AFX2 Bifurcated Endograft System BEA25-100/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00818009014726), received between Sep 28, 2016 and Feb 25, 2026 — classified as 3 deaths, 59 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (18 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 62 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Material Puncture/Hole; Deformation Due to Compressive Stress

  THE PATIENT WAS TREATED FOR A FUSIFORM ANEURYSM WITH A REVERSED AORTIC CURVATURE ON (B)(6) 2020 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG). THE AFX2 BSG WAS DEPLOYED VIA A LEFT APPROACH. PROGRESSIVE SAC GROWTH WAS OBSERVED ON (B)(6) 2026, WITH ANEURYSM EXPANSION OF 8MM WITHIN THE LAST SIX MONTHS. A DIAGNOSTIC ANGIOGRAPHY WAS PERFORMED; HOWEVER, IT WAS NOT POSSIBLE TO DEFINITIVELY DISTINGUISH BETWEEN A TYPE IA OR TYPE IIIB ENDOLEAK. REPORTEDLY, THE PHYSICIAN HIGHLY SUSPECTED A TYPE IIIB ENDOLEAK. REINTERVENTION WAS COMPLETED ON (B)(6) 2026 IN WHICH THE PHYSICIAN ELECTED TO RELINE THE EXISTING AFX2 BSG WITH A GORE (NON-ENDOLOGIX) EXCLUDER. AFTER CONFIRMING NO ABNORMALITIES, THE PROCEDURE WAS COMPLETED. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 24448112 ↗
• DeathDec 9, 2025Separation Problem; Separation Problem

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT SYSTEM AND AN AFX VELA SUPRARENAL EXTENSION FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2016. ON (B)(6) 2025, THE PATIENT PRESENTED WITH A TYPE IIIA ENDOLEAK BETWEEN THE AFX2 BIFURCATED STENT GRAFT AND VELA SUPRARENAL EXTENSION. THE PHYSICIAN ELECTED TO IMPLANT AN AFX VELA INFRARENAL AORTIC CUFF AND THE TYPE IIIA ENDOLEAK WAS RESOLVED. THE PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Aneurysm; Clinical Endoleak; Hemorrhage/Blood Loss/Bleeding; Renal Failure; Ruptured Aneurysm

  MAUDE report 23761197 ↗
• InjuryMay 30, 2025Break; Break

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THIS INITIAL PROCEDURE, THERE WAS AN ISSUE WITH THE TIP OF THE AFX2 BIFURCATED STENT GRAFT CONTRALATERAL LIMB SNAREABLE WIRE. IT WAS NOTED THAT THE WIRE MAY HAVE GOT HUNG UP ON THE TIP OF THE 7FR SHEATH AND THE WIRE STARTED TO UNRAVEL WHEN THE PHYSICIAN HAD TO USE EXTRA FORCE TO PULL IT INTO THE SHEATH. AFTER SUCCESSFULLY SNARING THE WIRE, THE PHYSICIAN PULLED ON THE CONTRALATERAL LIMB WIRE AND THE FLOPPY PORTION STARTED TO UNRAVEL. AN ATTEMPT TO PRESERVE THE WIRE WAS MADE, BUT WAS UNSUCCESSFUL AND ULTIMATELY THE DELIVERY SYSTEM OF THE AFX2 WAS REMOVED AND REPLACED WITH ANOTHER AFX2. THE DEVICE THAT BROKE WAS NOT ABLE TO BE REMOVED FROM THE HOSPITAL. THERE WAS NO CLINICAL OR PATIENT HARM INVOLVED WITH THE ISSUE AND THE PATIENT WAS SUCCESSFULLY TREATED. SUBSEQUENT TO THE INITIAL EVENT USER MEDWATCH MW5170279 WAS RECEIVED ON 23 MAY 2025. ROUTINE FOLLOW-UP COMPUTED TOMOGRAPHY SCAN IDENTIFIED THAT A SMALL PORTION OF THE SEPARATED CONTRALATERAL LIMB SNAREABLE WIRE REMAINED IN THE PATIENT WITH THE PROXIMAL END BETWEEN THE ENDOGRAFT AND THE AORTIC WALL AND THE DISTAL END IN TH

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119482 ↗
• InjuryApr 4, 2025Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  THE PATIENT WAS BEING TREATED FOR ENDOVASCULAR REPAIR (EVAR) ON (B)(6) 2025 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG). AN AFX SHEATH WAS INSERTED THROUGH THE RIGHT FEMORAL APPROACH. THE AFX SHEATH TIP MARKER WAS POSITIONED SLIGHTLY PROXIMAL TO THE AORTIC BIFURCATION. THE CONTRALATERAL WIRE OF THE AFX2 BSG WAS INSERTED INTO AN AFX SHEATH. AN ATTEMPT WAS MADE TO SNARE THE CONTRALATERAL WIRE NEAR THE AORTIC BIFURCATION BY USING A SNARE CATHETER, BUT IT WAS UNSUCCESSFUL. THE POSITION OF THE SNARE CATHETER WAS ADJUSTED, AND ANOTHER ATTEMPT WAS MADE, BUT IT WAS STILL UNSUCCESSFUL. AFTER THE SNARE CATHETER WAS ADVANCED TO THE UPPER SECTION OF THE ANEURYSM, THE WIRE WAS ABLE TO BE SNARED. AFTER ENSURING THAT THE TIP OF THE AFX2 BSG WAS LOCATED PROXIMALLY TO THE AORTIC BIFURCATION, THE DIRECTION OF THE CONTRALATERAL WIRE WAS CHECKED. THE CONTRALATERAL WIRE WAS ENTANGLED WITH THE DELIVERY SYSTEM; THEREFORE, THE ENTIRE DEVICE WAS ROTATED TO REMOVE THE ENTANGLEMENT. THE INNER CORE WAS ADVANCED, AND THE AFX2 BSG WAS RELEASED FROM THE SHEATH. THE WIRE WAS STILL ENTANGLED; THEREFORE, THE INNER CORE WAS ROTATED WHILE THE SHEATH WAS FIXED IN AN ATTEMPT TO REMOVE THE ENTANGLEMENT. HOW

  Patient problems: Ischemia

  MAUDE report 21773853 ↗
• InjuryJul 1, 2024Off-Label Use; Material Puncture/Hole; Device-Device Incompatibility; Off-Label Use; Material Puncture/Hole; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AFX LIMB STENT GRAFT, AFX VELA SUPRARENAL, AND AN OVATION IX EXTENDER ON (B)(6) 2023, TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE WAS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM PER THE IFU. ON (B)(6) 2024, DURING A ROUTINE FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT WAS IDENTIFIED WITH AN ENDOLEAK TYPE IIIB. THE PATIENT IS CURRENTLY IN STABLE CONDITION PENDING A RE-INTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19651900 ↗
• InjuryApr 18, 2024Lack of Effect; Lack of Effect

  MW5152915 WAS RECEIVED ON (B)(6) 2024, REPORTING THAT THE PATIENT HAD AN AFX2 BIFURCATED STENT GRAFT IMPLANTED AND ON (B)(6) 2024 IT WAS DISCOVERED THAT THERE WAS AN INDETERMINATE ENDOLEAK. REPORTEDLY, THE PATIENT IS BEING REFERRED TO A SURGEON TO HAVE THE AFX2 BIFURCATED STENT GRAFT REPAIRED.

  Patient problems: Clinical Endoleak

  MAUDE report 19134661 ↗
• InjuryMar 21, 2024Material Puncture/Hole; Lack of Effect; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL ON (B)(6), 2019. IT WAS REPORTED ON (B)(6), 2024, THAT THE PATIENT WAS IDENTIFIED WITH AN ENDOLEAK (INDETERMINATE ORIGIN), POTENTIALLY TYPE 2, TYPE 3A, OR TYPE 3B ENDOLEAK. THIS OBSERVATION WAS MADE DURING A REVIEW OF THE PATIENT'S COMPUTED TOMOGRAPHY (CT) SCAN ON (B)(6), 2024. THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18952430 ↗
• InjuryNov 17, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2018 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. ROUTINE FOLLOW-UP PERFORMED ON (B)(6) 2023 IDENTIFIED THAT THE ANEURYSM SAC CONTINUES TO GROW. REINTERVENTION TO RELINE THE INITIALLY IMPLANTED DEVICES IS SCHEDULED FOR (B)(6) 2023. THE PATIENT IS REPORTED TO BE FINE. REINTERVENTION HAS BEEN CANCELLED AS THE PATIENT IS HAVING BRAIN SURGERY.

  Patient problems: Aneurysm

  MAUDE report 18163449 ↗
• InjuryOct 20, 2023Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Lack of Effect; Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL, AN AFX VELA SUPRARENAL PROXIMAL EXTENSION AND AN OVATION IX EXTENDER DISTAL EXTENSION. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM PER DEVICE IFU. APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK (FROM THE DISTAL AORTA AND RIGHT COMMON ILIAC) AS DETECTED PER CT (COMPUTED TOMOGRAPHY) SCAN. REPORTEDLY, THE PATIENT IS ASYMPTOMATIC AND THE PHYSICIAN PLANS TO RE-INTERVENE. REINTERVENTION WAS COMPLETED ON (B)(6) 2023 WITH THE IMPLANT OF AN OVATION IX EXTENDER AND AN AFX LIMB STENT GRAFT. THE TYPE IB ENDOLEAK WAS SUCCESSFULLY TREATED. THE PATIENT WAS REPORTED TO BE DOING WELL POST REPAIR.

  Patient problems: Clinical Endoleak

  MAUDE report 17975377 ↗
• InjurySep 15, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND THE DECISION WAS MADE TO PERFORM COMPUTED TOMOGRAPHY (CT) SCAN. NO INTERVENTION WAS PERFORMED; HOWEVER, FIVE (5) DAYS LATER AN OPEN SURGICAL PROCEDURE WAS PERFORMED. THE OPEN SURGERY CONFIRMED THERE WERE FOUR (4) HOLES IN THE STENT GRAFT WHICH ARE CATEGORIZED AS TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO PLUG EACH HOLE WITH FELT BANDS. ADDITIONALLY, A TYPE 2 ENDOLEAK FROM INFERIOR MESENTERIC ARTERY (IMA) WAS OBSERVED, THEREFORE, THE IMA WAS SURGICALLY CLOSED WITH A CLIP. THE PATIENT WAS REPORTED AS STABLE POST THIS SECONDARY PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 17760426 ↗
• InjurySep 14, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS AFTER POST INITIAL PROCEDURE, THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFT DUE TO SAC ENLARGEMENT. THE PHYSICIAN REMOVED THE DEVICE ON (B)(6) 2023, AND IT WAS REPORTED THAT THE PATIENT IS CURRENTLY IN GOOD HEALTH WITH NO COMPLICATIONS.

  Patient problems: Aneurysm

  MAUDE report 17745955 ↗
• InjuryJul 14, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED AAA DUE TO A TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFT AND IT WAS NOTED THAT THERE WAS A TYPE 3B ENDOLEAK DESCRIBED AS A HOLE IN THE GRAFT CLOSE TO THE BIFURCATION. THE PATIENT STATUS WAS REPORTED AS STABLE POST THE EXPLANT PROCEDURE. THE EXPLANTED STENT GRAFT WAS RETURNED. ADDITIONAL INFORMATION: AN INTERNAL CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST ANEURYSM ENLARGEMENT OF 11.9MM OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE ANEURYSM ENLARGEMENT WAS DISCOVERED DURING REVIEW OF CT SCANS LABELED PRE AND 3 YEARS POST.

  Patient problems: Aneurysm; Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 17330285 ↗
• InjuryJun 14, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS AFTER POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW-UP, AN INCREASE IN THE ABDOMINAL AORTIC ANEURYSM (AAA) AND A POSSIBLE TYPE 3A ENDOLEAK IN THE DISTAL PART OF THE MAIN BODY WAS IDENTIFIED. THE PATIENT WAS ALSO COMPLAINING OF SOME BELLY PAIN. A RE-INTERVENTION WAS DONE AND THE PHYSICIAN IMPLANTED TWO (2) OVATION IX ILIAC LIMBS, OVATION PRIME FILL POLYMER, AND AN ALTO MAIN BODY. THE FINAL PATIENT STATUS REMAINS UNKNOWN.

  Patient problems: Abdominal Pain; Aneurysm; Clinical Endoleak

  MAUDE report 17125733 ↗
• InjuryNov 2, 2022Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, AN INFRARENAL AORTIC EXTENSION AND AN OVATION IX ILIAC LIMB TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH DISSECTION. 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 THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP A POSSIBLE TYPE 3B ENDOLEAK WAS IDENTIFIED. IT WAS ALSO REPORTED THAT THE RIGHT HYPOGASTRIC ARTERY COMMUNICATES WITH THE FALSE LUMEN. THE PATIENT IS STABLE AND IS ASYMPTOMATIC AND IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Failure of Implant

  MAUDE report 15715952 ↗
• DeathJul 29, 2022Difficult to Remove; Device-Device Incompatibility; Device Dislodged or Dislocated; Physical Resistance/Sticking; Difficult to Remove; Device-Device Incompatibility; Device Dislodged or Dislocated; Physical Resistance/Sticking

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT VELA INFRARENAL EXTENSION, A NON-ENDOLOGIX CUFF AND A NON-ENDOLOGIX BARE METAL STENT (OFF-LABEL) TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THE CONTRALATERAL LEG DEPLOYMENT OF THE BIFURCATED STENT GRAFT, THE CONTRALATERAL WIRE WAS PULLED TOO STRONGLY CAUSING THE DEVICE TO MOVE TOWARDS THE CONTRALATERAL LEG. DURING THE AFX VELA INFRARENAL DELIVERY SYSTEM RETRIEVAL, THE SYSTEM BECAME STUCK AT THE STENT GRAFT SKELETON CAUSING THE STENT DEFORMATION AROUND THE THORACIC AORTA. THE RESISTANCE WAS FELT TWICE DURING THE AFX VELA INFRARENAL DELIVERY SYSTEM RETRIEVAL. A BALLOON WAS INSERTED FROM THE CONTRALATERAL SIDE AND THE DELIVERY SYSTEM WAS RETRIEVED WITH BALLOONING. THE AFX VELA INFRARENAL WAS MOVED DOWNWARD ABOUT 20MM DURING THE DELIVERY SYSTEM RETRIEVAL; THEREFORE, A GORE (NON-ENDOLOGIX) CUFF WAS IMPLANTED AT THE PROXIMAL PORTION. REPORTEDLY, THE PATIENT¿S VESSEL CONDITION AND BOTH EXTERNAL ILIAC ARTERIES WERE NOT IN GOOD CONDITION WITH DISSECTIONS AND THROMBOSIS. THE ANGIOGRAPHY SHOWED NO ENDOLEAK AND THE OPERATION WAS COMPLETED. REPORTEDLY, THE PATIENT DIED 2 DAYS POST INITIAL PROCEDURE DUE TO MULTIPLE ORGAN

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 15133410 ↗
• InjuryJun 15, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND (3) SUPRARENAL STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 6 YEARS POST INITIAL PROCEDURE, PATIENT PRESENTED WITH ANEURYSM GROWTH AND A TYPE 3B ENDOLEAK. THE PATIENT WAS RELINED WITH A BIFURCATED STENT GRAFT AND (2) SUPRARENAL STENT GRAFT EXTENSIONS. THE PATIENT WAS REPORTED AS STABLE AFTER THE RELINE AND WAS DISCHARGED HOME.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14698170 ↗
• InjuryMar 8, 2022Material Puncture/Hole; Deformation Due to Compressive Stress; Appropriate Device Problem Term/Code Not Available; Material Puncture/Hole; Deformation Due to Compressive Stress; 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. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, PATIENT PRESENTED WITH A TYPE IA ENDOLEAK AND ANEURYSM SAC GROWTH (OF 2MM) AT ROUTINE FOLLOW-UP. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN AFX VELA SUPRARENAL ON (B)(6) 2020. THIS EVENT WAS PREVIOUSLY REPORTED PER MFR. REPORT # 2031527-2020-00384. ONE YEAR AND A HALF (1.5) POST SECONDARY ENDOVASCULAR PROCEDURE, THE PATIENT PRESENTED WITH A POSSIBLE ENDOLEAK (AT AN INDETERMINATE ORIGIN) PER CT (COMPUTED TOMOGRAPHY) SCAN AT ROUTINE FOLLOW-UP. THE PATIENT'S CURRENT CONDITION IS UNKNOWN, AND IT IS UNKNOWN IF THE PHYSICIAN PLANS TO RE-INTERVENE. THIS REPORT IS TO ADDRESS THIS INDETERMINATE ENDOLEAK EVENT.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13694169 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX INFRARENAL AORTIC EXTENSION. APPROXIMATELY THREE (3) AND A HALF YEARS POST INITIAL PROCEDURE, ANEURYSM ENLARGEMENT FROM 50MM TO 62MM WAS IDENTIFIED WITH NO IDENTIFIABLE ENDOLEAK. THOUGH NO ENDOLEAKS WERE CONFIRMED ON THE PRE-PROCEDURAL ANGIOGRAPHY, REINTERVENTION WAS PERFORMED. AN EXCLUDER (NON-ENDOLOGIX) WAS DEPLOYED IN THE IPSILATERAL LEG AND AN ADDITIONAL EXCLUDER (NON-ENDOLOGIX) WAS DEPLOYED IN THE CONTRALATERAL LEG VIA LEFT ACCESS. REPORTEDLY, THE PATIENT CONTINUES TO BE MONITORED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13482796 ↗
• InjuryJan 25, 2022Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY FOUR (4) AND A HALF YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A TYPE IB ENDOLEAK, AND A TYPE IIIA ENDOLEAK WITH IMPLANT SEPARATION WERE IDENTIFIED. SUCCESSFUL REINTERVENTION WAS COMPLETED WITH IMPLANT OF TWO (2) AFX VELA INFRARENAL, AN AFX VELA SUPRARENAL, AN OVATION IX EXTENDER, AND AN AFX LIMB STENT GRAFT. THE PATIENT WAS REPORTED TO BE STABLE AND DOING WELL POST REINTERVENTION.

  Patient problems: Abdominal Pain; Failure of Implant

  MAUDE report 13343167 ↗
• InjuryNov 8, 2021Unintended Movement; Separation Problem; Unintended Movement; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN AFX LIMB STENT GRAFT. APPROXIMATELY FOUR (4) YEARS LATER AT ROUTINE FOLLOW-UP, COMPUTERIZED TOMOGRAPHY IDENTIFIED A TYPE IIIA ENDOLEAK WITH IMPLANT SEPARATION. REINTERVENTION WAS COMPLETED WITH A FULL RELINE. REPORTEDLY, THERE WAS AN EXTREME AMOUNT OF ANGULATION REQUIRING IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, TWO (2) AFX VELA SUPRARENAL, AND AN AFX VELA INFRARENAL. ALL DEVICES WERE WELL POSITIONED, AND COMPLETION ANGIOGRAM REVEALED EXCLUSION OF THE ANEURYSM. THE PATIENT WAS REPORTED TO BE WELL POST-REINTERVENTION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12771545 ↗
• InjuryOct 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK. REINTERVENTION WAS COMPLETED WITH IMPLANT OF AN ENDURANT (NON-ENDOLOGIX) AORTIC EXTENSION SUCCESSFULLY SEALING THE TYPE IA ENDOLEAK. REPORTEDLY, THE PATIENT WAS WELL POST REINTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 12668856 ↗
• InjuryOct 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. AFTER THE AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED THE RIGHT LIMB BECAME OCCLUDED. THE PHYSICIAN ELECTED TO PERFORM A FEMORAL-TO-FEMORAL BYPASS FROM THE LEFT TO THE RIGHT CONNECTION RESOLVING THE LIMB OCCLUSION. IT WAS ALSO REPORTED THAT THE BIFURCATED STENT GRAFT WAS POSSIBLY SEATED ABOVE THE NATIVE AORTIC BIFURCATION; HOWEVER, NO COMPLICATIONS OCCURRED FROM THIS. THE PATIENT WAS REPORTED TO BE WITHOUT COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 12601370 ↗
• InjurySep 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL AND AN OVATION IX EXTENDER. THEREFORE, 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 DEVICE IFU. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE THE ROUTINE FOLLOW-UP IDENTIFIED A TYPE 3A ENDOLEAK. REINTERVENTION WAS COMPLETED WITH IMPLANT OF AN AFX VELA INFRARENAL AND AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT, SUCCESSFULLY SEALING THE TYPE 3A ENDOLEAK. THE FINAL PATIENT STATUS WAS REPORTED TO BE DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 12544140 ↗
• InjurySep 25, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, THE ACCESS VESSEL ON THE RIGHT SIDE WAS NARROW WITH CALCIFICATIONS AND THE DILATOR OF THE INTRODUCER SHEATH WAS INSERTED FIRST TO SECURE ACCESS AND THE BIFURCATED STENT GRAFT WAS DEPLOYED. BOTH COMMON ILIAC ARTERIES WERE NARROW AND THE LEGS OF THE BIFURCATED STENT GRAFT WERE TOUCHED UP WITH A BALLOON CATHETER. FOLLOWING DEPLOYMENT OF THE VELA SUPRARENAL EXTENSION THE ANGIOGRAPHY SHOWED A SUSPECTED TYPE 3B ENDOLEAK NEAR THE BIFURCATION. THE PHYSICIAN IMPLANTED AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT AND THE 3B ENDOLEAK WAS CONFIRMED TO HAVE BEEN RESOLVED. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 12530709 ↗
• InjuryMay 27, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AN INFRARENAL STENT GRAFT EXTENSION AND A LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 9 MONTHS POST INITIAL PROCEDURE DURING ROUTINE FOLLOW UP, A POSSIBLE IIIB ENDOLEAK WAS IDENTIFIED. THE PATIENT IS CURRENTLY BEING MONITORED. REFERENCE MFR. REPORT # 3008011247-2021-00029 FOR INITIAL REPORT TO PATIENT ID 52064, WHICH WAS SUBMITTED WITH THE INCORRECT CFN/FEI #.

  Patient problems: Failure of Implant

  MAUDE report 11896272 ↗

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-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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
• 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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• 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-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

…and 1 more.