Endurant® II ETLW1616C93E (UDI 00643169467569)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00643169467569), received between Jan 25, 2017 and Apr 15, 2026 — classified as 4 deaths, 24 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (17 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDEX ENDOVASCULAR PROCEDURE TO TREAT A 45 MM ABDOMINAL AORTIC ANEURYSM, AN ENDURANT II/IIS STENT GRAFT SYSTEM (ESBF3214C103E WITH ETLW1616C93E AND ETLW1620C93E) WAS IMPLANTED SUCCESSFULLY AND ENDO-ANCHORS WERE THEN DEPLOYED. FIVE ENDO-ANCHORS WERE IMPLANTED SUCCESSFULLY; HOWEVER, DURING DEPLOYMENT OF THE SIXTH ENDO-ANCHOR, THE ANCHOR WAS REPORTED TO NOT BE ENGAGED WITH THE GRAFT FABRIC OR ARTERIAL WALL WHEN DEPLOYED. THE ENDO-ANCHOR MIGRATED ABOVE THE SUPRARENAL STENTS OF ESBF3214C103E. THE PHYSICIAN REMOVED THE ENDO-ANCHOR DELIVERY SYSTEM, INSERTED THE DILATOR OF A 16 FR SHEATH, AND ADVANCED THE 16 FR SHEATH PROXIMAL TO THE SUPRARENAL STENTS OF ESBF3214C103E OVER A STIFF 0.035-INCH GUIDEWIRE, THEN REMOVED THE DILATOR. A GOOSE-NECK STYLE SNARE WAS INSERTED TO ATTEMPT TO SNARE THE UNFIXED ENDO-ANCHOR. DURING THIS MANEUVER THE 16 FR SHEATH AND SNARE WERE PULLED DOWN INTO THE GRAFT, AFTER WHICH THE SNARE BECAME TANGLED WITH THE SUPRARENAL STENTS OF ESBF3214C103E. THE PHYSICIAN ATTEMPTED UNSUCCESSFULLY TO FREE THE SNARE AND THEN CONVERTED TO AN OPEN SURGICAL REPAIR OF THE ABDOMINAL ANEURYSM. THE ESBF3214C103E, ETLW1616C93E, ETLW1620C93E, AND SA-85 ENDO-A

  Patient problems: Insufficient Information

  MAUDE report 24881323 ↗
• InjuryFeb 19, 2026Leak/Splash

  AN ETLW1616C93E STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 68MM AAA. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE WITH ABDOMEN AND BACK PAIN. COMPUTED TOMOGRAPHY ANGIOGRAPHY IDENTIFIED A POSSIBLE TYPE 1B ENDOLEAK IN THE RIGHT COMMON ILIAC, WHICH WAS CONFIRMED ON DIAGNOSTIC ANGIOGRAPHY. THE CAUSE OF THE EVENT WAS ATTRIBUTED TO DISEASE PROGRESSION. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM, WHERE AN ADDITIONAL ENDURANT LIMB WAS PLACED IN THE RIGHT COMMON ILIAC TO REPAIR THE LEAK. LEFT ILIAC ANGIOGRAPHY WAS ALSO PERFORMED, AND IT WAS DECIDED TO EXTEND ON THE LEFT AS THERE WAS MORE ROOM TO EXTEND TO THE INTERNAL ILIAC; THIS WAS TREATED WITH AN ENDURANT LIMB. THE EVENT WAS RESOLVED WITH PLACEMENT OF THE ILIAC LIMB IN THE RIGHT COMMON ILIAC.

  Patient problems: Abdominal Pain; Back pain; Pain

  MAUDE report 24387213 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  AN ETLW1616C93E STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ANEURYSM. IT WAS REPORTED THAT A PSEUDOANEURYSM DEVELOPED IN THE COMMON ILIAC ARTERY. THE EVENT WAS DISCOVERED FOLLOWING A CT SCAN TAKEN ON AN UN UNKNOWN DATE. NO DEFECT, LEAK, OR FAILURE OF THE STENT GRAFT WAS PRESENT. ON (B)(6) 2026 THE PHYSICIAN EXTENDED THE LEFT ILIAC LIMB OF THE DEVICE AND COILED THE INTERNAL ILIAC ARTERY TO ADDRESS THE ISSUE. THE LIMB WAS EXTENDED PAST THE PSEUDOANEURYSM, EFFECTIVELY COVERING IT. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE PSEUDOANEURYSM COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pseudoaneurysm

  MAUDE report 24332539 ↗
• MalfunctionFeb 9, 2026Leak/Splash; Difficult to Remove; Device Damaged by Another Device

  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 24289160 ↗
• MalfunctionSep 19, 2025Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ANEURYSM. IT WAS REPORTED THAT A FOLLOW-UP CT SCAN TAKEN APPROXIMATELY 1 MONTH LATER, SHOWED A TYPE IB ENDOLEAK ON THE LEFT SIDE ASSOCIATED WITH THE CATALOG # ETLW1616C93E STENT GRAFT. IT WAS NOTED THAT CONTRAST WAS CLEARLY SEEN GOING BEHIND THE GRAFT AND INTO THE ANEURYSM SAC. FUTURE TREATMENT IS PLANNED. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095451 ↗
• MalfunctionMar 31, 2025Defective Component; Activation, Positioning or Separation Problem; Defective Component; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR USING THE ETLW1616C93E STENT GRAFT TO TREAT A 55MM AAA . THE DELIVERY SYSTEM WAS INSERTED VIA THE LEFT GROIN AND POSITIONED AT THE FLOW DIVIDER OF AN ALREADY IMPLANTED BIFURCATED GRAFT. THE PHYSICIAN BEGAN DEPLOYMENT BY ROTATING THE BLUE HANDLE COUNTERCLOCKWISE. WHILE ROTATING THE BLUE HANDLE TO DEPLOY THE LIMB, IT WAS NOTICED ON FLUOROSCOPY THAT THE GRAFT COVER WAS NOT RETRACTING AS IT SHOULD TO EXPOSE THE LIMB STENT GRAFT WITHIN. THE SURGEON CONTINUED TO ATTEMPT TO FURTHER ROTATE THE BLUE HANDLE COUNTERCLOCKWISE AND NOTICED THERE WAS A UNUSUAL AMOUNT OF RESISTANCE. AFTER ROTATING THE BLUE HANDLE BACK 4CM FROM THE GRAY FRONT GRIP, THE GRAFT COVER ON FLUOROSCOPY HAD SEPARATED FROM THE TAPERED TIP BY APPROX 5MM AT THIS TIME IT WAS DECIDED THAT THE DELIVERY SYSTEM WAS DEEMED DEFECTIVE. THE DELIVERY SYSTEM WAS REMOVED WITH THE LIMB STENT GRAFT STILL INSIDE, AND A NEW ETLW1616C93E WAS OPENED AND DEPLOYED WITHOUT INCIDENT. THE CAUSE OF THE DEPLOYMENT ISSUE COULD NOT BE DETERMINED PER THE PHYSICIAN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730250 ↗
• InjuryJan 6, 2025Inadequacy of Device Shape and/or Size; Defective Component; Inadequacy of Device Shape and/or Size; Defective Component

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE TREATMENT OF A 62MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE ENDURANT II CONTRALATERAL LIMB WAS COUNTED AS 9 TO THE HYPOGASTRIC ARTERY. ENDURANT LIMB (ETLW1616C93) WAS PLACED HOWEVER, THE LIMB FORESHORTENED BY 2 CENTIMETRES. DUE TO THE FORESHORTENING, THERE WAS AN INSUFFICIENT AMOUNT LIMB INTO THE COMMON ILIAC ARTERY. TO ADDRESS THIS ISSUE, IT WAS RECOMMENDED TO ADD AN ETLW1616C82E GRAFT LIMB. THE HEALTHCARE PROFESSIONAL IDENTIFIED THE FORESHORTENING OF THE LIMB AS THE CAUSE OF THE EVENT. IT WAS RECOMMENDED TO ADD THE ETLW1616C82E TO ADDRESS THE ISSUE. THE REPORTED EVENT HAS NOT BEEN RESOLVED, AND THE DEVICE REMAINS IMPLANTED.

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

  MAUDE report 21078943 ↗
• InjuryNov 28, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT POST THE IMPLANT OF A ENDURANT STENT GRAFT FOR A 60MM ABDOMINAL AORTIC ANEURYSM, THE PATIENT PRESENTED EMERGENTLY WITH A TYPE IB ENDOLEAK FROM THE RIGHT ILIAC LIMB ETLW1616C93E. A NEW ILIAC LIMB EXTENSION WAS PLACED IN THE RIGHT COMMON ILIAC, AND COIL EMBOLIZATION OF THE HYPOGASTRIC ARTERY WAS PERFORMED. THE IB ENDOLEAK WAS ATTRIBUTED TO DISEASE PROGRESSION OF THE COMMON ILIAC ARTERY. NO ADDITIONAL CLINICAL WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 20805380 ↗
• InjuryNov 22, 2024Leak/Splash; Leak/Splash

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60MM AAA. AN ENDURANT CUFF ETCF2828C49E WAS IMPLANTED APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE DUE TO A TYPE IA ENDOLEAK WHICH WAS IDENTIFIED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE AND 1 MONTH POST INTERVENTION FOR THE TYPE IA WHERE A IB ENDOLEAK WAS OBSERVED IN THE LEFT ILIAC LIMB ETLW1613C93E. INTERVENTION WAS PERFORMED ON THE SAME DAY AND A LIMB EXTENSION ETLW1613C93E WAS IMPLANTED. THIS RESOLVED THE IB ENDOLEAK. IT WAS REPORTED THAT THE PATIENT PRESENTED 7 WEEKS POST THE INTERVENTION WITH A IB ENDOLEAK IN THE LEFT ILIAC. A ETEW1010C82E/ (B)(6) WAS IMPLANTED AS TREATMENT ON THE SAME DATE. PER THE PHYSICIAN THE CAUSE OF THE IB ENDOEAK WAS ANATOMY RELATED DUE TO ILIAC DISEASE PROGRESSION. THE ILIAC HAD DILATED DUE TO DISEASE PROGRESSION DETERIORATION. NO CAUSE OF THE IA ENDOLEAK WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 20756280 ↗
• InjuryJul 23, 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 69MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROX. ONE MONTH POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A COLD LEG THAT HAD NO PULSE. IT WAS D ETERMINED THAT THE EVAR LIMB HAD OCCLUDED. THAT PATIENT WAS TAKEN TO THE OR FOR EVALUATION, AND FOLLOW-UP IMAGING REVEALED THAT THE ENDURANT STENT GRAFT LIMB (ETLW1616C93E) WAS COMPROMISED DUE TO THE ANGLE AT WHICH THE RIGHT ILIAC ARTERY BRANCHED OFF THE AORTA. THE OCCLUSION ONLY AFFECTED THE ENDURANT STENT GRAFT LIMB (ETLW1616C93E) AND DID NOT EXTEND INTO THE ENDURANT BIFURCATED GRAFT. A WIRE WAS PASSED INTO THE STENT GRAFT, A THROMBECTOMY WAS PERFORMED, AND THE ENDURANT STENT GRAFT LIMB WAS RELINED WITH AN ALTERNATIVE ENDURANT LIMB (ETLW1610C124E) LANDING IN THE EXTERNAL ILIAC ARTERY. THE ENDURANT LIMB WAS REINFORCED WITH A NON MDT(10X39) BALLOON EXPANDABLE STENT AT THE ORIGIN OF THE RIGHT COMMON ILIAC ARTERY. BLOOD FLOW TO THE RIGHT LOWER EXTREMITY WAS SUCCESSFULLY RESTORED. PER THE PHYSICIAN THE CAUSE OF THE LIMB OCCLUSION WAS ANATOMY RELATED, DUE TO THE ANGLE AT WHICH THE RIGHT COMMON ILIAC ARTERY BRANCHED OFF THE DISTAL AORTA.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19808524 ↗
• InjuryJan 16, 2024Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A AAA. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 8 YEARS AND 9 MONTHS AFTER THE INDEX PROCEDURE AND A TYPE IB ENDOLEAK ON THE PATIENT'S RIGHT SIDE WAS DISCOVERED. THE PATIENT PRESENTED WITH A 130MM AAA AND WAS SYMPTOMATIC. THE PHYSICIAN ELECTED TO COIL THE HYPO AND BUILT DOWN TO THE EXTERNAL. ETLW1613C146E ((B)(6)) WAS IMPLANTED AND THE ENDOLEAK RESOLVED. NO CAUSE WAS PROVIDED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 18515972 ↗
• DeathOct 12, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TYPE 2 THORACOABDOMINAL AORTIC ANEURYSM (ZONE 4-9). THE 46X40 TAPER GRAFT WAS PLACED JUST DISTAL TO LSCA, FOLLOWED BY ANOTHER 46X40. A THORACIC BIFURCATED GRAFT WAS THEN PLACED WITH A UNITARY MANIFOLD DEVICE IN THE UPPER ABDOMINAL AORTA; INDIVIDUAL STENTING OF CELIAC, SMA WITH NON MDT AND SELF-EXPANDING STENTS; INDIVIDUAL STENTING OF RENALS WITH NON MDT SELF-EXPANDING STENTS WAS COMPLETED DUE TO TORTUOSITY; AN EXTENSION DISTALLY WITH ENDURANT 16X16X124; 16X21X99 LIMBS INTO ILIACS. IT WAS REPORTED DURING THE INDEX PROCEDURE, COMPLETION ANGIOGRAM SHOWED A DELAYED TYPE IV ENDOLEAK. FOLLOW UP CT ONE MONTH POST THE INDEX PROCEDURE NOTED "THERE ARE NEW FOCI OF AIR THAT IS SEEN WITHIN THE NATIVE DISTAL THORACIC AORTA OUTSIDE THE ENDOGRAFT. THIS COULD BE RELATED TO RECENT MANIPULATION OF THE ENDOGRAFT. INFECTIOUS PROCESS IS ARE NOT EXCLUDED. IT WAS REPORTED THE PATIENT HAD A COMPLICATED POST-OP RECOVERY FOLLOWING THE INDEX PROCEDURE AND ULTIMATELY THE PATIENT WAS SENT TO INPATIENT REHAB BUT SUFFERED SEPSIS AND EXPIRED NEXT DAY APPROXIMATELY 2 MONTHS POST THE INDEX PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE

  Patient problems: Embolism/Embolus; Sepsis

  MAUDE report 17919247 ↗
• DeathSep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO VALIANT NAVION STENT GRAFTS AND AN ENDURANT II STENT GRAFT SYSTEM WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TAA. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PATIENT WAS TRANSFERRED FROM ANOTHER HOSPITAL WITH CHEST PAIN. A 150MM TAA AND A SUSPECTED TYPE III ENDOLEAK FROM PRE-EXISTING GRAFT COMPONENTS WAS SEEN ON A CT. INTERVENTION WAS PERFORMED, THE VALIANT NAVION STENT GRAFTS WERE RE-LINED WITH 2 VALIANT CAPTIVIA STENT GRAFTS. VAMF4242C150TU WAS PLACED INSIDE PRE-EXISTING ENDOGRAFT WITHOUT SUBCLAVIAN COVERAGE. VAMC4242C150TU WAS PLACED ABOVE THE CHIMNEY STENTS FOR VISCERAL LEVEL. BOVINE PERICARDIAL PATCH WAS USED FOR ANGIOPLASTY OF RIGHT FEMORAL ARTERY. APPROXIMATELY 3 MONTHS POST THE INTERVENTION, 2 ADDITIONAL VALIANT CAPTIVIA STENT GRAFTS AND 2 ENDURANT II LIMBS WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT WAS IN SURGICAL ICU WITH CONCERN FOR ABDOMINAL COMPARTMENT SYNDROME AND THEY WERE TAKEN TO THE OR FOR AN EVALUATION OF THE BLEED. THE PATIENT EXPIRED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE. THE CAUSE WAS UNDETERMINED.

  Patient problems: Abdominal Distention; Chest Pain; Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Swelling/ Edema

  MAUDE report 17787378 ↗
• InjuryJul 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM AAA.  IT WAS REPORTED A CT WAS PERFORMED APPROXIMATELY 4 MONTHS POST THE INDEX PROCEDURE, WHICH REVEALED THE PROXIMAL PORTION OF THE ENDURANT LIMB 16X16X146  WAS COMPRESSED WITH THROMBUS FORMATION.  THE CT ALSO REVEALED A STENT STRUT LYING TRANSVERSE ACROSS THE PROXIMAL PORTION OF THE 16X16X93 LIMB. THERE APPEARS TO BE A STENT THAT IS DETACHED. IT WAS ALSO NOTED THAT THERE ARE MISPLACED STENTS SEEN ON THE CT BUT IT IS UNDETERMINED IF THEY ARE FROM THE BIFURCATE STENT GRAFT OR THE LIMB STENT GRAFT. THERE WAS NO RESTRICTION OF FLOW OR THROMBUS NOTED IN THE 16 X 16 X 90 LIMB OR ENDURANT BIFURCATE. THE PATIENT IS ASYMPTOMATIC.  PER THE PHYSICIAN THE CAUSE COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 17369637 ↗
• InjuryApr 7, 2023Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 70MM AAA.  IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP, A TYPE IB ENDOLEAK WAS IDENTIFIED ON THE ETLW1616C93E  LIMB . INTERVENTION WAS PERFORMED ON THE SAME DATE, THE ENDOLEAK WAS REPAIRED BY BUILDING DOWN INTO THE EXTERNAL WITH A 16/10/124 LIMB.  PER THE PHYSICIAN THE CAUSE OF THE IB ENDOLEAK WAS ANATOMY AND DUE TO THE DISSECTION NOT ALLOWING THE LIMB TO FULLY EXPAND.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16699793 ↗
• MalfunctionApr 4, 2023Difficult to Insert; Difficult to Insert

  AN ENDURANT II LIMB WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF ILIAC DISEASE. IT WAS REPORTED THAT DURING THE PROCEDURE, A DEFECTIVE LUMEN WAS NOTED AS THE GUIDEWIRE WOULD NOT LOAD. A DIFFERENT LIMB WAS USED INSTEAD TO COMPLETE THE PROCEDURE. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16672686 ↗
• DeathJan 23, 2023Adverse 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 A 100MM AAA.  IT WAS REPORTED ON AN UNKNOWN DATE A TYPE IA ENDOLEAK  AND ANEURYSM ENLARGEMENT WAS NOTED. AN ELECTIVE PROCEDURE TO EXPLANT THE STENT GRAFT WAS PERFORMED . DURING THE EXPLANT PROCEDURE THE TYPE IA ENDOLEAK WAS CONFIRMED IN A AREA OF THE RIGHT LATERAL ASPECT OF THE AORTA DISTAL TO THE RENAL ARTERY IS THE FORM OF A PSEUDOANEURYSM. IT WAS REPORTED DURING THE EXPLANT PROCEDURE, THE PATIENT WENT INTO CARDIAC ARREST, CPR WAS ADMINISTERED BUT THE PATIENT EXPIRED.  IT WAS CONFIRMED THE PATIENT DEATH WAS DUE TO COMPLICATIONS RESULTING FROM THE EXPLANT PROCEDURE. NO CAUSE OF THE TYPE IA ENDOLEAK WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 16222780 ↗
• InjuryDec 19, 2022Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT IIS BIFURCATE STENT GRAFT WAS IMPLANTED IN THE EMERGENT ENDOVASCULAR TREATMENT OF A 80MM RUPTURED AAA AND AORTA-CAVAL FISTULA.  AFTER THE BIFURCATE AND BILATERAL LIMBS WERE PLACED,  AN ENDOLEAK WAS NOTED. IT WAS CONFIRMED THE ENDOLEAK WAS ONLY COMING FROM THE BIFURCATE. THE PHYSICIAN THEN IMPLANTED AN ENDURANT CUFF UP TO THE RENAL ARTERIES BUT MISSED BY 1CM DUE TO POOR IMAGING. THE CUFF WAS USED BECAUSE THE INITIAL GRAFT LANDED 1CM DISTAL TO THE DESIRED LANDING ZONE. THE PATIENT WAS RECEIVING CPR AT THE TIME THE PHYSICIAN WAS DEPLOYING THE BIFURCATE, THE PRESSURE SHOT UP AND THE GRAFT WENT DISTAL, THE PHYSICIAN TRIED TO PUSH IT BACK UP BUT 3 STENT RINGS WERE ALREADY DEPLOYED AND THE DELIVERY SYSTEM WAS BUCKLING INTO THE LARGE ANEURYSM INSTEAD OF THE GRAFT GOING PROXIMAL. THE PHYSICIAN OPTED TO DEPLOY THE GRAFT KNOWING THAT HE WOULD HAVE TO CUFF PROXIMALLY. THE NEXT ANGIOGRAM PERFORMED SHOWED A LARGE ENDOLEAK THAT APPEARED TO BE A TYPE III ENDOLEAK. THE PHYSICIAN THEN PLACED 16MM LIMBS PROXIMALLY (B)(4) ON THE RIGHT AND (B)(4) ON THE LEFT,  LANDING 3CM ABOVE THE FLOW DIVIDER.  IT WAS SAID THE ENDOLEAK WAS STILL JUST AS BAD AFTER THIS.  IT WAS REPORTED IT COULD NOT BE SE

  Patient problems: Insufficient Information

  MAUDE report 16004261 ↗
• InjuryJul 27, 2022Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 70CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE. CT SHOWED A TYPE IB ENDOLEAK FROM THE LEFT COMMON ILIAC DUE TO EXPANSION OF THE NATIVE ILIAC ARTERY. THE RIGHT COMMON ILIAC ARTERY HAD ALSO EXPANDED BUT THERE WAS NO ENDOLEAK OBSERVED. THE PROXIMAL MAIN BODY GRAFT HAD NO TYPE IA ENDOLEAK OR LOSS OR SEAL, BUT WAS 7MM DISTAL TO THE RENAL ARTERIES. THE PHYSICIAN DETERMINED THAT THERE WAS NOT ENOUGH AREA BELOW THE LEFT ILIAC GRAFT TO FLARE A LIMB. THE PHYSICIAN THEN COILED THE LEFT HYPOGASTRIC ARTERY, AND EXTENDED INTO THE LEFT EXTERNAL ILIAC ARTERY WITH A ETLW1616C93E ((B)(4)). THERE WAS ABOUT 1CM OF DISTANCE FROM THE RIGHT LIMB OF THE GRAFT (NO TYPE 1B LEAK), SO THE PHYSICIAN PLACED A ETLW1620C93E ((B)(4)) TO MAINTAIN A SEAL IN THE RIGHT COMMON ILIAC. A ETCF2525C49E ((B)(4)) WAS THEN PLACED INSIDE THE MAIN BODY OF THE ENDURANT GRAFT AT THE LEVEL OF THE RENAL ARTERIES. THE PHYSICIAN THEN PLACED HELI-FX ENDOANCHORS AT THE TOP OF THE PLACED CUFF. IVUS SHOWED THAT THE LEFT HYPOGASTRIC ARTERY WAS NOT YET THROMBOSED AND RECEIVING COL

  Patient problems: Insufficient Information

  MAUDE report 15112043 ↗
• InjuryDec 6, 2021Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING A FOLLOW-UP VISIT APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE THAT THE RIGHT LIMB HAD PULLED OUT OF THE COMMON ILIAC ARTERY WITH LOSS OF SEAL AND THE LEFT LIMB HAD LOSS OF SEAL WITH ROUGHLY 1CM OF SEAL AND NO ENDOLEAKS SEEN. INTERVENTION WAS COMPLETED. THE PHYSICIAN PLACED A 16 X 13 X 156 LIMB EXTENDING THE RIGHT SIDE FROM THE FLOW DIVIDER ALL THE WAY DOWN TO SEAL IN THE RIGHT EXTERNAL ILIAC ARTERY. THE RIGHT HYPOGASTRIC ARTERY WAS COILED PRIOR TO THE LIMB IMPLANT. THE LEFT SIDE WAS ALSO EXTENDED COMPLETELY TO THE LEFT HYPOGASTRIC ARTERY WITH A 16 X 24 X 124 LIMB. THE FINAL ANGIO SHOWED PERFECT RESULTS. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12932682 ↗
• InjuryNov 8, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 64MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE THE PATEINT PRESENTED EMERGENTLY WITH BACK PAIN AND A CT WAS PREFORMED WHERE AN ANEURYSM RUPTURE WAS OBSERVED DUE TO A TYPE IB ENDOLEAK IN THE RCIA. THE ANEURYSM DIAMETER IS NOW NOTED AS 130MM X 80MM. THERE WAS NOW 3CM OF UNCOVERED RCIA. AN ENDURANT LIMB WAS INSERTED TO RESOLVE THE ENDOLEAK AND CONTAIN THE RUPTURE. THE ENDOLEAK WAS SEALED.  AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO ANATOMY AS THE ILIAC CONTINUED TO ELONGATE AND DILATE OVER TIME.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 12769827 ↗
• InjuryMay 24, 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 PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT RIGHT LIMB THROMBOSIS WAS NOTED DURING THE INDEX PROCEDURE. THE EVENT WAS TREATED WITH FEM FEM BYPASS ON THE SAME DAY AND THE ISSUE HAS BEEN RESOLVED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY. IT WAS STATED THAT THE PATIENT HAD A TIGHT AORTIC BIFURCATION NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11871001 ↗
• MalfunctionSep 23, 2020Material Deformation; Material Deformation

  AN ENDURANT II STENT GRAFT LIMB WAS PLANNED FOR IMPLANTATION IN THE PATIENT FOR A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE DEVICE WAS PREPPED AND FLUSHED AS NORMAL. WHEN THE PHYSICIAN TRIED TO ADVANCE THE DELIVERY SYSTEM OVER A STIFF WIRE, RESISTANCE WAS FELT. THE PHYSICIAN TOOK THE DELIVERY SYSTEM OFF THE WIRE AND FLUSHED AGAIN. THE PHYSICIAN TRIED TO ADVANCE THE DELIVERY SYSTEM AGAIN BUT FELT RESISTANCE AND DID NOT FEEL COMFORTABLE PUSHING HARDER. ANOTHER LIMB OF THE SAME SIZE WAS USED AND THE PROCEDURE WAS COMPLETED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10573164 ↗
• InjuryAug 28, 2020Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 99MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON THE DATE OF A CT, THREE YEARS AND FOUR MONTHS LATER, A IA AND IB ENDOLEAK WERE OBSERVED WITH AAA SAC EXPANSION. ADDITIONALLY IT APPEARED THAT THE RIGHT ILIAC ARTERY WAS ALSO OCCLUDED. INTERVENTION WAS PERFORMED TWO DAYS LATER. AN ENDURANT AORTIC CUFF WAS IMPLANTED DISTALLY TO THE ORIGIN OF THE SMA TO EXTEND THE PROXIMAL LANDING ZONE. AN ENDURANT LIMB WAS IMPLANTED IN THE RIGHT EXTERNAL ILIAC ARTERY IN A GOOD POSITION. THE GRAFTS WERE THEN BALLOONED WITH A RELIANT BALLOON. A FINAL ANGIOGRAM PERFORMED DEMONSTRATED RESOLUTION OF THE IA AND IB ENDOLEAKS. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 10464431 ↗
• InjuryJul 9, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE MAIN BODY BIFURCATE STENT GRAFT IMPLANTED. THE PHYSICIAN THEN PROCEEDED TO CANNULATE THE CONTRALATERAL LIMB. IT WAS REPORTED THAT AFTER A FEW ATTEMPTS TO CANNULATE, THE GUIDE WIRE ADVANCED UP INTO THE BIFURCATE STENT GRAFT AND THIS WAS CONFIRMED BY PIGTAIL FLUSH. A RETROGRADE TYPE SHEATH INJECTION WAS INJECTED THROUGH THE LEFT SHEATH AND A16X16X93 ENDURANT LIMB WAS ADVANCED INTO THE BIFURCATED GRAFT AND WAS THOUGHT TO BE ADVANCING IN THE CONTRALATERAL SIDE. AFTER COMPLETING THIS DEPLOYMENT, THE PHYSICIAN BEGAN TO PROCEED WITH COMPLETING THE DEPLOYMENT OF THE IPSILATERAL LIMB OF THE BIFURCATE STENT GRAFT, WHEN IT WAS NOTICED THE THE IPSILATERAL LIMB HAD AUTO- DEPLOYED. THE PHYSICIAN THEN PROCEEDED TO REMOVE THE DELIVERY SYSTEM OF THE BIFURCATE AND BEGAN USING ANOTHER RETROGRADE SHEATH INJECTION FROM THE LEFT GROIN. ANOTHER LIMB 16X 13 X 124 WAS CHOSEN AND WHILE DEPLOYING, IT WAS NOTICED THAT THE LEFT LIMB PROXIMALLY LOOKED ABNORMAL AND FOLLOWING COMPLETION OF OBLIQUE PROJECTIONS FROM A FIXED X-RAY UNIT, IT

  Patient problems: Injury

  MAUDE report 10249167 ↗

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-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 infra
• Z-2136-2021 · Jun 7, 2021 · Open, Classified
  Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoili
• Z-1543-2017 · Feb 27, 2017 · Terminated
  Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166