Endurant® II ETLW1613C124E (UDI 00643169467590)Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00643169467590), received between Dec 13, 2016 and Apr 8, 2026 — classified as 8 deaths, 49 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (14 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 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  AN ETLW1613C124E STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 51MM AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE BIFURCATE WAS IMPLANTED WITHOUT ANY ISSUES. THE GATE WAS CANNULATED AND AN OMNI FLUSH CONFIRMED CANNULATION. A NON-MEDTRONIC GLIDEWIRE WAS PLACED WITHIN THE OMNIFLUSH, THE C-ARM WAS PLACED INTO A 10-15 DEGREE LAO POSITION, AND AN ANGIOGRAM WAS OBTAINED OF THE LEFT COMMON /INTERNAL/EXTERNAL ILIACS. THE ETLW1613C124E WAS DEPLOYED WITH NO ISSUE. UPON THE FINAL ANGIOGRAM, IT WAS NOTICED THE LEFT INTERNAL ILIAC ARTERY COVERED BY THE LIMB. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO INCORRECT SIZING ON THE PRE-OP SIZING REPORT. THE LENGTHS IN THE PROCEDURE DID NOT LINE UP WITH PROCEDURAL LENGTHS, THE PHYSICIAN BELIEVES THE LENGTHS ON THE PREOP SIZING REPORT WERE INCORRECT AND REQUESTED THE SIZING TO BE RECHECKED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24814744 ↗
• MalfunctionJul 31, 2025Obstruction of Flow; Device Damaged by Another Device; Obstruction of Flow; Device Damaged by Another Device

  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 C

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 22673298 ↗
• InjuryJul 30, 2025Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM (ESBF2514C103E, ETLW1613C124E AND ETLW1610C156E) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A LARGE COMMON ILIAC ARTERY ANEURYSM . THE PATIENT WAS UNDERGOING TREATMENT FOR COLON CANCER AT THE SAME TIME. THE INTERNAL ILIAC ARTERY ON THAT SIDE HAD ALREADY BEEN EMBOLIZED AT THE TIME OF STENT GRAFT PLACEMENT. AN ADDITIONAL LIMB (ETEW1010C82E) WAS IMPLANTED APPROXIMATELY 5 YEARS AND 10 MONTHS LATER TO OBTAIN MORE SEAL IN THE ILIAC ARTERY. IT WAS REPORTED VIA THE PATIENT APPROX. 6 YEARS, 10 MONTHS POST INDEX PROCEDURE , THAT ALL FOUR STENT GRAFTS FAILED AND WERE SURGICALLY REMOVED. IT WAS CONFIRMED VIA THE SALES REP THAT THERE WAS NO PROBLEM WITH THE INTEGRITY OF THE STENT GRAFT SYSTEM BUT THE ANEURYSM WAS STILL BEING FED BY BLOOD FLOW FROM ACROSS THE PELVIS AND A BYPASS WITH EXPLANT WAS THE TREATMENT PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 22663896 ↗
• InjuryDec 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A PREVIOUS ABDOMINAL AORTIC ANEURYSM REPAIR, A TYPE 1B ENDOLEAK FROM THE RIGHT COMMON ILIAC ARTERY (RCIA) WAS IDENTIFIED, ALONG WITH A PRE-OPERATIVE ANEURYSM RUPTURE. THE PATIENT WAS TREATED FOR AN ANEURYSM MEASURING 64MM. THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND THE LIMB WAS EXTENDED TO THE RIGHT EXTERNAL ILIAC ARTERY USING AN ENDURANT 16/10/124 GRAFT. THE PROCEDURE INVOLVED BALLOONING, WHICH SUCCESSFULLY RESOLVED THE LEAK. PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK WAS SUSPECTED TO BE DUE TO GROWTH OF THE RCIA, LEADING TO A LOSS OF SEAL IN THAT ARTERY. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 20923436 ↗
• InjuryOct 22, 2024Obstruction of Flow; Obstruction of Flow

  HELI-FX ENDOANCHORS WERE IMPLANTED DUE TO CONCERN FOR LATE FAILURE IN AN ENDURANT STENT GRAFT SYSTEM DURING THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED 4 MONTHS POST THE INDEX PROCEDURE, FOLLOW UP ANGIOGRAM SHOWED KINKING IN THE LEFT ILIAC LIMB STENT WITH HIGH GRADE STENOSIS. THE PATIENT HAD COMPLAINED OF LEG FEELING HEAVY WHEN WALKING. PERCUTANEOUS ANGIOPLASTY OF THE LEFT COMMON ILIAC ARTERY LIMB OF THE PRIOR EVAR WAS PERFORMED. A STENT WAS NOT REQUIRED AND THE KINKING AND STENOSIS WAS CONFIRMED AS RESOLVED. THE SITE ASSESSED THE LEFT ILIAC KINKING AND STENOSIS AS RELATED TO THE ENDOGRAFT. THE SPONSOR ASSESSED THE LEFT ILIAC KINKING AND STENOSIS AS NOT RELATED TO THE DEVICE, PROCEDURE OR TREATED ANEURYSM.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20505625 ↗
• InjurySep 12, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM AAA . IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN SHOWED A IB ENDOLEAK ON THE LIMB ETLW1613C124E . INTERVENTION WAS PERFORMED ON THE SAME DAY AND LIMB EXTENSIONS WERE IMPLANTED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; Rupture

  MAUDE report 20200253 ↗
• InjuryJul 25, 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 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROX. 3 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED LEFT LEG PAIN. A CT SCAN REVEALED THAT THE ENDURANT STENT GRAFT LIMB (ETLW1613C124E) WAS FOUND TO BE OCCLUDED, ALTHOUGH NO ABNORMALITIES WERE FOUND IN THE LIMB ITSELF. 1 DAY POST FOLLOW UP, INTERVENTION WAS PERFORMED. THE PHYSICIAN INITIATED A CUTDOWN ON THE LEFT SIDE AND USED PERCUTANEOUS ACCESS ON THE RIGHT. A NON MDT (14MM) BALLOON WAS PLACED UP THE RIGHT SIDE, AND A NON MDT OVER- THE-WIRE WAS USED TO REMOVE THE CLOT. AFTER SEVERAL PASSES, A RELIANT BALLOON WAS USED TO EXTRACT THE REMAINING CLOT FROM THE ENDURANT LIMB. AN ANGIOGRAM WAS CONDUCTED, REVEALING A SMALL AMOUNT OF CLOT IN THE MAIN BODY PORTION OF THE GRAFT. TO ADDRESS THIS, AN ENDURANT CUFF (ETCF3232C49E) WAS PLACED IN THE MAIN BODY TO TRAP THE CLOT, AND A ENDURANT STENT GRAFT LIMB (ETLW1610C156E) WAS EXTENDED DOWN THE EXTERNAL ILIAC ARTERY SINCE THE HYPOGASTRIC ARTERY WAS OCCLUDED. AFTER BALLOONING THE LIMB, A NON MDT EXTENSION WAS ADDED. THE FINAL ANGIOGRAM REVEALED THE LEFT RENAL ARTERY HAD A STENOSIS VS. SMALL PIECE OF

  Patient problems: Limb Pain; Obstruction/Occlusion

  MAUDE report 19828300 ↗
• InjuryJun 21, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 70MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROX. 6 YEARS POST INDEX PROCEDURE, THE PATIENT PRESENTED EXPERIENCING ABDOMINAL PAIN. A CT SCAN REVEALED A 140MM ABDOMINAL AORTIC ANEURYSM, WHICH APPEARED TO RESULT FROM A TYPE IB ENDOLEAK FROM BOTH LIMBS OF THE STENT GRAFT. PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK WAS ANATOMY RELATED DUE TO THE PATIENTS SHORT COMMON ILIAC. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 19581998 ↗
• InjuryJun 7, 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 AN ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK MEASURED 56MM IN LENGTH AND WAS NARROW, WITH A POSTERIOR THROMBUS IN THE SEAL ZONE. PATENT CELIAC, SMA, AND 4MM IMA WERE NOTED, WHILE THE ILIAC ARTERIES WERE TORTUOUS. IT WAS REPORTED ONE MONTH POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH SEVERE LEG PAIN NUMBNESS AND WEAKNESS. NO PULSES WERE FELT ON EXAMINATION. CT SCAN REVEALED THROMBUS AND COMPRESSION WITHIN THE LEFT ENDURANT II STENT GRAFT LIMB (B)(6) EXTENDING FROM THE FLOW DIVIDER TO THE LEFT ILIAC LIMB. NO THROMBUS OR OCCLUSION WAS SEEN AT THE FLOW DIVIDER IN THE MAIN BODY AND ONLY IN THE LEFT LIMB. THROMBUS WAS IDENTIFIED IN THE COMMON FEMORAL, PROFUNDA FEMORIS, AND SFA, WITH NO CONTRAST SEEN ALL THE WAY DOWN THE LEG, RESULTING IN ISCHEMIA. MODERATE STENOSIS OF THE LEFT ILIAC STENT. INTERVENTION WAS PERFORMED WHERE A THROMBECTOMY, AND A 4 COMPARTMENT FASCIOTOMY WAS PERFORMED. DURING THE INTERVENTION COMPRESSION ON THE RIGHT SIDE WAS SEEN. BALLOONING WAS COMPLETED THROUGHOUT THE WHOLE GRAFT TO RESOLVE COMPRESSION SEEN ON THE RIGHT SIDE. FINAL AORTOGRAM SHOWED NO GROSS FILLING

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia; Limb Pain; Numbness; Obstruction/Occlusion

  MAUDE report 19490225 ↗
• InjuryMay 14, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY EXPERIENCING ABDOMINAL PAIN. A CT SCAN REVEALED BILATERAL TYPE IB ENDOLEAKS IN BOTH ENDURANT II STENT GRAFT LIMBS (ETLW1613C124E <(>&<)> ETLW1616C156E).  INTERVENTION WAS PERFORMED, WITH AN IBE WAS PLACED INSIDE STENT GRAFT (ETLW1616C156) ON THE LEFT SIDE, COILING A AND COVER WERE PLACED IN THE RIGHT HYPOGASTRIC ARTERY .A TAPERED LIMB WAS PLACED LANDING IN THE RIGHT EXTERNAL ILIAC ARTERY, SUCCESSFULLY RESOLVING THE TYPE IB ENDOLEAKS. PER THE PHYSICIAN THE CAUSE OF THE BILATERAL IB ENDOLEAKS ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 19308295 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT (ETBF2513C145E / V30715715) AND ENDURANT LIMB (ETLW1613C124E / V30815251) WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A PENETRATING ABDOMINAL AORTIC ULCER ON (B)(6) 2022. IT WAS REPORTED ON (B)(6) 2024, FOLLOW-UP CT IDENTIFIED OCCLUSION OF THE RIGHT LIMB OF THE ENDOGRAFT. ON (B)(6) 2024 INTERVENTION WAS PERFORMED WHERE AN ENDURANT LIMB ETLW1613C124E WAS IMPLANTED ON THE RIGHT SIDE. NON-MDT (2-8MM X 57MM) BALLOON EXPANDABLE STENTS WERE PLACED ON THE RIGHT AND LEFT SIDE USING A KISSING TECHNIQUE AT THE BIFURCATION. POST ANGIOGRAM CONFIRMED NO LIMB OCCLUSION. AS PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION WAS ANATOMY RELATED DUE TO THE PATIENTS NARROW DISTAL AORTA MEASURING 14MM IN DIAMETER. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 18756619 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT LIMB WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE DURING PATIENT FOLLOW-UP FOR CLAUDICATION IT WAS NOTED THAT THERE WAS LEFT LIMB OCCLUSION. THE PATIENT HAD A FEM-FEM BYPASS ON THE SAME DAY. NO CAUSE WAS PROVIDED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 18110279 ↗
• DeathAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THROUGH DEVICE REGISTRATION, THAT IT WAS NOTED THE PATIENT HAD EXPIRED THE SAME DAY THE STENT GRAFTS WERE IMPLANTED. IT WAS THEN CONFIRMED THE CAUSE OF DEATH WAS A RUPTURE. THE PATIENT CODED TWICE PRIOR AND THE PATIENT EXPIRED ON THE TABLE. THE RUPTURE OCCURRED POST THE IMPLANT OF THE MAIN BODY AND LIMB. THE CAUSE OF DEATH WAS A ANEURYSM RUPTURE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Rupture

  MAUDE report 17659858 ↗
• InjuryAug 15, 2023Adverse 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 53MM ABDOMINAL AORTIC ANEURYSM  IT WAS REPORTED APPROXIMATELY 7 MONTHS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A SUSPECTED LIMB OCCLUSION. REVIEW OF CTA IMAGING CONFIRMED LIMB OCCLUSION DUE TO TIGHT DISTAL ANATOMY IN THE LEFT COMMON ILIAC ARTERY (LCIA). THE PHYSICIAN ELECTED TO COMPLETE A FEM-FEM BYPASS ON THE SAME DATE AND THE PATIENT RECOVERED FINE.  PER THE PHYSICIAN THE CAUSE OF THE LIMB OCCLUSION WAS ANATOMY RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17547803 ↗
• InjuryJun 19, 2023Device Damaged by Another Device; Device Damaged by Another Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 55MM AAA. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY 16 DAYS POST-INDEX PROCEDURE WITH A THROMBOSED LIMB. THE DISTAL NECK (52MM LENGTH) MEASURED 18MM IN DIAMETER, IN PROXIMITY TO THE FLOW DIVIDER OF THE GRAFT. THE IPSILATERAL LIMB (RIGHT SIDE) WAS DEPLOYED APPROXIMATELY 1CM DOWN FROM THE FLOW DIVIDER DURING THE INDEX EVAR. THERE WAS NO KINK, DEFORMATION OR ISSUES WITH THE FUNCTIONALITY NOTED IN THE THROMBOSED LIMB. ON FOLLOW UP SCAN, IT APPEARED THIS LIMB WAS BEING COMPRESSED BY THE OTHER SIDE. ON THE SAME DATE, THE PHYSICIAN PERFORMED A THROMBECTOMY  AND PLACED A 16 X 16 X 82MM LIMB AT THE FLOW DIVIDER ON THE RIGHT SIDE, FOLLOWED BY THE KISSING BALLOON TECHNIQUE. THE EVENT RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE THROMBOSED LIMB WAS COMPRESSION FROM THE GREATER RADIAL FORCE ON THE CONTRALATERAL SIDE. THERE WAS NO KINK ,DEFORMATION OR OCCLUSION NOTED IN THE CONTRALATERAL SIDE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17151931 ↗
• InjuryNov 21, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFTS SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 80MM+ SYMPTOMATIC AAA. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. A TYPE IV ENDOLEAK WAS NOTED ON THE COMPLETION ANGIOGRAM. IT WAS REPORTED THE FOLLOWING DAY, THE PATIENTS HEMOGLOBIN DECREASED UNEXPECTEDLY AND A CTA OF THE CHEST / ABDOMEN / PELVIS WAS COMPLETED. THE CTA SHOWED A LARGE ENDOLEAK.  THE PATIENT WAS BROUGHT TO OR LATER THAT DAY FOR AN ANGIOGRAM +/- INTERVENTION. AN ANGIOGRAM WAS COMPLETED SHOWING A SMALL ENDOLEAK (POSSIBLE TYPE 1A). THE PHYSICIAN  PLACED 10 ENDOANCHORS WITHIN THE PROXIMAL SEAL ZONE AND REPEATED AN ANGIOGRAM. THE ANGIOGRAM SHOWED THE ENDOLEAK WAS UNCHANGED. 10 MORE ENDOANCHORS  WERE PLACED WITHIN THE SEAL ZONE AND THE LEAK WAS SOME WHAT DECREASED. THE PHYSICIAN THEN DECIDED TO EXTEND THE RIGHT ILIAC LIMB TO THE LEVEL OF THE RIGHT HYPOGASTRIC ARTERY DUE TO THE POSSIBILITY OF THE A TYPE 1B ENDOLEAK. POST PROCEDURE, THE CASE WAS DISCUSSED AND IN CONCLUSION IT WAS THOUGHT THE PATIENT HAS A SMALL TYPE IA ENDOLEAK AND A LARGE TYPE IV ENDOLEAK.  PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNKNOWN.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATI

  Patient problems: Insufficient Information

  MAUDE report 15833029 ↗
• MalfunctionJul 4, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT WAS INTENDED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 52X54MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON AN UNKNOWN DATE APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT DEMONSTRATED SAC GROWTH TO 63X64MM. THE PHYSICIAN SUSPECTS A POSSIBLE TYPE II ENDOLEAK AND A TYPE IIIB ENDOLEAK IN THE RIGHT LIMB MAY BE CAUSING THE SAC GROWTH. PER THE PHYSICIANTHE 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 14905387 ↗
• InjuryJun 29, 2022Leak/Splash; Leak/Splash

  AN ENDURANT LLS STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF  A 73MM ANEURYSM. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, AFTER REVIEWING FOLLOW UP CT'S, IT WAS CONFIRMED THE PRESENCE OF INSUFFICIENT SEAL IN BOTH ILIAC ARTERIES. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS DUE TO THE PATIENT'S ANATOMY. IT WAS STATED THAT  THE PATIENT IS VERY LARGE IMPACTING THE ABILITY TO IMAGE.  NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 14849525 ↗
• InjuryMay 27, 2022Obstruction of Flow; Obstruction of Flow

  AN ENDURANT II LIMB WAS IMPLANTED AS PART OF THE ENDOVASCULAR TREATMENT OF A 59MMX56.5MM ABDOMINAL AORTIC ANEURYSM .  IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP , THE CTA PERFORMED SHOWED A KINK IN THE LIMB WITH MILD THROMBOSIS FORMATION. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT HAS A DUPLEX WHICH SHOWED MONOPHASIC FLOW THROUGH THE LIMB 12 DAYS LATER . THE PHYSICIAN CARRIED OUT AN INTERVENTION PROCEDURE ANOTHER TWO DAYS LATER . AT THE TIME OF THE REINTERVENTION THERE WAS NO FLOW IN THE LIMB, SO A NEW LIMB WAS PLACED INSIDE THE THROMBOSED LIMB AND BARE METAL STENTS WERE PLACED INSIDE THE LIMBS AT THE LEVEL OF THE KINK. THE THROMBUS SQUEEZED OUT DISTAL TO THE LIMB, AND THEN A THROMBECTOMY WAS PERFORMED. AS PER THE PHYSICIAN THE CAUSE OF THE STENT KINK AND THROMBOSIS WAS AS A RESULT OF THE PATIENTS ANATOMY DUE AS THE ILIAC ARTERY HAD A VERY ACUTE BEND COMING OFF THE DISTAL AORTA. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14520850 ↗
• DeathMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II AUI WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A RUPTURED 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE THE AUI WAS SUCCESSFULLY IMPLANTED ALONG WITH 2 ENDURANT LIMBS AS ILIAC EXTENSION TO SEAL THE DISTAL END OF THE AUI GRAFT. A POSSIBLE TYPE IA ENDOLEAK WAS OBSERVED. DUE TO LACK OF INVENTORY NO FURTHER DEVICES WERE AVAILABLE FOR IMPLANT. IT WAS REPORTED THE PATIENT DID NOT RECOVER AND EXPIRED. DUE TO SHOCK THE RUPTURED ABDOMINAL AORTIC ANEURYSM. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK IS UNDETERMINED. THE CAUSE OF DEATH WAS DUE TO SHOCK FROM THE RUPTURED AAA. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Insufficient Information; Rupture; Shock

  MAUDE report 14302893 ↗
• MalfunctionApr 26, 2022Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  AN ENDURANT IIS BIFURCATED STENT GRAFT WAS IMPLANTED DURING THE AAA REPAIR OF A 47MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT, THE PATIENT PRESENTED TO ER WITH BACK PAIN, BUT NO RUPTURED AAA AND WAS DECIDED TO TO REPAIR THE AAA. DURING REPAIR IT WAS NOT POSSIBLE TO CANNULATE THE GATE FROM THE GROIN. IN THE GATE, THE WIRE WOULD NOT ADVANCE PAST THE DISTAL ASPECT OF THE GRAFT (JUST ABOVE FLOW DIVIDER). THE PHYSICIAN WAS THEN SUCCESSFUL IN GOING UP AND OVER FROM IPSI LATERAL SIDE AND SNARED THE WIRE. AFTER THAT, IT WAS STILL VERY DIFFICULT TO ADVANCE THE CATHETER PASSING THE DISTAL ASPECT OF GRAFT. DESPITE THIS TROUBLE, THE PHYSICIAN TRIED TO ADVANCE A ENDURANT LIMB 16-13-124 INTO THE GATE BUT THE TAPERED TIP OF THE DEVICE WOULD NOT PAST THE DISTAL HOOD OF GRAFT (JUST PROXIMAL TO THE FLOW DIVIDER). IT WAS THEN DECIDED BY THE PHYSICIAN TO CONVERT TO AN AUI BUT THE IMPLANTATION OF AN AUI COULD NOT BE ACHIEVED BECAUSE JUST PRIOR TO INTRODUCING IT, A ILIAC LIMB (16-13-124) WAS DEPLOYED TOO HIGH IN THE HOOD OF THE BIFURCATED DEVICE WHICH DID NOT LEAVE ENOUGH ROOM TO FULLY DEPLOY THE AUI. THIS RESULTED IN A TYPE IA ENDOLEAK. PER PHYSICIAN, THE CAUSE OF THE TYPE IA ENDOLEAK COULD NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14205950 ↗
• InjuryJan 4, 2022Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 44MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED 2 WEEKS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH PAIN IN THE LEFT LEG. A CT SHOWED A THROMBOSED LEFT LIMB. INTERVENTION WAS COMPLETED WHERE THE PHYSICIAN USED A NON MDT ASPIRATION DEVICE WHICH SUCCESSFULLY REMOVED THE THROMBUS. THE PHYSICIAN THEN PLACED A COVERED STENT IN THE LIMB WHERE THERE APPEARED TO BE A NARROWING TO EXPAND THE AREA. BILATERAL BARE METAL STENTS WERE THEN PLACED FROM THE COMMON ILIAC TO THE EXTERNAL ARTERY COVERING THE HYPO ON BOTH SIDES TO EXPAND THE LUMEN IN THAT AREA. THE ASPIRATION DEVICE WAS USED DOWNSTREAM TO REMOVE THROMBUS FROM THE FEMORAL TO JUST BELOW THE KNEE. EVIDENCE OF ARTERIAL FLOW TO THE FEET WAS VISUALIZED BEFORE PROCEDURE WAS COMPLETED. AS PER THE PHYSICIAN THE CAUSE OF THE THROMBUS AND NARROWING COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain; Thrombosis/Thrombus

  MAUDE report 13150982 ↗
• InjuryNov 26, 2021Obstruction of Flow; Obstruction of Flow

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF  56MM ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED THAT NEARLY 3 MONTHS LATER THE PATIENT PRESENT TO THE EMERGENCY ROOM WITH LEG PAIN, A CT WAS CARRIED OUT WHICH REVEALED THE LEFT LIMB WAS COMPLETELY OCCLUDED. THE PHYSICIAN STATED THE LIKELY CAUSE WAS THE DISTAL END OF THE LIMB WAS PINCHED DOWN. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO ANATOMY.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; Obstruction/Occlusion; Pain

  MAUDE report 12877973 ↗
• MalfunctionNov 12, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF AN UNKNOWN SIZE . IT WAS REPORTED DURING A FOLLOW-UP CT OVER A YEAR LATER, THAT A TYPE 1B ENDOLEAK WAS OBSERVED ON THE LIMB ETLW1613C124E. AS PER THEY PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE PATIENTS OWN ANATOMY AND DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801834 ↗
• DeathOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 51MM RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 1 MONTH POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE ER WITH LEFT LEG PAIN. A CT WAS PERFORMED WHICH SHOWED THE LEFT LIMB OF THE DEVICE WAS OCCLUDED. THE LEFT LIMB APPEARED TO HAVE A VERY TIGHT STENOSIS IN THE LEFT LIMB AT THE LEVEL OF THE AORTIC BIFURCATION. THE PATIENT WAS TAKEN TO THE OR, THE PHYSICIAN PERFORMED A CUTDOWN  ON THE LEFT GROIN AND PLACED A  BALLOON UP AND PULLED OUT ALL  OF THE CLOT. AFTER REESTABLISHING FLOW, BILATERAL BARE METAL STENTS WERE IMPLANTED AND POST BALLOONED ON BOTH LIMBS. THE PHYSICIAN CLOSED THE GROIN AND THE PATIENT WAS NOTED TO HAVE GREAT PULSES TO THE FOOT.  THE PATIENT HAD NO FLOW FOR OVER 12 HOURS PRIOR , SO THE PHYSICIAN PERFORMED A FASCIOTOMY OF THE LEFT LEG. THE PATIENT WAS BEING TREATED FOR  RHABDOMYOLYSIS AFTER THE PROCEDURE.   AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND WAS NOTED TO HAVE A TIGHT DISTAL AORTA MEASURING 17X17. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 12566966 ↗

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