AFX2 Bifurcated Endograft System BEA25-90/I20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00818009014825), received between Sep 24, 2016 and Jul 27, 2026 — classified as 3 deaths, 40 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (14 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 43 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Lack of Effect

  The patient was treated for an abdominal aortic aneurysm on (b)(6)2022 with the implant of an AFX2 Bifurcated Stent Graft and an AFX Vela Suprarenal. On (b)(6)2026, an indeterminate endoleak was identified during a medical checkup. Reintervention was performed on (b)(6)2026 to treat bilateral Type IB Endoleaks. An Ovation iX Iliac Limb was deployed in the left leg while preserving the left internal iliac artery (IIA). For the right leg, an attempt was made to preserve the right IIA at the time of deployment using a fenestrated AFX Limb Extension; however, cannulation into the right IIA was difficult. During the attempt, angiography performed with an altered C-arm angle revealed a clear Type IB Endoleak from the right leg. Consequently, preservation of the right IIA was abandoned, and another AFX Limb Extension was also deployed for relining. Final angiography confirmed the resolution of the Type IB Endoleak, and the procedure was completed. It was noted, based on imaging findings, that the sit-on/landing of the device might have been insufficient during the initial procedure.

  Patient problems: Clinical Endoleak

  MAUDE report 50046403 ↗
• InjuryMar 25, 2026Lack of Effect

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED GRAFT AND TWO (2) AFX VELA SUPRARENAL EXTENSIONS FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2018. ON (B)(6) 2026 DURING A ROUTINE FOLLOW UP APPOINTMENT, THE COMPUTED TOMOGRAPHY (CT) REVEALED AN INDETERMINATE ENDOLEAK (TYPE II ENDOLEAK OR TYPE IIIB ENDOLEAK). THE PATIENT IS BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Clinical Endoleak

  MAUDE report 24691441 ↗
• InjuryJan 20, 2026Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2019 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, TWO (2) AFX VELA SUPRARENAL STENT GRAFTS AND AN OVATION IX EXTENDER. REPORTEDLY THE PATIENT UNDERWENT A PROCEDURE WITH INTERVENTIONAL RADIOLOGY IN (B)(6) 2025 WHERE A DIRECT SAC PUNCTURE INTO THE SAC WITH A CHIVE NEEDLE (NON-ENDOLOGIX) AND 6 FRENCH SHEATH (NON-ENDOLOGIX) THROUGH THE VENA CAVA TO POSSIBLY COIL EMBOLIZE COLLATERAL VESSELS. IT WAS LATER SEEN ON IMAGES THAT THE GRAFT WAS ENTERED DURING THIS PROCEDURE AND THERE WAS A PUNCTURE INTO THE GRAFT THAT WAS NOT REPORTED. THE PATIENT BECAME SYMPTOMATIC WITH BELLY PAIN AND INCREASING ANEURYSM SIZE ONE MONTH LATER. APPARENTLY, THE HOLE IN THE GRAFT REMAINED OPEN AND THIS IS LIKELY THE REASON FOR A POSSIBLE TYPE IIIB ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE THE GRAFT EVEN THOUGH THEY WERE UNABLE TO IDENTIFY A DEFINITIVE ENDOLEAK ON THE INITIAL INTRAOPERATIVE ANGIOGRAM NOR THE COMPUTED TOMOGRAPHY ANGIOGRAM. REINTERVENTION WAS COMPLETED ON (B)(6) 2025 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL AND AN OVATION IX EXTENDER. THE PATIENT¿S BELLY PAIN WAS COMPLETELY RES

  Patient problems: Abdominal Pain; Aneurysm; Clinical Endoleak

  MAUDE report 24116606 ↗
• InjuryJun 3, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR ABDOMINAL AORTIC ANEURYSM THAT WAS PROTRUDING TO THE LEFT ON (B)(6) 2019. THE AFX2 BIFURCATED STENT GRAFT (BSG) WAS IMPLANTED VIA THE LEFT FEMORAL ARTERY. THE AFX VELA SUPRARENAL WAS IMPLANTED PER THE INSTRUCTIONS. THE AORTA HAD A SLIGHT S-SHAPED CURVE FROM THE NECK TO THE ANEURYSM, AND THE ANGIOGRAPHY AFTER TOUCH-UP CONFIRMED A TYPE IIIA ENDOLEAK. THE JUNCTION OF THE AFX2 BSG AND AFX VELA SUPRARENAL WAS TOUCHED UP AGAIN, LEADING TO A DECREASE IN THE ENDOLEAK. THEREFORE, THE PROCEDURE WAS COMPLETED. POST-OPERATIVE FOLLOW-UPS REVEALED GRADUAL ENLARGEMENT OF THE ANEURYSM (MAXIMUM SHORT-AXIS DIAMETER: 56MM), BUT NO APPARENT ENDOLEAK WAS DETECTED. HOWEVER, DUE TO POSSIBLE IMPENDING RUPTURE, OPEN CONVERSION WAS PERFORMED ON (B)(6) 2024. DURING THE OPEN SURGERY, THE ANEURYSM WAS OPENED, AND THROMBUS WAS REMOVED. THEN, BLOOD SPURTED OUT FROM THE POSTERIOR SIDE OF THE AFX2 BSG. THEREFORE, THE STENT GRAFT WAS EXPLANTED, AND ARTIFICIAL GRAFT REPLACEMENT SURGERY WAS PERFORMED. UPON INSPECTION OF THE EXPLANTED AFX2 BSG DAMAGE ON THE BIFURCATION WAS IDENTIFIED AT THE LOCATION OF THE DAMAGE CORRESPONDING TO THE SITE OF THE BLOOD LEAKAGE.THE PATIENT WAS IN GOOD CONDIT

  Patient problems: Aneurysm

  MAUDE report 22133674 ↗
• InjuryJan 2, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  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'S. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, THERE APPEARED TO BE A TYPE IIIB ENDOLEAK AND THE ANEURYSM HAD GROWN FROM 5.5CM TO 7.5CM. THE PHYSICIAN ELECTED TO RELINE THE IMPLANTED AFX2 BIFURCATED STENT GRAFT WITH A NEW AFX2 BIFURCATED STENT GRAFT AND THE ENDOLEAK APPEARED TO BE RESOLVED. DURING THE DEPLOYMENT, AFTER TURNING THE YELLOW CAP AND PULLING TO RELEASE THE WRAPPER, THE WRAPPER WOULD NOT COME OFF. THE ISSUE WAS TROUBLESHOOTED BY PULLING THE CONTRA YELLOW COVER WITH SIGNIFICANT FORCE AND PULLING ON THE YELLOW CAP STRINGS WITH SIGNIFICANT FORCE AT THE SAME TIME. THIS RELEASED THE WRAPPER. THE PATIENT IS REPORTED AS DOING WELL AND EXPECTED TO BE DISCHARGED NEXT DAY. (REPORTED UNDER MFR#: 3011063223-2024-00141). APPROXIMATELY (3) THREE MONTHS POST SECONDARY PROCEDURE, ROUTINE FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN SHOWED THAT THE LIMB APPEARED TO BE CRUSHED. INTERVENTION WAS PLANNED FOR ON (B)(6) 2024 BUT WAS CANCELLED. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 21057811 ↗
• InjuryNov 8, 2024Material Puncture/Hole; Material Puncture/Hole

  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 AND A HALF (4.5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED A SUSPECTED ANEURYSM ENLARGEMENT. APPROXIMATELY TWO (2) MONTHS AFTER FOLLOW-UP REINTERVENTION WAS PERFORMED. A TYPE IIIB ENDOLEAK WAS IDENTIFIED AND THE AFX2 BIFURCATED STENT GRAFT WAS RELINED WITH A TERUMO (NON-ENDOLOGIX) TREO ABDOMINAL STENT GRAFT SYSTEM. THE FINAL WAS REPORTED AS DISCHARGED.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 AND A HALF (4.5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED A SUSPECTED ANEURYSM ENLARGEMENT. APPROXIMATELY TWO (2) MONTHS AFTER FOLLOW-UP REINTERVENTION WAS PERFORMED. A TYPE IIIB ENDOLEAK WAS IDENTIFIED AND THE AFX2 BIFURCATED STENT GRAFT WAS RELINED WITH A TERUMO (NON-ENDOLOGIX) TREO ABDOMINAL STENT GRAFT SYSTEM. THE FINAL WAS REPORTED AS DISCHARGED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20640018 ↗
• InjuryOct 2, 2024Material Puncture/Hole; Material Puncture/Hole

  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'S. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, THERE APPEARED TO BE A TYPE IIIB ENDOLEAK AND THE ANEURYSM HAD GROWN FROM 5.5CM TO 7.5CM. THE PHYSICIAN ELECTED TO RELINE THE IMPLANTED AFX2 BIFURCATED STENT GRAFT WITH A NEW AFX2 BIFURCATED STENT GRAFT AND THE ENDOLEAK APPEARED TO BE RESOLVED. DURING THE DEPLOYMENT, AFTER TURNING THE YELLOW CAP AND PULLING TO RELEASE THE WRAPPER, THE WRAPPER WOULD NOT COME OFF. THE ISSUE WAS TROUBLESHOOTED BY PULLING THE CONTRA YELLOW COVER WITH SIGNIFICANT FORCE AND PULLING ON THE YELLOW CAP STRINGS WITH SIGNIFICANT FORCE AT THE SAME TIME. THIS RELEASED THE WRAPPER. THE PATIENT IS REPORTED AS DOING WELL AND EXPECTED TO BE DISCHARGED NEXT DAY.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20351621 ↗
• InjuryAug 27, 2024Off-Label Use; Deformation Due to Compressive Stress; Migration; Off-Label Use; Deformation Due to Compressive Stress; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, TWO (2) GORE EXCLUDER CUFFS (NON-ENDOLOGIX), AND AN ENDURANT CUFF (NON-ENDOLOGIX) TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) AND A RIGHT COMMON ILIAC ARTERY ANEURYSM ON 13 DECEMBER 2019. 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. A GORE EXCLUDER CUFF (NON-ENDOLOGIX) WAS PLACED AT THE INFERIOR MESENTERIC ARTERY TO EMBOLIZE AND THEN THE AFX2 BIFURCATED STENT GRAFT WAS PLACED. AN ENDURANT CUFF (NON-ENDOLOGIX) WAS PLACED ON THE PROXIMAL SIDE OF THE AFX2 BIFURCATED STENT GRAFT. ANOTHER GORE EXCLUDER CUFF (NON-ENDOLOGIX) WAS PLACED FROM THE RIGHT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. THE FINAL ANGIOGRAM SHOWED A TYPE IB ENDOLEAK FROM THE LEFT COMMON ILIAC ARTERY. THE PHYSICIAN ELECTED TO FINISH THE PROCEDURE JUDGING THE ENDOLEAK WOULD BE RESOLVED. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, AN ADDITIONAL PROCEDURE WAS PERFORMED DUE TO THE TYPE IB ENDOLEAK FROM THE LEFT COMMON ILIAC ARTERY AND TO REINFORCE THE JUNCTION OF THE AFX2 BIFURCATED STENT GRAFT AND THE ENDURANT CUFF. A GORE VBX GRA

  Patient problems: Clinical Endoleak

  MAUDE report 20080045 ↗
• InjuryJun 6, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM AND COMMON ILIAC ARTERY ANEURYSMS ON (B)(6) 2019, WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AN AFX VELA SUPRARENAL AND TWO EXCLUDER (NON-ENDOLOGIX) CUFFS. THIS INITIAL PROCEDURE IS OUTSIDE OF THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF THE TWO (2) EXCLUDER CUFFS WITH THE AFX2 SYSTEM. ON (B)(6) 2024, A CONTRAST COMPUTED TOMOGRAPHY WAS TAKEN, SAC ENLARGEMENT AND TYPE IIIB ENDOLEAK WAS OBSERVED. REINTERVENTION WAS PERFORMED ON (B)(6) 2024. THE INTRAOPERATIVE ANGIOGRAPHY CONFIRMED THE TYPE IIIB ENDOLEAK WAS FROM AFX2 MAIN BODY WHERE AFX VELA SUPRARENAL DISTAL EDGE IS POSITIONED. THE PHYSICIAN ELECTED TO ADD AN ENDURANT (NON-ENDOLOGIX) AND ENDOLEAK WAS RESOLVED. THE FINAL PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19477275 ↗
• InjuryMar 27, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2018. DURING THE PROCEDURE, AN AFX VELA SUPRARENAL WAS POSITIONED JUST BELOW THE RENAL ARTERY. HOWEVER, DURING RETRIEVAL OF THE DELIVERY SYSTEM TIP, THE AFX VELA SUPRARENAL MIGRATED DOWNWARD, NECESSITATING THE ADDITION OF ANOTHER AFX VELA SUPRARENAL. THE PROCEDURE CONCLUDED SUCCESSFULLY WITHOUT ANY SIGNS OF ENDOLEAKS. A TYPE II ENDOLEAK (NON-DEVICE-RELATED FAILURE) WAS DETECTED ON SUBSEQUENT FOLLOW-UP COMPUTED TOMOGRAPHY (CT) IMAGES, ALTHOUGH THE EXACT TIMING OF ITS OCCURRENCE IS UNKNOWN. THE PATIENT WAS CLOSELY MONITORED IN RESPONSE. ON (B)(6) 2023, ANOTHER FOLLOW-UP CT SCAN REVEALED AN ANEURYSM ENLARGEMENT AND A POSSIBLE ENDOLEAK ORIGINATING FROM THE MAIN BODY. ON (B)(6) 2024, OPEN SURGERY WAS PERFORMED. THE PRESENCE OF A TYPE IIIB ENDOLEAK FROM SUTURE HOLES, OBSERVED ON BOTH THE FRONT AND BACK SIDES, AND A TYPE II ENDOLEAK WERE CONFIRMED. THE AFX2 STENT GRAFT WAS EXPLANTED, AND VESSEL REPLACEMENT WAS UNDERTAKEN. THE ADDITIONAL SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE PATIENT'S POST-OPERATIVE CONDITION REMAINED STABLE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18989256 ↗
• InjuryJan 9, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN ARTIFICIAL PROSTHESIS IN 2013 (EXACT DATE IS UNKNOWN). ON (B)(6) 2022 THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION FOR THE TREATMENT OF PSEUDOANEURYSM OBSERVED AT THE DISTAL EDGE OF THE ARTIFICIAL PROSTHESIS. ON (B)(6) 2023, AN OPEN SURGICAL PROCEDURE WAS PERFORMED BECAUSE THE PSEUDOANEURYSM WAS ENLARGING. DURING THE PROCEDURE ENDOLEAKS FROM SUTURE HOLES WERE CONFIRMED. THE DISTAL PORTION OF THE AFX2 BIFURCATED STENT GRAFT FROM THE BIFURCATION TO THE LIMBS WAS EXPLANTED. THE PROXIMAL PORTION OF THE VELA WAS ALSO EXPLANTED WITH THE PROXIMAL PORTION LEFT IN THE PATIENT AND SUTURED TO THE NEWLY IMPLANTED "Y" SHAPED SURGICAL GRAFT. THE EXPLANTED STENT GRAFT IS AVAILABLE FOR RETURN.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18478077 ↗
• InjuryDec 27, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND AN INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, AFTER EXAMINATION, THE PATIENT WAS FOUND TO HAVE A TYPE 3B AND A TYPE 2 (ANATOMY RELATED) ENDOLEAK AS WELL AS ANEURYSM ENLARGEMENT. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING PLANNED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18399788 ↗
• InjuryDec 21, 2023Lack of Effect; Lack of Effect

  THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2020. REPORTEDLY, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED WITH THE IMPLANT OF AN UNKNOWN (NON-ENDOLOGIX) BARE METAL STENT TO TREAT A DISSECTION IN THE RIGHT FEMORAL ARTERY PRIOR TO THE IMPLANT OF THE AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL. THE FINAL ANGIOGRAPHY SHOWED NO ENDOLEAK, AND THE OPERATION WAS COMPLETED. REINTERVENTION WAS COMPLETED ON (B)(6) 2023 WITH THE IMPLANT OF A GORE (NON-ENDOLOGIX) EXCLUDER STENT TO TREAT SAC ENLARGEMENT AND AN INDETERMINANT ENDOLEAK. THE PATENT CONDITION POST-REINTERVENTION WAS REPORTED TO BE STABLE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18372067 ↗
• InjuryNov 7, 2023Insufficient Device Problem Information; Lack of Effect; Insufficient Device Problem Information; Lack of Effect

  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 ON (B)(6) 2018. ON (B)(6) 2023, THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. ANEURYSM ENLARGEMENT WAS IDENTIFIED WITH NO NOTICEABLE TYPE IIA OR TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE THE INITIALLY IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT, AND AFX VELA SUPRARENAL AND AN OVATION IX EXTENDER. THE RELINE WAS SUCCESSFUL AND EXCLUDED THE PATIENT¿S ANEURYSM. THE PATIENT WAS REPORTED TO BE GOOD POST REINTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak; Pain

  MAUDE report 18086766 ↗
• InjuryOct 25, 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, AN AFX SUPRARENAL AORTIC EXTENSION AND AN AFX INFRARENAL AORTIC EXTENSION. APPROXIMATELY TWO AND HALF (2.5) YEARS POST INITIAL PROCEDURE, A RECENT FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) IDENTIFIED A TYPE 1B ENDOLEAK COMING FROM THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN ELECTED TO EXTEND BOTH LIMBS WITH FOUR (4) OVATION IX EXTENDERS TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST THIS SECONDARY PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18002390 ↗
• InjuryOct 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT RECEIVED TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) THROUGH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL DEVICE. APPROXIMATELY ONE (1) DAY FOLLOWING THE INITIAL PROCEDURE, THE PATIENT PRESENTED WITH SYMPTOMS OF BACK PAIN AND EXPERIENCED RENAL OCCLUSION. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS CONDUCTED, WHICH CONFIRMED PROPER BLOOD FLOW TO THE RENAL AREA. LATER THAT DAY, IT WAS REPORTED THAT THE PATIENT NECESSITATED A SURGICAL CONVERSION, DURING WHICH THE AFX VELA SUPRARENAL DEVICE WAS EXPLANTED (MANUFACTURER REPORT NUMBER 2031527-2023-00189). THE PATIENT WAS REPORTEDLY DISCHARGED ON (B)(6), 2023. A CLINICAL ASSESSMENT REVEALED THAT AN ADDITIONAL ENDOVASCULAR PROCEDURE ALSO TOOK PLACE, INVOLVING THE PLACEMENT OF A FENESTRATED GRAFT ON (B)(6), 2023. THIS SUPPLEMENTARY INTERVENTION'S DISCOVERY WAS BASED ON A COMPREHENSIVE REVIEW OF THE OPERATIVE REPORT DATED (B)(6), 2023 AND DISCHARGE SUMMARY DATED (B)(6), 2023. IT WAS REPORTED THAT THE GRAFT HAD BEEN EXTENDED WITH A FENESTRATED CUFF. THE FINAL PATIENT STATUS WAS REPORTED AS STABLE POST-INTERVENTION. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE REGARDING THIS INITIAL REPORT. THIS

  Patient problems: Insufficient Information; Respiratory Failure

  MAUDE report 17944305 ↗
• InjuryJul 31, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, DURING A FOLLOW UP, THERE WAS EVIDENCE OF BILATERAL TYPE 1B ENDOLEAKS AND ANEURYSM SAC GROWTH. THE PHYSICIAN ELECTED TO IMPLANT NON ENDOLOGIX (ENDURANT) STENTS BILATERALLY TO RESOLVE THIS EVENT.

  Patient problems: Clinical Endoleak

  MAUDE report 17425385 ↗
• DeathJul 18, 2023Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  THE PATIENT WAS EMERGENTLY TREATED FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. WHILE THE PATIENT WAS STABILIZED PRIOR TO THE INITIAL IMPLANT, THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO EMERGENT USE OF THE AFX2 SYSTEM PER DEVICE IFU. DURING THE INITIAL IMPLANT PROCEDURE AND UPON FEMORAL ACCESS, THE PATIENT RUPTURED AGAIN AND BECAME UNSTABLE. THE PHYSICIAN QUICKLY IMPLANTED THE MAIN BODY, AFTER WHICH THE PATIENT STABILIZED. THE PROXIMAL EXTENSION WAS THEN IMPLANTED, AND A FULL SEAL OBTAINED. HOWEVER, DUE TO THE HIGH BLOOD VOLUME LOSS, THE PATIENT ULTIMATELY PASSED AWAY ONE (1) DAY POST PROCEDURE. ADDITIONAL INFORMATION: INTERNAL CLINICAL ASSESSMENT IDENTIFIED THAT AN INTRAOPERATIVE ENDOLEAK (AT AN INDETERMINATE ORIGIN) WAS ALSO PRESENT AND THAT PATIENT REQUIRED A BLOOD TRANSFUSION. THE PATIENT DEATH WAS DEEMED UNRELATED TO AN ENDOLOGIX DEVICE DUE TO THE RUPTURED ANEURYSM THAT WAS PRESENT PRIOR TO INITIAL IMPLANT WITH AFX DEVICES.

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

  MAUDE report 17344086 ↗
• InjuryJul 11, 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 LIMB STENT GRAFT EXTENSION. DURING THE INITIAL IMPLANT PROCEDURE, A POSSIBLE ENDOLEAK (AT AN INDETERMINATE ORIGIN) WAS IDENTIFIED. BALLOON ANGIOPLASTY WAS PERFORMED WITH SOME RESOLUTION. THE PHYSICIAN ELECTED TO CONCLUDE THE PROCEDURE AND MONITOR THE ENDOLEAK. IT WAS NOTED THAT THE HOSPITAL WILL NOT SHARE ANY ADDITIONAL PATIENT IDENTIFIERS.

  Patient problems: Clinical Endoleak

  MAUDE report 17299851 ↗
• InjuryMar 31, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, THE VESSEL CONDITION WAS NOT GOOD WITH SOME CALCIFICATION. FROM THE RIGHT ACCESS, THE AFX2 BIFURCATED STENT GRAFT SYSTEM WAS INSERTED. THE AFX2 BIFURCATED STENT GRAFT WAS DEPLOYED. NO RESISTANCE WAS FELT; HOWEVER, THE AFX2 BIFURCATED STENT GRAFT SYSTEM AND AFX INTRODUCER SHEATH HAD TO BE REMOVED TOGETHER AS THERE WAS DAMAGE TO THE AFX INTRODUCER SHEATH. USING A NEW AFX INTRODUCER SHEATH THE AFX VELA INFRARENAL WAS IMPLANTED AS PLANNED. BALLOON TOUCH UP OF BOTH LIMBS AND ANGIOGRAPHY WAS PERFORMED REVEALING AN INTRAOPERATIVE TYPE IIIB ENDOLEAK. A SECOND AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED INSIDE THE FIRST AFX2 BIFURCATED STENT GRAFT. THE ENDOLEAK VOLUME DECREASED, BUT IT DID NOT COMPLETELY RESOLVE. ANGIOGRAPHY WAS PERFORMED AGAIN FROM THE DIFFERENT ANGLE, AND IT WAS CONFIRMED AS TYPE IIIB ENDOLEAK RESIDUE. THE PATIENT WILL BE MONITORED, AND A FOLLOW-UP COMPUTERIZED TOMOGRAPHY WILL BE PERFORMED TO DETERMINE IF ADDITIONAL TREATMENT IS REQUIRED.

  Patient problems: Clinical Endoleak

  MAUDE report 16659310 ↗
• DeathMar 10, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT WAS EMERGENTLY TREATED FOR A RUPTURED AORTIC BIFURCATION, WHICH OCCURRED DURING A ROUTINE PERIPHERAL PROCEDURE. REPORTEDLY, DURING THE BALLOONING OCCLUSION WHEN THE RUPTURE OCCURRED, AN EXTENSIVE BLOOD CLOT WAS FORMED. THE AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED TO TREAT THE RUPTURE AT THE BIFURCATION; HOWEVER, DUE TO THE BLOOD CLOT THE PROCEDURE WAS STOPPED, AND THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM TO CONVERT THE PATIENT TO OPEN SURGERY. IT IS UNKNOWN IF THE CONVERSION WAS COMPLETED. THE PATIENT WAS TRANSPORTED TO AN UNKNOWN OUTSIDE HOSPITAL AND PASSED AWAY ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE REGARDING THIS INITIAL REPORT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16524003 ↗
• InjuryFeb 15, 2023Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL AORTIC EXTENSION AND A GORE EXCLUDER (NON-ENDOLOGIX ILIAC LIMB) 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 THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE AN UNKNOWN TYPE OF INFECTION AND OPEN SURGERY WAS BEING WAS BEING DISCUSSED. UPON FURTHER FOLLOW-UP A TYPE 3B ENDOLEAK WAS SUSPECTED. ON (B)(6) 2023 A SECONDARY PROCEDURE WAS COMPLETED AND THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER AFX2 BIFURCATED STENT GRAFT AND THE TYPE 3B ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PATIENT WAS PLACED ON ANTIBIOTICS FOR TREATMENT OF THE INFECTION; HOWEVER, THE INFECTION CONDITION IS CURRENTLY NOT STABLE AND THE PHYSICIAN STATED THERE IS A POSSIBILITY OF EXPLANTING THE STENT GRAFTS AT A LATER DATE IF NECESSARY.

  Patient problems: Clinical Endoleak; Unspecified Infection

  MAUDE report 16380871 ↗
• InjurySep 29, 2022Unintended Movement; Unintended Movement

  THE PATIENT WAS BEING TREATED EMERGENTLY FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) THAT WAS IMPENDING RUPTURE. AN AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL WERE IMPLANTED. APPROXIMATELY SIX (6) MONTHS POST INITIAL PROCEDURE ROUTINE FOLLOW-UP IDENTIFIED ANEURYSM ENLARGEMENT OF APPROXIMATELY 5MM WITH A SHORTER OVERLAP. REINTERVENTION IS BEING PLANNED. PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15506086 ↗
• InjuryAug 11, 2022Material Puncture/Hole; Material Puncture/Hole

  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, AT ROUTINE FOLLOW-UP, A TYPE 3B ENDOLEAK WAS IDENTIFIED AT THE NECK OF THE AFX2 BIFURCATED STENT GRAFT. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT. FINAL PATIENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15214307 ↗
• InjuryMay 23, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) SUPRARENAL AORTIC EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE, THE POST OPERATIVE COMPUTED TOMOGRAPHY (CT) SHOWED A 2CM ANEURYSM ENLARGEMENT WITH NO VISIBLE ENDOLEAK. THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFTS AND TO TREAT THE PATIENT SURGICALLY. IT WAS REPORTED THAT DURING THE EXPLANT PROCEDURE THE PHYSICIAN SAW A HOLE IN THE GRAFT (CATEGORIZED AS TYPE 3B ENDOLEAK); HOWEVER, THE PHYSICIAN IS NOT SURE IF THE GRAFT DAMAGE OCCURRED DURING THE EXPLANT PROCEDURE OR IF IT WAS THERE ALREADY AND IT WAS THE CAUSE OF THE SAC ENLARGEMENT. THE PATIENT WAS REPORTED AS DOING FINE POST THE EXPLANT PROCEDURE. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN/EVALUATION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14470897 ↗

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-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-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-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-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-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-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-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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-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.