ENDURANT® ENBF2816C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994762498), received between Mar 20, 2017 and Oct 29, 2021 — classified as 1 death, 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2021Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 9 YEARS AND 2 MONTHS POST INDEX PROCEDURE FOR FAINTING. IT WAS DISCOVERED THAT THE PATIENT HAD A CONTAINED AORTIC RUPTURE AND A TYPE IA ENDOLEAK.  INTERVENTION WAS PERFORMED THE NEXT DAY, THE PHYSICIAN WAS ABLE TO CANNULATE THE TYPE IA ENDOLEAK AND WAS ABLE TO DEPLOY SEVERAL COILS INTO THE ANEURYSM SAC AND INTO THE ENDOLEAK CHANNEL. THE PHYSICIAN  THEN IMPLANTED A  NON MDT  CUFF AND FINALLY PLACED 3 HELI FX ENDOANCHORS. THIS RESOLVED THE EVENT.  AS PER THE PHYSICIAN THE CAUSE OF THE RUPTURE WAS THE POSTERIOR TYPE IA ENDOLEAK AND THE CAUSE OF THE IA ENDOLEAK IS UNKNOWN.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture; Syncope/Fainting

  MAUDE report 12717779 ↗
• DeathDec 18, 2020Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 5 MONTHS POST IMPLANT THE PATIENT HAD A IB ENDOLEAK OF THE LEFT LIMB. INTERVENTION WAS PERFORMED AND THE PHYSICIAN PLACED COILS BEHIND THE LIMB OF THE GRAFT AND THE ENDOLEAK APPEARED TO BE RESOLVED. APPROXIMATELY 5 MONTHS LATER, THE PATIENT PRESENTED WITH A RUPTURED ANEURYSM. THE PATIENT WAS REPORTED AS VERY UNSTABLE. THERE APPEARED TO BE IA ENDOLEAK OBSERVED ON ANGIO AND AN ENDURANT AORTIC CUFF WAS IMPLANTED. AN ENDURANT LIMB WAS BEING PREPPED TO BE IMPLANTED NEXT BUT AS THIS WAS BEING DONE, THE PATIENT BECAME PULSELESS. CPR WAS PERFORMED BUT THE PATIENT DID NOT RESPOND AND THE PATIENT EXPIRED. AS PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS ARE UNKNOWN. THE CAUSE OF THE RUPTURE WAS REPORTEDLY DUE TO THE IB ENDOLEAK. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Rupture

  MAUDE report 11035878 ↗
• InjuryApr 23, 2019Leak/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 A CT CARRIED OUT 8 YEARS LATER SHOWED THE GRAFT WAS NOT APPOSED ON THE POSTERIOR ASPECT AT THE LEVEL OF THE TOP OF THE GRAFT AND ANGULATED ANGIOGRAPHY SHOWED A TYPE IA ENDOLEAK. THE BIFURCATED STENT GRAFT WAS FULLY EXPANDED AND SEALED ON THE ANTERIOR SURFACE, BUT NOT THE POSTERIOR SURFACE. THE AORTA WAS MEASURING 30MM AT THE LEVEL OF THE POSTERIOR GRAFT MARKER. A 32MM CUFF (ETCF3232C49E) WAS IMPLANTED UP TO THE LEVEL OF THE RIGHT RENAL ARTERY GAINING APPROXIMATELY 6MM OF GRAFT ABOVE THE BIFURCATED STENT GRAFT ON THE POSTERIOR ASPECT. EIGHT ENDOANCHORS WERE THEN IMPLANTED, MAINLY ON THE POSTERIOR LATERAL SIDE. AFTER BALLOONING, THE ANGIOGRAPHY SHOWED A PERSISTENT TYPE IA ENDOLEAK WITH MUCH DIMINISHED RATE OF FLOW. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS BEING MONITORED.

  Patient problems: Injury

  MAUDE report 8539166 ↗
• MalfunctionDec 19, 2018Material Deformation; Material Deformation

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. THE PATIENT REPORTED APPROXIMATELY SEVEN YEARS LATER VIA TECHNICAL THAT HIS STENTS ARE SHRINKING. THE PATIENT HAS A FOLLOW UP APPOINTMENT SCHEDULED IN JANUARY. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8178129 ↗
• InjurySep 28, 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 EMERGENTLY. THE PATIENT HAD A PROXIMAL TYPE I ENDOLEAK AND THE RUPTURED AORTA. REVIEW OF THE FILMS REVEALED THAT THE ENDURANT BIFURCATED STENT GRAFT WAS INTENTIONALLY IMPLANTED LOW IN THE AORTIC NECK TO SALVAGE A LARGE ACCESSORY RENAL ARTERY. THE ENDOGRAFT REMAINED JUST BELOW THE LEVEL OF THE ACCESSORY RENAL WITH NO MIGRATION; HOWEVER THE AORTIC NECK HAD CONTINUED DISEASE PROGRESSION RESULTING IN AORTIC NECK DILATATION. THERE WAS 2-3CMS ABOVE THE ACCESSORY RENAL TO THE LEVEL OF THE PRIMARY RENAL ARTERIES. THE PHYSICIAN GAINED GUIDE WIRE ACCESS TO THE ACCESSORY RENAL AND COIL EMBOLIZED THE ACCESSORY RENAL ARTERY SO THERE WOULD BE NO BACK BLEEDING. THEN TWO ENDURANT AORTIC CUFFS 28X28X49 WERE IMPLANTED INTO THE PREVIOUS STENT GRAFT AND EXTENDED ABOVE THE BIFURCATED UP TO THE LEVEL OF THE PRIMARY RENAL ARTERIES. THE ENDURANT AORTIC CUFFS WERE THEN BALLOONED USING A RELIANT BALLOON. AN AORTAGRAM WAS THEN PERFORMED AND THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE TYPE I ENDOLEAK AND RUPTURED

  Patient problems: Rupture

  MAUDE report 6899940 ↗
• 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: Rupture

  MAUDE report 6509920 ↗
• InjuryMar 20, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 7 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A RECENT FOLLOW UP CT REVEALED A PROXIMAL TYPE I ENDOLEAK. THE FOLLOWING DAY THE PATIENT HAD AN INTERVENTION. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER MANUFACTURER¿S COVERED STENT, SNORKELING WITH A STENT IN LEFT RENAL ARTERY WHILE IMPLANTING AN ENDURANT AORTIC CUFF UP TO THE RIGHT RENAL ARTERY. APTUS ENDOANCHORS WERE IMPLANTED; HOWEVER, THE PROXIMAL TYPE I ENDOLEAK WAS NOT RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK WAS RELATED TO PATIENT¿S ANATOMY; SHORT AND ANGLED PROXIMAL AORTIC NECK. THE PATIENT ALSO HAS PROGRESSIVE SPINE DISEASE THAT MAY HAVE CONTRIBUTED TO THE INCREASED ANGULATION AND LOSS OF PROXIMAL STENT GRAFT SEAL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THE PHYSICIAN.

  Patient problems: Injury

  MAUDE report 6419189 ↗

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-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-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-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-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-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