Endurant® IIs ESBF3614C103E (UDI 00643169439955)Recalls & reported problems

Summary

The FDA's MAUDE database contains 214 adverse event reports that list this exact device (DI 00643169439955), received between Dec 1, 2016 and Sep 24, 2026 — classified as 37 deaths, 125 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (130 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 214 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Leak/Splash; Material Deformation

  An Endurant IIs bifurcated stent graft system was implanted during the treatment of a 77mm abdominal aortic aneurysm. It was reported approximately 1 month post the index procedure, CT imaging identified a type Ia endoleak and stent graft infolding midway through the main body. Per the physician the cause of the event was undetermined and the event is unresolved. No additional clinical sequelae were reported and the patient is fine.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881829 ↗
• MalfunctionAug 24, 2026Difficult to Remove; Material Deformation

  An Endurant IIs stent graft (b)(6) was implanted during the endovascular treatment of a 58.5 mm abdominal aortic aneurysm. It was reported that during the index procedure, after visual inspection prior to use, the stent graft was delivered through the left common femoral artery to the implantation site. During deployment of the device, the physician applied gentle backward force pulling, rather than advancing, to keep the radiopaque markers aligned with the renal artery lines drawn on the screen. No resistance was felt by the physician. The device was delivered easily into position and implanted successfully. During removal of the delivery system, which was performed in accordance with the instructions for use (IFU), difficulty was encountered while attempting to remarry the delivery system , as the grey handle would not slide fully to the blue handle after advancing approximately halfway. Manual rotation of the blue handle was required to bring it into contact with the grey handle. Following removal, inspection identified a large twist or kink in the distal portion of the graft cover portion of the delivery device. The delivery device was successfully removed from the left groin,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50404789 ↗
• InjuryMar 10, 2026Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A AAA. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE. CT SHOWED A RUPTURE WITH NO EVIDENT ENDOLEAK. THE PHYSICIAN DECIDED TO COMPLETE AN OPEN REPAIR. DURING THE OPEN REPAIR, A HOLE WAS FOUND IN THE MAIN BODY LEFT LIMB SEGMENT OF THE STENT GRAFT ESBF3614C103E ENDUR IIS BIF, APPROXIMATELY 1 CM DISTAL TO THE FLOW DIVIDER. THE PATIENT UNDERWENT OPEN REPAIR AND EXPLANT OF THE MAIN BODY STENT GRAFT. THE STENT GRAFT ETLW1616C156E ENDUR II LIMB AND STENT GRAFT ETLW1620C156E ENDUR II LIMB WERE ALSO EXPLANTED AS PART OF THE INTERVENTION. THERE WAS NO ISSUES NOTED ON THE LIMBS. THE CAUSE OF THE RUPTURE AND TYPE IIIB ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 24558911 ↗
• MalfunctionFeb 10, 2026Leak/Splash; Material Deformation

  IT WAS REPORTED THAT AN ESBF3614C103E STENT GRAFT WAS USED TO TREAT A 60 MILLIMETER ABDOMINAL AORTIC ANEURYSM DURING THE INDEX PROCEDURE. THE PROXIMAL AORTIC NECK DIAMETER AT PRE IMAGING THE PROXIMAL AORTIC NECK DIAMETER WAS 22-29-30MM AND 40MM IN LENGTH. A LARGE INFOLD OF THE GRAFT OCCURRED FROM THE TOP OF THE GRAFT TO THE FLOW DIVIDER, WHICH CAUSED A TYPE 1 ENDOLEAK OBSERVED ON THE FIRST FINAL ANGIOGRAM AFTER IMPLANT. THE GRAFT INFOLD REMAINED VISIBLE ON FLUOROSCOPY IMAGES. DEVICE OVERSIZING WAS ALLEGED AS THE CAUSE OF THE EVENT. THE LEAK APPEARED TO HAVE DISAPPEARED AFTER RE-BALLOONING, BUT THE INFOLD PERSISTED. FUTURE COMPUTED TOMOGRAPHY SCAN IN THREE MONTHS AND POTENTIAL INTERVENTION IF A LEAK IS DETECTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS NOTED THAT THE INITIAL CASE PLAN WAS COMPLETED USING STANDARD CT AND NOT 3D. THE STANDARD CT SHOWED THE NECK SOMEWHAT LARGERSUGGESTING THAT A 36 GRAFT WOULD BE APPROPRIATE HOWEVER AFTER THE PROCEDURE REVIEW OF 3D ANALYSIS SUGGESTED A 36 GRAFT WAS OVERSIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303640 ↗
• InjuryJan 14, 2026Leak/Splash; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR FOR A 73 MM ANEURYSM, THE STENT GRAFT ESBF3614C103E ENDUR IIS BIF WAS IMPLANTED IN THE ABDOMINAL AORTA. DURING THE INDEX PROCEDURE, THE OPERATOR INSERTED THE 36 EIIS IPSILATERALLY ON THE PATIENT¿S LEFT SIDE AND POSITIONED THE PROXIMAL M ARKERS AT THE BOTTOM OF L1. THE DESIRED GATE ORIENTATION WAS ANTERIOR AND SLIGHTLY TO THE PATIENT¿S LEFT. THE OPERATOR SETTLED ON AN ORIENTATION WITH THE GATE AROUND 1PM, WITH THE ¿E¿ MARKER CLEARLY VISIBLE AND ITS TAIL POINTING TOWARD THE PATIENT¿S LEFT. NO LAO/RAO OBLIQUITY WAS NECESSARY TO VISUALIZE THE TARGET RIGHT RENAL OSTIUM. A 20-DEGREE CRANIAL ANGULATION WAS USED TO ELIMINATE PARALLAX ON THE MAIN BODY PROXIMAL MARKERS. CONTRAST WAS INJECTED VIA A PIGTAIL CATHETER FROM THE PATIENT¿S RIGHT, AND THE TARGET RIGHT RENAL WAS MARKED. THE OPERATOR POSITIONED THE FOUR PROXIMAL MARKERS AT THE MID-OSTIUM OF THE RIGHT RENAL AND PROCEEDED TO OPEN THE GRAFT COVER ON THE MAIN BODY. AS THE GRAFT COVER WAS ABOUT TO PASS THE FIRST ROW OF STENT RINGS (WITH APPROXIMATELY 8¿9 MM OF GRAFT MATERIAL UNCOVERED), A RAPID MOVEMENT WAS OBSERVED IN THE STENT RINGS ON THE PATIENT¿S RIGHT SIDE OF THE MAIN BODY. TH

  Patient problems: Insufficient Information

  MAUDE report 24065363 ↗
• MalfunctionNov 12, 2025Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THE STENT GRAFT ESBF3614C103E ENDUR IIS BIF WAS IMPLANTED IN THE PROXIMAL AORTA DURING A PROCEDURE TO TREAT A 55 MM ANEURYSM. A CT SCAN PERFORMED 2 MONTHS LATER SHOWED THAT THE PROXIMAL GRAFT WAS INFOLDED, RESULTING IN A TYPE IA ENDOLEAK. 1.5 YEARS LATER, A FOLLOW-UP CT SHOWED THAT THE INFOLDING HAD RESOLVED. AN ANGIOGRAM PERFORMED THE FOLLOWING DAY CONFIRMED THAT THE TYPE IA ENDOLEAK WAS NO LONGER PRESENT. BOTH THE STENT GRAFT INFOLDING AND THE TYPE IA ENDOLEAK WERE REPORTED TO HAVE SELF-RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNDETERMINED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530421 ↗
• MalfunctionOct 24, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE FOR TREATMENT OF A 57MM ANEURYSM, THE STENT GRAFT ESBF3614C103E ENDUR IIS BIF WAS IMPLANTED IN THE ABDOMINAL AORTA. A COMPLETION ANGIOGRAM IDENTIFIED A TYPE 1A ENDOLEAK, ALTHOUGH THE POSITION OF THE PROXIMAL GRAFT EDGE WAS OPTIMAL AND ENDOANCHORS WERE PLACED IN THE DESIRED LOCATIONS. NO ADDITIONAL STEPS WERE TAKEN AT THE TIME, AND FOLLOW-UP IMAGING WAS PLANNED IN 30 DAYS TO FURTHER EVALUATE THE SITUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377247 ↗
• InjurySep 15, 2025Leak/Splash; Leak/Splash

  A ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 58MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A FINAL CONTRAST ANGIOGRAM REVEALED A TYPE IA ENDOLEAK INVOLVING THE ESBF3614C103E BIFURCATE STENT GRAFT. AN ENDURANT CUFF (ETCF3636C49E) WAS PLACED TO TREAT THE ENDOLEAK AND WAS DEPLOYED WITHOUT ISSUE. HOWEVER, DURING REMOVAL OF THE ENDURANT CUFF DELIVERY SYSTEM, THE SPINDLE CAUGHT THE STENT STRUTS, PULLING ONE OF THE STRUTS DOWNWARD AND CAUSING IT TO REMAIN IN THIS POSITION. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO REPOSITION THE STENT STRUT USING A 12MM BALLOON AND A RELIANT BALLOON. SINCE THE TYPE IA ENDOLEAK WAS RESOLVED, THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT FURTHER ISSUES. PER THE PHYSICIAN, THE CAUSE OF THE EVENTS WAS ANATOMY RELATED DUE TO AN ANGLED AND CONICAL INFRARENAL AORTIC NECK. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 23050517 ↗
• InjuryJun 23, 2025Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  AN ENDURANT IIS BIFURCATE STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 65MM AAA.  POST-OPERATIVELY,  A TYPE IA ENDOLEAK WAS DISCOVERED ON CT. THE ENDOLEAK WAS ATTRIBUTABLE TO IN-FOLDING IN THE BODY OF THE BIFURCATED GRAFT, WHICH WAS WELL-POSITIONED AT THE RENAL ARTERIES. THE PATIENT WAS TREATED NON-EMERGENTLY WITH TWO NON MDT STENTS IMPLANTED TO FLATTEN THE IN-FOLDING, WHICH ELIMINATED THE ENDOLEAK . THERE WERE ACCESS ISSUES WITH THE CLOSURE DEVICES, AND A CUTDOWN WAS PERFORMED ON THE RIGHT FEMORAL ARTERY TO CLOSE THE ACCESS SITE.  PER THE PHYSICIAN THE CAUSE OF THE INFOLDING/ IA ENDOLEAK COULD NOT BE DETERMINED.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22306224 ↗
• InjuryMay 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ABDOMINAL PAIN, AND A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) CONFIRMED A 1A ENDOLEAK ASSOCIATED WITH THE STENT GRAFT ESBF3614C103E ENDUR IIS BIF. THE AAA MEASURED 75MM. THE PATIENT HAD DISEASE PROGRESSION, AND LOSS OF PROXIMAL SEAL. THE HEALTHCARE TEAM INTERVENED WITH TWO 36X49 CUFFS TO CORRECT THE 1A ENDOLEAK. THE CAUSE OF THE EVENT WAS ATTRIBUTED TO ANATOMY-RELATED FACTORS.

  Patient problems: Abdominal Pain; Insufficient Information

  MAUDE report 22070096 ↗
• MalfunctionMay 22, 2025Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM AAA . IT WAS CONFIRMED THERE WAS NO DIFFICULTY IN DEPLOYING THE STENT GRAFT OR REMOVING THE DELIVERY SYSTEM. IT WAS REPORTED THAT ON THE ONE MONTH FOLLOW-UP ON CT, THE PHYSICIAN INITIALLY THOUGHT THERE WAS A PERSISTENT TYPE II ENDOLEAK BUT UPON FURTHER REVIEW IT IS REPORTED THAT THERE IS AN INFOLDING OF THE MAIN BODY AND A IA ENDOLEAK. THE CAUSE OF THE INFOLDING AND IA ENDOLEAK CANT NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22068268 ↗
• InjuryMay 6, 2025Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT A PATIENT WITH A 77 MM ANEURYSM EXPERIENCED A PRE-OPERATIVE ANEURYSM RUPTURE AND WAS TREATED WITH A STENT GRAFT ESBF3614C103E ENDUR IIS BIF. APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE, A TYPE IA ENDOLEAK AND GRAFT INFOLDING WERE IDENTIFIED. THE GRAFT EXHIBITED A CRESCENT SHAPE INFOLDING TOWARDS THE FLOW DIVIDER, AND A SMALL TYPE 1 ENDOLEAK WAS NOTED. INTERVENTION WAS PERFORMED APPROXIMATELY 3 MONTHS LATER, INCLUDING INTRAVASCULAR ULTRASOUND AND BALLOONING WITH TWO RELIANT BALLOONS; HOWEVER, THE INFOLD AND ENDOLEAK REMAINED UNRESOLVED. A DECISION WAS MADE TO USE AN APTUS DEVICE TO ADDRESS THE SMALL TYPE IA ENDOLEAK. THE LEAK WAS NOT VISIBLE ON ANGIOGRAMS, LEAVING ITS RESOLUTION UNCERTAIN. IT WAS NOTED THAT THE PATIENT GOT VERY SICK AFTER THE CT SCAN AND WAS HOSPITALIZED AND NEEDED EXTRA TIME TO RECOVER FROM HIS HOSPITALIZATION. A REPEAT COMPUTED TOMOGRAPHY SCAN WAS PLANNED TO FURTHER EVALUATE THE STENT GRAFT AND ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK AND INFOLDING IS UNDETERMINED. IT WAS STATED THAT NO THROMBUS, CALCIFICATION, TORTUOSITY, OR GRAFT OVERSIZING CONTRIBUTED TO THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE

  Patient problems: Insufficient Information

  MAUDE report 21966524 ↗
• InjuryMay 2, 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 THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROX. 10 YEARS, 4 MONTHS POST INDEX PROCEDURE, AN INTERVENTION WAS PERFORMED TO ADDRESS ISSUES WITH THE EXISTING STENT GRAFTS. TWO 20X20X82 MM ENDURANT II STENT GRAFT EXTENSIONS WERE IMPLANTED.. THE EVENT WAS RESOLVED WITH THE DEVICES REMAINING IMPLANTED AND IN SERVICE.

  Patient problems: Insufficient Information

  MAUDE report 21948234 ↗
• MalfunctionApr 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A 30 DAY FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) AFTER AN ENDOVASCULAR AORTIC REPAIR, AN INFOLDING OF THE BIFURCATED ENDURANT IIS GRAFT WAS OBSERVED. THE INFOLD EXTENDED FROM THE PROXIMAL FABRIC THROUGH THE GRAFT BIFURCATION AND WAS THROMBOSED THROUGHOUT, ALTHOUGH IT DID NOT APPEAR TO BE CAUSING A LEAK AT THAT TIME. THE PATIENT HAD BEEN TREATED FOR A 63MM ANEURYSM WITH THE ENDOVASCULAR AORTIC REPAIR . NO ISSUES WERE REPORTED DURING THE IMPLANT PROCEDURE OR THE POST-IMPLANT ANGIOGRAM ON THE DAY OF THE PROCEDURE. . THE CAUSE OF THE INFOLDING WAS NOTED TO BE THE EXTENSIVE THROMBUS IN THE PROXIMAL NECK AT THE TIME OF IMPLANT. AS THERE IS NO LEAK DUE TO THE PRESENCE OF THROMBUS, NO INTERVENTION IS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21772272 ↗
• InjuryApr 4, 2025Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. THE PATIENT CONTACTED TECHNICAL SERVICES SEVEN MONTHS LATER AND STATED THAT THERE WAS A SMALL LEAK IN ONE OF THE STENT GRAFTS AND A SECONDARY PROCEDURE WAS NEEDED TO REPAIR THE LEAK. THE ENDOLEAK WAS FOUND DURING ROUTINE FOLLOW-UP AND THE PATIENT HAD NO SIGNS OR SYMPTOMS. THE SECONDARY PROCEDURE WAS PERFORMED AND AN ENDURANT II STENT GRAFT WAS IMPLANTED. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 21772179 ↗
• InjuryApr 2, 2025Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE INVOLVING THE IMPLANTATION OF A 36MM ENDURANT IIS STENT GRAFT FOR THE TREATMENT OF A 55MM ANEURYSM, THERE WAS A MODERATE THROMBUS BURDEN SO NO POST DILATATION OF THE MAIN BODY STENT GRAFT WAS PERFORMED DURING INDEX PROCEDURE DUE TO THROMBUS. ON A CT SCAN 25 DAYS LATER IT WAS NOTED THAT THE MAIN BODY OF THE STENT GRAFT EXHIBITED INFOLDING, APPEARING TO HAVE STARTED AT THE TOP PORTION OF THE STENT GRAFT WHICH ALSO LED TO A IA ENDOLEAK. CT IMAGING ALSO REVEALED THAT THE "E" MARKER ON THE MAIN BODY NEVER FULLY OPENED. NO ISSUES WERE OBSERVED WITH THE ENDURANT LIMBS. IT WAS NOTED THAT THE PHYSICIAN PLANS TO SCAN THE PATIENT IN 3 MONTHS TO ASSESS IF THE GRAFT WILL OPEN MORE AS THE THROMBUS DISSIPATES. THE CAUSE THE INFOLDING WAS POSSIBLY DUE TO THROMBUS BURDEN IN THE PROXIMAL SEAL ZONE WHICH NARROWED THE FLOW LUMEN. IT WAS CONFIRMED THE STENT GRAFT WAS SIZED APPROPRIATELY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21751064 ↗
• DeathMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFTS SYSTEM AND ENDOANCHORS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA AS PART OF THE HERCULES POST MARKET CLINICAL STUDY. APPROXIMATELY 5 WEEKS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH LOWER ABDOMINAL PAIN AND CONSTIPATION. THE PATIENT WAS ALSO NOTED TO BE EXPERIENCING DELIRIUM. THE PATIENT HAD A CT SCAN THE FOLLOWING DAY WHICH SHOWED A NON-ENHANCEMENT OF THE LOWER AND MID POLES OF THE RIGHT KIDNEY IN KEEPING WITH AN ACUTE INFARCTION. THERE WAS A PERINEPHRIC INFLAMMATORY STRANDING WHICH WAS SAID TO BE LIKELY THE CAUSE OF THE PATIENTS SYMPTOMS. ABRUPT FILLING DEFECT IN THE DISTAL HILAR ASPECT OF THE MORE LATERAL BRANCH OF THE RIGHT RENAL ARTERY IS CONSISTENT WITH ARTERIAL INFARCT. MINOR INFARCT SEEN ON THE LEFT UPPER POLE OF THE LEFT KIDNEY. IT IS REPORTED THAT APPROXIMATELY 5 MONTHS LATER THE PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. THE DEATH WAS ASSESSED BY THE MEDICAL MONITOR TO BE POSSIBLY RELATED TO THE STENT GRAFT , NOT RELATED TO THE ENDOANCHORS, NOT RELATED TO THE INDEX PROCEDURE , NOT RELATED TO THE STENT GRAFT DEPLOYMENT AND POSSIBLY RELATED TO THE ANEURYSM. THE DEATH WAS ASSESSED BY THE SITE AS NOT RELATE

  Patient problems: Confusion/ Disorientation; Constipation; Insufficient Information; Kidney injury; Pain

  MAUDE report 21730659 ↗
• InjuryMar 25, 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 PATIENT PRESENTED EMERGENTLY DUE TO A TYPE IA ENDOLEAK APPROXIMATELY 4.5 YEARS SINCE IMPLANTATION OF AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM. THE TREATMENT INVOLVED AN OPEN SURGICAL CONVERSION, DURING WHICH THE PRODUCT WAS EXPLANTED. IT WAS NOTED THERE WERE NO ISSUES WITH THE LIMB STENT GRAFTS. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS UNDERSIZING. THE EVENT WAS RESOLVED THROUGH THIS OPEN SURGICAL CONVERSION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21685935 ↗
• MalfunctionMar 21, 2025Material Deformation; Material Deformation

  AN ESBF3614C103E ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 53MM AAA. IT WAS REPORTED THE PATIENTS PRE-OPERATIVE CT WAS NON-CONTRAST DUE TO RENAL DISEASE. WHEN THE PRE-OPERATIVE SIZING WAS PERFORMED, PER THE IFU, A 36MM STENT GRAFT WAS APPROPRIATE PER THE IFU. THE PRE-OPERATIVE CT WAS PERFORMED ABOUT SIX WEEKS PRIOR TO THE INDEX PROCEDURE, THE DIAMETER OF THE PROXIMAL NECK WAS NOTED TO MEASURE 30MM-31MM ALONG A 20MM LENGTH. NO AORTIC NECK CALCIFICATION OR THROMBUS WERE REPORTED. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, ONCE THE PATIENTS ANATOMY WAS MEASURED WITH IVUS , IT WAS EVIDENT THERE WAS A DISCREPANCY BETWEEN THE IVUS MEASUREMENTS AND THE PRE-OP CT MEASUREMENTS AS AORTIC NECK MEASURED 27MM ON IVUS. IT WAS AGREED WITH THE PHYSICIAN THAT THE 36MM STENT GRAFT WOULD STILL BE OK FOR THE PROCEDURE, BUT A 32MM WAS ALSO OFFERED. ONCE THE BIFURCATE WAS IMPLANTED, AND WHEN CHECKING FOR GATE CANNULATION WITH IVUS, THE PHYSICIAN NOTED A INFOLDING OF THE GRAFT. THE LIMBS WERE THEN IMPLANTED AND BALLOONING WAS PERFORMED TWICE WITH A RELIANT BALLOON. THERE WAS NO CHANGE TO THE INFOLDING. THE PHYSICIAN THEN INFLATED A NON COMPLAINT AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661835 ↗
• InjuryMar 18, 2025Malposition of Device; Malposition of Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60MM AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PHYSICIAN DEPLOYED THE CONTRALATERAL LIMB WITHOUT ISSUE AND THEN DEPLOYED ON THE IPSI-LATERAL SIDE AND PUSHED THE DELIVERY SYSTEM OF THE BIFURCATE PROXIMAL. THE PHYSICIAN BEGAN TO PULL THE DELIVERY SYSTEM INTO THE BIFURCATE. THE SALES REPRESENTATIVE ATTENDING THE CASE ADVISED THE PHYSICIAN TO STOP DUE TO THE TIP CAPTURE BEING OPEN HOWEVER THE PHYSICIAN CONTINUED AND SAID THAT IT WAS CLOSED. THE PHYSICIAN CONTINUED TO PULL AT THE DEVICE DESPITE IT BEING CAUGHT AND EVENTUALLY PULLED THE BIFURCATE 50 MM INTO THE AORTA. THE PHYSICIAN REMOVED THE DEVICE AND IN DOING SO CAUSED A DISSECTION IN THE COMMON ILIAC ARTERY. THE PHYSICIAN THEN IMPLANTED TWO CUFFS FROM THE LOWEST RENAL INTO THE BIFURCATE AND REPAIRED THE RIGHT COMMON ILIAC ARTERY. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS USER ERROR. ONCE THE DELIVERY SYSTEM WAS REMOVED THE REP LOOKED AT IT ON THE BACK TABLE AND TURNED THE BACK WHEEL CLOSING THE TIP CAPTURE CONFIRMING IT WAS OPEN WHEN BEING REMOVED FROM THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS

  Patient problems: Perforation of Vessels

  MAUDE report 21629795 ↗
• InjuryMar 12, 2025Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE TO TREAT A 56 MM AAA INVOLVING THE STENT GRAFT ESBF3614C103E ENDUR IIS BIF, THE DEVICE WAS INTRODUCED AND DEPLOYED WITHOUT DIFFICULTY, BUT AN ABNORMAL PROXIMAL MARKER OF THE GRAFT WAS NOTED. IVUS WAS PERFORMED REVEALING THAT THE MID BODY OF THE BIFURCATED DEVICE UNFOLDED ON ITSELF AND WAS NOT CIRCUMFERENTIALLY OPENED. THERE WAS NO INFOLDING NOTED AT THE TOP OF THE GRAFT. UPON COMPLETION OF DEPLOYMENT, MODERATE BALLOONING WAS PERFORMED AND 1 ENDOANCHOR WAS IMPLANTED IN THE MID-BODY OF THE GRAFT TO TO PUSH THE INFOLDED PORTION OF THE GRAFT OVER TO SECURE IT AGAINST THE OUTSIDE WALL AND LIMIT FLOW DYNAMICS IN THE MAINBODY OF THE GRAFT , BUT THIS DID NOT COMPLETELY RESOLVE THE INFOLDING. POSTERIOR WALL DILATION WITH MODERATE CONSTRICTION OF THE DISTAL SEAL ZONE, COMBINED WITH ANTERIOR MOVEMENT OF THE AORTA, NEGATIVELY AFFECTED THE GRAFT, RESULTING IN A TYPE 1A ENDOLEAK. AN ADDITIONAL PROCEDURE WAS PERFORMED 2 DAYS LATER TO ADDRESS THE ENDOLEAK USING COIL EMBOLIZATION AND ADDITIONAL ENDOANCHORS. THE ENDOLEAK APPEARED TO HAVE BEEN RESOLVED AT THE END OF THE PROCEDURE. THE PATIENT WAS EXTUBATED AND RECOVERED WELL FROM THE SECONDARY REPAIR, W

  Patient problems: Insufficient Information

  MAUDE report 21584471 ↗
• MalfunctionFeb 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE FOR TREATING A 56MM ABDOMINAL AORTIC ANEURYSM T, THE REAR SCREW GEAR OF THE ENDURANT IIS BIFURCATE STENT GRAFT DETACHED FROM THE MAIN DELIVERY SYSTEM. THE EVENT WAS DISCOVERED DURING THE PROCEDURE, AND THE ENTIRE DELIVERY WAS WALKED OFF THE WIRE WITHOUT INCIDENT. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE AND REPLACED WITH ANOTHER MEDTRONIC STENT GRAFT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405013 ↗
• DeathJan 29, 2025Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. THE PATIENT HAD AN EXISTING VALIANT CAPTIVA AND ENDURANT IIS STENT GRAFT SYSTEM IMPLANTED SIX MONTHS EARLIER. IT WAS REPORTED THAT CORELAB REVIEW OF A CT TAKEN ON THE SAME DATE SHOWED A IA AND IIIA ENDOLEAKS INVOLVING THE VALIANT NAVION. THERE WAS NO FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION OBSERVED. THE MAXIMUM AORTIC DIAMETER WAS 96.8MM. IT WAS NOTED THAT THE VALIANT NAVION WAS FAILING TO SEAL WITH THE OTHER DEVICES. THE SITE COULD NOT CONFIRM WHICH DEVICE THE NAVION HAS LOST SEAL AGAINST. IT IS UNKNOWN IF THERE WERE INTERVENTIONS PERFORMED TO TREAT THE ENDOLEAKS. NO CAUSE WAS PROVIDED. IT WAS REPORTED THE PATIENT EXPIRED THE SAME YEAR. NO CAUSE OF DEATH WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED

  Patient problems: Insufficient Information

  MAUDE report 21263085 ↗
• InjuryJan 20, 2025Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 52MM ABDOMINAL AORTIC ANEURYSM. POSTERIOR ANGULATION WAS IDENTIFIED. IT WAS REPORTED DURING THE INDEX PROCEDURE, A POSSIBLE TYPE IA ENDOLEAK WAS OBSERVED. THEN ON FINAL ANGIOGRAM A POSSIBLE TYPE I OR IV ENDOLEAK WAS NOTED IN A BIFURCATE STENT GRAFT. THE ENDOLEAK WAS DESCRIBED AS MORE OF A SWIRL THROUGH THE FABRIC. TO ADDRESS THE ENDOLEAK, AN ENDURANT CUFF (ETCF3636C49E) WAS IMPLANTED, WHICH THE RESOLVED THE ENDOLEAK. NO ISSUES WERE REPORTED WITH THE ENDURANT II LIMBS. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS NOT DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 21189650 ↗
• MalfunctionJan 3, 2025Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF THE ENDURANT II STENT GRAFTS, A GRAFT INFOLDING WAS IDENTIFIED DURING A FOLLOW-UP CT SCAN, WHICH RESULTED IN A TYPE 1A LEAK. THE PATIENT WAS INITIALLY TREATED FOR A 65MM ANEURYSM. A SEVERE THROMBUS IN THE PROXIMAL NECK WAS NOTED, WHICH CONTRIBUTED TO THE EVENT, AND POST-IMPLANTATION BALLOONING WAS NOT PERFORMED DUE TO THE PRESENCE OF THE THROMBUS. FUTURE TREATMENT IS PLANNED, SPECIFICALLY BALLOONING OF THE PROXIMAL NECK, TO ADDRESS THE ISSUE. THE EVENT HAS NOT YET BEEN RESOLVED, AND THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066283 ↗

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-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