Endurant® IIs ESBF2514C103ERecalls & reported problems

Summary

The FDA's MAUDE database contains 136 adverse event reports that list this exact device (DI 00643169439986), received between Dec 19, 2016 and May 19, 2026 — classified as 18 deaths, 98 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (69 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 136 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 11 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFIED A TYPE IA AND POSSIBLE BILATERAL TYPE IB ENDOLEAKS. THE PHYSICIAN ELECTED TO TRANSFER THE PATIENT TO A DIFFERENT FACILITY FOR POSSIBLE FURTHER INTERVENTION. THE CAUSE OF THE ENDOLEAKS ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216629 ↗
• InjuryMay 1, 2026Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 1 MONTH POST THE INDEX PROCEDURE, FOLLOW UP CT SHOWED WHAT APPEARS TO BE SOME CONTRAST IN AAA SAC AND IS SUSPECTED TO BE A TYPE IA ENDOLEAK. INTERVENTION AND ANGIOS ARE PLANNED. PER THE PHYSICIAN THE CAUSE IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055391 ↗
• InjuryDec 15, 2025Malposition of Device; Malposition of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 11 MONTHS POST-INDEX PROCEDURE, A TYPE IB ENDOLEAK WAS IDENTIFIED INVOLVING THE RIGHT LIMB (ETLW1613C93E). THE COMMON ILIAC ARTERY ANATOMY HAD DILATED, CAUSING THE LIMB TO LOSE ITS SEAL AND MIGRATE PROXIMALLY INTO THE ANEURYSM SAC. AN INTERVENTION WAS PERFORMED TWO DAYS LATER, DURING WHICH AN ENDURANT LIMB AND AN ENDURANT CUFF WERE IMPLANTED. IT WAS SAID THAT ALTHOUGH THERE WAS NO TYPE IA ENDOLEAK, IT WAS NOTED THAT THERE WAS ADDITIONAL SPACE FROM THE TOP OF THE ESBF2514C103E GRAFT TO THE RENAL ARTERIES, AS THE ORIGINAL IMPLANT HAD LANDED LOWER THAN PLANNED. THE PHYSICIAN NOTED THAT THERE WAS NO CONCERNS WITH THE BIFURCATE STENT GRAFT, BUT WANTED TO IMPLANT THE CUFF TO PREVENT FURTHER ISSUES. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE TYPE IB ENDOLEAK WAS MOST LIKELY DUE TO A SHORT COMMON ILIAC ARTERY LANDING ZONE, COMBINED WITH PROGRESSIVE DILATION OF THE COMMON ILIAC ARTERY, WHICH RESULTED IN LOSS OF SEAL OVER TIME. NO ADDITIONAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 23800993 ↗
• MalfunctionDec 8, 2025Leak/Splash; Leak/Splash

  AN ESBF2514C103EE STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT A FOLLOW-UP CT SCAN TAKEN APPROXIMATELY 2 YEARS POST-INDEX PROCEDURE SHOWED AN ENDOLEAK, POSSIBLY A TYPE IA; HOWEVER, PHYSICIAN IS UNSURE WHETHER THIS IS A TYPE IA OR A TYPE II. IT WAS NOTED THAT THERE APPEARS TO BE CALCIUM IN THE AORTIC NECK, WHICH MAY HAVE PREVENTED THE STENT GRAFT FROM FULLY SEALING AGAINST THE VESSEL WALL. FUTURE TREATMENT IS PLANNED. THE DATE IS YET TO BE DETERMINED, AND AN ANGIOGRAM WILL LIKELY BE PERFORMED TO CONFIRM THE ENDOLEAK TYPE. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS ANATOMY RELATED , POSSIBLY DUE TO CALCIUM. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23740024 ↗
• InjuryDec 1, 2025Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN EVAR PROCEDURE AFTER THE AUI AND LIMB EXTENSION WERE DEPLOYED AND ANGIOPLASTY WAS PERFORMED WITH A COMPLIANT NON MDT BALLOON, A HELI-FX ENDOANCHORING SYSTEM WAS THEN PREPARED AS NORMAL. THE FLUOROSCOPY IMAGING WAS ADJUSTED TO REMOVE PARALLAX AND ROTATED TO THE 45DEGREE OBLIQUE VIEW AS PLANNED. THE FIRST ENDOANCHOR WAS DELIVERED WITHOUT INCIDENT. THE SURGEON THEN REDIRECTED THE SG-64 TO THE OPPOSITE SIDE OF THE AORTA TO PLACE AN ENDOANCHOR ON THE OPPOSING WALL OF THE GRAFT. THE SA-85 WAS LOADED WITH THE SECOND ENDOANCHOR AND ADVANCED TO THE TARGET SITE. WHEN POSITIONED, THE SURGEON INITIATED THE 1ST STAGE DEPLOYMENT AND IT WAS VISUALIZED THAT THE ENDOANCHOR HAD MADE GOOD PENETRATION THROUGH THE GRAFT MATERIAL AND INTO THE AORTIC WALL. THE SURGEON THEN PRESSED THE ADVANCE BUTTON TO COMPLETE THE ANCHOR DEPLOYMENT, AND IT APPEARED THE ANCHOR WAS FULLY DEPLOYED SUCCESSFULLY. THE SA-85 WAS THEN REMOVED, AND THE SURGICAL TECHNICIAN ATTEMPTED TO LOAD A 3RD ENDOANCHOR. HOWEVER, THE APPLIER WOULD NOT GO INTO THE "REVER SE" MODE TO ENGAGE A NEW ANCHOR. UPON CLOSE INSPECTION, THE TEAM REALIZED THAT PART OF THE 2ND ANCHOR REMAINED IN THE APPLIER AND HAD BROKEN DUR

  Patient problems: Obstruction/Occlusion

  MAUDE report 23678050 ↗
• InjurySep 15, 2025Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT THE PATIENT'S WIFE CALLED, STATING THEY CONDUCTED YEARLY FOLLOW-UPS, DURING WHICH A SLOW ENDOLEAK WAS IDENTIFIED. IT WAS NOTED THAT THE PATIENT EXHIBITED NO SIGNS OR SYMPTOMS, AND AN INTERVENTION WAS PERFORMED 7 YEARS POST IMPLANT. NO CAUSE OF WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 23049491 ↗
• InjuryAug 6, 2025Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM AAA. ELEVEN YEARS LATER DURING A ROUTINE FOLLOW UP CT SCAN, A LARGE ENDOLEAK WAS NOTED COMING FROM A TEAR IN THE GRAFT. INTERVENTION WAS PERFORMED ON THE SAME DATE WHERE THE ENDOLEAK WAS REPAIRED WITH AN 8MM NON-MEDTRONIC OCCLUDER DEVICE. PER THE PHYSICIAN THE CAUSE OF THE IIIB ENDOLEAK COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22724822 ↗
• InjuryMay 29, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH AN EMERGENCY DUE TO AN AORTIC RUPTURE. THE PATIENT WAS ORIGINALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) MEASURING 55MM USING AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM. THE HEALTHCARE PROFESSIONAL SUSPECTED A TYPE III GRAFT TEAR AT THE BIFURCATED DEVICE, BUT IT WAS UNCLEAR WHETHER IT WAS THE SUSPECTED TYPE IIIB OR POSSIBLY A LARGE TYPE II ENDOLEAK FROM A LUMBAR VESSEL THAT CAUSED THE ANEURYSM RUPTURE. DURING INTERVENTION, THE INITIALLY DEPLOYED ENDURANT AUI MIGRATED UPON REMOVAL OF THE DELIVERY SYSTEM, NECESSITATING THE USE OF A SECOND AUI DEVICE TO CORRECT AND REALIGN THE POSITION. ALTHOUGH IT WAS INITIALLY STATED THAT THE FIRST AUI WAS DEPLOYED CORRECTLY, THE PHYSICIAN INADVERTENTLY RETRACTED THE NOSE CONE WITHOUT RECAPTURING THE SPINDLE. IT WAS STATED THE DEVICE WAS PULLED IN A RUSH , BECAUSE THE PATIENT WAS IN A CRITICAL CONDITION. THIS ACTION BYPASSED THE STANDARD PROCEDURAL STEPS, WHICH INCLUDE ADVANCING AND PUSHING UP THE NOSE CONE, RECAPTURING IT, TWISTING IT BACK DOWN, TRANSITIONING FROM GREY TO BLUE, AND FINALLY, TWISTING PROPERLY WHILE REMOVING THE DEVICE FROM THE ILIAC ARTERY. TWO AUI DEVICES AND AN ILIAC LIMB WER

  Patient problems: Rupture

  MAUDE report 22103737 ↗
• MalfunctionMay 23, 2025Malposition of Device; Activation, Positioning or Separation Problem; Material Deformation; Malposition of Device; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING THE DEPLOYMENT OF THE SUPRARENAL STENT OF A STENT GRAFT ESBF2514C103E ENDUR IIS BIF, THE BACK-END SCREW GEAR WAS FOUND TO BE BROKEN IN HALF. THE EVENT OCCURRED DURING THE INDEX PROCEDURE TREATING A 49MM ANEURYSM. THE SCREW GEAR APPEARED TO HAVE SNAPPED DURING DEVICE PREPARATION, BUT THE DAMAGE WENT UNNOTICED UNTIL THE DEPLOYMENT OF THE SUPRARENAL STRUTS. IT IS BELIEVED THAT THE DAMAGE OCCURRED DURING PRE OP, AS IT DID NOT APPEAR THAT THE SCRUB TECH REMOVED THE CLEAR PLASTIC TAB BEFORE LIFTING THE BACK END OF THE DEVICE TO FLUSH THE CATHETER. THE PHYSICIAN WAS ABLE TO MANUALLY HOLD THE SCREW GEAR TO FACILITATE DEPLOYMENT OF THE SUPRARENAL STRUTS AND SUCCESSFULLY CAPTURE THE TIP FOR REMOVAL. HOWEVER, THIS DEVICE ISSUE IMPACTED THE DEPLOYMENT, CAUSING THEGRAFT TO LAND LOWER THAN INITIALLY INTENDED. DESPITE THIS, THE OUTCOME WAS CONSIDERED SATISFACTORY DUE TO AN ADEQUATE NECK LENGTH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076928 ↗
• InjuryMay 16, 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 AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED VIA TECHNICAL SERVICES, THAT THE PATIENT EXPERIENCED NEUROPATHY IN THE LEGS AND WAS REFERRED TO PHYSICIAN. NO ADDITIONAL CLINICAL SEQUEL WAS REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: Neuropathy; Obstruction/Occlusion

  MAUDE report 22034755 ↗
• DeathMar 25, 2025Malposition of Device; Material Deformation; Malposition of Device; Material Deformation

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF BILATERAL COMMON ILIAC ANEURYSMS. DURING THE INDEX PROCEDURE THE DISTAL AORTA WAS REINFORCED BY USING TWO 8- OR 9-MM NON-MDT BALLOONS AT THE COMMON AND EXTERNAL ILIAC ARTERIES AFTER DEPLOYING THE LIMB EXTENSIONS. THE PHYSICIAN ALSO USED TWO 9 MM NON-MDT BILIARY STENTS AND THEN USED TWO NON-MDT BALLOONS TO REINFORCE THE DISTAL AORTA. THIS WAS DONE BECAUSE THE DISTAL AORTA WAS ABOUT 18MM IN DIAMETER. IT WAS NOTED THAT GATE DEPLOYMENT WAS CROSSED DUE TO WIRES CROSSING. THE RIGHT ILIAC EXTENSION ON THE RIGHT ILIAC DID NOT DEPLOY AT MAX OVERLAP (50 MM) AND WAS DEPLOYED ABOUT 10 MM BELOW THE FLOW DIVIDER. IT WAS REPORTED THAT LATER THAT EVENING, INTERVENTION WAS PERFORMED AS IT WAS REPORTED THE LIMB HAD SHUT DOWN. BOTH LIMBS WERE IDENTICAL AND IT WAS NOT POSSIBLE TO IDENTIFY WHICH SERIAL NUMBER IS FOR THE LEFT VS RIGHT ILIAC. DURING THE INTERVENTION, ACCESS WAS ESTABLISHED AND AN ANGIOGRAM WAS DONE. A NARROWING OF THE CONTRALATERAL GATE COULD BE VISUALIZED. THREE NON-MDT STENTS WERE IMPLANTED AT THE FLOW DIVIDER AND INTO THE BILATERAL ILIAC LIMBS. A FINAL ANGIOGRAM SHOWED IMPROVEMENT. THE FOLLOWIN

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 21686732 ↗
• InjuryMar 12, 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 AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT ELEVEN DAYS POST THE INDEX PROCEDURE THE PATIENT PRESENTED TO THE ER WITH CONSTIPATION. THE PATIENT WAS GIVEN MEDICATION AND DISCHARGED ON THE SAME DAY. THE SITE ADDRESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX PROCEDURE AND NOT RELATED TO THE DEVICE AND AN UNDERLYING CONDITION AND/OR DISEASE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Constipation

  MAUDE report 21585353 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNKNOWN ENDURANT II/IIS STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AS PART OF THE POST MARKET ADVANCE STUDY. IT WAS REPORTED POST INDEX PROCEDURE, THE PATIENT EXPERIENCED NAUSEA AND VOMITING, LEADING TO A SERIOUS DETERIORATION IN HEALTH THAT REQUIRED TREATMENT. ZOFRAN WAS ADMINISTERED, AND THE PATIENT'S HOSPITALIZATION WAS PROLONGED (2 DAYS). THE PATIENT IS RECOVERING. THE SITE ASSESSED THE NAUSEA AND VOMITING AS HAVING A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE, WITH A POSSIBLE RELATIONSHIP TO THE UNDERLYING CONDITION / DISEASE BUT UNRELATED TO THE STUDY DEVICE THE SPONSOR ASSESSED THE NAUSEA AND VOMITING AS HAVING A CAUSAL RELATIONSHIP WITH THE INDEX PROCEDURE AND NOT RELATED TO THE STUDY DEVICE OR ANY UNDERLYING CONDITION OR DISEASE. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Nausea; Vomiting

  MAUDE report 21433785 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; 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. ESBF2514C103E WAS SUCCESSFULLY PLACED FOLLOWED BY ETLW1613C156E IN THE RIGHT ILIAC ARTERY, AND ETLW1613C156E IN THE LEFT ILIAC ARTERY. IT WAS REPORTED 1 DAY POST INDEX PROCEDURE, THE PATIENT HAD A POST PROCEDURE CREATININE LEVEL OF 1.55 MG/DL. THE ACUTE KIDNEY INJURY OCCURRED DUE TO THE COILING OF THE PATIENTS¿ ACCESSORY RENAL ARTERIES DUE TO THE PATIENT¿S ANATOMY DURING THE EVAR PROCEDURE PROLONGING THE PATIENTS EXISTING HOSPITALIZATION. THE PATIENT RECEIVED TREATMENT AND WAS HYDRATED WITH FLUIDS AND MONITORED OVERNIGHT. IT WAS REPORTED THE FOLLOWING DAY, THAT THE PATIENTS CREATININE LEVEL DROPPED AND WAS 1.52 MG/DL. THE PATIENT WAS DISCHARGED ON THE SAME DAY WITH AN ORDER FOR FOLLOW-UP LABS TO MONITOR CREATININE LEVELS. THE SPONSOR ASSESSED THE AS RELATED TO THE INDEX PROCEDURE AND NOT RELATED TO THE DEVICE.

  Patient problems: Renal Failure

  MAUDE report 21239195 ↗
• InjuryJan 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT TREATED FOR AN ANEURYSM EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING 1A AND 1B LEAKS, NECK AND ILIAC DILATION, AND VESSEL DILATION. THE ISSUES WERE IDENTIFIED DURING A FOLLOW-UP VISIT. THE PATIENT UNDERWENT TREATMENT INVOLVING THE USE OF AN ENDURANT 16X10X93 ILIAC LIMB WITH RIGHT HYPOGASTRIC EMBOLIZATION, A NON-MDT 30MM X 70MM CUFF WITH THREE-VESSEL LASER FENESTRATION (RIGHT RENAL, LEFT RENAL, AND SUPERIOR MESENTERIC ARTERY), NON-MDT STENTS, AND HELIFX ENDOANCHORS. ADDITIONALLY, A 16X13X93 ENDURANT LIMB WAS USED TO ADDRESS A 1B LEAK. THE EVENTS WERE ATTRIBUTED TO ANATOMICAL FACTORS, INCLUDING NECK AND ILIAC DILATION. THE REPORTED ISSUES WERE RESOLVED FOLLOWING THE INTERVENTIONS, AND THE DEVICES REMAIN IMPLANTED AND IN SERVICE.

  Patient problems: Insufficient Information

  MAUDE report 21065714 ↗
• DeathNov 11, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED 45MM AAA. IT WAS REPORTED THAT THE PATIENT HAD A TYPE I ENDOLEAK AT THE END OF THE PROCEDURE. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE INTERVENTION WAS PERFORMED FOR A RUPTURE DUE TO THE TYPE IA. 10 END OANCHORS WERE PLACED, HOWEVER ON THE POST-ANGIO THE TYPE IA ENDOLEAK REMAINED. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS DUE TO UNDER-SIZING. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Cardiac Arrest; Rupture

  MAUDE report 20650570 ↗
• InjuryOct 18, 2024Adverse 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 A AAA. IT WAS REPORTED APPROX. 45 DAYS POST INDEX PROCEDURE THAT THE PATIENT SUFFERED AN ACUTE RENAL INJURY. IT WAS NOTED THAT THERE WAS A DECREASE IN THE PATIENTS GFR FROM BASELINE AND DISCHARGE VITALS. THERE WAS NO INJURY TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED. THE SITE ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX PROCEDURE, NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO AN UNDERLYING CONDITION/ DISEASE. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX PROCEDURE AND NOT RELATED TO THE DEVICE OR AN UNDERLYING CONDITION/ DISEASE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; Renal Failure; Renal Impairment

  MAUDE report 20478776 ↗
• InjuryOct 7, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 9MM AAA. IT WAS NOTED THAT THE PATIENT WAS INITIALLY TREATED FOR A 10MM SHORT AND HIGHLY ANGULATED PROXIMAL NECK AND DID NOT RETURN FOR FOLLOW-UP. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED TO THE ER WITH STOMACH PAIN. A CT SHOWED A IA ENDOLEAK. THE PHYSICIAN ELECTED TO TRY TO PLACE A NON-MDT CUFF TO FIX THE LEAK BUT IT WAS NOT SUCCESSFUL. AN ENDURANT CUFF AND HELI-FX ENDOANCHORS WERE PLACED WHICH RESOLVED THE ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT'S ANATOMY. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain; Insufficient Information

  MAUDE report 20381847 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED VIA CUSTOMER SERVICES ON APPROX. 1 MONTH AND 23 DAYS POST INDEX PROCEDURE THAT THE PATIENT CONTACTED TO REPORT A SUSPECTED ALLERGIC REACTION TO THE IMPLANTED DEVICES. THE PATIENT ENQUIRED ABOUT THE STENT GRAFT MATERIALS AND STATED THAT THE PHYSICIAN ADVISED THERE WAS NO METAL ALLOYS IN THE IMPLANTS. THE PATIENT IS GOING TO SEE AN ALLERGIST TO TRY AND DIAGNOSE. TS AGENT PROVIDED INFORMATION AND EDUCATION ON THE ENDURANT STENT GRAPHS NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED.

  Patient problems: Local Reaction; Seroma

  MAUDE report 20188300 ↗
• InjuryAug 26, 2024Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED BY THE PATIENT TO TECHNICAL SERVICES THAT POST THE IMPLANT PROCEDURE THE PATIENT WAS ''UNABLE TO WALK'' FOR THREE MONTHS. THE PATIENT STATED THAT THE PHYSICIAN HAD NOTED THERE WAS A ''KINK IN THE GRAFT WHICH HAD CAUSED A BLOOD CLOT TO DEVELOP ELIMINATING BLOOD FLOW TO THE RIGHT LEG''. THE PATIENT STATED HE HAD AN IMAGE OF THE KINKED GRAFT. THE PATIENT REPORTED ANOTHER PHYSICIAN COMPLETED SURGERY ON THE CLOT TO ENABLE MOBILITY AGAIN. THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Embolism/Embolus; Limb Pain; Numbness; Obstruction/Occlusion

  MAUDE report 20062957 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS REPORTED THAT ALMOST FOUR YEARS LATER, THE PATIENT PRESENTED EMERGENTLY AND A CT PERFORMED WHICH SHOWED ANEURYSM ENLARGEMENT. NO ENDOLEAK COULD BE CLEARLY IDENTIFIED ON THE CT. INTERVENTION WAS PERFORMED WHERE A ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED. THE SAC MEASURED 73MM AT THE TIME OF INTERVENTION. THE CAUSE OF THE ANEURYSM ENLARGEMENT IS UNKNOWN. NO ADDITIONAL CLINICAL'S SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 19991721 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; 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 AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE PATIENT EXPERIENCED HIGH INTRAOPERATIVE BLOOD LOSS ATTRIBUTED TO THE FAILURE OF THE NON MDT PERCUTANEOUS CLOSURE DEVICE. THE NON-MDT DEVICE FAILED ON THE LEFT SIDE. AN ADDITIONAL TWO CLOSURE DEVICES WERE PLACED WHICH SEEMED TO SHOW HEMOSTASIS. THE WIRE OF THE DEVICE WAS THEN PULLED AND PRESSURE HELD, BUT BLEEDING CONTINUED. AN ARTERY CUT DOWN AND OPEN REPAIR WAS PREFORMED, WHICH LED TO ELEVATED BLOOD LOSS DUE TO THE PATIENT'S HABITUS AND FRAGILE TISSUES. AS A RESULT OF THE COMPLICATIONS, THE PATIENT REQUIRED PROLONGED EXISTING HOSPITALIZATION FROM (B)(6) 2024, TO (B)(6) 2024. THE SITE ASSESSED THE INTRAOPERATIVE BLOOD LOSS AS HAVING A CAUSAL RELATIONSHIP TO THE INDEX PROCEDURE AND NOT DEVICE RELATED OR RELATED TO UNDERLYING PATIENT CONDITION. THE SPONSOR ASSESSED THE THE INTRAOPERATIVE BLOOD LOSS AS HAVING A CAUSAL RELATIONSHIP TO THE INDEX PROCEDURE AND NOT DEVICE RELATED OR RELATED TO UNDERLYING PATIENT CONDITION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18991258 ↗
• InjuryMar 27, 2024Malposition 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 54MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE DUE TO USER ERROR BOTH LIMBS WERE IMPLANTED AT THE IPSI-GATE. THE PHYSICIAN ELECTED TO CONVERT AND IMPLANT AN ENDURANT AUI TO THE RIGHT COMMON ILIAC WITH A FEM-FEM BYPASS AND LEFT COMMON ILIAC OCCLUSION. THE CAUSE WAS DUE TO USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 18987702 ↗
• MalfunctionNov 20, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT SCAN AND ANGIOGRAPHY REVEALED A TYPE IIIB ENDOLEAK AS THE PHYSICIAN BELIEVED THERE WAS A HOLE IN THE STENT GRAFT. PER THE PHYSICIAN THE CAUSE OF THE TYPE IIIB ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169815 ↗
• InjuryNov 3, 2023Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM AAA .  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT WAS AWAKE AND  WAS NOT INTUBATED. ACCESS WAS ESTABLISHED UTILIZING A ULTRASOUND USING A MICROPUNCTURE KIT. BOTH GROINS WERE ACCESSED. FLOPPY WIRES WERE UTILIZED FIRST AND EXCHANGED TO STIFF WIRES OVER A CATHETER. THE PIGTAIL WAS PLACED ON THE PATIENT'S LEFT. THE ESBF2514C103E WAS PLACED ON THE PATIENT'S RIGHT BAREBACK (WITHOUT SHEATH). THE PIGTAIL WAS PLACED AROUND THE BOTTOM OF LUMBAR 1/TOP OF LUMBAR 2. THE ESBF2514C103E WAS PLACED ABOUT THE MID L1 REGION. FOR ANGIOGRAPHY IMAGING, PATIENT WAS ASKED TO TAKE A DEEP BREATH AND HOLD - THIS WAS DONE TO PREVENT DISRUPTED FRAME IMAGING DURING INJECTION OF THE CONTRAST AGENT. A INJECTION SETTING OF 15 FOR 20 WITH 800 PSI WAS DONE. THE LEFT RENAL WAS SLIGHTLY LOWER, WHICH WAS CONFIRMED BY PHYSICIAN. THE GATE PLACEMENT WAS AGREED ANTERIOR POSITION SINCE THE WIRES WERE ON TOP OF EACH OTHER. SCREEN WAS MARKED. THE DEPLOYMENT OF THE GRAFT WAS DONE BY TURNING THE BLUE SLIDER COUNTER CLOCKWISE. ABOUT 2 STENTS WERE OPENED, AND THEN THE DEVICE WAS LINED TO THE LOWEST RENAL (LEFT RENA

  Patient problems: Obstruction/Occlusion

  MAUDE report 18066135 ↗

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