Vela Proximal Endograft System A28-28/C95-O20 VRecalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00818009013637), received between Feb 10, 2016 and Mar 11, 2026 — classified as 2 deaths, 64 injuries.

The most frequently reported specific device problem is “Leak/Splash” (27 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 66 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Off-Label Use; Unintended Movement

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM MINOR AXIS DIAMETER OF 51.5MM WITH THE LEFT COMMON ILIAC ARTERY (CIA) WITH A DILATED PORTION WITH A MAXIMUM DIAMETER OF 25MM ON (B)(6) 2019. THE LEFT INTERNAL ILIAC ARTERY (IIA) EMBOLIZED WITH A PLUG VIA A RIGHT FEMORAL APPROACH, A GORE (NON-ENDOLOGIX) EXCLUDER LEG WAS DEPLOYED FROM THE LEFT CIA TO THE EXTERNAL ILIAC ARTERY (EIA) VIA A LEFT APPROACH. THE AFX2 BIFURCATED STENT GRAFT (BSG) AND THE AFX VELA SUPRARENAL WERE DEPLOYED ACCORDING TO THE STANDARD PROCEDURE. INTRAOPERATIVE ANGIOGRAPHY (DSA) CONFIRMED A TYPE IA ENDOLEAK AT THE PROXIMAL SIDE OF THE AFX VELA SUPRARENAL; THEREFORE, A GORE (NON-ENDOLOGIX) EXCLUDER CUFF (28.5-33) WAS DEPLOYED AS AN INTERNAL LINING. THE PROCEDURE WAS COMPLETED AFTER CONFIRMING THE RESOLUTION OF THE ENDOLEAK. ON (B)(6) 2026, JUNCTION SEPARATION BETWEEN THE AFX2 MAIN BODY AND THE VELA WAS CONFIRMED DURING A ROUTINE FOLLOW-UP. REINTERVENTION WAS PERFORMED ON (B)(6) 2026. THERE WAS NO SIGNIFICANT LEAK OBSERVED AT THE JUNCTION BETWEEN THE AFX2 BSG AND AFX VELA SUPRARENAL. A AFX VELA INFRARENAL WAS DEPLOYED AT THE JUNCTION, AND THE PROCEDURE WAS COMPLETED. NOTE: THE AFX2 SYSTEM WAS E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573292 ↗
• InjuryMay 6, 2025Fracture; Separation Problem; Fracture; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL ON (B)(6) 2016, TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS AFTER THE INITIAL PROCEDURE, THE PATIENT PRESENTED WITH FLANK PAIN, AND A TYPE IIIA ENDOLEAK WAS IDENTIFIED. AT AN UNKNOWN DATE AND LOCATION, THE PHYSICIAN IMPLANTED AN ADDITIONAL VELA LIMB TO ADDRESS THE ISSUE. (MRN 2031527-2019-00495). ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER) DUE TO ANOTHER TYPE IIIA ENDOLEAK. IMAGING STUDIES, INCLUDING A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA), REVEALED STENT FRACTURES IN WHAT APPEARS TO BE THE ORIGINAL VELA, WHICH HAD PREVIOUSLY BEEN RELINED WITH ANOTHER VELA. THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 21970155 ↗
• InjuryApr 17, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2017 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. ROUTINE FOLLOW-UP PERFORMED ON (B)(6) 2025 IDENTIFIED A TYPE IA ENDOLEAK. REINTERVENTION WAS COMPLETED ON (B)(6) 2025 WITH THE IMPLANT OF AN AFX VELA INFRARENAL. THE TYPE IA ENDOLEAK WAS SEALED AND THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21860932 ↗
• InjurySep 3, 2024Collapse; Migration or Expulsion of Device; Material Puncture/Hole; Collapse; Migration or Expulsion of Device; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2017, WITH THE IMPLANTATION OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL STENT. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A TYPE IB ENDOLEAK AND AN ENDOLEAK OF INDETERMINATE ORIGIN, POSSIBLY A TYPE 3B OR TYPE IA ENDOLEAK. AN ANGIOGRAPHIC COMPUTED TOMOGRAPHY (CT) SCAN REVEALED DISTAL MIGRATION AND A SIGNIFICANTLY KINKED VELA SUPRARENAL AND PROXIMAL MIGRATION OF THE AFX BIFURCATED STENT GRAFT WITHIN A 110MM DIAMETER ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2024, THE PATIENT UNDERWENT A RE-INTERVENTION DURING WHICH THE PHYSICIAN IMPLANTED AN AFX2 BIFURCATED STENT GRAFT AND TWO AFX LIMB STENT GRAFTS. IT WAS REPORTED THAT THE ENDOLEAK WAS NOT RESOLVED. THE FINAL STATUS OF THE PATIENT REMAINS UNKNOWN, AS THIS INFORMATION WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Clinical Endoleak

  MAUDE report 20126603 ↗
• InjuryMay 2, 2024Malposition of Device; Malposition of Device

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT (BSG) AND TWO (2) AFX VELA SUPRARENAL AORTIC EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE ANEURYSM MEASURED 5.9 CM IN DIAMETER. THE DISTANCE BETWEEN LOWEST RENAL AND BIFURCATION WAS 139MM. THE AFX2 BSG DEPLOYMENT WENT FINE. THE RIGHT ILIAC ARTERY HAD TO BE BALLOONED TO ADVANCE THE 17FR SHEATH PAST THE RENAL ARTERIES TO DEPLOY THE PROXIMAL AFX VELA SUPRARENAL. AN ANGIOGRAM WAS TAKEN, AND THE RENAL ARTERIES WERE MARKED. THE AFX VELA SUPRARENAL WAS DEPLOYED WITHOUT PROBLEMS AND LANDED 2-3MM BELOW THE RENAL ARTERIES. THE SHEATH WAS RE-ADVANCED, AND IT WAS NOTICED MID GRAFT DEPLOYMENT THE SHEATH WOULD NOT GO UP. THE PHYSICIAN STOPPED THE PROCEDURE AND DID NOT CONTINUE PUSHING. THE DELIVERY SYSTEM WAS PULLED BACK AND ROTATED THEN THE DEVICE WENT UP WITHOUT ISSUE. THE SECOND AFX VEAL SUPRARENAL WAS INSERTED AND DEPLOYED JUST ABOVE THE BIFURCATION, WELL BELOW THE RENAL ARTERIES. THE PHYSICIAN POST BALLOONED WITH A CODA (NON-ENDOLOGIX) BALLOON IN THE AORTA AS WELL AS BILATERALLY IN THE ILIAC ARTERIES. POST IMPLANT IMAGE SHOWED THE PROXIMAL AFX VELA SUPRARENAL WAS NOW WELL ABOVE THE RENAL ARTERIES AND PART

  Patient problems: Obstruction/Occlusion

  MAUDE report 19230489 ↗
• InjuryAug 28, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL AORTIC EXTENSION AND AN INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, CONTRAST WAS SEEN IN THE ANEURYSM SAC. THE DISTAL END OF THE STENT GRAFT APPEARED SEALED. IT WAS CONFIRMED THAT A TYPE 1A ENDOLEAK WAS PRESENT. THE PHYSICIAN ELECTED TO IMPLANT AN AFX SUPRARENAL AORTIC EXTENSION TO SUCCESSFULLY RESOLVE THIS EVENT. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17638745 ↗
• InjuryAug 14, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. VESSEL TORTUOSITY IN THE RIGHT COMMON INTERNAL ARTERY AND POOR WALL APPOSITION WAS NOTED AT INITIAL IMPLANT. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, ANEURYSM SAC ENLARGEMENT (UNKNOWN DIAMETER) WAS IDENTIFIED. THEN ANOTHER TWO (2) YEARS LATER, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN EXCLUDER (NON-ENDOLOGIX) LEG ON (B)(6) 2022. REFERENCE MFR. REPORT # 2031527-2022-00239 FOR THIS EVENT. APPROXIMATELY FIVE (5) MONTHS POST SECONDARY PROCEDURE, THE PHYSICIAN PERFORMED RE-INTERVENTION DUE TO A TYPE IIIB ENDOLEAK. AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED ON (B)(6) 2013. REFERENCE MFR. REPORT # 2031527-2023-00205 FOR THIS EVENT. APPROXIMATELY FIVE (5) MONTHS POST TERTIARY PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IA ENDOLEAK. THE PHYSICIAN EMERGENTLY TREATED THE PATIENT BY IMPLANTING AN ENDURANT (NON-ENDOLOGIX) DEVICE ON (B)(6) 2023. THE ENDOLEAK WAS CONFIRMED AS RESOLVED. THIS REPORT IS TO ADDRESS THE TYPE IA E

  Patient problems: Clinical Endoleak

  MAUDE report 17546465 ↗
• InjuryJul 18, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY ONE (1) DAY AFTER THE INITIAL PROCEDURE, THE PATIENT EXHIBITED SYMPTOMS OF BACK PAIN AND EXPERIENCED A STOPPAGE OF URINE OUTPUT. IN RESPONSE, A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED, REVEALING PROPER BLOOD FLOW TO THE RENAL AREA. HOWEVER, LATER ON, THE SAME DAY, IT WAS REPORTED THAT THE PATIENT REQUIRED A SURGICAL CONVERSION, DURING WHICH THE AFX VELA SUPRARENAL DEVICE WAS EXPLANTED. UNFORTUNATELY, NO FURTHER DETAILS HAVE BEEN PROVIDED REGARDING THE CURRENT STATUS OF THE PATIENT'S SURGICAL CONVERSION. CLARIFICATION: THE PATIENT EXPERIENCED RENAL OCCLUSION AT TIME OF EVENT. ADDITIONAL INFORMATION: A CLINICAL ASSESSMENT IDENTIFIED AN ADDITIONAL ENDOVASCULAR PROCEDURE ALSO OCCURRED. THIS PROCEDURE INVOLVED PLACING A FENESTRATED GRAFT ON (B)(6) 2023. THE FINDING FOR THIS SUPPLEMENTARY INTERVENTION WAS BASED ON A THOROUGH REVIEW OF THE OPERATIVE REPORT AND DISCHARGE SUMMARY. A SEPARATE REPORT WILL BE FILED FOR THIS TERTIARY INTERVENTION EVENT (REFERENCE PATIENT ID (B)(6)).

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 17347567 ↗
• InjuryJul 14, 2023Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL ON (B)(6) 2016. IT SHOULD BE NOTED THAT PRIOR TO THE INDEX PROCEDURE, THE SIZING SHEET DATED (B)(6) 2016, THE NECK DIAMETER WAS OFF LABEL AS IT MEASURED 17.2MM AND SHOULD MEASURE BETWEEN 18 AND 32MM. ADDITIONALLY, THE MAX ANEURYSM DIAMETER WAS OFF LABEL AS IT MEASURED AT 49.9MM AND SHOULD MEASURE = 50MM. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS TRANSFERRED FROM AN OUTSIDE FACILITY ON (B)(6) 2023 DUE TO TYPE IA ENDOLEAK WITH A POTENTIAL CONTAINED RUPTURE. IT IS UNKNOWN WHEN THE TYPE IA ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2023, REINTERVENTION WAS PERFORMED WITH THE IMPLANT OF A COOK ALPHA (NON-ENDOLOGIX) IN THE AORTA, A GORE VIABAHN VBX (NON-ENDOLOGIX) IN THE CELIAC ARTERY FENESTRATION, A GORE VIABAHN VBX (NON-ENDOLOGIX) IN THE SUPERIOR MESENTERIC ARTERY FENESTRATION, AND A GORE VBX (NON-ENDOLOGIX) IN THE RIGHT RENAL ARTERY LASER FENESTRATION. COMPLETION AORTOGRAM DEMONSTRATED SUCCESSFUL EXCLUSION OF THE TYPE IA ENDOLEAK AND A DELAYED TYPE II ENDOLEAK. THE PHYSICIAN ELECTED TO END THE PROCEDURE AND THE PATIENT WA

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 17330299 ↗
• InjuryMay 3, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IA ENDOLEAK AS DETECTED PER CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) ENDURANT (NON-ENDOLOGIX) CUFF AT THE PROXIMAL PORTION OF THE SYSTEM ON (B)(6) 2023, AND THE ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PATIENT WAS REPORTEDLY IN STABLE CONDITION AT THE CONCLUSION OF THE RE- INTERVENTION PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 16862102 ↗
• InjuryApr 27, 2023Patient-Device Incompatibility; Unintended Movement; Lack of Effect; Patient-Device Incompatibility; Unintended Movement; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND A SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY SEVEN AND A HALF (7.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ENDOLEAK (INDETERMINATE ORIGIN). THE PHYSICIAN ELECTED TO RELINE THE ORIGINALLY IMPLANTED AFX STENT GRAFTS WITH AN ALTO STENT GRAFT SYSTEM TO SUCCESSFULLY RESOLVE THIS ENDOLEAK. ADDITIONAL INFORMATION: AN INTERNAL CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST 19.4 MM ANEURYSM ENLARGEMENT AND PROXIMAL EXTENSION MIGRATION OF 10MM OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE ANEURYSM ENLARGEMENT AND MIGRATION WERE DISCOVERED DURING REVIEW OF THE 03/31/2023 COMPUTED TOMOGRAPHY (CT) SCAN.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16826171 ↗
• InjurySep 1, 2022Off-Label Use; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL AND AN OVATION IX ILIAC LIMB. 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. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, AT THE SIXTY (60) MONTH ROUTINE FOLLOW-UP, A TYPE IA ENDOLEAK WAS IDENTIFIED WITHIN THE STENT BODY BETWEEN THE METAL STRUTS AND THE GRAFT MATERIAL. REINTERVENTION PLANS WERE NOT MADE AVAILABLE. THE PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 15337167 ↗
• InjuryJun 9, 2022Migration; Migration

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY THREE AND A HALF (3.5) YEARS POST-INITIAL PROCEDURE, ANEURYSM ENLARGEMENT WITH NO ENDOLEAK WAS IDENTIFIED. AT REINTERVENTION IT WAS IDENTIFIED THAT THE AFX VELA SUPRARENAL HAD MIGRATED APPROXIMATELY 15MM. THERE WAS NO ENDOLEAK PRESENT. THE PHYSICIAN SUSPECTED ENDOTENSION. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF THE ALTO STENT GRAFT SYSTEM (ONE (1) ALTO MAIN BODY, TWO (2) OVATION IX ILIAC LIMBS). THE PATIENT IS REPORTED TO BE DOING WELL. ADDITIONAL INFORMATION: THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE IA ENDOLEAK OCCURRED ON 06/08/2022 THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE CLINICAL ASSESSMENT ALSO DETERMINED THAT IN 2019 (EXACT DATE UNKNOWN) THE PATIENT HAD A TYPE II ENDOLEAK WHICH WAS REPAIRED IN 2019. THE TYPE IA ENDOLEAK AND TYPE II ENDOLEAK WERE DISCOVERED DURING A REVIEW OF THE OPERATIVE NOTES. TYPE II ENDOLEAKS ARE ANATOMY RELATED EVENTS AND ARE NOT CAUSED OR CONTRIBUTED BY THE DEVICE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14647193 ↗
• InjuryNov 22, 2021Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL STENT GRAFT. APPROXIMATELY (3) THREE YEARS AFTER POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ANEURYSM SAC ENLARGEMENT HOWEVER AN ENDOLEAK WAS NOT IDENTIFIED WITH AN ANGIOGRAM. IT WAS NOTED THAT THE AFX VELA SUPRARENAL STENT GRAFT WAS A FEW MILLIMETERS BELOW THE RENAL ARTERY, BUT STILL NO ENDOLEAK PRESENT. AS A PRE-CAUTION, THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RE-LINING THE ORIGINALLY IMPLANTED DEVICES WITH ANOTHER AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL STENT GRAFT. THE RE-INTERVENTION PROCEDURE WAS SUCCESSFUL. THE FINAL PATIENT STATUS WAS REPORTED AS DOING GREAT. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST TWO OTHER ENDOVASCULAR PROCEDURES OCCURRED THAT WERE NOT INCLUDED IN THE EVENT AS REPORTED: IN MARCH OF 2020 A TYPE II ENDOLEAK (NON-DEVICE RELATED FAILURE) WAS COILED FROM THE LUMBAR ARTERY AND ON (B)(6) 2020 ANOTHER TYPE II ENDOLEAK (NON-DEVICE RELATED FAILURE) WAS COILED IN THE SACRAL ARTERY. THESE ADDITIONAL ENDOVASCULAR PROCEDURES WERE DISCOVE

  Patient problems: Aneurysm

  MAUDE report 12858246 ↗
• InjuryOct 29, 2021Unintended Movement; Unintended Movement

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY ONE AND A HALF (1.5) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IA ENDOLEAK DUE TO DISTAL MOVEMENT OF THE PROXIMAL EXTENSION, AND A TYPE IB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL AFX VELA SUPRARENAL WITH AN OVATION IX EXTENDER ON (B)(6) 2021. THE ENDOLEAKS WERE SUCCESSFULLY RESOLVED AND THE PATIENT IS REPORTEDLY IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 12720327 ↗
• InjurySep 28, 2021Fracture; Material Puncture/Hole; Material Integrity Problem; Fracture; Material Puncture/Hole; Material Integrity Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL PROXIMAL EXTENSION. REPORTEDLY, PATIENT MAY HAVE BEEN PREVIOUSLY TREATED WITH A NON-ENDOLOGIX ENDOGRAFT, BUT THIS CANNOT BE CONFIRMED. NOW APPROXIMATELY SEVEN AND A HALF (7.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IA ENDOLEAK, ANEURYSM SAC GROWTH (UNKNOWN DIAMETER), A TYPE II ENDOLEAK (NON-DEVICE-RELATED), AND A BLOWN-OUT AND TORN PROXIMAL EXTENSION GRAFT (CLASSIFIED AS A TYPE IIIB ENDOLEAK). THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12544558 ↗
• InjurySep 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, TWO (2) SUPRARENAL AORTIC EXTENSIONS, AND TWO (2) INFRARENAL AORTIC EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE THERE WAS A TYPE 1A ENDOLEAK NOTED AND A SUSPECTED TYPE 2 (NON-DEVICE-RELATED) ENDOLEAK. THE PHYSICIAN ELECTED TO COIL EMBOLIZE TO RESOLVE THE TYPE 1A ENDOLEAK AND COIL EMBOLIZE THE LUMBAR ARTERY TO RESOLVE THE TYPE 2 ENDOLEAK.

  Patient problems: Failure of Implant

  MAUDE report 12411494 ↗
• InjuryAug 31, 2021Material Puncture/Hole; Device-Device Incompatibility; Material Integrity Problem; Material Puncture/Hole; Device-Device Incompatibility; Material Integrity Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. THE ANEURYSM WAS AT 5CM POST-PROCEDURE. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, AT ROUTINE FOLLOW-UP, THE ANEURYSM HAD SHRUNK TO 3.9CM. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, AT A FOLLOW-UP ROUTINE PROCEDURE, A TYPE 3B ENDOLEAK OF THE AFX VELA SUPRARENAL WAS IDENTIFIED. ADDITIONALLY, THE ANEURYSM HAD GROWN BACK TO 4.4CM AT THE SUSPECTED TYPE 3B ENDOLEAK. REINTERVENTION IS PLANNED. THE PATIENT IS REPORTEDLY STABLE. ADDITIONAL INFORMATION: THE PATIENT UNDERWENT A RE-INTERVENTION. THE PHYSICIAN ELECTED TO IMPLANT AN AFX VELA SUPRARENAL AND AN AFX2 BIFURCATED STENT GRAFT. A CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A NON ENDOLOGIX STENT WAS PLACED IN THE LEFT COMMON ILIAC ARTERY BACK IN 2018. THE STENT WAS PLACED DUE TO THE PATIENT'S LEFT COMMON ILIAC OCCLUDED DISTAL OF AFX GRAFT. IT WAS PLACED TO IMPROVE GRAFT OUTFLOW. THIS WAS NOT RELATED TO A DEVICE FAILURE. THE FINAL PATIENT STATUS WAS REPORTED AS HAVING GOOD PULSES IN BOTH LEGS SO THE PHYSICIAN ELECTED TO FINISH THE PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 12389657 ↗
• InjuryMay 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 2.5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IA ENDOLEAK PER CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) ADDITIONAL AFX VELA SUPRARENAL ON (B)(6) 2021. THE PATIENT IS REPORTEDLY IN STABLE CONDITION AND THE ENDOLEAK WAS SUCCESSFULLY SEALED.

  Patient problems: Failure of Implant

  MAUDE report 11770677 ↗
• InjuryApr 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 5.5 YEARS POST INITIAL IMPLANT, THE PATIENT WAS IDENTIFIED WITH A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE WITH AN AFX VELA INFRARENAL, AFX2 BIFURCATED STENT GRAFT, AFX VELA SUPRARENAL, AND A PALMAZ (NON-ENDOLOGIX DEVICE) STENT TO TEAT THE 1A ENDOLEAK. PER THE ANGIOGRAM, THE ENDOLEAK WAS RESOLVED.

  Patient problems: Failure of Implant

  MAUDE report 11606251 ↗
• InjuryJan 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED FOR ROUTINE FOLLOW UP WITH NO ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED AND IDENTIFIED A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A SUPRARENAL AORTIC EXTENSION TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING FINE POST SECONDARY PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 11198057 ↗
• InjuryNov 3, 2020Malposition of Device; Malposition of Device

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE AT ROUTINE FOLLOW-UP, THE PROXIMAL EXTENSION WAS DIAGNOSED TO HAVE BEEN MISPOSITIONED AS IT WAS IMPLANTED WITHIN THE STENT STRUTS OF THE BIFURCATED STENT GRAFT. THE PATIENT'S CURRENT CONDITION IS UNKNOWN, AND IT IS UNKNOWN IF THE PHYSICIAN PLANS TO RE-INTERVENE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10781583 ↗
• InjuryOct 21, 2020Material Puncture/Hole; Insufficient Device Problem Information; Material Puncture/Hole; 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 FIVE (5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE 1A ENDOLEAK WITH SAC ENLARGEMENT, THROMBUS WITHIN SAC, AND A POSSIBLE TYPE 3B ENDOLEAK WERE IDENTIFIED. A RE-INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINALLY IMPLANTED DEVICES WITH ANOTHER BIFURCATED STENT GRAFT AND THE SUPRARENAL STENT GRAFT EXTENSION TO RESOLVE THIS EVENT. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Aneurysm; Failure of Implant; Thrombus

  MAUDE report 10714905 ↗
• InjuryJul 16, 2020Insufficient Device Problem Information; 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. APPROXIMATELY 1 YEAR POST INITIAL PROCEDURE, IMPLANT PATIENT WAS IDENTIFIED WITH A TYPE 2 ENDOLEAK. NOW, 1.5 YEARS LATER A TYPE 1A ENDOLEAK WITH OUTFLOW TO THE IMA (INFERIOR MESENTERIC ARTERY) WITH NO SAC GROWTH HAS BEEN IDENTIFIED. PATIENT IS STABLE AND THE PHYSICIAN IS PLANNING TO RE-INTERVENE. ADDITIONAL INFORMATION: THE PATIENT WAS TREATED WITH A VELA INFRARENAL STENT GRAFT EXTENSION AND PALMAZ (NON- ENDOLOGIX) STENT. IT WAS REPORTED THAT THERE WAS STILL A RESIDUAL ENDOLEAK DUE TO EXTREME CALCIFICATION IN THE AORTA. ANOTHER RE-INTERVENTION IS BEING PLANNED. THE FINAL PATIENT STATUS REMAINS STABLE.

  Patient problems: Aneurysm

  MAUDE report 10286425 ↗
• InjuryDec 13, 2019Material Puncture/Hole; Insufficient Device Problem Information; Material Puncture/Hole; 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 5.5 YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW UP, SAC GROWTH WITH TYPE 1A ENDOLEAK AND A POSSIBLE 3B OF THE PROXIMAL EXTENSION (SUPRARENAL STENT GRAFT) WAS REPORTED. A RE-INTERVENTION HAS BEEN SCHEDULED AND THE PATIENT WAS REPORTED AS DOING FINE. ADDITIONAL INFORMATION: A REINTERVENTION WAS COMPLETED WITH AN AFX BIFURCATED STENT AND OVATION IX LIMB EXTENSION ON (B)(6) 2019. THE FINAL PATIENT STATUS WAS REPORTED AS STABLE AND DISCHARGED HOME THE NEXT DAY.

  Patient problems: Aneurysm

  MAUDE report 9468380 ↗

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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-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-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-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL

…and 1 more.