Endurant® II ETLW1624C93E (UDI 00643169467460)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169467460), received between Apr 20, 2017 and May 12, 2023 — classified as 2 deaths, 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA .  IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW-UP , A TYPE IB ENDOLEAK WAS NOTED WHEN A CT WAS PERFORMED.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16917911 ↗
• DeathNov 11, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION (V08147847) STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TYPE IA ENDOLEAK AS A ENDOGRAFT EXTENSION WITH BILATERAL RENAL ARTERY AND SMA SNORKELING. A ENDURANT II STENT GRAFT SYSTEM HAD BEEN IMPLANTED 3 YEARS AND 5 MONTHS PREVIOUSLY. ABOUT 5 MONTHS POST THE NAVION IMPLANT, THE PATIENT WAS STRUGGLING WITH VARIOUS ENDOLEAKS AND COIL EMBOLIZATION AND GLUE WAS USED AS TREATMENT. 4 MONTHS LATER, AN AORTIC ENDOLEAK REQUIRED INTERVENTION WITH ONYX GLUE. ANOTHER 8 MONTHS LATER, THE PATIENT HAS A TAAA THAT IS AT AN OPERABLE SIZE. THE PATIENT UNDERWENT AN OPEN REPAIR, A NON MDT BRANCH GRAFT WAS PLACED WHILE THE VALIANT NAVION V08147847 WAS EXPLANTED. ANOTHER 6 MONTHS LATER, A NEW THORACIC AORTIC ANEURYSM AND THORACOABDOMINAL AORTIC DISSECTION WERE OBSERVED SO 6 VALIANT NAVIONS WERE IMPLANTED. A CT SCAN WAS PERFORMED JUST OVER 3 MONTHS POST THE 6 VALIANT NAVION IMPLANTS. A CT OF THE CHEST DEMONSTRATES THE DIMENSIONS OF THE THORACIC AORTIC ANEURYSM IN THE APPEARANCE OF THE ENDOGRAFT REPAIR ARE STABLE. THE NATIVE ANEURYSM MEASURES UP TO 6.3 CM AXIALLY IN THE DESCENDING AORTA. THE DENSITY OF THE CLOT IN THE ANEURYSM OF THE DESCENDING THORACIC AORTA IS DIMINISHED FR

  Patient problems: Insufficient Information; Pleural Effusion

  MAUDE report 15779999 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS NOTED THAT THE PATIENT HAS HIGH VESSEL TORTUOSITY AND MILD VESSEL CALCIFICATION BOTH AT IMPLANT AND CURRENTLY. IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT APPROXIMATELY 4 YEARS AND 8 MONTHS AFTER THE INDEX PROCEDURE WHERE THROMBUS WAS OBSERVED INSIDE BOTH LEFT AND RIGHT ILIAC LIMBS . THE PHYSICIAN RELINED THE LEFT LIMB USING A 16-16-82 LIMB AND RIGHT LIMB WITH A 16-24-124 LIMB. AS PER THE PHYSICIAN THE CAUSE OF THE STENT THROMBUS IS UNKNOWN.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14732122 ↗
• InjuryApr 13, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 70 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ALMOST 6 YEARS LATER, THE PATIENT RETURNED FOR FOLLOW-UP,WHERE AN ENDOLEAK TYPE 1B WAS NOTED ON THE RIGHT LIMB. AN ETLW1613C114E WAS IMPLANTED TO TREAT THE EVENT THE FOLLOWING DAY. THE ENDOLEAK WAS RESOLVED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS ANATOMY DUE TO ENLARGED COMMON ILIAC ARTERY DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT FINE.

  Patient problems: Insufficient Information

  MAUDE report 11655234 ↗
• InjuryJan 21, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM GREATER THAN 50MM. IT WAS REPORTED THAT DURING A FOLLOW-UP APPROXIMATELY 27 MONTHS POST INDEX PROCEDURE, AN ENDOLEAK TYPE 1B WAS NOTED AT THE LCI. THE EVENT WAS TREATED WITH A LIMB EXTENSION TO HYPOGASTRIC ON THE SAME DAY. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO A LACK OF PURCHASE IN LCI AND TORTUOUSLY. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11206997 ↗
• InjuryAug 28, 2018Migration or Expulsion of Device; Increase in Pressure; Migration or Expulsion of Device; Increase in Pressure

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS LATER, THE PATIENT HAD A TYPE IB ENDOLEAK. THE RIGHT STENT GRAFT LIMB HAD MIGRATED TO A POSITION AWAY FROM THE RIGHT ILIAC AND INTO THE ANEURYSM SAC. THE PATIENT RECEIVED TREATMENT WITH THE ADDITION OF A STENT GRAFT LIMB AT THE FLOW DIVIDER OF EXISTING MAIN STENT GRAFT BODY AND AN EXTENSION TO THE RIGHT EXTERNAL ILIAC. THE RIGHT HYPOGASTRIC WAS ALSO EMBOLIZED AND THE ENDOLEAK WAS CONFIRMED AS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS SUSPECTED TO BE ANATOMY RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7822027 ↗
• InjuryJul 5, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF AN UNKNOWN SIZE. IT WAS REPORTED THAT, APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE, DURING A FOLLOW UP CT, ANEURYSM EXPANSION WAS OBSERVED WITH A LOSS OF SEAL ON THE IMPLANTED RIGHT ILIAC LIMB. IT WAS REPORTED THAT A TYPE I ENDOLEAK WAS OBSERVED FROM THE RIGHT ILIAC. IT WAS NOTED THAT AS THE ANEURYSM HAD EXPANDED DOWN TO THE HYPOGASTRIC ARTERY ON THE RIGHT THERE WAS NOT ROOM FOR SEAL UNLESS THE HYPOGASTRIC WAS COVERED. THE PHYSICIAN DECIDED TO EXPLANT THE STENT GRAFT AND DURING THE SURGERY A SMALL ANTERIOR WALL LEAK BY THE RENAL ARTERIES WAS DISCOVERED. IT WAS REPORTED THAT THE SURGICAL CONVERSION WAS SUCCESSFUL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Injury

  MAUDE report 7663637 ↗
• DeathJun 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM AND TALENT OCCLUDER PLUGS WERE IMPLANTED IN A PATIENT FOR THE EMERGENCY ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM AND WAS GREY IN COLOR UPON ARRIVAL. IT WAS REPORTED THAT THE PHYSICIAN CHOSE THE SIZING OF THE DEVICES VIA ANGIOGRAM CHOOSING AN ENDURANT AUI AND A 16X24X93 ENDURANT LIMB. TWO TALENT OCCLUDER PLUGS WERE IMPLANTED ON THE RIGHT SIDE TO OCCLUDE THE ILIAC ARTERY. ONCE THE EVAR PROCEDURE WAS COMPLETED THE PROCEDURE TRANSITIONED TO A FEM-FEM BYPASS. IT WAS REPORTED THAT THE PATIENTS¿ BLOOD PRESSURE WAS LOW DURING THE ENTIRE PROCEDURE AND REMAINED LOW AFTER THE EVAR. THE PHYSICIAN REMARKED THAT THE PATIENTS ABDOMEN FELT LIKE A DRUM AND THE DECISION WAS MADE TO OPEN UP THE ABDOMEN TO EXPLORE FOR INTERNAL BLEEDING, NONE WAS FOUND YET THE PATIENTS¿ BLOOD PRESSURE KEPT DROPPING. RESUSCITATION WAS ATTEMPTED FOR 20 MINUTES BUT THE PATIENT EXPIRED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO MULTIPLE COMORBIDITIES; CHRONIC RENAL FAILURE AND SHOCK. THE DEFINITIVE CAUSE OF THE RUPTURE COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUEL

  Patient problems: Cardiac Arrest; Death

  MAUDE report 7637059 ↗
• MalfunctionNov 14, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL APPROXIMATELY 6 YEARS AND 2 MONTHS POST INDEX PROCEDURE WITH ABDOMINAL PAIN. A CT SCAN SHOWED THAT THE ANEURYSM HAS GROWN FROM 5.5 CM TO 8.6CM A PROXIMAL TYPE I ENDOLEAK AND A DISTAL TYPE I ENDOLEAK WAS ALSO NOTED ON THE RIGHT. THE LEFT APPEARED TO HAVE A SEAL. THE PHYSICIAN IMPLANTED A 36X36X49 ENDURANT CUFF PROXIMALLY AND A 16X24X93 ENDURANT RIGHT SIDE EXTENSION DISTALLY. THE PROXIMAL ENDOLEAK HAS RESOLVED WITH THE CUFF PLACEMENT. THE RIGHT SIDE EXTENSION WAS PLACED WITH A SMALL RESIDUAL ENDOLEAK THAT WAS BALLOONED MULTIPLE TIMES. THE ENDOLEAK IMPROVED BUT THE DECISION WAS MADE TO HAVE A FOLLOW UP CT SCAN AFTER DISCHARGE. A RETROGRADE ANGIOGRAM WAS DONE ON THE LEFT SIDE AND NO ENDOLEAK WAS VISUALIZED. IT WAS REPORTED THAT THE PHYSICIAN CONFIRMED THAT, POST RE-INTERVENTION, THE PATIENT WAS NO LONGER HAVING ABDOMINAL PAIN OR TENDERNESS. PER THE PHYSICIAN THE EVENT WAS ANATOMY RELATED (DISEASE PROGRESSION). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7028195 ↗
• InjuryApr 20, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A RUPTURED ANEURYSM WHICH HAD PREVIOUSLY BEEN TREATED WITH AN ENDURANT STENT GRAFT. THE INITIAL CT COULD NOT IDENTIFY THE ENDOLEAK, BUT THE ABDOMEN HAD BLOOD THROUGHOUT. THE ANEURYSM IS CURRENTLY 7 CM IN DIAMETER. IT WAS NOTED THAT THE PATIENT HAD BEEN STABLE THROUGHOUT. AN ANGIOGRAM WAS THEN PERFORMED AND A TYPE IB ENDOLEAK WAS IDENTIFIED IN THE IPSILATERAL LIMB OF THE ENDURANT STENT GRAFT BIFURCATE. AN ILIAC EXTENSION WAS PLACED, BUT WAS ONLY ABLE TO GAIN AN ADDITIONAL 5 MM OF SEAL AND THE LEAK PERSISTED. THE RIGHT HYPOGASTRIC ARTERY WAS THEN COILED AND ANOTHER ILIAC EXTENSION WAS PLACED INTO THE RIGHT EXTERNAL ILIAC ARTERY AND A LEAK COULD NO LONGER BE SEEN. THIS REPORTEDLY RESOLVED THE EVENT. THE PHYSICIAN STATED THAT THE CASE OF THE TYPE IB ENDOLEAK WAS DUE TO PATIENT ANATOMY; SPECIFICALLY, THE CONTINUED DILATION OF THE ILIAC ARTERY. THE PHYSICIAN STATED THAT THE EVENT WAS NOT RELATED TO THE DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6509922 ↗

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-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-0290-2022 · Oct 15, 2021 · Open, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• 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