Endurant® II ETLW1616C124E (UDI 00643169467675)Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00643169467675), received between Jan 27, 2017 and Sep 29, 2026 — classified as 9 deaths, 54 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (39 reports).

6 other recalls cover devices cleared under the same FDA submission (P100021); 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 79 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Leak/Splash

  Patient problems: Insufficient Information

  MAUDE report 50932772 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR FOR A 50 MM ANEURYSM, FOLLOWING THE BALLOONING OF THE IMPLANTED GRAFTS, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE. A POSSIBLE RUPTURED ILIAC ARTERY WAS IDENTIFIED JUST DISTAL TO THE RIGHT COMMON LIMB. THE STENT GRAFT ETLW1610C93E ENDUR II LIMB (16X10X93MM) WAS USED TO EXTEND FROM THE RIGHT COMMON LIMB TO THE RIGHT EXTERNAL ILIAC AS TREATMENT. PRE-OPERATIVE IMAGING, SHOWED BILATERAL MODERATE CALCIFICATION. THE EVENT WAS DISCOVERED DURING THE INDEX PROCEDURE. THE EVENT WAS RESOLVED BY EXTENSION OF THE LIMB TO THE RIGHT EXTERNAL ILIAC WITH THE STENT GRAFT. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED BY THE HEALTHCARE PROFESSIONAL.

  Patient problems: Rupture

  MAUDE report 24428160 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. THE PATIENT MADE CONTACT THROUGH TECHNICAL SERVICES AND REPORTED A POSSIBLE ALLERGIC REACTION DESCRIBED AS GI SYMPTOMS. TECHNICAL SERVICES THEREFORE PROVIDED INFORMATION ON THE STENT GRAFT MATERIALS. TWO DAYS LATER, ANOTHER CALLER AGAIN REQUESTED THE MATERIALS OF THE STENT GRAFT AND REPORTED A POTENTIAL REACTION. FURTHER INFORMATION WAS ATTEMPTED TO BE PROVIDED BUT WAS DECLINED AS IT WAS STATED THE INFORMATION WAS ALREADY RECEIVED. ANOTHER CALL WAS RECEIVED TO REPORT THE PATIENT HAD PAINS IN HIS ABDOMEN AND LOST WEIGHT AND WAS FOUND BY ALLEGISTS TO HAVE A PREVIOUSLY UNKNOWN NICKEL ALLERGY. PET SCANS SHOWED INFLAMMATION IN THE STOMACH. THE CALLER REQUESTED A SAMPLE OF THE STENT WHICH IT WAS EXPLAINED WE DO NOT PROVIDE AND ALTHOUGH THE MATERIALS OF THE STENT GRAFT WERE PROVIDED ACTUAL PERCENTAGES COULDN'T BE PROVIDED. THE PHYSICIAN CONFIRMED THAT THERE IS NO RECORD OF COMPLAINTS OF INFECTION OR ISSUES REGARDING THE ENDURANT DEVICE FOR THIS PATIENT.

  Patient problems: Local Reaction; Pain; Unspecified Gastrointestinal Problem

  MAUDE report 23001875 ↗
• InjuryMar 28, 2025Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM AAA. IT WAS REPORTED THAT DURING A FOLLOW-UP, BILATERAL TYPE IB ENDOLEAKS WERE NOTED. AN ILIAC LIMB WAS PLACED WITHIN ETLW1616C124E TO CORRECT THE TYPE IB ENDOLEAK ON THE LEFT SIDE, WHILE NO INTERVENTION WAS PERFORMED ON THE RIGHT SIDE. THE TYPE IB OF THE LEFT ILIAC WAS TREATED AND RESOLVED. DISEASE PROGRESSION OF THE COMMON ILIAC ARTERIES BILATERALLY WAS NOTED AS THE CAUSE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21718021 ↗
• InjuryMar 25, 2025Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN ON AN UNKNOWN DATE SHOWED A IB ENDOLEAK. INTERVENTION WAS TAKEN PLACE AND THE ENDOLEAK RESOLVED BY EXTENDING TO THE HYPOGASTRIC ARTERY WITH A 16 X 16 LIMB. PER THE PHYSICIAN, THE CAUSE OF THE TYPE IB ENDOLEAK IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21685814 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT LIMB WAS REGISTERED AS IMPLANTED DURING AN UNKNOWN PROCEDURE. IT WAS CLARIFIED THAT DURING THE PROCEDURE, THE ATTENDING SURGEONS IMPLANTED AN AUI DEVICE (ALWAYS BROUGHT TO CASES IN CASE OF EMERGENCY) INSTEAD OF THE PLANNED BIFURCATED DEVICE. THE SURGEONS DID NOT REALIZE THE MISTAKE UNTIL AFTER IMPLANTING TWO LIMBS INTO THE DISTAL END OF THE AUI AND DOING THE FINAL ANGIO RUN. THE ATTENDING CT SURGEON THEN CHOSE TO EXPLANT THE LIMB DEVICE FROM THE LEFT COMMON ILIAC ARTERY AND PERFORM A FEM-FEM BYPASS. THERE WERE NO TECHNICAL ISSUES WITH ANY OF THE ENDURANT DEVICES IMPLANTED. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 21571809 ↗
• InjuryFeb 25, 2025Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT LIMB WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ANEURYSM RUPTURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER THE PHYSICIAN HAD BALLOONED THE STENT GRAFT, A HOLE WAS SEEN IN THE LIMB. THE PHYSICIAN COVERED THE STENT GRAFT WITH ANOTHER ENDURANT II LIMB. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 21456476 ↗
• MalfunctionNov 19, 2024Device Damaged Prior to Receipt by User; Deformation Due to Compressive Stress; Device Damaged Prior to Receipt by User; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING AN INDEX PROCEDURE INVOLVING A STENT GRAFT ENDUR II LIMB, THE DEVICE WAS FOUND TO BE KINKED OUT OF THE BOX AND LINKED/DAMAGED OUT OF PACKAGING. THE STENT GRAFT AND/OR THE DELIVERY SYSTEM DID NOT COME INTO CONTACT WITH THE PATIENT. THE PATIENT WAS TREATED FOR A DISSECTION WITH A LENGTH OF 120 MILLIMETERS. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT LIMB FROM TRUNK STOCK AS A BACKUP DEVICE. IT WAS NOTED THAT THE BOX WAS SEALED WHEN OPENED AND THE KINK WAS OBSERVED ON THE PACKAGING TRAY. THE PHYSICIAN SUSPECTS THE BOX HAD BEEN BENT DURING SHIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725037 ↗
• DeathOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THREE ENDURANT STENT GRAFTS (ETLW1616C124E, SN (B)(6); ETLW1620C124E, SERIAL # (B)(6) AND ETLW1624C93E, SERIAL# (B)(6)) WERE IMPLANTED EMERGENTLY TO TREAT AN ANEURYSM RUPTURE DUE TO A TYPE IIIA ENDOLEAK INVOLVING A PREVIOUSLY IMPLANTED TALENT AAA STENT GRAFT SYSTEM IMPLANTED 16 YEARS PRIOR. THE PATIENT ALSO HAD AN ADDITIONAL ENDURANT II LIMB IMPLANTED 3 YEARS AND 10 MONTHS PRIOR TO THIS INTERVENTION. THE ENDURANT LIMBS HAD TO HAVE BEEN EXTENDED ALL THE WAY UP TO FLOW DIVIDER OF BIFURCATED TALENT GRAFT TO ACHIEVE A JUNCTIONAL SEAL FOLLOWED BY AGGRESSIVE BALLOONING WITH A RELIANT BALLOON. AN ANGIOGRAM CONFIRMED THE RESOLUTION OF THE TYPE III ENDOLEAK. THE PATIENT CONTINUED TO RECEIVE TREATMENT AFTER FOR COMPLICATIONS RELATED TO THE ANEURYSM RUPTURE. IT WAS REPORTED THE PATIENT EXPIRED. PER THE PHYSICIAN THE CAUSE OF THE TYPE III ENDOLEAK AND SUBSEQUENT RUPTURE IS UNDETERMINED. THE CAUSE AND EXACT DATE OF DEATH WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20514975 ↗
• InjuryOct 14, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60 MM AAA. IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN ON (B)(6) 2024 SHOWED A IA ENDOLEAK. INTERVENTION WAS PERFORMED APPROXIMATELY 8 YEARS AND 10 MONTHS POST-INDEX PROCEDURE WHERE A NON-MDT (TREO ENDOGRAFT) WAS IMPLANTED AND THE SMA AND BOTH RENAL ARTERIES WERE FENESTRATED AND STENTED. IT WAS REPORTED THAT BILATERAL TYPE IB ENDOLEAKS WERE ALSO TREATED WITH NON-MEDTRONIC STENTS AT THE SAME TIME. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 20437378 ↗
• InjuryOct 2, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTA ANEURYSM. AN ADDITIONAL ENDURANT LIMB ETLW1616C93E WAS IMPLANTED UNDER FIVE YEARS LATER DUE TO AN UNKNOWN REASON. IT WAS REPORTED THE FOLLOWING YEAR A FOLLOW UP CT REVEALED A TYPE IB ENDOLEAK ON ETLW1616C124E/ V07808220. A ETLW1610124E ILIAC EXTENSION WAS PLACED IN THE LEFT ILIAC AND THE IB ENDOLEAK SUBSEQUENTLY RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK WAS ANATOMY RELATED DUE TO DISEASE PROGRESSION OF THE OF ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 20350050 ↗
• InjuryMar 27, 2024Malposition of Device; Malposition of Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 54MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE DUE TO USER ERROR BOTH LIMBS WERE IMPLANTED AT THE IPSI-GATE. THE PHYSICIAN ELECTED TO CONVERT AND IMPLANT AN ENDURANT AUI TO THE RIGHT COMMON ILIAC WITH A FEM-FEM BYPASS AND LEFT COMMON ILIAC OCCLUSION. THE CAUSE WAS DUE TO USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 18987719 ↗
• InjuryMar 7, 2024Device Damaged by Another Device; Device Damaged by Another Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 52MM AAA. IT WAS REPORTED THAT 12 HOURS POST THE INDEX PROCEDURE IT WAS NOTED THAT THE RIGHT LIMB ETLW1610C156E WAS OCCLUDED DUE TO BEING CRUSHED IN THE DISTAL AORTA BY THE LEFT LIMB ETLW1616C124E . INTERVENTION WAS PERFORMED WHERE A THROMBECTOMY WAS PERFORMED. A NON-MDT STENT WAS PLACED IN THE RIGHT LIMB AT THE PROXIMAL END. A 10X59 BALLOON EXPANDABLE STENT WAS PACED AT THE SAME TIME IN THE LEFT LIMB TO PREVENT THAT SIDE FROM BEING CRUSHED, BUT THE LEFT LIMB WAS NOT BLOCKED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED. IT WAS NOTED THAT THERE WAS CALCIUM PRESENT IN THE DISTAL AORTA. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 18854656 ↗
• InjuryJan 31, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM (ESBF2814C103E) AND ENDURANT LIMBS (ETLW1620C93E) / (ETLW1616C124E) WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY. A CT SCAN IDENTIFIED A A TYPE IB ENDOLEAK ON ENDURANT LIMB (ETLW1616C124E). INTERVENTION WAS PERFORMED AND TWO ADDITIONAL ENDURANT LIMBS (ETLW1624C124E / ETLW1616C146E) WERE SUCCESSFULLY IMPLANTED RESOLVING THE TYPE IB ENDOLEAK.  IT WAS CONFIRMED THE 16/16/124 WAS THE ONLY GRAFT THAT CONTAINED A IB ENDOLEAK AND THERE WERE NO ISSUES WITH THE OTHER STENT GRAFTS. PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK WAS ANATOMY RELATED DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 18612197 ↗
• InjuryDec 14, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM (ESBF2814C103E) AND ENDURANT LIMBS (ETLW1616C93E & ETLW1616C124E) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 62MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2023. THE PROXIMAL AORTIC NECK WAS 23MM AND 26MM IN LENGTH WITH MILD NECK CALCIFICATION. MILD LEFT AND RIGHT ILIAC CALCIFICATION WAS NOTED. IT WAS REPORTED 4 DAYS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A COLD LEG. FOLLOW-UP IMAGING REVEALED A LIMB THROMBOSIS OF THE LEFT LIMB (ETLW1616C124E). ON (B)(6)2023, OPEN AORTO BIFEM INTERVENTION TO TREAT THE LIMB THROMBOSIS WAS PERFORMED. DURING THE PROCEDURE, BOTH ENDURANT LIMBS (ETLW1616C124E & ETLW1616C93E) WERE EXPLANTED, AND THE ENDURANT IIS (ESBF2814C103E) WAS PARTIALLY EXPLANTED, LEAVING THE SUPRARENAL FIXATIONS IN PLACE AND 2/3S OF THE MAIN BODY BIFURCATE. TWO ENDURANT II AORTIC CUFFS (ETCF2828C49E & ETCF3232C49E) WERE IMPLANTED TO SEAL THE PROXIMAL NECK ATTHE RENAL ARTERIES. HOWEVER, ON (B)(6) 2023 THE PATIENT CONTINUED TO EXPERIENCE PROXIMAL LEAKAGE DESPITE THE AORTO BIFEM PROCEDURE AND CUFF IMPLANTS. THE PHYSICIAN OPTED TO EXPLANT BOTH OF THE CUFFS AND NON MDT GRAFTS WERE IMPLANTED. PER THE PHYSICIAN THE CAUSE OF T

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 18333059 ↗
• MalfunctionSep 5, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ENDURANT II STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED 84MM AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE WHILE ATTEMPTING TO IMPLANT THE STENT GRAFT, THE GRAFT DEPLOYED AS NORMAL UNTIL THE 3 MOST DISTAL STENT RINGS WHICH REMAINED TIGHT. THE DELIVERY SYSTEM WAS REMOVED AND THE STENT GRAFT WAS OPENED WITH AN 8MM PTA BALLOON FOLLOWED BY A RELIANT BALLOON FOR FINAL EXPANSION. PER THE PHYSICIAN THE CAUSE OF THE DEPLOYMENT ISSUE IS UNKNOWN. NO ADDITIONAL SEQUELAEWERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17681621 ↗
• MalfunctionSep 5, 2023Device Damaged Prior to Receipt by User; Material Deformation; Device Damaged Prior to Receipt by User; Material Deformation

  AN ENDURANT II STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED 80.4MM AAA. IT WAS REPORTED THAT WHEN THE PRODUCT WAS OPENED THE DELIVERY SYSTEM WAS BROKEN. ANOTHER ENDURANT II STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE DEFORMATION WAS SHIPPING/ STORAGE RELATED. THERE WAS NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17681398 ↗
• DeathApr 20, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN AN ENDOVASCULAR PROCEDURE. IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE,THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. THE PATIENT SUBSEQUENTLY PASSED AWAY THE FOLLOWING DAY. NO CAUSE OF DEATH WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Pain

  MAUDE report 16776158 ↗
• MalfunctionDec 19, 2022Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED AAA .  IT WAS REPORTED ON THE DATE OF THE CT, ANEURYSM ENLARGEMENT AND A IB ENDOLEAK WAS NOTED.  PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY. IT WAS SAID THE SAC AND ILIAC ANATOMY HAS GROWN AND THE SEAL MAY BE COMPROMISED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003413 ↗
• InjuryNov 4, 2022Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA .  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY , WHERE A IB ENDOLEAK WAS DIAGNOSED. INTERVENTION WAS PERFORMED ON THE SAME DATE, AND BOTH ENDURANT LIMBS WERE EXTENDED WITH NEW LIMBS. THE ENDOLEAK (S) RESOLVED.  NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15729378 ↗
• InjuryJul 27, 2022Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 70CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE. CT SHOWED A TYPE IB ENDOLEAK FROM THE LEFT COMMON ILIAC DUE TO EXPANSION OF THE NATIVE ILIAC ARTERY. THE RIGHT COMMON ILIAC ARTERY HAD ALSO EXPANDED BUT THERE WAS NO ENDOLEAK OBSERVED. THE PROXIMAL MAIN BODY GRAFT HAD NO TYPE IA ENDOLEAK OR LOSS OR SEAL, BUT WAS 7MM DISTAL TO THE RENAL ARTERIES. THE PHYSICIAN DETERMINED THAT THERE WAS NOT ENOUGH AREA BELOW THE LEFT ILIAC GRAFT TO FLARE A LIMB. THE PHYSICIAN THEN COILED THE LEFT HYPOGASTRIC ARTERY, AND EXTENDED INTO THE LEFT EXTERNAL ILIAC ARTERY WITH A ETLW1616C93E ((B)(4)). THERE WAS ABOUT 1CM OF DISTANCE FROM THE RIGHT LIMB OF THE GRAFT (NO TYPE 1B LEAK), SO THE PHYSICIAN PLACED A ETLW1620C93E ((B)(4)) TO MAINTAIN A SEAL IN THE RIGHT COMMON ILIAC. A ETCF2525C49E ((B)(4)) WAS THEN PLACED INSIDE THE MAIN BODY OF THE ENDURANT GRAFT AT THE LEVEL OF THE RENAL ARTERIES. THE PHYSICIAN THEN PLACED HELI-FX ENDOANCHORS AT THE TOP OF THE PLACED CUFF. IVUS SHOWED THAT THE LEFT HYPOGASTRIC ARTERY WAS NOT YET THROMBOSED AND RECEIVING COL

  Patient problems: Insufficient Information

  MAUDE report 15112042 ↗
• DeathMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATED STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A RUPTURED 50MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED VIA THE POST PROCEDURE ANGIOGRAM THAT THERE WAS A PRESENCE OF A TYPE IA ENDOLEAK. THE PHYSICIAN RE-BALLOONED THE PROXIMAL AORTA BUT THE TYPE IA PERSISTED.  IT WAS REPORTED 2 DAYS LATER, THE PATIENT UNDERWENT AN OPEN EXPLORATORY ABDOMINAL REPAIR. THE BLOOD LOSS AND PROLONGED HYPOTENSION LED TO MULTI-SYSTEM FAILURE AND THE PATIENT EXPIRED. NO CAUSE OF THE TYPE IA ENDOLEAK WAS PROVIDED. NO CAUSE OF THE TYPE IA ENDOLEAK WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

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

  MAUDE report 14511996 ↗
• InjuryMay 4, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II LIMB STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A FOLLOW UP CT , DISEASE PROGRESSION AND A TYPE IB ENDOLEAK OF THE RIGHT COMMON ILIAC ARTERY WAS FOUND.  THE PATIENT HAD A COIL EMBOLIZATION TREATMENT PERFORMED , WITH NO ISSUES. THE PHYSICIAN PLANS TO IMPLANT A LIMB EXTENSION AT A LATER DATE. PER PHYSICIAN THE CAUSE WAS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 14277472 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II LIMB WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN 62MM X 67MM ABDOMINAL AORTIC ANEURYSM AND A SMALL DISSECTION PROXIMAL TO REIA. ENDOANCHORS WERE ALSO USED. A SMALL ANEURYSMAL AREA AND THROMBUS WERE ALSO FOUND PRIOR TO THE INDEX PROCEDURE. MODERATE LEFT ILIAC CALCIFICATION WAS NOTED. ACCESS DIAMETER OF THE LEFT ILIAC WAS 8.6MM. IT WAS REPORTED 2 WEEKS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED TO THE ER WITH COLD LEFT LEG. THE CT SCAN FOUND A LIMB OCCLUSION AND THE PATIENT UNDERWENT A FEM-FEM BYPASS. PER PHYSICIAN, THE CAUSE OF THE OCCLUSION COULD NOT BE DETERMINED, AND HYPERCOAGULATION ISSUES ARE SUSPECTED. NO ADDITIONAL CLINICALS SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 14216757 ↗
• InjuryFeb 17, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 58MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED A TYPE IB ENDOLEAK WAS OBSERVED ON THE RIGHT ENDURANT LIMB. THE PHYSICIAN EXTENDED THE LIMB WITH ETLW1616C93E THE NEXT DAY AND THE ENDOLEAK RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED AS THE GRAFT LIMB PLACEMENT ON INITIAL EVAR WAS SHORT.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13547602 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100021. One submission often covers many models, so check the product and lot details in each record.

• Z-0290-2022 · Oct 15, 2021 · Open, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• Z-0292-2022 · Oct 15, 2021 · Open, Classified
  Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STEN
• Z-0291-2022 · Oct 15, 2021 · Open, Classified
  Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT G
• Z-2136-2021 · Jun 7, 2021 · Open, Classified
  Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoili
• Z-2135-2021 · Jun 7, 2021 · Open, Classified
  Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infra
• Z-1543-2017 · Feb 27, 2017 · Terminated
  Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166