Vela Proximal Endograft System A34-34/C100 VRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00818009013552), received between Jul 14, 2017 and Dec 30, 2024 — classified as 3 deaths, 23 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2024Off-Label Use; Material Puncture/Hole; Lack of Effect; Off-Label Use; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, SEPARATION OF THE SUPRARENAL EXTENSION FROM THE MAIN BODY WITH A TYPE IIIA ENDOLEAK WERE DETECTED BY ANGIOGRAM. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN INFRARENAL AFX DEVICE, AND NO DEVICES WERE EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO COMPLICATIONS. (REPORTED ON MFG#2031527-2018-00779). ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT CONFIRMING THE PRESENCE OF A TYPE IIIB ENDOLEAK WITH STENT CAGE DILATION OF THE MAIN BODY AND CUFF AT THE TIME OF THE EVENT. (REPORTED ON MFG#2031527-2018-00941). NOW, APPROXIMATELY SIX YEARS POST-SECONDARY PROCEDURE DURING A ROUTINE FOLLOW-UP, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED A POSSIBLE INDETERMINATE TYPE OF ENDOLEAK AND ADDITIONAL IMAGING IS REQUIRED. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Clinical Endoleak

  MAUDE report 21035946 ↗
• InjuryDec 9, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2009 WITH THE IMPLANT OF AN INTUITRAK BIFURCATED STENT GRAFT AND AN INTUITRAK INFRARENAL AORTIC EXTENSION. THE PATIENT WAS TREATED FOR A TYPE IA ENDOLEAK WITH LATERAL DISPLACEMENT ON (B)(6) 2017 WITH THE IMPLANT OF AN AFX VELA INFRARENAL, AN AFX VELA SUPRARENAL ND AN AFX LIMB STENT GRAFT. (REPORTED UNDER MFR# 2031527-2017-00456.) IT WAS REPORTED ON 25 NOVEMBER 2024, THAT THE PATIENT HAD BEEN LOST TO FOLLOW-UP AND THE ANEURYSM HAD ENLARGED TO 12CM, AND THERE WAS AN INDETERMINANT ENDOLEAK. REINTERVENTION WAS PERFORMED ON (B)(6) 2024 WITH THE IMPLANT OF TWO AFX VELA INFRARENAL, AN AFX VELA SUPRARENAL AND AN OVATION IX EXTENDER. AT REINTERVENTION IT WAS BELIEVED THAT THE INDETERMINANT ENDOLEAK WAS RESOLVED. HOWEVER, THE COMPUTED TOMOGRAPHY SCAN (B)(6) 2024 SHOWED A POSSIBILITY THAT THERE IS STILL AN INDETERMINANT ENDOLEAK. THE PATIENT WILL BE SENT TO ANOTHER PHYSICIAN FOR A SECOND OPINION. THE PATIENT S REPORTED TO BE DOING WELL.

  Patient problems: Aneurysm

  MAUDE report 20880769 ↗
• DeathJun 27, 2024Positioning Failure; Positioning Failure

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOTED THAT THE AFX VELA INFRARENAL REQUIRED REPOSITIONING, WHICH NECESSITATED THE REMOVAL OF THE ENTIRE SHEATH. AS THE VELA COULD NOT BE RE-SHEATHED BEFORE INSERTION INTO THE AORTA, A SECONDARY AFX VELA INFRARENAL WAS USED. THE PATIENT WAS REPORTED TO BE RECOVERING WELL POST-PROCEDURE. IT WAS REPORTED THAT THE FAMILY WITHDREW CARE FOR AN UNKNOWN REASON AND THE PATIENT PASSED AWAY ON (B)(6) 2024.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Renal Failure

  MAUDE report 19624577 ↗
• InjuryMar 27, 2024Off-Label Use; Migration; Lack of Effect; Off-Label Use; Migration; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT, AFX VELA INFRARENAL, AND AN OVATION IX ILIAC LIMB ON (B)(6) 2017. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM PER THE INSTRUCTIONS FOR USE (IFU). APPROXIMATELY 3.5 YEARS POST-INITIAL PROCEDURE, DURING A ROUTINE FOLLOW-UP (CTA) COMPUTED TOMOGRAPHY ANGIOGRAPHY, THE PATIENT WAS IDENTIFIED WITH A TYPE 1A ENDOLEAK. REINTERVENTION WAS NOT REPORTED TO ENDOLOGIX (PREVIOUSLY REPORTED UNDER MFR#2031527-2021-00233). DURING A ROUTINE FOLLOW-UP ON (B)(6) 2024, A TYPE 1A ENDOLEAK WAS IDENTIFIED DUE TO THE PROXIMAL EXTENSION FALLING OUT OF THE NECK. ON (B)(6) 2024, THE PATIENT UNDERWENT A RE-INTERVENTION WHERE THE PHYSICIAN IMPLANTED TWO (2) AFX VELA INFRARENALS, TWO (2) AFX VELA SUPRARENALS, AND AN OVATION IX EXTENDER. THE FINAL PATIENT STATUS REMAINS UNKNOWN. THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18986336 ↗
• InjuryMay 9, 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 ON (B)(6)2017. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IIIA ENDOLEAK (AND COMPLETE COMPONENT SEPARATION), A NON-DEVICE-RELATED TYPE II ENDOLEAK (OF THE INTERNAL MESENTERIC ARTERY), SIGNIFICANT ANEURYSM SAC ENLARGEMENT (OF 17.5MM) AND A TYPE IIIB ENDOLEAK OF THE BIFURCATED STENT GRAFT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) AFX VELA INFRARENAL ON (B)(6) 2023. REFERENCE MFR. REPORT # 2031527-2023-00062. NOW APPROXIMATELY FIFTEEN (15) DAYS POST-SECONDARY INTERVENTION, THE PATIENT PRESENTED WITH AN ISCHEMIC LEFT LEG DUE TO THE PERCLOSE (NON-ENDOLOGIX) DEVICE PINCHING OFF THE COMMON FEMORAL ARTERY, AND AN UNRESOLVED TYPE IIIA ENDOLEAK. THE PHYSICIAN IMPLANTED ONE (1) AFX VELA INFRARENAL ON (B)(6)2023, AND THE ENDOLEAK WAS CONFIRMED RESOLVED AND FLOW RESTORED TO THE PATIENT'S LEFT LEG.

  Patient problems: Clinical Endoleak

  MAUDE report 16896793 ↗
• InjuryApr 13, 2023Unintended Movement; Lack of Effect; Unintended Movement; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (2) TWO YEARS POST INITIAL PROCEDURE A TYPE 1A ENDOLEAK WAS IDENTIFIED. AS A RESULT, THE PHYSICIAN INTENDS TO PERFORM A RE-INTERVENTION. ADDITIONAL INFORMATION: THE PATIENT UNDERWENT A RE-INTERVENTION IN WHICH THE DOCTOR IMPLANTED AN AFX VELA SUPRARENAL. THE FINAL PATIENT STATUS WAS REPORTED AS DISCHARGED HOME ON POSTOPERATIVE DAY ONE. A CLINICAL EVALUATION ALSO SHOWS REASONABLE EVIDENCE TO SUGGEST AN ANEURYSM ENLARGEMENT OF 9.6 MM, A TYPE II ENDOLEAK (NON¿DEVICE RELATED FAILURE), AND MOVEMENT OF THE INFRARENAL PROXIMAL EXTENSION ALSO OCCURRED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16733314 ↗
• InjuryJul 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO AND A HALF (2.5) MONTHS POST-INITIAL PROCEDURE, THE PATIENT WAS ADMITTED TO AN UNKNOWN HOSPITAL DUE TO A FEVER AND ABDOMINAL PAIN. AROUND ONE (1) MONTH POST-ADMISSION, THE PATIENT WAS TRANSFERRED TO THE HOSPITAL WHERE THE INDEX PROCEDURE HAD BEEN PERFORMED (THE EXACT DATE IS UNKNOWN). ON (B)(6) 2022, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. A COMPUTERIZED TOMOGRAPHY WAS DONE AND IDENTIFIED AN AORTIC RUPTURE AROUND THE PROXIMAL NECK (NON-ANEURYSM RUPTURE). THERE WAS NO ENDOLEAK OBSERVED. REPORTEDLY, THE BIFURCATED STENT GRAFT AND SUPRARENAL EXTENSION MORPHOLOGY HAD CHANGED SINCE THE INITIAL IMPLANT, AND THE PATIENT HAS BEEN TAKING STEROIDS FOR AN UNKNOWN REASON. ON (B)(6) 2022, REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF THREE (3) GORE (NON-ENDOLOGIX) EXCLUDERS AND ONE (1) GORE (NON-ENDOLOGIX) C-TAG. THE PATIENT¿S STATUS POST-REINTERVENTION IS UNKNOWN.

  Patient problems: Abdominal Pain; Failure of Implant; Rupture

  MAUDE report 15017620 ↗
• InjuryJun 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL, AN AFX LIMB STENT GRAFT, AND AN OVATION IX EXTENDER. THIS 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 (4) MONTHS POST-INITIAL PROCEDURE, A NON-DEVICE RELATED REINTERVENTION WAS PERFORMED WITH THE IMPLANT OF THREE (3) OVATION IX ILIAC LIMBS. APPROXIMATELY SEVEN (7) MONTHS LATER, A NON-DEVICE RELATED REINTERVENTION WAS PERFORMED WITH THE IMPLANT OF AN OVATION IX ILIAC LIMB AND AN AFX LIMB STENT GRAFT. APPROXIMATELY THREE (3) MONTHS LATER, A NON-DEVICE RELATED REINTERVENTION WAS PERFORMED WITH THE IMPLANT OF AN AFX LIMB STENT GRAFT AND TWO (2) OVATION IX ILIAC LIMBS. NOW, APPROXIMATELY ONE (1) YEAR LATER, A POSSIBLE TYPE IA ENDOLEAK WAS IDENTIFIED AT ROUTINE FOLLOW-UP. REPORTEDLY, THE PHYSICIAN PLANNED TO TREAT THE PATIENT WITH A NON-ENDOLOGIX DEVICE ON 06/13/2022. IT IS UNKNOWN IF THE REINTERVENTION TOOK PLACE. THE PATIENT STATUS IS NOT KNOWN.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 14780333 ↗
• InjuryMay 10, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY, 1 MONTH POST INITIAL PROCEDURE A COMPUTED TOMOGRAPHY (CT) IDENTIFIED A 1A ENDOLEAK. PHYSICIAN ELECTED TO TREAT THE PATIENT WITH A MEDTRONIC (NON-ENDOLOGIX) AORTIC CUFF. NOTE: THIS EVENT IS FOR THE TYPE 1A ENDOLEAK RE-INTERVENTION WHICH WAS DISCOVERED DURING A RECENT REPORTED EVENT FOR A TYPE 3A ENDOLEAK WITH SEPARATION OF THE VELA INFRARENAL AND THE MEDTRONIC (NON-ENDOLOGIX) AORTIC CUFF. THE EVENT FOR THE 3A ENDOLEAK WILL BE REPORTED UNDER A SEPARATE REPORT.

  Patient problems: Failure of Implant

  MAUDE report 14347216 ↗
• InjuryApr 18, 2022Off-Label Use; Unintended Movement; Migration; Off-Label Use; Unintended Movement; Migration

  CLARIFICATION: THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) AFX VELA INFRARENAL PROXIMAL EXTENSIONS. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IIIB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT AND VELA INFRARENAL ON (B)(6) 2022 (QUATERNARY INTERVENTION). THE ENDOLEAK WAS SUCCESSFULLY RESOLVED, AND THE PATIENT WAS REPORTEDLY IN STABLE CONDITION. THIS EVENT WAS PREVIOUSLY REPORTED PER MFR. REPORT # 2031527-2022-00047. DURING CLINICAL ASSESSMENT TO THE PREVIOUS EVENT, THE FOLLOWING ADDITIONAL FINDING WAS DISCOVERED: FIRST INFRARENAL STENT MOVEMENT (OF 9.2MM) AND AN ENDOLEAK (OF INDETERMINATE ORIGIN) AT THE SECOND INFRARENAL STENT, JUST BELOW THE SUPERIOR STENT MARGIN. THE PHYSICIAN TREATED BY IMPLANTING A NON-ENDOLOGIX SUPRARENAL DEVICE AND BILATERAL RENAL SNORKELS ON 12 JULY 2019 (SECONDARY INTERVENTION). THIS MDR (MEDICAL DEVICE REPORT) IS TO ADDRESS THIS EVENT OF STENT MOVEMENT AND ENDOLEAK AT INDETERMINATE ORIGIN. IN ADDITION, A DELAYED TYPE II ENDOLEAK OF THE LUMBAR ARTERY (NON-DEVICE-RE

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14137565 ↗
• InjuryOct 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND TWO (2) VELA INFRARENAL AORTIC EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, DURING A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN A TYPE 1A ENDOLEAK AND ANEURYSM ENLARGEMENT WERE IDENTIFIED. THE PATIENT IS CURRENTLY BEING MONITORED AND WAS REPORTED THAT THE PATENT IS NO LONGER SYMPTOMATIC. AS OF NOW, THERE ARE NO PLANS FOR RE-INTERVENTION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12569151 ↗
• DeathJun 15, 2021Material Puncture/Hole; Insufficient Device Problem Information; Material Puncture/Hole; Insufficient Device Problem Information

  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 STENT GRAFT. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL DUE TO A TYPE 3A ENDOLEAK. A RE-INTERVENTION WAS COMPLETED THE FOLLOWING DAY. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL AFX VELA INFRARENAL STENT GRAFT AT THE SEPARATION HOWEVER THE PROXIMAL EDGE OF THE NEW VELA DID NOT FULLY APPOSE; THEREFORE, AN ADDITIONAL NON-ENDOLOGIX STENT GRAFT (EXCLUDER) WAS IMPLANTED WITH SUCCESS. THE PATIENT WAS STABLE POST-PROCEDURE (MFR REPORT# 2031527-2020-00148). APPROXIMATELY (1) ONE YEAR POST-RE-INTERVENTION THE PATIENT ENTERED INTO A SHOCK STATE RESULTING FROM A TYPE 3A ENDOLEAK. AN (EVAR) ENDOVASCULAR ANEURYSM REPAIR WAS PERFORMED AND A NON-ENDOLOGIX STENT GRAFT (EXCLUDER) PROXIMAL EXTENSION WAS ADDITIONALLY ADDED TO THE INSIDE OF THE EXISTING STENT-GRAFTS, THERE WAS NO INCREASE IN THE BLOOD PRESSURE AND THE PATIENT¿S CONDITION DID NOT IMPROVE WITH THEM REMAINING IN A SHOCK STATE. THE PATIENT EXPIRED ON THE SAME DAY.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12002866 ↗
• InjuryJun 10, 2021Device-Device Incompatibility; Insufficient Device Problem Information; Device-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL STENT GRAFT EXTENSION AND AN OVATION IX ILIAC LIMB TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS CASE IS OUTSIDE THE INDICATIONS OF USE DUE TO THE USE OF AFX WITH OVATION DEVICES. APPROXIMATELY 3.5 YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW UP (CTA) COMPUTED TOMOGRAPHY ANGIOGRAPHY, THE PATIENT WAS IDENTIFIED WITH A TYPE 1A ENDOLEAK. A RE-INTERVENTION IS BEING DISCUSSED AND THE PATIENT IS STABLE AND BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 11972261 ↗
• InjuryJun 7, 2021Material Puncture/Hole; Device-Device Incompatibility; Material Puncture/Hole; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX VELA INFRARENAL; THIS INITIAL IMPLANT IS OUTSIDE THE INDICATIONS OF USE DUE TO THE ABSENCE OF A BIFURCATED STENT GRAFT. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A POSSIBLE FABRIC TEAR (CLASSIFIED AS A TYPE IIIB ENDOLEAK). THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. PATIENT IS REPORTEDLY DOING WELL. ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT INDICATING A SECONDARY ENDOVASCULAR PROCEDURE WAS COMPLETED SOMETIME BETWEEN (B)(6) 2020 AND (B)(6) 2021 WHERE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A NON-ENDOLOGIX STENT PROXIMALLY NEAR SNORKELS.

  Patient problems: Failure of Implant

  MAUDE report 11948041 ↗
• InjuryAug 10, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4 YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW-UP IT WAS IDENTIFIED THAT THE PROXIMAL COMPONENT HAD MIGRATED WITH A TYPE IA ENDOLEAK. SUCCESSFUL RE-INTERVENTION WAS COMPLETED WITH IMPLANT OF TWO AFX VELA SUPRARENAL¿S. THE PATIENT WAS REPORTED TO BE WELL.

  Patient problems: Failure of Implant

  MAUDE report 10389057 ↗
• InjuryNov 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3.5 YEARS POST INITIAL PROCEDURE, A TYPE 1A ENDOLEAK WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN IMPLANTED ANOTHER INFRARENAL STENT GRAFT EXTENSION, A NON- ENDOLOGIX (MEDTRONIC VALIANT THORACIC) STENT AND A NON- ENDOLOGIX (APTUS) ANCHORS BUT THERE WAS STILL A LARGE TYPE 1A ENDOLEAK. THE PHYSICIAN THEN IMPLANTED A NON- ENDOLOGIX (VALIANT) STENT TO RESOLVE THIS ENDOLEAK. PATIENT WAS REPORTED AS DOING WELL POST PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 9342869 ↗
• InjurySep 30, 2019Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  THE PATIENT WAS TREATED WITH A (NON-ENDOLOGIX) OPEN PROSTHESIS FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) MORE THAN 10 YEARS AGO. AT THE INITIAL IMPLANT, A SUTURE SUFFICIENCY AND PROXIMAL BROADENING WERE PROVIDED WITH TWO (2) AFX INFRARENAL STENT GRAFT EXTENSIONS USING THE CHIMNEY STRATEGY; THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL). APPROXIMATELY EIGHT (8) MONTHS (EXACT DATE NOT PROVIDED) POST INITIAL IMPLANT, A TYPE IA ENDOLEAK WAS REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED CONFIRMING THE PHYSICIAN COMPLETED A SUCCESSFUL RE-INTERVENTION WITH A TWO (2) WAY CHIMNEY CONSTRUCTION AND AN ADDITIONAL VELA INFRARENAL STENT GRAFT.

  Patient problems: Failure of Implant

  MAUDE report 9136972 ↗
• InjuryMay 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A TYPE 1A ENDOLEAK WAS IDENTIFIED WITH COMPUTERIZED TOMOGRAPHY (CT) SCAN. A INTERVENTION IS BEING DISCUSSED AND THE PATIENT IS REPORTED TO BE DOING WELL. ADDITIONAL INFORMATION RECEIVED; AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT A SUPRARENAL STENT GRAFT EXTENSION TO TREAT THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 8621457 ↗
• DeathApr 3, 2019Improper or Incorrect Procedure or Method; Separation Problem; Improper or Incorrect Procedure or Method; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND TWO (2) SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE WAS IDENTIFIED AS OUTSIDE THE INDICATIONS FOR USE (OFF-LABEL) DUE TO THE BILATERAL RENAL ARTERY SNORKEL PROCEDURE. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WITH SEPARATION OF THE PROXIMAL AORTIC EXTENSION AND THE BIFURCATED STENT GRAFT AND SAC GROWTH WERE IDENTIFIED. (THIS EVENT WAS PREVIOUSLY REPORT UNDER 2031527-2017-00424). THE PHYSICIAN ELECTED TO IMPLANT TWO (2) INFRARENAL STENT GRAFT EXTENSION TO RESOLVE THIS EVENT. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS REPORTED AS DOING WELL. NOW APPROXIMATELY 1.5 YEARS POST-SECONDARY PROCEDURE THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH A RUPTURED AORTA. ANOTHER 3A ENDOLEAK WITH MULTIPLE DEVICE SEPARATION WERE IDENTIFIED. ANOTHER INTERVENTION WAS PERFORMED. DURING THE PROCEDURE, IT WAS REPORTED THAT IT WAS DIFFICULT TO TRACK A SHEATH, DEPLOY THE INFRARENAL STENT GRAFT AND REMOVE THE DELIVERY SYSTEM DUE TO ANGULATION AND MULTIPLE DEVICE SEPARATIONS. THE PROCEDURE WAS COMPLETED AND AN ANOTHER INFRARENAL STENT GRAFT

  Patient problems: Death; Rupture

  MAUDE report 8479943 ↗
• InjuryDec 13, 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 CONFIRMING THAT THE PHYSICIAN IS UNRESPONSIVE REGARDING POSSIBLE TREATMENT FOR THE REPORTED ENDOLEAK. CLINICAL ASSESSMENT CONFIRMED A TYPE II ENDOLEAK WAS ALSO PRESENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Failure of Implant

  MAUDE report 8160571 ↗
• InjuryNov 9, 2018Loss of or Failure to Bond; Leak/Splash; Loss of or Failure to Bond; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED DURING CLINICAL ASSESSMENT REPORTED NEW EVENTS OF A VELA TYPE 1A ENDOLEAK AND STENT CAGE DILATION. THERE WAS A TYPE IA ENDOLEAK, AND A TYPE IIIB ENDOLEAK WITH COMPLETE STENT BUCKLING OF THE MAIN BODY STENT. THIS COMPLAINT IS MOST LIKELY DEVICE RELATED. NO PROCEDURE RELATED HARMS WERE DETECTED. REFERENCE MDR # 2031527-2018-00711.

  Patient problems: Failure of Implant

  MAUDE report 8057797 ↗
• InjuryNov 9, 2018Leak/Splash; Leak/Splash

  THE PRIMARY PROCEDURE WAS PERFORMED ON (B)(6) 2012, AND THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND AN AFX SUPRARENAL AORTIC EXTENSION. AT IMPLANT BILATERAL COMMON FEMORAL ARTERY ENDARTERECTOMIES AND PATCH ANGIOPLASTIES WERE DONE AND THERE WAS A DISSECTION OF THE RIGHT COMMON ILIAC ARTERY. ON POST-OPERATIVE DAY ONE ((B)(6) 2012), THERE WAS WOUND DEHISCENCE WITH SKIN NECROSIS REQUIRING A SURGICAL DEBRIDEMENT. ALSO DUE TO SWELLING OF THE MUSCLE A FASCIAL RELEASE. COMPUTED TOMOGRAPHY ON (B)(6) 2016, INDICATED THE FABRIC WAS COMPROMISED AND DEVICE SEPARATION RESULTING IN A TYPE 3B ENDOLEAK WITH STENT FULLY EXPANDED AND A TYPE 3A ENDOLEAK WITH THE MAIN BODY SEPARATED FROM THE SUPRARENAL. ON (B)(6) 2016, THE DEVICES WERE RELINED WITH TWO AFX VELA INFRARENAL AORTIC EXTENSIONS AND AN AFX VELA SUPRARENAL AORTIC EXTENSION TO RE-LINE AND SEAL CORRECTING THE ISSUE. THE PROCEDURE WENT WELL AND THE PATIENT WAS IN STABLE CONDITION. ON (B)(6) 2018, THE PATIENT THAT HAS PRESENTED WITH ABDOMINAL PAIN, A CONTAINED RUPTURE AND A TYPE 3B ENDOLEAK. ON (B)(6) 2018, THIS WAS TREATED WITH IMPLANT OF AFX2 BIFURCATED STENT GRAFT. ENDOLOGIX CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EV

  Patient problems: Failure of Implant; Perforation of Vessels

  MAUDE report 8055842 ↗
• InjuryOct 24, 2018Loss of or Failure to Bond; Leak/Splash; Unintended Movement; Loss of or Failure to Bond; Leak/Splash; Unintended Movement

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX DEVICE IN 2014. DURING THE INVESTIGATION OF (B)(4) IT WAS DISCOVERED THAT APPROXIMATELY 2 YEARS POST IMPLANT, THE PATIENT UNDERWENT A PROCEDURE TO PLACE A VELA SUPRARENAL CUFF FOR A POSSIBLE MIGRATION AND TYPE 1A ENDOLEAK. AS OF THE DATE OF THIS REPORT THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. THE PATIENT STATUS IS UNKNOWN AND NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS CASE IN 2016.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8001355 ↗
• InjuryApr 30, 2018Failure To Adhere Or Bond; Leak/Splash; Occlusion Within Device; Failure To Adhere Or Bond; Leak/Splash; Occlusion Within Device

  THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA INFRARENAL ON (B)(6) 2014. A FOLLOW-UP CT SCAN DETECTED OCCLUSION OF THE PROXIMAL EXTENSION AND A SMALL FLOW LUMEN GOING BEHIND THE OCCLUDED PROXIMAL EXTENSION AND FLOWING BACK INTO THE MAIN BODY, PERFUSING THE LOWER EXTREMITIES; THIS IS CATEGORIZED AS AN ENDOLEAK FROM AN INDETERMINATE ORIGIN. THE PHYSICIAN HAS ELECTED TO TREAT THE PATIENT BY MECHANICAL THROMBECTOMY OF THE EXTENSION AND ADDITION OF A PROXIMAL EXTENSION, WITH RE-INTERVENTION SCHEDULED FOR (B)(6) 2018. THE PATIENT IS CURRENTLY REPORTED TO BE STABLE AND ASYMPTOMATIC.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7473475 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AN UNKNOWN DATE, THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH A VENTANA. ON (B)(6) 2015, THE VENTANA WAS PROACTIVELY RE-LINED WITH AN AFX VELA INFRARENAL. ON (B)(6) 2017, AN ADDITIONAL PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON. AT THIS PROCEDURE A AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 7443801 ↗

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-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-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-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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• 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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• Z-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL

…and 1 more.