-2018-00379), CLINICAL WAS ABLE TO FIND SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING ADDITIONAL FINDINGS OF 1A ENDOLEAK AND MIGRATION OF THE INFRARENAL EXTENSION (CUFF) .THIS REPORT IS FOR THE 1A ENDOLEAK AND MIGRATION OF THE INFRARENAL EXTENSION (CUFF) ONLY.

  Patient problems: Failure of Implant

  MAUDE report 7627686 ↗
• InjuryApr 4, 2018Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  ON (B)(6) 2018- ENDOLOGIX WAS MADE AWARE BY A PHYSICIAN DURING A ONE (1) MONTH FOLLOW UP ON A PATIENT FOR A REPORTED MIGRATION (1CM) OF THE CUFF, WITHOUT TYPE 1A ENDOLEAK. PATIENT CURRENT STATUS IS STABLE. PATIENT WAS NOT SYMPTOMATIC AND NO RE-INTERVENTION IS SCHEDULED. INITIAL IMPLANT DATE (B)(6) 2017.

  Patient problems: Failure of Implant

  MAUDE report 7397543 ↗
• InjuryJan 3, 2018Partial Blockage; Occlusion Within Device; Partial Blockage; Occlusion Within Device

  THE PATIENT WAS INITIALLY TREATED WITH AFX. APPROXIMATELY, THREE (3) MONTHS POST IMPLANT, THE PATIENT PRESENTED EMERGENTLY WITH COLD LEGS. UPON CT AND ANGIO IT WAS DISCOVERED THE GRAFT WAS FILLED WITH A CLOT BELOW THE RENALS TO THE HYPOGASTRIC ARTERIES. THE PATIENT UNDERWENT INTERVENTION DAY OF EMERGENT PRESENTATION. THE PHYSICIAN USED FOGERTY BALLOON CATHETER'S AND LINED THE ILIACS WITH LIFESTREAM COVERED STENTS. THE FINAL ANGIO SHOWED GOOD FLOW THROUGHOUT THE GRAFT. THE PATIENT IS REPORTED AS WELL POST INTERVENTION.

  Patient problems: Occlusion; Pain; Thrombosis

  MAUDE report 7162563 ↗
• InjurySep 1, 2017Failure To Adhere Or Bond; Hole In Material; Leak/Splash; Failure To Adhere Or Bond; Hole In Material; Leak/Splash

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND TWO INFRARENAL AORTIC EXTENSIONS. AT THE COMPLETION OF THE IMPLANT PROCEDURE THERE WAS AN ENDOLEAK REMAINING. THE OBSERVED LEAK WAS DIAGNOSED AS A POTENTIAL TYPE 3B ENDOLEAK OF THE INFRARENAL AORTIC EXTENSION OR A TYPE 2 ENDOLEAK. THE PATIENT HAS NOT HAD A SECONDARY PROCEDURE AND HAS NOT BEEN SCHEDULED FOR A SECONDARY PROCEDURE AT THIS TIME. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT AND THE PATIENT IS REPORTED TO BE DOING WELL POST PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 6840189 ↗
• InjuryMay 4, 2017Failure To Adhere Or Bond; Leak/Splash; Off-Label Use; Improper or Incorrect Procedure or Method; Failure To Adhere Or Bond; Leak/Splash; Off-Label Use; Improper or Incorrect Procedure or Method

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION AND TWO INFRARENAL AORTIC EXTENSIONS. THE INFRARENAL AORTIC EXTENSIONS WERE IMPLANTED IN THE LEFT AND RIGHT ILIAC ARTERIES AS LIMB EXTENSIONS. A FOLLOW UP COMPUTED TOMOGRAPHY (CT) IN (B)(6) 2017, SHOWED THE PATIENT HAD A TYPE 1B ENDOLEAK FROM THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN OBSERVED THE LIMB EXTENSION WAS COMPRESSED CAUSING BLOOD FLOW TO LEAK INTO THE ANEURYSM SAC, THERE WAS NO ANEURYSM SAC GROWTH OBSERVED. THE PHYSICIAN ELECTED TO IMPLANT AN OVATION LIMB EXTENSION TO SEAL THE ENDOLEAK. AT THE COMPLETION OF THE SECONDARY INTERVENTION THERE WAS AN ENDOLEAK REMAINING. THE PHYSICIAN IS GOING TO REFER THE PATIENT TO ANOTHER PHYSICIAN FOR ADDITIONAL TREATMENT. TO DATE A SECONDARY INTERVENTION HAS NOT BEEN REPORTED TO ENDOLOGIX.

  Patient problems: Failure of Implant

  MAUDE report 6543097 ↗

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-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-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-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• 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-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

…and 1 more.