Endurant® IIs ESBF2814C103E (UDI 00643169439979)Recalls & reported problems

Summary

The FDA's MAUDE database contains 254 adverse event reports that list this exact device (DI 00643169439979), received between Dec 7, 2016 and Aug 31, 2026 — classified as 34 deaths, 176 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (147 reports).

2 FDA recall records name this device's identifier, 2 still open.

5 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · 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-0292-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 254 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Leak/Splash

  It was reported that a patient with a rapidly growing 6 mm abdominal aortic aneurysm was treated with an Endurant IIs stent graft system for a short-neck indication. The physician believed the aneurysm may have represented a contained rupture; however, pre-operative aneurysm rupture was reported as absent. A residual type 1a endoleak was identified during the index procedure following treatment. A 28 mm Endurant cuff was used to treat the residual type 1a endoleak. During the  procedure,  Endurant cuff outer box was found to be damaged; however,  the inner sterile packaging was not compromised, and the graft was use to successfully treat the patient and seal the type 1a leak. The damage to the box was considerd to be due to handling during shipping. It was reported that the main body did not seal the proximal edge of the renal artery ostium.

  Patient problems: Insufficient Information

  MAUDE report 50516760 ↗
• InjuryAug 7, 2026Leak/Splash; Malposition of Device

  An Endurant IIs stent graft system was implanted during the endovascular treatment of a 71mm abdominal aortic aneurysm. It was reported that during the index procedure, EVAR was performed and, upon completion angiography, the device was found not to have been delivered to the intended location. The proximal edge of the graft was positioned approximately 6 mm distal to the left renal artery, and a Type Ia endoleak was identified. An aortic extension ETCF2828C49E was placed in desired proximal position with no endoleak observed. Per the physician the cause is undetermined. No additional clinical sequelae were reported and the patient is fine.

  Patient problems: Insufficient Information

  MAUDE report 50173737 ↗
• MalfunctionMay 19, 2026Leak/Splash

  IT WAS REPORTED THAT A TYPE IA ENDOLEAK ASSOCIATED WITH AN ESBF2814C103E STENT GRAFT WAS IDENTIFIED ON A CT TAKEN ON AN UNKNOWN DATE. THE PHYSICIAN PLANS TO IMPLANT A CUFF EXTENDING TO THE RENAL ARTERIES; HOWEVER, THE PROCEDURE HAS NOT YET BEEN SCHEDULED. THE END OLEAK IS BELIEVED TO BE DUE TO DISEASE PROGRESSION. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221330 ↗
• MalfunctionApr 29, 2026Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED AS A PART OF A POST-MARKET CLINICAL STUDY. IT WAS REPORTED THAT A TYPE IA ENDOLEAK ENDOLEAK WAS IDENTIFIED ON THE SAME DATE OF THE INDEX PROCEDURE. NO INTERVENTION HAS BEEN PERFORMED. NO CAUSE WAS PROVIDED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25026634 ↗
• MalfunctionApr 29, 2026Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT SHOWED A TYPE IA ENDOLEAK IN THE NECK OF THE GRAFT. INTERVENTION IS PLANNED TO BE COMPLETED. PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK IS UNCERTAIN, BUT MAY BE RELATED TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25025663 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 1 MONTH LATER , THE PATIENT WAS DIAGNOSED WITH A CHRONIC KIDNEY DISEASE. THE PATIENT'S EGRF LEVELS DECLINED GREATER THAN 20 PERCENT COMPARED TO THE VALUE AT THE TIME OF IMPLANT TWO YEARS AGO. THE SITE ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE, INDEX PROCEDURE AND AN UNDERLYING CONDITION AND OR DISEASE.

  Patient problems: Renal Failure

  MAUDE report 24869222 ↗
• InjuryMar 26, 2026Malposition of Device

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR OF A 77 MILLIMETER ABDOMINAL AORTIC ANEURYSM, AFTER STANDARD EVAR WAS COMPLETED ON FINAL ANGIOGRAM THE PHYSICIAN WAS CONCERNED THAT THE GRAFT LANDED 5 MILLIMETERS BELOW THE RENAL ARTERIES (20MM NECK LENGTH). NO ENDOLEAK WAS OBSERVED. THE PHYSICIAN ELECTED TO IMPLANT A 28X49 ENDURANT II CUFF.  AFTER DEPLOYING THE ENTIRE CUFF BUT BEFORE RELEASE OF THE BARE SPRINGS THE PHYSICIAN WAS CONCERNED ABOUT BEING TOO HIGH ON THE RENALS. NEGATIVE PRESSURE ON THE DELIVERY SYSTEM WAS APPLIED WHILE ROTATING THE SMALL BLUE KNOB TO RELEASE THE BARE SPRINGS. THE BLUE KNOB WAS TURNED UNTIL IT COULD NOT TURN ANY FURTHER BUT DID NOT RELEASE AS INTENDED, LEAVING 3 MILLIMETERS OF BARE SPRINGS IN THE NOSE CONE. SLIGHT FORWARD PRESSURE ON THE DEVICE AND A WRIGGLING MOVEMENT WAS ATTEMPTED BUT THE BARE SPRINGS DID NOT RELEASE.  BAIL OUT TECHNIQUES WERE EMPLOYED AND THE BACK END WH EEL REMOVED TO TRY AND SLIDE CLEAR THE TABS FORWARD TO MANUALLY PUSH UP THE NOSE CONE TO RELEASE THE SPRINGS BUT THIS DID NOT WORK. A RELIANT BALLOON WAS INSERTED VIA THE CONTRA SIDE UP AGAINST THE NOSE CONE AND INFLATED. IT EFFECTIVELY RELEASED THE SPRINGS/HOOKS FROM THE NOS

  Patient problems: Insufficient Information

  MAUDE report 24696176 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED VIA TECHNICAL SERVICES THAT APPROXIMATELY 2 YEARS AND 4 MONTHS POST-INDEX PROCEDURE, THE PATIENT HAS EXPERIENCED FOUR EPISODES OF SEPSIS DUE TO PSEUDOMONAS AERUGINOSA, WHICH WERE ALLEGED TO HAVE BEEN CAUSED BY THE MEDTRONIC STENT GRAFTS. THE PATIENT ALSO EXPERIENCED TOXIC SHOCK. THE PATIENT IS CURRENTLY BEING TREATED WITH ANTIBIOTICS AND IS STABLE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: Sepsis; Septic Shock

  MAUDE report 24577501 ↗
• InjuryFeb 26, 2026Leak/Splash; Material Deformation

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED VIA TECHNICAL SERVICES THROUGH THE PATIENTS REPRESENTATIVE (PATIENTS WIFE) THAT SHORTLY AFTER THE INDEX PROCEDURE TH E PATIENT WAS THOUGHT TO HAVE AN ENDOLEAK. THE STENT GRAFT EVENTUALLY COLLAPSED AND A NEW STENT WAS IMPLANTED INSIDE THE STENT GRAFT 7 WEEKS POST IMPLANT. THE PATIENT IS NOW REPORTING PRESSURE WHEN EATING, A PROTRUSION BETWEEN THE DIAPHRAGM AND NAVAL WHEN LYING DOWN AND A GASSY FEELING WHEN EATING. THE PATIENT ALSO REPORTED EXTREME PRESSURE IN THE HEAD SINCE THE IMPLANT. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 24451440 ↗
• InjuryFeb 9, 2026Leak/Splash; Difficult to Remove; Malposition of Device; Device Damaged by Another Device; Material Deformation

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 65MM AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PROXIMAL ASPECT OF THE ENDURANT BIFURCATE WAS DEPLOYED AS NORMAL WITHOUT INCIDENT. DURING CANNULATION OF THE CONTRALATERAL GATE, THE IPSILATERAL LIMB'S DELIVERY SYSTEM WAS INADVERTENTLY PULLED DOWN, POTENTIALLY ENGAGING ONE OF THE BARE METAL STENTS AND CAUSING IT TO INVERT. THIS MAY HAVE OCCURRED OFF SCREEN SO IT WAS NOT SEEN. AFTER DEPLOYMENT OF THE CONTRALATERAL LIMB, SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING REMOVAL OF THE IPSILATERAL DELIVERY SYSTEM, AND THE STENT WAS OBSERVED TO ENGAGE IN THE TOP CAP AND SPINDLE OF THE DELIVERY SYSTEM. THE PHYSICIAN PASSED THE SYSTEM BACK UPWARD AND SEVERAL MORE ATTEMPTS WERE MADE ONLY RESULTING IN INVERSION OF THE BARE STENTS WHEN THE FORCE REQUIRED TO REMOVE THE DELIVERY SYSTEM REQUIRED WAS APPLIED. THE INVERSION CAUSED THE ENDURANT STENT GRAFT TO BE DRAGGED OUT OF THE NECK SEAL ZONE AND INTO THE ANEURYSM. INTRAVASCULAR ULTRASOUND WAS USED TO DETERMINE THAT THE LUMEN WAS MOSTLY CLEAR AND SUITABLE FOR AORTIC CUFF PLACEMENT. A 282849 CUFF WAS PLACED, BUT A TYPE 1A ENDOLEAK WAS OBSERVED

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289153 ↗
• DeathJan 22, 2026Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 54MM ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS NOTED THAT THE PHYSICIAN PERFORMED BILATERAL CUTDOWNS AND THE BEGINNING OF THE PROCEDURE AND WAS ASSISTED BY TWO FELLOW DOCTORS. DURING THE INDEX PROCEDURE, THE FINAL ANGIOGRAM APPEARED EXCELLENT, WITH NO ISSUES NOTED, AND THE CASE WAS DEEMED A SUCCESS. HOWEVER, IT WAS REPORTED THAT DURING CLOSURE, THE PATIENT'S BLOOD PRESSURE DROPPED, AND ALL VASCULAR ACCESS WAS LOST. THE PHYSICIAN QUICKLY REGAINED ACCESS, INSERTED A 16FR SHEATH, AND INFLATED A RELIANT BALLOON WITHIN THE BODY OF THE STENT GRAFT FROM THE LEFT SIDE. IT WAS SAID THAT THE RELIANT BALLOON HELPED DURING THE PROCEDURE, AS IT ALLOWED THE PHYSICIAN GAIN ACCESS ON THE OPPOSITE SIDE. IT WAS NOTED THAT DURING CLOSURE, THE RIGHT LIMB OF THE STENT GRAFT (ETLW1610C93E, SERIAL # (B)(6) WAS CRUSHED UPWARDS, RESULTING IN A RUPTURE OF THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN PROMPTLY RE-LINED THE STENT GRAFT USING A NON-MEDTRONIC STENT GRAFT. DESPITE THESE EFFORTS, THE PATIENT PASSED AWAY ON THE TABLE ON (B)(6) 2026. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE EVENTS, INCLUDING THE PATIENT'S DEATH

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 24142686 ↗
• InjuryNov 19, 2025Leak/Splash; Migration or Expulsion of Device; Detachment of Device or Device Component; Leak/Splash; Migration or Expulsion of Device; Detachment of Device or Device Component

  AN ESBF2814C103E STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT APPROXIMATELY 7 YEARS AND 8 MONTHS POST-INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH BACK AND ABDOMINAL PAIN. A CT SCAN WAS PERFORMED REVEALING AN ENLARGED AAA MEASURING 86MM IN DIAMETER WITH A LARGE TYPE 1A ENDOLEAK. IMAGING ALSO INDICATED SEPARATION OF THE SUPRARENAL STENT FROM THE ENDURANT BIFURCATED MAIN BODY GRAFT, WITH DISTAL MIGRATION OF THE GRAFT FABRIC. THE SUPRARENAL STENT REMAINED POSITIONED PROXIMAL TO THE RENAL ARTERIES, WHILE THE GRAFT FABRIC HAD MIGRATED DOWNWARD, LIKELY CONTRIBUTING TO THE TYPE 1A ENDOLEAK. THE PATIENT WAS TREATED WITH PLACEMENT OF A 28X49 ENDURANT AORTIC CUFF, REBUILDING THE GRAFT UP TO THE LEVEL OF THE RENAL ARTERIES. ADDITIONALLY, FOUR HELI-FX ENDOANCHORS WERE IMPLANTED TO ENHANCE SEAL AND FIXATION. THE ENDOLEAK WAS NO LONGER PRESENT FOLLOWING THIS INTERVENTION. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE SUPRARENAL STENT SEPARATION IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm expansion; Pain; Rupture

  MAUDE report 23592645 ↗
• InjuryNov 13, 2025Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 52 MM AAA. IT WAS REPORTED THAT DURING PATIENT FOLLOW-UP AN IA ENDOLEAK WAS OBSERVED. AN ENDURANT CUFF WAS IMPLANTED ON THE SAME DATE AS INTERVE NTION. THE ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO GROWTH OF THE ANEURYSM AND THE NECK DILATED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm expansion

  MAUDE report 23542044 ↗
• InjuryJul 31, 2025Leak/Splash; Obstruction of Flow; Leak/Splash; Obstruction of Flow

  IT WAS REPORTED THAT FOLLOWING THE TREATMENT OF A 55 MM ABDOMINAL AORTIC ANEURYSM USING AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM, A CONTRALATERAL LIMB OCCLUSION OCCURRED THAT COULD NOT BE CROSSED VIA ENDOVASCULAR METHODS. IT WAS CONFIRMED THAT THE ENDURANT STENT GRAFT LIMB ((B)(6)) HAD BEEN DEPLOYED INTO THE IPSILATERAL ENDURANT IIS STENT GRAFT LIMB DURING THE INDEX PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT EXHIBITED NO PALPABLE OR DOPPLERABLE PULSES DISTAL TO THE FEMORAL PULSE. THE LEFT LOWER EXTREMITY WAS NOTED TO BE COOL AND MOTTLED, WITH NO PALPABLE PULSE. A SURGICAL CUTDOWN TO THE LEFT COMMON FEMORAL ARTERY (LCFA) WAS PERFORMED, FOLLOWED BY AN ENDARTERECTOMY. AN ANGIOGRAM REVEALED AN OCCLUSION IN THE PROXIMAL TO MID PORTION OF THE CONTRALATERAL LIMB AT THE LEVEL OF THE AORTIC BIFURCATION. THE IPSILATERAL LIMB REMAINED FULLY PATENT WITH NO REDUCED FLOW, THIS WAS VERIFIED BY ANGIOGRAPHY. FOR A CAUSE THE PHYSICIANS DETERMINED THERE WAS A MECHANICAL OCCLUSION OF FLOW THROUGH THE LEFT LIMB AND SUBSEQUENT DISTAL ANATOMY, AND FELT THE CONTRALATERAL LIMB WAS "CRUSHED" BY THE IPSILATERAL LIMB. THE PHYSICIAN REPORTED THAT THE CALCIFIED AND NARROW 18MM AORTIC BIFURCATION LIKELY

  Patient problems: Obstruction/Occlusion

  MAUDE report 22673296 ↗
• InjuryJul 10, 2025Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 57 MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2025. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE BIFURCATE STENT GRAFT LANDED A LITTLE LOWER THEN PLANNED, THEREFORE THE PHYSICIAN OPTED TO IMPLANTED AN ENDURANT II AORTIC EXTENSION TO COVER UP TO THE LOWEST RENAL ARTERY. IT WAS NOTED THAT ANATOMY PLAYED A ROLE IN THE INACCURATE DELIVERY AS THE NECK WAS CONICAL AND ALSO THE PHYSICIAN MAY HAVE LET THE STENT GRAFT COME DOWN A LITTLE BIT DURING THE DEPLOYMENT PROCESS. SEVERAL HOURS AFTER THE PROCEDURE, THE PATIENT DEVELOPED A COLD LEG AND IT WAS NOTED THAT THE LEFT ILIAC LIMB HAD THROMBOSED. IT WAS CONFIRMED THE LEFT LIMBS WERE 16-20/124, 16-13/124, AND 16-10/124 THAT WERE OCCLUDED INTERVENTION WAS PERFORMED ONE DAY POST THE INDEX PROCEDURE. BARE METAL STENTS AND A 16-16/124 ENDURANT ILIAC LIMB WERE USED TO RE-LINE THE LIMB, AND A NON MDT CATHETER WAS USED TO REMOVE THE CLOT. THE HEALTHCARE PROFESSIONAL INDICATED THAT THE CAUSE OF THE EVENT WAS OVER-SIZING , THE PHYSICIAN FELT THE 16- 10 LIMB MAY HAVE BEEN SLIGHTLY OVERSIZED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 22466600 ↗
• InjuryJun 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT REPORTED TO THE PHYSICIAN TO HAVE EXPERIENCED RENAL FAILURE ON AN UNKNOWN DATE AFTER THE ORIGINAL IMPLANT. ADDITIONALLY, THE PATIENT WAS NOTED TO HAVE AN UNKNOWN ENDOLEAK IDENTIFIED ON AN UNKNOWN DATE. INTERVENTION WAS PERFORMED APPROXIMATELY 2 YEARS POST-INDEX PROCEDURE. THE LEFT HYPOGASTRIC ARTERY WAS COILED AND THE LEFT DISTAL SEAL WAS EXTENDED INTO THE LEFT EXTERNAL ARTERY WITH A ETLW1610C93E LIMB. THE ENDOLEAK TYPE COULD NOT BE DETERMINED AND IT IS UNKNOWN IF IT HAS SUCCESSFULLY RESOLVED AFTER THE INTERVENTION. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Renal Failure

  MAUDE report 22306018 ↗
• InjuryJun 20, 2025Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ENDURANT II STENT GRAFT WAS USED TO TREAT A 52 MM ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, AFTER COMPLETE DEPLOYMENT OF THE BIFURCATED DEVICE VIA THE RIGHT LEG, CANNULATION OF THE CONTRALATERAL GATE WAS ATTEMPTED FROM THE LEFT GROIN ACCESS. THE IPSILATERAL LIMB OF THE DEVICE WAS ACCIDENTALLY CANNULATED INSTEAD OF THE CONTRALATERAL LIMB, AND THIS ERROR WENT UNNOTICED INITIALLY. THE CONTRALATERAL LIMB TO THE LEFT LEG WAS THEN DEPLOYED INSIDE THE IPSILATERAL LIMB OF THE MAIN DEVICE, LEAVING THE CONTRALATERAL GATE OF THE MAIN DEVICE UN-CANNULATED. BOTH LIMBS WERE ULTIMATELY DEPLOYED INSIDE THE IPSILATERAL LIMB OF THE MAIN DEVICE, WITH NOTHING ON THE CONTRALATERAL SIDE. DURING THE FINAL DIAGNOSTIC RUN, SLOW FILLING ON THE LEFT SIDE AND A LARGE ENDOLEAK FILLING THE SAC WERE OBSERVED. IT WAS SUSPECTED THAT A CLOT INSIDE THE GRAFT WAS IMPEDING FLOW DOWN THE LEFT LEG , SO A VENOUS STENT WAS INSERTED BILATERALLY INSIDE THE LIMBS , WHICH IMPROVED FLOW. THE CAUSE OF THE INACCURATE DELIVERY WAS ATTRIBUTED TO USER ERROR. THE EVENT WAS RESOLVED ENDOVASCULARLY AT A DIFFERENCE HEALTHCARE FACILITY. A 16X24X124 MM LIMB WAS PLACED INTO THE LEFT LIMB AND UP TO THE FLOW

  Patient problems: Obstruction/Occlusion

  MAUDE report 22296194 ↗
• InjuryJun 11, 2025Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 51 MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2025. ADDITIONALLY, FOUR ENDOANCHORS WERE IMPLANTED. DURING THE INDEX PROCEDURE, AFTER THE FINAL DIAGNOSTIC RUN, DIFFICULTY WAS ENCOUNTERED WHEN ATTEMPTING TO REMOVE A WIRE FROM THE RIGHT GROIN. MULTIPLE ATTEMPTS TO REMOVE THE WIRE WERE UNSUCCESSFUL. FLUOROSCOPY REVEALED THAT TWO SUPRARENAL STENTS HAD BEEN PULLED DOWN BY THE WIRE, WHICH HAD BECOME CAUGHT IN THE SUPRARENAL DEVICE. A DIAGNOSTIC RUN SHOWED NO ENDOLEAK AND STABLE ENDOANCHOR PLACEMENT. A NON-MDT CATHETER AND THE APTUS SYSTEM DILATOR WERE ADVANCED OVER THE WIRE IN ATTEMPTS TO FREE IT, BUT THESE EFFORTS WERE UNSUCCESSFUL. THE WIRE WAS SUBSEQUENTLY CUT INSIDE THE PATIENT AT THE LEVEL OF THE MID EXTERNAL ILIAC USING AN ARTHROSCOPY CUTTING TOOL. AN NON-MDT 8X40MM SELF-EXPANDING STENT WAS DEPLOYED DISTAL TO THE HYPOGASTRIC ARTERY TO PUSH THE DISTAL END OF THE WIRE AGAINST THE VESSEL WALL. THE PROXIMAL END OF THE WIRE REMAINED KNOTTED AROUND THE INVERTED SUPRARENAL STENT, AND THE WIRE WAS LEFT IN THE PATIENT. A FINAL DIAGNOSTIC AORTOGRAM CONFIRMED NO ENDOLEAK. THE EVENT WAS ATTRIBUTE

  Patient problems: Insufficient Information

  MAUDE report 22182954 ↗
• InjuryJun 10, 2025Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM AAA. IT WAS REPORTED THAT A FOLLOW-UP CT SHOWED AN IA ENDOLEAK. THE EVENT WAS ATTRIBUTED TO DISEASE PROGRESSION RELATED TO ANATOMY. THE LEAK WAS DISCOVERED AT A FOLLOW-UP VISIT, AND A CUFF WAS PLACED TO ADDRESS THE ISSUE. THE LEAK WAS SUBSEQUENTLY REPORTED AS RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 22174944 ↗
• InjuryMay 23, 2025Malposition of Device; Malposition of Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE . IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PROXIMAL STENT GRAFT MIGRATED DISTALLY BY APPROXIMATELY 4MM DURING BALLOONING WITH A NON-MEDTRONIC BALLOON (CODA). AN AORTIC CUFF WAS IMPLANTED DURING THE INDEX PROCEDURE AS INTERVENTION . THE SPONSOR ASSESSED THE EVENT AS RELATED TO THE STUDY DEVICE AND THE INDEX PROCEDURE. THE SITE ASSESSED THE EVENT AS A TECHNICAL ERROR BY THE SURGEON DURING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 22076957 ↗
• MalfunctionMay 14, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A ESBF2814C103E ENDUR IIS BIFURCATE STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. ON AN UNKNOWN DATE A TYPE IA ENDOLEAK WAS NOTED IN A PATIENT WHO HAS A TORTUOUS AND SHORT AORTIC NECK. FUTURE TREATMENT IS PLANNED FOR THE PATIENT. THE REPORTED EVENT HAS NOT BEEN RESOLVED, AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016521 ↗
• InjuryMay 13, 2025Leak/Splash; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A AAA. IT WAS REPORTED THAT MULTIPLE TYPE II ENDOLEAKS WERE OBSERVED AND THE PATIENT UNDERWENT MULTIPLE ENDOVASCULAR INTERVENTIONS INCLUDING LUMBAR EMBOLIZATION AND COILING OF THE LEFT HYPO WITH EXTENSION INTO THE LEFT EIA EIGHT YEARS LATER. IT WAS REPORTED THAT ABOUT 18 MONTHS AGO THE PATIENT UNDERWENT AN IR EMBOLIZATION OF A MEDIAN SACRAL ARTERY. THERE WAS ANOTHER POSSIBLE TYPE II ENDOLEAK FROM AN L3 LUMBAR ARTERY THAT THE PHYSICIAN COULDN'T ACCESS AT THAT TIME. A CTA TAKEN SHOWED STABLE SAC SIZE BUT PERSISTENT ENDOLEAK. THE PATIENT WENT BACK FOR ADDITIONAL IR EMBOLIZATION OF THE IMA AND THE L3 LUMBAR. A CTA TAKEN SIX MONTHS LATER SHOWED STABLE SAC WITH PERSISTENT ENDOLEAK. A NON-CONTRAST CT FIVE MONTHS LATER SHOWED STABLE SAC SIZE. A CTA TAKEN 10 YEARS POST THE INDEX PROCEDURE SHOWED INCREASED SAC SIZE, A NEW TYPE IA ENDOLEAK, AND SUPRARENAL STENT SEPARATION. NO ISSUES WERE NOTED WITH THE ENDURANT ILLIAC LIMBS. THE PATIENT WAS THEN ADMITTED WITH ABDOMINAL PAIN AND FURTHER SAC ENLARGEMENT AND UNDERWENT OPEN EXPLANT AND REPAIR. THE SUPRARENAL FIXATION WAS COMPLETELY SEPARATED FROM THE REST OF THE

  Patient problems: Abdominal Pain; Aneurysm expansion

  MAUDE report 22011329 ↗
• MalfunctionMar 19, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE FOR TREATING A 65-MILLIMETER ABDOMINAL AORTIC ANEURYSM WITH A STENT GRAFT ESBF2814C103E ENDUR IIS BIF, A PORTION OF THE IMPLANTING PHYSICIAN'S GLOVE BECAME STUCK BETWEEN THE OUTER DELIVERY SHEATH AND THE STRAIN RELIEF. THE STRAIN RELIEF WAS CUT LONGITUDINALLY WITH AN 11 BLADE TO REMOVE THE GLOVE PIECE. HOWEVER, THE DEPLOYMENT MECHANISM IN THE DELIVERY SYSTEM WAS JAMMED, NECESSITATING A MANUAL DEPLOYMENT OF THE OUTER SHEATH AFTER BREAKING DOWN THE DELIVERY SYSTEM ON THE FIELD. THERE WAS NO INJURY TO THE PATIENT, AND THE CASE CONTINUED WITHOUT ANY INDICATION OF INJURY TO THE ACCESS VESSEL OR ASSOCIATED VASCULAR STRUCTURES. IT WAS STATED THE DELIVERY SYSTEM WAS IN PERFECT CONDITION PRIOR TO INSERTION IN THE PATIENT AND DEPLOYMENT, AND THERE WERE NO VISIBLE ISSUES WITH THE DELIVERY SYSTEM. ALL DEPLOYMENT STEPS WERE FOLLOWED PERT HE INSTRUCTIONS FOR USE ( IFU). THE EVENT WAS CAUSED BY AN EXTERNAL IMPLEMENT, IN THIS CASE, A GLOVE GETTING CAUGHT IN THE STRAIN RELIEF OF THE DELIVERY SYSTEM, WHICH CAUSE THE DELIVERY TO JAM. THE EVENT WAS ATTRIBUTED TO USER ERROR. THE DEVICE WAS SUCCESSFULLY DEPLOYED, AND THE DELIVERY SYSTEM WAS REMOVED, COMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641034 ↗
• MalfunctionFeb 7, 2025Leak/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 WAS IMPLANTED AS PART OF THE ADVANCE STUDY FOR THE TREATMENT OF ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED ON THE SAME DATE, CT IMAGING CONFIRMED THE PRESENCE OF A UNKNOWN TYPE ENDOLEAK. THE SPONSOR ASSESSED THE UNKNOWN ENDOLEAK AS BEING POSSIBLE RELATED TO THE INDEX PROCEDURE AND DEVICE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332500 ↗
• MalfunctionJan 20, 2025Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR PROCEDURE OF AN AAA IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN FOUR YEARS LATER SHOWED A POSSIBLE ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190322 ↗

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-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 i
• 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 aort
• 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