Endurant IIRecalls & reported problems across all models

We found 114 models of Endurant II by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,594 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2016 and Sep 29, 2026 — classified as 186 deaths, 1,111 injuries, 297 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (853 reports).

5 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Endurant II recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 21, 2021Open, Classified

   Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.

   Z-0657-2022 · Root cause: Nonconforming Material/Component · names 33 of these models · Recall details · FDA record ↗

2. Oct 15, 2021Open, Classified

   Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

   Z-0291-2022 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗

3. Jun 7, 2021Open, Classified

   During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

   Z-2135-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Apr 28, 2021Terminated

   Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.

   Z-1976-2021 · Root cause: Process control · Recall details · FDA record ↗

5. Feb 27, 2017Terminated

   Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.

   Z-1543-2017 · Root cause: Packaging change control · names 12 of these models · Recall details · FDA record ↗

Most reported Endurant II problems

Endurant II models

114 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• Endurant® II ETCF2828C49E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls7 deaths44 reports
• Endurant® II ETUF2814C102E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls8 deaths37 reports
• Endurant® II ETUF3614C102E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls16 deaths36 reports
• Endurant® II ETBF3216C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls2 deaths32 reports
• Endurant® II ETCF3636C49E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall15 deaths77 reports
• Endurant® II ETBF2513C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls1 death22 reports
• Endurant® II ETBF2516C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls3 deaths17 reports
• Endurant® II ETBF2516C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls17 reports
• Endurant® II ETUF2514C102E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls3 deaths13 reports
• Endurant® II ETCF2525C49E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls1 death11 reports
• Endurant® II ETBF2313C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls3 deaths7 reports
• Endurant® II ETBF2316C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls2 deaths7 reports
• Endurant® II ETBF2513C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls7 reports
• Endurant® II ETBF2316C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls1 death5 reports
• Endurant® II ETBF2316C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 recalls1 report
• Endurant® II ETCF3232C49E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall7 deaths51 reports
• Endurant® II ETBF2816C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall49 reports
• Endurant® II ETBF2816C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall4 deaths41 reports
• Endurant® II ETBF3616C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall4 deaths40 reports
• Endurant® II ETBF3616C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death39 reports
• Endurant® II ETLW1616C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  9 deaths79 reports
• Endurant® II ETUF3214C102E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall8 deaths23 reports
• Endurant® II ETTF3636C70E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death21 reports
• Endurant® II ETBF2813C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death18 reports
• Endurant® II ETBF2813C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 deaths16 reports
• Endurant® II ETBF2313C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall15 reports
• Endurant® II ETLW1613C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  8 deaths64 reports
• Endurant® II ETBF3220C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death11 reports
• Endurant® II ETTF3232C70E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death11 reports
• Endurant® II ETUF2314C102E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall3 deaths11 reports
• Endurant® II ETBF2313C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death10 reports
• Endurant® II ETBF3216C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall9 reports
• Endurant® II ETBF2513C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death9 reports
• Endurant® II ETBF2516C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death8 reports
• Endurant® II ETCF2323C49E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall8 reports
• Endurant® II ETBF2820C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall7 reports
• Endurant® II ETTF2323C70E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 reports
• Endurant® II ETTF2525C70E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 reports
• Endurant® II ETTF2828C70E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 reports
• Endurant® II ETLW1620C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths50 reports
• Endurant® II ETLW1610C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths49 reports
• Endurant® II ETLW1610C156E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 deaths41 reports
• Endurant® II ETBF3216C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths40 reports
• Endurant® II ETLW1616C156E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths37 reports
• Endurant® II ETLW1616C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths34 reports
• Endurant® II ETLW1624C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths33 reports
• Endurant® II ETLW1613C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths29 reports
• Endurant® II ETLW1613C156E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths28 reports
• Endurant® II ETLW1620C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths25 reports
• Endurant® II ETLW1628C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths22 reports
• Endurant® II ETLW1620C156E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  16 reports
• Endurant® II ETLW1620C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  14 reports
• Endurant® II ETLW1610C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death14 reports
• Endurant® II ETLW1616C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  13 reports
• Endurant® II ETLW1624C156E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death12 reports
• Endurant® II ETLW1616C146E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  12 reports
• Endurant® II ETLW1628C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths11 reports
• Endurant® II ETLW1628C156E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death10 reports
• Endurant® II ETLW1624C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths10 reports
• Endurant® II ETBF2816C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  9 reports
• Endurant® II ETEW2828C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  9 reports
• Endurant® II ETEW2020C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death8 reports
• Endurant® II ETLW1616C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  8 reports
• Endurant® II ETLW1610C199E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  8 reports
• Endurant® II ETLW1610C146E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths8 reports
• Endurant® II ETBF3620C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death7 reports
• Endurant® II ETEW1313C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths7 reports
• Endurant® II ETLW1620C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 reports
• Endurant® II ETLW1620C146E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 reports
• Endurant® II ETBF3620C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  6 reports
• Endurant® II ETLW1628C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  6 reports
• Endurant® II ETEW1010C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths6 reports
• Endurant® II ETLW1616C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death6 reports
• Endurant® II ETLW1616C156E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  6 reports
• Endurant® II ETLW1620C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  6 reports
• Endurant® II ETLW1613C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths6 reports
• Endurant® II ETLW1613C199E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths6 reports
• Endurant® II ETLW1610C146E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  6 reports
• Endurant® II ETLW1613C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• Endurant® II ETLW1616C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• Endurant® II ETLW1624C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• Endurant® II ETLW1628C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death4 reports
• Endurant® II ETLW1620C156E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 reports
• Endurant® II ETLW1616C199E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death4 reports
• Endurant® II ETLW1613C146E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 reports
• Endurant® II ETLW1624C146E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 reports
• Endurant® II ETEW2424C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death3 reports
• Endurant® II ETLW1620C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• Endurant® II ETLW1624C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• Endurant® II ETLW1624C156E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• Endurant® II ETLW1620C146E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death3 reports
• Endurant® II ETLW1610C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Endurant® II ETLW1610C156E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Endurant® II ETLW1613C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Endurant® II ETLW1613C156E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Endurant® II ETLW1624C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Endurant® II ETLW1628C199E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death2 reports
• Endurant® II ETLW1624C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Endurant® II ETLW1610C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death2 reports
• Endurant® II ETLW1610C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports

Recent Endurant II adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Leak/Splash

  Patient problems: Insufficient Information

  MAUDE report 50932772 ↗
• InjurySep 28, 2026Leak/Splash; Migration or Expulsion of Device

  It was reported approximately 4 years post the index procedure, the patient presented emergently to an outside hospital with a ruptured aneurysm. Both implanted Endurant II limb stent grafts had reportedly pulled up into the aneurysm, and a Type Ib endoleak was identified. The patient was transferred to another healthcare facility and was treated using a non-Medtronic iliac branch device on the left side, embolization of the right internal iliac artery and extension of the right limb to the external artery. Per the physician, the aneurysm rupture was related to the Type Ib endoleak. The migration of the stent grafts into the aneurysm was attributed to disease progression. The reported event was resolved following treatment and no further patient complications were reported.

  Patient problems: Rupture

  MAUDE report 50912803 ↗
• InjurySep 25, 2026Leak/Splash

  It was reported that an endoleak was identified on a follow-up CT scan performed approximately four 4 post-index procedure. The source of the endoleak could not be determined from the CT scan; therefore, the patient underwent angiographic evaluation. Multiple angiograms were performed to assess the source of the endoleak and to rule out Type II, Type Ia, and Type Ib endoleaks. According to the physician, the endoleak was believed to be associated with a tear in the graft fabric involving the left limb stent graft ; however, the exact location of the defect could not be identified angiographically. The cause of the endoleak is unknown. Tortuous anatomy was noted, while calcification and thrombus were not considered contributing factors. The left limb was relined during after which the endoleak resolved. No further patient consequences were reported.

  Patient problems: Insufficient Information

  MAUDE report 50895063 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during treatment of a 61 mm abdominal aortic aneurysm, a type 1a endoleak from a previously implanted non-Medtronic product was treated with an Endurant II aortic cuff extension. There was 10 mm of proximal seal length between the right renal artery and the proximal edge of the previously implanted bifurcated graft. A 28 x 28 x 49 mm Endurant II aortic cuff extension was implanted. Guidewire was biased toward the left lateral aortic wall made exact visualization of the right lateral proximal graft position challenging. Completion  angiography identified partial coverage of the right renal artery, estimated at approximately 40%. The aortic extension landed in the intended position, and patient anatomy reportedly required partial right renal artery coverage to optimize the proximal seal zone. Intervention was required and a 7 mm renal stent was placed in the right renal artery to maintain patency. Completion angiography demonstrated patency of both renal arteries and no residual type 1a endoleak. Per the physician the cause of the occlusion was anatomy related and noted the patient¿s anatomy required partial coverage of right renal artery to optimize proximal sea

  Patient problems: Obstruction/Occlusion

  MAUDE report 50588321 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  An Endurant IIs stent graft system and Endurant cuff ETCF3636C49E were implanted during the endovascular treatment of a 37mm X 42mm abdominal aortic aneurysm with PAU. Left Hypogastric embolization due to Lt Common Iliac aneurysm was also performed. It was reported during the index procedure, the main body was landed low due to conical neck and ETCF3636C49E, was used to cuff up to the renal with no difficulty and the procedure completed. It was reported on the one month follow up it was identified that the left renal had been covered but still with flow into it. Review of CTA showed that it appeared the ostium of the left renal was occluded but had flow distal to the occlusion. Intervention was completed (b)(6) 2026) with the implant of a renal stent. Post the intervention the physician reported that the during the intervention procedure technically everything went fine putting stent in the left renal, but later the patient had some hypotension and some other renal issues. The patient is currently being monitored in ICU. Per the physician the cause was anatomy related due to conical Infrarenal neck. No additional clinical sequelae were reported and the patient is fine.

  Patient problems: Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Unspecified Kidney or Urinary Problem

  MAUDE report 50032301 ↗
• InjuryJun 12, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY TO THE EMERGENCY ROOM WITH PAIN. CT SHOWED AND AN ABDOMINAL AORTIC ANEURYSM MEASURING 65 MM WITH A CONTAINED AORTIC RUPTURE. THE LEFT ILIAC LIMB (ETLW1624C124E) HAD PULLED UP INTO THE ABDOMINAL AORTIC ANEURYSM SAC WITH AN ASSOCIATED TYPE IB ENDOLEAK. A 24MM LIMB WAS IMPLANTED O THE LEFT LIMB, AND THE EVENT WAS REPORTED AS RESOLVED. THERE WAS NO ENDOLEK ON THE RIGHT LIMB BUT THE PHYSICIAN DECIDED TO EXTEND THE DISTAL SEAL USING A 20MM LIMB. PER THE PHYSICIAN THE CAUSE WAS ANATOMY AND DISEASE PROGRESSION, WHICH WAS DESCRIBED AS A SHORT, DILATED, TORTUOUS ILIAC. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY POST INTERVENTION.

  Patient problems: Pain; Rupture

  MAUDE report 25485196 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 56MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 MONTHS POST THE INDEX PROCEDURE FOLLOW UP CT SHOWED LEFT ILIAC HAD DISEASE PROGRESSION ASSOCIATED WITH ETLW1628C146E AND HAD ENLARGED. THERE WAS NO ENDOLEAK BUT THE PHYSICIAN ELECTED TO EXTEND INTO THE EXTERNAL ILIAC BEFORE ANY ISSUES OCCURRED. 2 ENDURANT LIMBS (16-16-124 & 16-13-124 ) WERE IMPLANTED AND EXTENDED INTO THE LEFT EXTERNAL ILIAC ARTERY RESOLVING THE ECTATIC LCIA. PER THE PHYSICIAN THE CAUSE WAS DUE TO DISEASE PROGRESSION SINCE ORIGINAL PROCEDURE WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm expansion

  MAUDE report 25484356 ↗
• InjuryMay 28, 2026Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 90MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFIED A TYPE IB ENDOLEAK IN ETLW1620C146E ((B)(6)). INTERVENTION WAS COMPLETED. AN INITIAL ANGIOGRAM CONFIRMED A TYPE IB ENDOLEAK. A CATHETER WAS PLACED BEHIND THE GRAFT INTO THE ABDOMINAL AORTIC ANEURYSM SAC AND THE SAC WAS EMBOLIZED USING NON MDT (PENUMBRA COILS) AND GLUE. A RIGHT GRAFT LIMB EXTENSION ETLW1620C156E ((B)(6) WAS THEN IMPLANTED. AN INJECTION THROUGH THE SHEATH AGAIN SHOWED A TYPE IB ENDOLEAK. AFTER DISCUSSION, THE RIGHT HYPOGASTRIC ARTERY WAS EMBOLIZED AND THE RIGHT GRAFT LIMB WAS EXTENDED AND RELINED INTO THE PROXIMAL RIGHT EXTERNAL ILIAC ARTERY WITH ETLW1613C156E & ETLW1616C146E AND THE ENDOLEAK WAS CONFIRMED AS RESOLVED. PER THE PHYSICIAN THE CAUSE WAS DUE TO ANATOMY, SPECIFICALLY DILATATION OF THE RIGHT COMMON ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 25315803 ↗
• InjuryMay 27, 2026Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 70MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 9 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY. CT CONFIRMED THAT THE RIGHT ILIAC LIMB HAD PULLED OUT OF THE RIGHT ILIAC ARTERY. THE PHYSICIAN NOTED THAT THERE WAS SOME SORT OF TRAUMA TO THE PATIENT THAT MAY HAVE CAUSED IT SINCE PREVIOUS FOLLOW UP CT'S HAD ALL BEEN NORMAL BUT WAS UNSURE. INTERVENTION WAS COMPLETED WHERE THE RIGHT LIMB WAS RELINED. ENDURANT ILIAC LIMBS 16-16/124 AND A 16-16/93 ILIAC LIMB WERE IMPLANTED AND RESOLVED THE ENDOEAK. THE CAUSE WAS UNDETERMINED BUT POSSIBLE TRAUMA MAY HAVE CONTRIBUTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 25298689 ↗
• DeathMay 25, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 50 MM ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY 9.5 YEARS LATER WITH A RUPTURED ANEURYSM. IT WAS NOTED THAT THE PATIENT HAD A FALL AT THEIR HOME 3 DAYS BEFORE. TOTAL OCCLUSION OF THE RIGHT ILIAC LIMB, NOTED AS THE IPSILATERAL LIMB OF THE BIFURCATE WAS ALSO IDENTIFIED ON THE CT SCAN. AN ENDOLEAK WAS IDENTIFIED AND WAS SUSPECTED TO BE A TYPE III FABRIC ENDOLEAK. A 28 AUI STENT GRAFT WAS THEN IMPLANTED VIA THE LEFT SIDE BUT THE ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN ATTEMPTED TO ACCESS THE RIGHT LIMB BY CUTTING DOWN ON THE COMMON FEMORAL BUT WERE UNABLE TO PASS A WIRE UP THE LIMB SO NO THEY COULD NOT PERFORM ANY TREATMENT TO RESTORE FLOW. THE PRE-OPERATIVE CTA PERFORMED SHOWED THE RIGHT LIMB TOTALLY OCCLUDED , HOWEVER, THERE WAS SOME FLOW INTO THE RIGHT LIMB OBSERVED DURING THE PROCEDURAL ANGIOGRAM. IT WAS REPORTED THAT THE PATIENT EXPIRED ON THE SAME DAY. ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS ATTRIBUTED TO THE TYPE III ENDOLEAK FOLLOWING TRAUMA.

  Patient problems: Insufficient Information

  MAUDE report 25268828 ↗
• DeathMay 25, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 50 MM ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY 9.5 YEARS LATER WITH A RUPTURED ANEURYSM. IT WAS NOTED THAT THE PATIENT HAD A FALL AT THEIR HOME 3 DAYS BEFORE. TOTAL OCCLUSION OF THE RIGHT ILIAC LIMB, NOTED AS THE IPSILATERAL LIMB OF THE BIFURCATE WAS ALSO IDENTIFIED ON THE CT SCAN. AN ENDOLEAK WAS IDENTIFIED AND WAS SUSPECTED TO BE A TYPE III FABRIC ENDOLEAK. A 28 AUI STENT GRAFT WAS THEN IMPLANTED VIA THE LEFT SIDE BUT THE ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN ATTEMPTED TO ACCESS THE RIGHT LIMB BY CUTTING DOWN ON THE COMMON FEMORAL BUT WERE UNABLE TO PASS A WIRE UP THE LIMB SO NO THEY COULD NOT PERFORM ANY TREATMENT TO RESTORE FLOW. THE PRE-OPERATIVE CTA PERFORMED SHOWED THE RIGHT LIMB TOTALLY OCCLUDED , HOWEVER, THERE WAS SOME FLOW INTO THE RIGHT LIMB OBSERVED DURING THE PROCEDURAL ANGIOGRAM. IT WAS REPORTED THAT THE PATIENT EXPIRED ON THE SAME DAY. ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS ATTRIBUTED TO THE TYPE III ENDOLEAK FOLLOWING TRAUMA.

  Patient problems: Obstruction/Occlusion; Rupture

  MAUDE report 25268466 ↗
• DeathMay 25, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 50 MM ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY 9.5 YEARS LATER WITH A RUPTURED ANEURYSM. IT WAS NOTED THAT THE PATIENT HAD A FALL AT THEIR HOME 3 DAYS BEFORE. TOTAL OCCLUSION OF THE RIGHT ILIAC LIMB, NOTED AS THE IPSILATERAL LIMB OF THE BIFURCATE WAS ALSO IDENTIFIED ON THE CT SCAN. AN ENDOLEAK WAS IDENTIFIED AND WAS SUSPECTED TO BE A TYPE III FABRIC ENDOLEAK. A 28 AUI STENT GRAFT WAS THEN IMPLANTED VIA THE LEFT SIDE BUT THE ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN ATTEMPTED TO ACCESS THE RIGHT LIMB BY CUTTING DOWN ON THE COMMON FEMORAL BUT WERE UNABLE TO PASS A WIRE UP THE LIMB SO NO THEY COULD NOT PERFORM ANY TREATMENT TO RESTORE FLOW. THE PRE-OPERATIVE CTA PERFORMED SHOWED THE RIGHT LIMB TOTALLY OCCLUDED , HOWEVER, THERE WAS SOME FLOW INTO THE RIGHT LIMB OBSERVED DURING THE PROCEDURAL ANGIOGRAM. IT WAS REPORTED THAT THE PATIENT EXPIRED ON THE SAME DAY. ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS ATTRIBUTED TO THE TYPE III ENDOLEAK FOLLOWING TRAUMA.

  Patient problems: Rupture

  MAUDE report 25268460 ↗
• InjuryMay 18, 2026Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 12 YEARS POST THE INDEX PROCEDURE, DURING A CT SCAN FOR A DIFFERENT REASON AN INCIDENTAL FINDING OF AN ENDOLEAK WAS IDENTIFIED WITH COMMON ILIAC ARTERY ENLARGEMENT. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AT THE TIME OF THE FINDING. INTERVENTION WAS PERFORMED WHERE A LIMB EXTENSION (16-24-93) WAS IMPLANTED WITH AN EXCELLENT RESULT. THE PHYSICIAN ATTRIBUTED THE FINDING TO ANATOMY WITH DISEASE PROGRESSION OVER A 12-YEAR PERIOD. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm expansion

  MAUDE report 25199464 ↗
• InjuryMay 18, 2026Difficult to Remove; Device Damaged by Another Device

  IT WAS REPORTED THAT AN ENDURANT II AUI STENT GRAFT WAS USED DURING AN INITIAL PROCEDURE TO TREAT A 55 MM ABDOMINAL AORTIC ANEURYSM WITH PLANNED DEPLOYMENT OF A 28 AUI WITH A 10 MM LIMB EXTENSION TO THE RIGHT COMMON ILIAC ARTERY IN A PATIENT WITH A PRE-EXISTING OCCLUDED LEFT COMMON ILIAC ARTERY AND A PREVIOUSLY PLACED RIGHT COMMON ILIAC ARTERY STENT. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE RIGHT ILIAC STENT WAS PRE-DILATED WITH A 9 MM ANGIOPLASTY BALLOON, AND THE 28 AUI WAS ADVANCED AND SUCCESSFULLY DEPLOYED. IT WAS NOTED THAT THE DEVICE WAS INSPECTED UPON OPENING WITH NO ISSUES NOTED AND THE INSTRUCTIONS FOR USE WERE FOLLOWED DURING DEPLOYMENT. DURING RE-SHEATHING, THE DELIVERY SYSTEM BECAME STUCK ON THE PROXIMAL SEGMENT OF THE PRE-EXISTING ILIAC STENT, AND THE ILIAC STENT WAS PULLED BACK DURING ATTEMPTED RE-SHEATHING, CAUSING A BEND IN THE ILIAC STENT. THE PHYSICIAN WAS UNABLE TO REMOVE THE DELIVERY SYSTEM ACROSS THE BENT ILIAC STENT. AXILLARY ACCESS WAS OBTAINED AND A WIRE, CATHETER, AND BALLOON WERE ADVANCED FROM ABOVE IN AN ATTEMPT TO CROSS THE ILIAC STENT AND OPEN IT, BUT THIS WAS UNSUCCESSFUL. THE PATIENT WAS TRANSPORTED TO ANOTHER HOSPITAL FOR CONTINUATION OF CARE.

  Patient problems: Insufficient Information

  MAUDE report 25197398 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ETLW1616C156E STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 25MM LEFT COMMON ILIAC ANEURYSM. IT WAS REPORTED THAT DISEASE PROGRESSION IN THE LEFT COMMON ILIAC ARTERY WAS IDENTIFIED ON THE DATE THE PATIENT RETURNED FOR FOLLOW-UP APPROXIMATELY 10 YEARS POST-INDEX PROCEDURE, WITH NO ENDOLEAK OBSERVED ON ANGIOGRAPHY. EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY WAS PERFORMED THE NEXT DAY, AND THE STENT GRAFT WAS EXTENDED INTO THE LEFT EXTERNAL ILIAC ARTERY USING ETLW1613C124E. THE EVENT WAS REPORTED AS RESOLVED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm expansion

  MAUDE report 25147501 ↗

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