Vela Proximal Endograft System A34-34/C80-O20 VRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00818009013606), received between Mar 8, 2016 and Feb 24, 2025 — classified as 38 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (13 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2025Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS BEING TREATED FOR AN ENDOVASCULAR REPAIR (EVAR) OF A FUSIFORM AORTIC ANEURYSM WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AFX VELA SUPRARENAL ON (B)(6) 2019. REPORTEDLY, THE PATIENT HAD A RELATIVELY THICK AND CALCIFIED PROXIMAL NECK. DUE TO THE RELATIVELY SHORT RIGHT COMMON ILIAC ARTERY, COIL EMBOLIZATION WAS PERFORMED, AND THEN A GORE (NON-ENDOLOGIX) EXCLUDER CUFF WAS IMPLANTED. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX2 SYSTEM PER THE IFU. THE AFX2 BSG WAS INSERTED TO GENTLY SIT ON THE AORTIC BIFURCATION THROUGH THE RIGHT FEMORAL APPROACH BEFORE AN AFX VELA SUPRARENAL WAS ADDED. AFTER BALLOON TOUCH-UP WAS PERFORMED LIGHTLY, ANGIOGRAPHY SHOWED AN ENDOLEAK THAT APPEARED TO BE TYPE IA OR TYPE IIIA. ANOTHER AFX VELA INFRARENAL WAS IMPLANTED IMMEDIATELY BELOW THE RENAL ARTERIES. AFTER TOUCH-UP WAS PERFORMED, THE FINAL ANGIOGRAPHY SHOWED THAT THE ENDOLEAK BECAME LESS NOTICEABLE. IT WAS DETERMINED THAT THE PATIENT WOULD BE DISCHARGED AND MONITORED THROUGH FOLLOW-UP APPOINTMENTS.

  Patient problems: Clinical Endoleak

  MAUDE report 21453918 ↗
• InjuryNov 26, 2024Migration or Expulsion of Device; Malposition of Device; Migration or Expulsion of Device; Malposition of Device

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL, AND AN AFX VELA SUPRARENAL ON (B)(6) 2022. REPORTEDLY, THE PATIENT HAS A REVERSE TAPER NECK AND SHAGGY AORTA. THE AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED THROUGH THE RIGHT ACCESS. THE AFX VELA INFRARENAL WAS IMPLANTED IMMEDIATELY BELOW THE RENAL ARTERIES. BALLOON TOUCH UP WAS PERFORMED AND THE AFX VELA INFRARENAL MIGRATED DISTALLY 1CM. THERE WAS NO ENDOLEAK; HOWEVER, AN AFX VELA SUPRARENAL WAS ALSO IMPLANTED. THE PROCEDURE WAS COMPLETED WITH NO APPARENT ENDOLEAK. REPORTEDLY ON (B)(6) 2024, ANEURYSM DIAMETER ENLARGEMENT OF APPROXIMATELY 1CM WITHOUT APPARENT ENDOLEAK WAS CONFIRMED DURING FOLLOW-UP. THERE IS ADEQUATE OVERLAP BETWEEN THE AFX2 BIFURCATED STENT GRAFT, AFX VELA INFRARENAL, AND AFX VELA SUPRARENAL; HOWEVER, THERE IS A POSSIBILITY OF TYPE IA ENDOLEAK BECAUSE THERE WAS THE DISTAL MIGRATION OF THE AFX VELA SUPRARENAL AFTER BEING IMPLANTED. THIS MIGRATION MAY HAVE OCCURRED DUE TO A BAD SEAL CREATED BETWEEN THE AFX VELA INFRARENAL, AND AFX VELA SUPRARENAL AND THE AORTA AFTER THE AFX VELA SUPRARENAL WAS IMPLANTED ON THE BARE STENT OF THE VELA INFRARENAL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20783107 ↗
• InjuryJul 22, 2024Patient-Device Incompatibility; Lack of Effect; Patient-Device Incompatibility; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A POSSIBLE TYPE 1A ENDOLEAK WAS IDENTIFIED AND THE PATIENT WAS DOING WELL. THE PHYSICIAN ELECTED TO BALLOON THE STENT GRAFT ON (B)(6) 2024 TO RESOLVE THE TYPE 1A ENDOLEAK. THE PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Clinical Endoleak

  MAUDE report 19793612 ↗
• InjuryFeb 10, 2023Complete Blockage; Complete Blockage

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL PROXIMAL EXTENSION AND TWO (2) NON-ENDOLOGIX STENTS IN THE DISTAL LEFT ILIAC LIMB. THIS INITIAL IMPLANT PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE (NON-ENDOLOGIX) DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM PER DEVICE IFU, AND DUE TO THE PLACEMENT OF A PROXIMAL VELA SUPRARENAL EXTENSION IN THE PATIENT'S ILIAC. LESS THAN TWO (2) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH CLAUDICATION. THE SUBSEQUENT ANGIOGRAM DETECTED AN OCCLUDED LEFT GRAFT LIMB. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY PERFORMING A BILATERAL ILIOFEMORAL ENDARTERECTOMIES AND A RIGHT-TO-LEFT CROSS FEMORAL BYPASS ON (B)(6) 2016. THIS EVENT WAS PREVIOUSLY REPORTED PER MFR. REPORT # 2031527-2016-00594. TWO (2) DAYS POST SECONDARY PROCEDURE, AN EVERFLEX (NON-ENDOLOGIX) STENT WAS PLACED WITHIN THE PATIENT'S RIGHT ILIAC LIMB INTO THE EXTERNAL ILIAC ARTERY TO TREAT STENOSIS. ANOTHER FOUR (4) MONTHS POST TERTIARY PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH AN OCCLUSION OF THE LEFT ILIAC GRAFT/EXTENSION. IT IS UNKNOWN I

  Patient problems: Obstruction/Occlusion

  MAUDE report 16351480 ↗
• InjuryJun 24, 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 AFX BIFURCATED STENT GRAFT, A VELA SUPRARENAL PROXIMAL EXTENSION, AND A LIMB STENT GRAFT. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) OVATION IX ILIAC LIMBS, AN ALTO MAIN BODY, AND SOME OVATION PRIME FILL POLYMER. THE ENDOLEAK WAS CONFIRMED TO BE RESOLVED. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL AND DISCHARGED FROM THE HOSPITAL.

  Patient problems: Failure of Implant; Hematoma

  MAUDE report 14807035 ↗
• InjuryMar 31, 2022Improper or Incorrect Procedure or Method; Appropriate Device Problem Term/Code Not Available; Improper or Incorrect Procedure or Method; 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. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A TYPE IA ENDOLEAK WAS IDENTIFIED AT ROUTINE FOLLOW-UP. REINTERVENTION HAS NOT YET BEEN SCHEDULED. THE PATIENT IS STABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13969061 ↗
• InjuryMar 29, 2022Migration; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A VELA INFRARENAL STENT GRAFT EXTENSION AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4 YEARS POST INITIAL PROCEDURE THE PATIENT WAS IDENTIFIED WITH ANEURYSM ENLARGEMENT FROM POSSIBLE IMPLANT MOVEMENT OF THE VELA SUPRARENAL STENT GRAFT EXTENSION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING THE ORIGINALLY IMPLANTED DEVICES WITH THE ALTO STENT GRAFT SYSTEM. IT WAS DIFFICULT TO CANNULATE CONTRALATERAL GATE AND OTHER DEPLOYMENT ISSUES OCCURRED. THE SURGEON DECIDED TO PERFORM A FEM-FEM BYPASS. THE PROCEDURE WAS COMPLETED. THE NEW EVENTS OF DEPLOYMENT ISSUE WITH THE ALTO STENT GRAFT SYSTEM WILL BE REPORTED AND INVESTIGATED UNDER A SEPARATE MDR.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13935070 ↗
• InjuryMar 17, 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 IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL PROXIMAL EXTENSION AND TWO (2) OVATION IX EXTENDERS. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM PER IFU. APPROXIMATELY THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT AND SCAN IN ANOTHER 30 DAYS TO DISCERN IF THE ENDOLEAK SELF-RESOLVES.

  Patient problems: Failure of Implant

  MAUDE report 13792519 ↗
• InjuryDec 22, 2021Off-Label Use; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE A TYPE IA ENDOLEAK WAS IDENTIFIED AT ROUTINE FOLLOW-UP. REINTERVENTION WAS COMPLETED WITH IMPLANT OF AN ADDITIONAL AFX VELA SUPRARENAL SUCCESSFULLY SEALING THE TYPE IA ENDOLEAK. REPORTEDLY, THE PATIENT IS DOING WELL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13060417 ↗
• InjuryDec 15, 2021Off-Label Use; Migration; Off-Label Use; Migration

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN IMPLANT OF AN AFX BIFURCATED STENT GRAFT, AND AN AFX VELA SUPRARENAL. APPROXIMATELY SEVEN (7) YEARS POST INITIAL IMPLANT THE PATIENT PRESENTED DURING A ROUTINE FOLLOW-UP WITH AN IMPLANT MIGRATION, AND A TYPE IA ENDOLEAK. THE PATIENT WAS REPORTED TO BE STABLE AND IS BEING MONITORED. AFTER THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT REINTERVENTION WAS COMPLETED. THE FIRST ALTO MAIN BODY INSERTED TO THE PATIENT WOULD NOT ADVANCE OVER THE LUNDERQUIST (NON-ENDOLOGIX) GUIDEWIRE. THE GUIDEWIRE WAS EXCHANGED FOR A NEW LUNDERQUIST (NON-ENDOLOGIX) GUIDEWIRE; HOWEVER, THE DEVICE WAS STILL UNABLE TO ADVANCE. THE PHYSICIAN FLUSHED THE DEVICE MULTIPLE TIMES AND ATTEMPTED TO TAKE DIFFERENT WIRES TO ADVANCE THROUGH EITHER END OF THE ALTO MAIN BODY. THE WIRES WOULD GO IN THE BACK END, BUT NOT THE CORRECT END TO GET THE ALTO MAIN BODY UP. THE ALTO MAIN BODY WAS REMOVED FROM THE PATIENT. A NEW ALTO STENT GRAFT SYSTEM WAS INTRODUCED TO THE PATIENT AND DEPLOYED SUCCESSFULLY TREATING THE TYPE IA ENDOLEAK WITH MIGRATION. THE PATIENT WAS STABLE POST-REINTERVENTION. THE CLINICAL ASSESSMENT DETERMINED

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13011365 ↗
• InjuryJun 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A SUPRARENAL AORTIC EXTENSION, AND AN OVATION IX EXTENSION 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 AFX SYSTEM PER THE IFU. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE 1A ENDOLEAK WAS IDENTIFIED. THE PATIENT IS DOING FINE AND IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Failure of Implant

  MAUDE report 12045992 ↗
• InjuryJun 8, 2021Use of Device Problem; Use of Device Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO REVERSE TAPERED NECK WITH SEVERE ANGULATION. THE PATIENT IS CURRENTLY BEING MONITORED. NO RE-INTERVENTION HAS BEEN SCHEDULED DUE TO THE PATIENTS CONDITION AND STABLE SAC SIZE.

  Patient problems: Failure of Implant

  MAUDE report 11963103 ↗
• InjuryMay 25, 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 AFX VELA SUPRARENAL. APPROXIMATELY FOUR (4) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK AT ROUTINE FOLLOW-UP. THE PATIENT IS REPORTEDLY STABLE, AND THE PHYSICIAN PLANS TO RE-INTERVENE.

  Patient problems: Failure of Implant

  MAUDE report 11880935 ↗
• InjuryMay 3, 2021Insufficient Device Problem Information; 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). A TYPE 1A ENDOLEAK WAS OBSERVED ON THE FINAL ANGIOGRAM. THE PHYSICIAN ELECTED TO IMPLANT A PALMAZ (NON-ENDOLOGIX) BALLOON EXPANDABLE STENT WHICH PARTIALLY RESOLVED THE ENDOLEAK; HOWEVER, THERE WAS STILL AN ENDOLEAK PRESENT. THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 11766395 ↗
• InjuryNov 23, 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 AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 1A ENDOLEAK, MIGRATION AND SAC GROWTH WERE DISCOVERED DURING A ROUTINE FOLLOW UP. THIS EVENT WAS RESOLVED BY IMPLANTING A SUPRARENAL STENT GRAFT EXTENSION AND A INFRARENAL STENT GRAFT EXTENSION THIS EVENT WAS PREVIOUSLY REPORTED UNDER 2031527-2019-00254. APPROXIMATELY THREE (3) MONTHS POST RE- INTERVENTION, A TYPE 2 ENDOLEAK WAS DISCOVERED DURING A ROUTINE FOLLOW UP. A TYPE 2 ENDOLEAK IS NOT A DEVICE RELATED FAILURE THEREFORE NO FURTHER DETAILS WERE PROVIDED. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, ANOTHER TYPE 1A AND SAC GROWTH WAS IDENTIFIED. THIS EVENT WAS RESOLVED BY IMPLANTING A SUPRARENAL STENT GRAFT EXTENSION AND A LIMB STENT GRAFT EXTENSION. THIS EVENT WAS PREVIOUSLY REPORTED UNDER 2031527-2020-00263. DURING THE INVESTIGATION OF THE PREVIOUS REPORTED EVENTS, IT WAS IDENTIFIED THAT THE PATIENTS ANATOMY IS OUTSIDE THE INDICATIONS OF USE (OFF- LABEL) DUE TO THE INFRARENAL ANGULATION OF 55°. NOW, APPROXIMATELY 2 MONTHS POST THE RE- INTERVENTION, ANOTHER 1A EN

  Patient problems: Failure of Implant

  MAUDE report 10885453 ↗
• InjuryOct 21, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS LATER DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) IDENTIFIED A TYPE 1A ENDOLEAK. THE PHYSICIAN COMPLETED A REINTERVENTION AND RELINED THE VELA SUPRARENAL STENT GRAFT EXTENSION WITH ANOTHER VELA SUPRARENAL STENT GRAFT EXTENSION. THE ENDOLEAK WAS RESOLVED AND SEALED. THE PATIENT REPORTEDLY IS RECOVERING AND DOING WELL POST PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 10715715 ↗
• InjuryOct 7, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO AND A HALF (2.5) YEARS LATER, ANEURYSM GROWTH, STENT MOVEMENT, AND A TYPE 3A ENDOLEAK WERE IDENTIFIED. THE PHYSICIAN COMPLETED AN INTERVENTION ON (B)(6) 2016 , AND ELECTED TO IMPLANT AN INFRARENAL AORTIC EXTENSION TO TREAT THIS EVENT. THIS WAS REPORTED ON MDR# 2031527-2016-00580. NOW, APPROXIMATELY SIX AND A HALF (6.5) YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW UP, A NEW TYPE 3A ENDOLEAK WAS IDENTIFIED, AND THE ORIGINALLY IMPLANTED SUPRARENAL AORTIC EXTENSION HAS EXPANDED OUTSIDE THE INFRARENAL AORTIC EXTENSION. THE PATIENT IS CURRENTLY BEING MONITORED. ADDITIONAL INFORMATION: A RE-INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL. THE TYPE 3A ENDOLEAK WAS RESOLVED AND THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 10645640 ↗
• InjuryOct 2, 2020Improper or Incorrect Procedure or Method; Separation Problem; Improper or Incorrect Procedure or Method; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT THIS INITIAL CASE WAS OFF-LABEL PER SIZING REPORT. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW UP, IT WAS DISCOVERED THAT THE ANEURYSM HAD CONTINUED TO GROW IN A LATERAL FASHION AND HAS DISPLACED THE AORTIC EXTENSION IDENTIFYING AS A 3A ENDOLEAK. RE-INTERVENTION WAS COMPLETED AND AN ADDITIONAL ONE (1) AFX2 BIFURCATED STENT GRAFT WITH TWO (2) AORTIC EXTENSIONS WERE IMPLANTED ON (B)(6) 2020. PATIENT STATUS WAS REPORTED AS DOING WELL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10621156 ↗
• InjuryAug 10, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY 5 YEARS POST INITIAL IMPLANT IT WAS IDENTIFIED THAT THE VELA SUPRARENAL HAD MIGRATED DOWN APPROXIMATELY 20-22MM. THERE WAS NO ENDOLEAK IDENTIFIED AND THE AAA HAS DECREASED 1CM SINCE IMPLANT. THE PATIENT IS STABLE; THEREFORE, THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. ADDITIONAL INFORMATION: CLINICAL ASSESSMENT IDENTIFIED TYPE 2 LUMBAR ENDOLEAKS (NON-DEVICE RELATED FAILURES) DURING A REVIEW OF THE COMPUTED TOMOGRAPHY (CT) SCAN DATED (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10388431 ↗
• InjuryJul 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY, 1 MONTH POST INITIAL PROCEDURE PATIENT WAS IDENTIFIED WITH A TYPE IB ENDOLEAK AND WAS TREATED WITH A AFX LIMB EXTENSION SUCCESSFULLY SEALING THE TYPE IB ENDOLEAK.

  Patient problems: Failure of Implant

  MAUDE report 10316937 ↗
• InjuryJun 24, 2020Use 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 IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING INITIAL PROCEDURE A SMALL TYPE 1A ENDOLEAK WAS OBSERVED ON FINAL ANGIOGRAM. THE PHYSICIAN HAS ELECTED TO PERFORM ANOTHER CTA IN 90 DAYS. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Code Available

  MAUDE report 10192474 ↗
• InjuryMar 10, 2020Patient-Device Incompatibility; Device-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Device-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY EIGHT (8) MONTHS POST A RE-INTERVENTION, A TYPE 1A WAS IDENTIFIED PER A CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT WHO IS REPORTEDLY IN STABLE CONDITION. NOTE: THIS PATIENT HAS HAD TWO (2) PREVIOUSLY REPORTED EVENTS: 1) 2031527-2016-00282 WAS PREVIOUS REPORTED TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN INFRARENAL STENT GRAFT TO RESOLVED THIS EVENT. 2) 2031527-2019-00277 FOR PREVIOUS REPORTED TYPE IIIB ENDOLEAK HOWEVER HAS BEEN CONFIRMED AS TYPE II ENDOLEAK WITH SAC GROWTH (NON- DEVICE RELATED FAILURE), THE PHYSICIAN ELECTED TO IMPLANT ANOTHER BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION. ADDITIONAL INFORMATION: CLINICAL ASSESSMENT IDENTIFIED SAC GROWTH OF 21 MM AND OFF LABEL AORTIC NECK LENGTH OF 3 MM.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9812546 ↗
• InjuryMay 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED CONFIRMING THAT THE PHYSICIAN ELECTED TO IMPLANT AN ABBOTT (NON-ENDOLOGIX) 6X19 BARE STENT INTO THE LEFT-SIDE RENAL TO TREAT THE DISPLACED AFX VELA SUPRARENAL; THE BARE STENT WAS PLACED DURING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8642097 ↗
• InjuryDec 29, 2018Loss of or Failure to Bond; Leak/Splash; Use of Device Problem; Loss of or Failure to Bond; Leak/Splash; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT CONFIRMING THAT THE PATIENT HAD AN OFF-LABEL NECK ANATOMY AT THE TIME OF THE INITIAL IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 8205377 ↗
• InjuryDec 19, 2018Leak/Splash; Insufficient Device Problem Information; Leak/Splash; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE THREE (3) MONTH ROUTINE FOLLOW-UP IDENTIFIED A TYPE 1A ENDOLEAK AND AN INDETERMINATE ENDOLEAK (POSSIBLE TYPE 3A OR 2). A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER SUPRARENAL STENT GRAFT EXTENSION TO RESOLVE THE REPORTED THE EVENT. THE PATIENT WAS DISCHARGED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8180462 ↗

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-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-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-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-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• 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-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-0590-06 · 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
• Z-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL

…and 1 more.