AFX2 Bifurcated Endograft System BEA22-90/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00818009015136), received between Jun 3, 2016 and Aug 5, 2026 — classified as 4 deaths, 42 injuries, 2 malfunctions.

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 48 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Off-Label Use

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 50144704 ↗
• DeathApr 9, 2026Off-Label Use

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM AND LEFT COMMON ILIAC ARTERY ANEURYSM ON (B)(6) 2019 WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA INFRARENAL. DUE TO THE OCCLUSION OF THE LEFT ILIAC ARTERY, AN EXCLUDER LEG (NON-ENDOLOGIX) WAS DEPLOYED FROM THE LEFT COMMON ILIAC ARTERY (LCIA) TO THE EXTERNAL ILIAC ARTERY. AN AFX2 BSG WAS IMPLANTED VIA THE RIGHT APPROACH FOLLOWED BY PLACEMENT OF AN AFX VELA INFRARENAL JUST BELOW THE RENAL ARTERIES. AN ANEURYSM WAS ALSO NOTED IN IN THE RIGHT COMMON ILIAC ARTERY (RCIA); HOWEVER, THE PROCEDURE WAS CONCLUDED AS A STAGED EMBOLIZATION OF THE RCIA WAS PLANNED BUT IT IS UNKNOWN WHETHER THE EMBOLIZATION WAS PERFORMED. ON (B)(6) 2021 A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A TYPE IB ENDOLEAK FROM THE DISTAL RIGHT LEG AND MIGRATION OF THE PROXIMAL STENT GRAFT. CONSEQUENTLY, A SECONDARY ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED USING AN EXCLUDER AORTIC EXTENSION (NON-ENDOLOGIX) AND AN EXCLUDER LEG (NON-ENDOLOGIX), ALONG WITH EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY. THIS EVENT WAS REPORTED IN MDR # 3011063223-2026-00041. ON (B)(6) 2023, THE PATIENT PRESENTED TO A HOSPITAL WITH SUDDEN LOWER

  Patient problems: Clinical Endoleak; Pain; Ruptured Aneurysm

  MAUDE report 24836005 ↗
• InjuryApr 9, 2026Off-Label Use; Migration

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM AND LEFT COMMON ILIAC ARTERY ANEURYSM ON (B)(6) 2019 WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA INFRARENAL. DUE TO THE OCCLUSION OF THE LEFT ILIAC ARTERY, AN EXCLUDER LEG (NON-ENDOLOGIX) WAS DEPLOYED FROM THE LEFT COMMON ILIAC ARTERY (LCIA) TO THE EXTERNAL ILIAC ARTERY. AN AFX2 BSG WAS IMPLANTED VIA THE RIGHT APPROACH FOLLOWED BY PLACEMENT OF AN AFX VELA INFRARENAL JUST BELOW THE RENAL ARTERIES. AN ANEURYSM WAS ALSO NOTED IN IN THE RIGHT COMMON ILIAC ARTERY (RCIA); HOWEVER, THE PROCEDURE WAS CONCLUDED AS A STAGED EMBOLIZATION OF THE RCIA WAS PLANNED BUT IT IS UNKNOWN WHETHER THE EMBOLIZATION WAS PERFORMED. ON (B)(6) 2021 A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A TYPE IB ENDOLEAK FROM THE DISTAL RIGHT LEG AND MIGRATION OF THE PROXIMAL STENT GRAFT. CONSEQUENTLY, A SECONDARY ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED USING AN EXCLUDER AORTIC EXTENSION (NON-ENDOLOGIX) AND AN EXCLUDER LEG (NON-ENDOLOGIX), ALONG WITH EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY. NOTE: THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DE

  Patient problems: Clinical Endoleak

  MAUDE report 24835976 ↗
• InjuryMar 17, 2026Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) ON (B)(6)2026. THE INFERIOR MESENTERIC ARTERY AND LUMBAR ARTERIES HAD BEEN PRE-EMBOLIZED. AFTER THE AFX2 BSG WAS DEPLOYED VIA THE RIGHT ACCESS THE CONTRALATERAL LEG WAS DEPLOYED. BALLOON TOUCH-UP WAS PERFORMED ON THE ENTIRE GRAFT. A TYPE II ENDOLEAK FROM A LUMBAR ARTERY WAS CONFIRMED, THE PROCEDURE WAS COMPLETED AS IT WAS JUDGED TO BE NON-PROBLEMATIC. ON (B)(6) 2026, A TYPE IIIB ENDOLEAK WAS OBSERVED AT THE MID-SECTION OF THE AFX2 BSG, CORRESPONDING TO THE SACCULAR ANEURYSM SITE DURING A POST-OPERATIVE FOLLOW-UP. THE PATIENT IS ASYMPTOMATIC AND NO ADDITIONAL PROCEDURE IS PLANNED.

  Patient problems: Clinical Endoleak

  MAUDE report 24622231 ↗
• InjuryFeb 24, 2026Difficult to Remove; Difficult or Delayed Activation; Detachment of Device or Device Component

  THE PATIENT WAS BEING IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2026. UPON DEPLOYMENT OF THE STENT GRAFT, THE PHYSICIAN ATTEMPTED TO RELEASE THE PROXIMAL PORTION OF THE GRAFT BY PULLING THE YELLOW CAP AND CHORD AS WELL AS THE CONTRALATERAL YELLOW CHORD. THE PIGTAIL REMOVAL OF THE TOP WIRE WAS SUCCESSFUL. HOWEVER, UPON TRYING TO REMOVE THE DELIVERY SYSTEM NOSECONE INNER CORE, THE NOSECONE GOT CAUGHT ON THE RIGHT ILIAC LIMB. THE PHYSICIAN UNSHEATHED THE LIMB, BUT IT STILL APPEARED TO BE CONSTRAINED. THE PHYSICIAN ATTEMPTED SEVERAL MANEUVERS AND EVENTUALLY THE INNER CORE BROKE AND THE NOSECONE WAS LEFT STUCK IN THE ILIAC LIMB. THE NOSECONE WAS STILL ATTACHED TO THE SHEATH SYSTEM. THE PHYSICIAN WAS ABLE TO USE A DESTINO (NON-ENDOLOGIX) SHEATH TO COME UP AND OVER THE BIFURCATION OF THE STENT GRAFT AND INSERTED A WIRE DOWN THE ILIAC LIMB AROUND THE NOSECONE AND REMOVED THE NOSECONE WITH A SNARE. THE GRAFT WAS THEN TRAVERSED WITH SERIAL BALLOONS TO DILATE THE LIMB AND TO RELEASE THE NOSECONE. THE SHEATH WAS THEN REMOVED. A SMALL SKINK INCISION WAS MADE AND THE PHYSICIAN WAS ABLE TO CATCH AND MANUALLY REMOVE THE NOSECONE. THE STENT

  Patient problems: Rupture

  MAUDE report 24432350 ↗
• MalfunctionFeb 10, 2026Detachment of Device or Device Component

  THE PATIENT WAS BEING IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2026. THE AFX2 BIFURCATED STENT GRAFT WAS DEPLOYED THROUGH AN AFX SHEATH FROM THE RIGHT ACCESS, COMPLETING THE DEPLOYMENT STEPS UP TO THE CONTRALATERAL SIDE PER THE INSTRUCTIONS FOR USE. AT THAT POINT, IT WAS NOT NOTICED THAT THE MAIN COVER HAD FAILED TO BE PULLED OUT. AFTER REMOVING THE CONTRALATERAL WIRE, CANNULATION WAS PERFORMED AGAIN, FOLLOWED BY BALLOONING. DURING THE RETRIEVAL OF THE DELIVERY SYSTEM, THE TIP COULD NOT BE RETRACTED INTO THE SHEATH. THEREFORE, THE ENTIRE DELIVERY SYSTEM WAS WITHDRAWN TOGETHER WITH THE AFX SHEATH, AND THE SHEATH WAS REPLACED WITH A NEW AFX SHEATH. UPON CHECKING THE REMOVED AFX SHEATH AND TIP, IT WAS CONFIRMED THAT THE MAIN COVER WAS CAUGHT BETWEEN THEM. ADDITIONALLY, THE CONTROL CORD AND THE MAIN COVER HAD BECOME DETACHED. THE PROCEDURE WAS COMPLETED AFTER BALLOON TOUCH-UP, CONFIRMING THAT NO ENDOLEAK WAS PRESENT. THE PHYSICIAN NOTED THAT NO EXCESSIVE FORCE WAS APPLIED DURING THE DEPLOYMENT OF THE AFX2 BIFURCATED STENT GRAFT, AND THERE WAS ALMOST NO RESISTANCE. UPON CHECKING THE CONTROL CORD AND THE MAIN COVER SHOWED NO SIGN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307240 ↗
• MalfunctionFeb 9, 2026Difficult to Remove; Detachment of Device or Device Component

  THE PATIENT WAS BEING IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT A PATIENT WITH OCCLUSIVE DISEASE ON (B)(6) 2026. IT WAS REPORTED THAT AFTER SNARING THE YELLOW WIRE, THE PHYSICIAN FELLOW WAS PULLING THE SNARE AND WIRE OUT AND THEY GOT CAUGHT IN A STENOTIC AREA AND CAUSED THE SHEATHS TO PINCH TOGETHER. WHEN CONTINUING TO PULL THE SNARED WIRE, THE WIRE BEGAN TO UNRAVEL. THE PHYSICIAN WAS ABLE TO EXTERNALIZE THE DISTAL END OF THE WIRE, HOWEVER, THE WIRE CONTINUED TO UNRAVEL, THEREFORE THE PHYSICIAN DECIDED TO CUT THE END OF THE WIRE AND PULL THE ENTIRE GRAFT OUT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24295971 ↗
• InjuryDec 22, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2019 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL EXTENSION. DURING THE INDEX PROCEDURE THE AFX2 BIFURCATED STENT GRAFT WAS DEPLOYED VIA THE RIGHT APPROACH, AN AFX VELA SUPRARENAL EXTENSION WAS IMPLANTED. SUBSEQUENTLY, TOUCH-UP WAS PERFORMED ONLY ON THE LEGS, AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT ON (B)(6) 2025, DURING A ROUTINE FOLLOW-UP AN ENDOLEAK WAS CONFIRMED. ON (B)(6) 2025, ANGIOGRAPHY CONFIRMED A SUSPECTED TYPE IIIB ENDOLEAK. ON (B)(6) 2025, AN ADDITIONAL EVAR WAS PERFORMED. THE PHYSICIAN IMPLANTED AN AFX2 BIFURCATED STENT GRAFT FOR RELINING OF THE PREVIOUSLY IMPLANTED DEVICE. THE PROCEDURE WAS COMPLETED WITH NO ENDOLEAKS CONFIRMED. THE PATIENT¿S STATUS WAS NOT REPORTED.

  Patient problems: Clinical Endoleak

  MAUDE report 23868105 ↗
• InjuryDec 16, 2025Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL EXTENSION FOR THE TREATMENT OF A 59.3 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2022. ON 29 OCTOBER 2025 A FOLLOW-UP REPORT INDICATED THAT THERE WAS A FOLD IN THE MIDDLE OF THE AFX2 BIFURCATED STENT GRAFT. DUE TO THE AAA EXPANSION FROM 59.3 MM TO 76.1 MM IN DIAMETER, THE AFX2 AND INFRARENAL VELA EXTENSION HAVE DISCONNECTED BECAUSE OF LATERAL DISPLACEMENT. IT WAS REPORTED THAT ON (B)(6) 2026 THE PATIENT WAS TREATED WITH AN AFX VELA INFRARENAL EXTENSION. IT WAS REPORTED THAT A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED A FEW DAYS LATER, WHICH REVEALED A SMALL TYPE IV ENDOLEAK. ON (B)(6) 2026, AN AFX VELA INTRARENAL EXTENSION WAS IMPLANTED. THE PROBLEM HAS NOW BEEN RESOLVED, AND THE PATIENT IS DOING VERY WELL.

  Patient problems: Aneurysm; Clinical Endoleak; Failure of Implant

  MAUDE report 23818168 ↗
• InjuryJul 11, 2025Positioning Failure; Off-Label Use; Material Puncture/Hole; Deformation Due to Compressive Stress; Positioning Failure; Off-Label Use; Material Puncture/Hole; Deformation Due to Compressive Stress

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AND A GORE (NON-ENDOLOGIX) EXCLUDER CUFF. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) AS THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED. THE GORE (NON-ENDOLOGIX) DRYSEAL SHEATH WAS ADVANCED BELOW THE NECK, AND THE AFX2 BSG WAS SET UP. THE AFX2 BSG WAS EXPOSED WITHIN THE BLOOD VESSEL BY ADVANCING THE INNER CORE. DUE TO ANGULATION, TORQUE WAS DIFFICULT TO TRANSMIT, BUT THE CONTRALATERAL LEG'S ORIENTATION WAS ADJUSTED BY ROTATING THE INNER CORE, AND A SIT-ON WAS PERFORMED. THE AFX2 BSG WAS DEPLOYED AS PER THE INSTRUCTIONS. HOWEVER, THE GRAFT LEG WAS TWISTED AT THE AORTIC BIFURCATION, RESULTING IN DEFORMITY OF THE STENT AT THE CONTRALATERAL ORIGIN. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO REGAIN ACCESS TO MODIFY THE TWISTED LEG AND DEFORMED STENT, BUT ALL ATTEMPTS FAILED. AFTERWARDS, DURING A BALLOON TOUCH-UP OF THE ENTIRE BSG WITH A (NON-ENDOLOGIX) BALLOON WAS PERFORMED; HOWEVER, BALLOON RUPTURE OCCURRED. ANGIOGRAPHY FROM THE LEFT FEMOR

  Patient problems: Clinical Endoleak; Ischemia; Vascular Dissection

  MAUDE report 22479424 ↗
• InjuryJun 13, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ENDOVASCULAR ANEURYSM REPAIR ON (B)(6) 2020 WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL BEING IMPLANTED. ON (B)(6) 2023 COIL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY EMBOLIZATION WAS PERFORMED TO TREAT A TYPE II ENDOLEAK. ON (B)(6) 2024, REINTERVENTION WAS PERFORMED TO TREAT A TYPE II ENDOLEAK WITH THE IMPLANT OF AN ADDITIONAL AFX VELA SUPRARENAL. THE ENDOLEAK WAS OBSERVED AT THE BOTTOM OF THE FIRST SEGMENT FROM THE PROXIMAL EDGE OF THE INITIALLY IMPLANTED AFX VELA SUPRARENAL. FINAL ANGIOGRAPHY POST BALLOON TOUCH-UP SHOWED THAT THE ENDOLEAK HAD DISAPPEARED. ON (B)(6) 2025 A SUSPECTED TYPE IIIB ENDOLEAK AROUND THE DISTAL END OF THE VELA SUPRARENAL WAS OBSERVED. TWO DAYS LATER, THE INTRAOPERATIVE ANGIOGRAPHY SHOWED A TYPE IIIB ENDOLEAK. A PIGTAIL CATHETER WAS INSERTED INTO THE GRAFT TO PREVENT THE GUIDEWIRE FROM ENTERING THE ENDOSKELETON. THE PIGTAIL CATHETER WAS ADVANCED OUTSIDE THE AFX2 BIFURCATED STENT GRAFT DUE TO SUSPICIONS THAT THE GRAFT HAD BEEN DAMAGED AND THAT THERE WAS ALREADY SIGNIFICANT GRAFT PERFORATION THROUGH WHICH THE PIGTAIL CATHETER COULD PASS. THE PIGTAIL CATHETER WAS PULLED BACK INSIDE THE GRAFT AND ADVANCED

  Patient problems: Clinical Endoleak

  MAUDE report 22202410 ↗
• InjuryApr 24, 2025Device Stenosis; Device Stenosis

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025. THERE WAS A SLIGHT TYPE IA ENDOLEAK OBSERVED ON ANGIOGRAPHY, SO A PROXIMAL TOUCH-UP WAS PERFORMED. AFTER THE SUBSEQUENT ANGIOGRAPHY CONFIRMED THE DISAPPEARANCE OF THE TYPE I ENDOLEAK, THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT'S ANKLE BRACHIAL INDEX, (ABI) WAS 1.13/1.16 PREOPERATIVELY, BUT A PRESSURE GRADIENT WAS OBSERVED POSTOPERATIVELY AND HAD AN ABI OF 1.12/0.72. THE PHYSICIAN ELECTED TO IMPLANT AN EXPRESS VASCULAR LD 8MM-27MM (NON-ENDOLOGIX) STENT IN THE LEFT COMMON ILIAC ARTERY ON (B)(6) 2025 AFTER WHICH THE PRESSURE GRADIENT IMPROVED. THE PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Stenosis

  MAUDE report 21901989 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  THE PATIENT UNDERWENT ENDOVASCULAR ANEURYSM REPAIR ON (B)(6) 2020. REPORTEDLY, PRIOR TO IMPLANT, THE ANEURYSM SAC MEASURED AT 5MM. AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL WERE IMPLANTED. ON (B)(6) 2023, IT WAS IDENTIFIED THAT THE ANEURYSM DIAMETER HAD ENLARGED TO 60MM DUE TO A TYPE II ENDOLEAK. COIL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY EMBOLIZATION WAS PERFORMED ON (B)(6) 2023 TO TREAT THE TYPE II ENDOLEAK. THE FINAL PATIENT STATUS WAS NOT PROVIDED. IT WAS REPORTED THAT ON (B)(6) 2024, REINTERVENTION WAS PERFORMED TO TREAT AN INDETERMINATE ENDOLEAK WITH THE IMPLANT OF AN ADDITIONAL AFX VELA SUPRARENAL. THE INTRAOPERATIVE ANGIOGRAPHY WAS UNABLE TO IDENTIFY THE TYPE OF THE ENDOLEAK. THE ENDOLEAK WAS OBSERVED AT THE BOTTOM OF THE FIRST SEGMENT FROM THE PROXIMAL EDGE OF THE INITIALLY IMPLANTED AFX VELA SUPRARENAL; HOWEVER, THE TYPE COULD NOT BE DETERMINED. FINAL ANGIOGRAPHY POST BALLOON TOUCH-UP SHOWED THAT THE ENDOLEAK HAD DISAPPEARED; THEREFORE, THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED ON (B)(6) 2024. CLINICAL ASSESSMENT DETERMINE THAT THE INDETERMINATE ENDOLEAK WAS A TYPE II ENDOLEAK. TYPE II ENDOLEAKS ARE ANATOMY-RELATED EVENTS AND ARE NOT

  Patient problems: Clinical Endoleak

  MAUDE report 20903685 ↗
• InjuryOct 17, 2024Lack 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 CUFF. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM. A (NON-ENDOLOGIX) DRY SEAL SHEATH WAS INSERTED THROUGH THE RIGHT FEMORAL ARTERY AND A VELA SUPRARENAL WAS PLACED AT THE JUNCTION OF THE AFX2 BIFURCATED STENT GRAFT AND THE AFX VELA CUFF. AN ADDITIONAL EXCLUDER (NON-ENDOLOGIX) CUFF WAS PLACED TO REINFORCE THE FIXATION OF THE ADDED VELA SUPRARENAL. THE PROCEDURE WAS COMPLETED WITH A BALLOON CATHETER TOUCH-UP TO ENSURE THAT THERE WAS NO ENDOLEAK.

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 20476627 ↗
• InjuryJun 12, 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 AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). A VIABAHN (NON-ENDOLOGIX) STENT WAS IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY (CIA) AREA OF 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 FOUR AND HALF (4.5) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS EMERGENTLY TRANSFERRED FROM (B)(6) HOSPITAL DUE TO ANEURYSM RUPTURE. ANGIOGRAM SHOWED A TYPE IIIB ENDOLEAK SO THE PHYSICIAN ELECTED TO RELINE THE AFX2 BIFURCATED STENT GRAFT WITH AN EXCLUDER. PATIENT STATUS IS UNKNOWN.

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 19521548 ↗
• InjuryApr 11, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE ON (B)(6) 2021, DURING WHICH AN AFX2 BIFURCATED STENT GRAFT AND TWO AFX VELA SUPRARENALS WERE IMPLANTED. ON MARCH 26, 2024, THE PHYSICIAN REPORTED SUSPICION OF AN ENDOLEAK TYPE IIIB, WHERE THE DISTAL END OF THE CUFF TOUCHES THE MAIN BODY. DISCUSSIONS REGARDING PLANS FOR RE-INTERVENTION ARE UNDERWAY. THE PATIENT'S CONDITION IS REPORTED AS STABLE WITH NO COMPLICATIONS.

  Patient problems: Clinical Endoleak

  MAUDE report 19086990 ↗
• InjuryApr 5, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024. THE AFX2 DELIVERY SYSTEM WAS INSERTED, AND THE BIFURCATED STENT GRAFT WAS DEPLOYED WITHOUT A PROBLEM. WHEN THE PHYSICIAN PULLED THE CONTRALATERAL COVER, THE CONTRALATERAL LIMB WAS ABLE TO BE DEPLOYED; BUT THE YELLOW COVER STOPPED AFTER THE DEPLOYMENT AND THE COVER WAS UNABLE TO BE RETRIEVED. WHEN THE PHYSICIAN PULLED WITH A STRONG FORCE, THE COVER AND WIRE WERE PULLED OUT FROM THE BODY, BUT THE CONTRALATERAL WIRE WAS BROKEN. APPROXIMATELY 1CM OF THE PROXIMAL PORTION OF THE WIRE REMAINED INSIDE THE BODY AND WAS STILL ATTACHED TO THE AFX2 DELIVERY SYSTEM TIP. THE PHYSICIAN CONTINUED THE PROCEDURE AND DEPLOYED THE IPSILATERAL LIMB. WHEN REMOVING THE AFX2 DELIVERY SYSTEM, THE REMAINING PART OF THE CONTRALATERAL WIRE CAME OFF FROM THE AFX2 DELIVERY SYSTEM TIP. THE PHYSICIAN DID NOT NOTICE AT THAT POINT. THE AFX VELA SUPRARENAL WAS INSERTED. THE PHYSICIAN COULD FEEL A DIFFERENCE WHEN ADJUSTING THE AFX VELA SUPRARENAL POSITION BUT DID NOT NOTICE THAT IT WAS DUE TO THE DETACHED CONTRALATERAL WIRE. AFX VELA SUPRARENAL WAS DEPLOYED. THE PHYSICIAN NOTICED A FOREIGN MATERIAL (THE DETACHED CONTRALATERAL WIRE) I

  Patient problems: Foreign Body In Patient

  MAUDE report 19053673 ↗
• InjuryDec 27, 2023Improper or Incorrect Procedure or Method; Lack of Effect; Improper or Incorrect Procedure or Method; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT DURING THE PROCEDURE, AN ENDOLEAK OF INDETERMINATE ORIGIN WAS SUSPECTED, PROMPTING ADDITIONAL INTERVENTIONS, INCLUDING A BALLOON TOUCH-UP AND THE ADDITION OF AN EXCLUDER CUFF. IT WAS LATER DETERMINED THAT THE INDETERMINATE ORIGIN ENDOLEAK WAS A TYPE 2 (ANATOMY-RELATED) ENDOLEAK. APPROXIMATELY THREE (3) YEARS POST THE INITIAL PROCEDURE, A CT (COMPUTED TOMOGRAPHY) SCAN IDENTIFIED AN ANEURYSM ENLARGEMENT, BUT THE EXACT SOURCE OF THE ENDOLEAK WASN'T IDENTIFIED. THE PATIENT UNDERWENT A RE-INTERVENTION. ANGIOGRAPHY DID NOT REVEAL ANY ENDOLEAK, EVEN WITH ATTEMPTS TO IDENTIFY LEAKS UNDER THE RENAL ARTERIES. STENT GRAFTS WERE ADDED, INCLUDING THE EXCLUDER BODY AND CONTRALATERAL LEG, DESPITE NOT CONFIRMING THE LEAK. THE LAST ANGIOGRAPHY SHOWED NO ENDOLEAK, COMPLETING THE ADDITIONAL INTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 18406165 ↗
• InjuryAug 24, 2023Material 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 PROXIMAL EXTENSION. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A SUSPECT TYPE IIIB ENDOLEAK. WHILE SUBSEQUENT CT (COMPUTED TOMOGRAPHY) IMAGING SHOWED THE ENDOLEAK AT THE DISTAL EDGE OF THE VELA DEVICE, ANGIOGRAPHY DID NOT CONFIRM THE ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING FOUR (4) GORE (NON-ENDOLOGIX) EXCLUDER DEVICES ON (B)(6) 2023. REPORTEDLY, THE PATIENT WAS STABLE POST RE-INTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 17620227 ↗
• InjuryFeb 21, 2023Unintended Movement; Unintended Movement

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS SUBSEQUENT TO THE INITIAL PROCEDURE, THE PATIENT UNDERWENT A RE-INTERVENTION DUE TO IMPLANT MOVEMENT, CHARACTERIZED BY A DECREASE IN OVERLAP LENGTH. THE ATTENDING PHYSICIAN OPTED TO PROCEED WITH AN AFX VELA INFRARENAL IMPLANTATION. THE FINAL PATIENT STATUS WAS REPORTED AS BEING IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 16414617 ↗
• InjuryOct 11, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT RAFT AND AN AFX VELA INFRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY THREE YEARS POST INITIAL PROCEDURE THE PATIENT WAS IDENTIFIED WITH AN ANEURYSM ENLARGEMENT, AND AN ENDOLEAK TYPE 1B. THE PHYSICIAN IS PLANNING TO PERFORM A RE-INTERVENTION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15574416 ↗
• DeathSep 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND AN INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT THE PATIENT HAD POOR ANATOMY, DESCRIBED AS SEVERE CALCIFICATION AND A NARROWED EXTERNAL ILIAC ARTERY (EIA). AFTER THE STENT GRAFTS WERE IMPLANTED THE PROCEDURE WAS COMPLETED WITHOUT ANY ENDOLEAKS. FOUR (4) DAYS POST IMPLANT A SHOWER EMBOLIZATION EVENT OCCURRED AND THE PATIENT DETERIORATED TO A FATAL CONDITION. PER THE PHYSICIAN, THE INTERNAL ILIAC ARTERIES (IIA) WERE ALSO FOUND EMBOLIZED. THE PATIENT'S BLOOD PRESSURE CHANGED AND NECROSIS WAS OBSERVED IN THE LOWER LEGS AT THE TIME OF THE SHOWER EMBOLIZATION. DIALYSIS WAS PERFORMED AT THAT TIME. IT WAS REPORTED THAT THE PATIENT EXPIRED FOUR DAYS POST IMPLANT. THE CAUSE OF DEATH IS MULTI ORGAN FAILURE DUE TO INTESTINAL ISCHEMIA. BOTH THE IIA AND THE INFERIOR MESENTERIC ARTERY (IMA) WERE OCCLUDED AT THE SAME TIME WHEN THE STENT GRAFTS WERE IMPLANTED AND BECAUSE OF THROMBI WHICH COULD HAVE LEAD TO THE ISCHEMIA EVENT.

  Patient problems: Embolism/Embolus; Ischemia; Multiple Organ Dysfunction Syndrome; Necrosis

  MAUDE report 15341900 ↗
• InjuryJul 19, 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. APPROXIMATELY TWO (2) YEARS POST-INITIAL PROCEDURE, AN INDETERMINANT ENDOLEAK WAS IDENTIFIED AT THE ROUTINE FOLLOW-UP COMPUTERIZED TOMOGRAPHY (CT). TEN (10) DAYS LATER ANOTHER CT WAS PERFORMED AND ANEURYSM ENLARGEMENT OF APPROXIMATELY 10 MM WITH A TYPE IIIB ENDOLEAK WAS IDENTIFIED. REINTERVENTION WAS PERFORMED WITH THE IMPLANT OF A GORE (NON-ENDOLOGIX) EXCLUDER STENT INSIDE AFX2 BIFURCATED STENT GRAFT. THE TYPE IIIB ENDOLEAK WAS RESOLVED. THE FINAL PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15055283 ↗
• InjuryJun 20, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 5.5 YEARS POST INITIAL PROCEDURE, PATIENT WAS IDENTIFIED WITH ANEURYSMAL SAC GROWTH, A TYPE 1B ENDOLEAK AND A TYPE 2 ENDOLEAK. PATIENT IS BEING MONITORED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14744604 ↗
• InjuryMay 23, 2022Off-Label Use; Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND A MEDTRONIC ENDURANT LEG STENT (NON-ENDOLOGIX) 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 3 MONTHS POST INITIAL PROCEDURE, A TYPE II ENDOLEAK (NON- DEVICE RELATED FAILIURE) WAS IDENTIFIED WITH NO RE-INTERVENTION. NOW, REPORTEDLY, 6 MONTHS POST INITIAL PROCEDURE THE PATIENT PRESENTED WITH A RUPTURED ANEURYSM DUE TO A TYPE IIIB ENDOLEAK. THE PHYSICIAN ELECTED PERFORM AN OPEN REPAIR WITH EXPLANT THE DEVICES AND TREATED THE PATIENT WITH A Y-GRAFT (NON-ENDOLOGIX). THE RE-INTERVENTION WAS SUCCESSFULLY COMPLETED.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 14473997 ↗

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

…and 1 more.