Endurant® II ETLW1610C124E (UDI 00643169467644)Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00643169467644), received between Feb 14, 2017 and May 25, 2026 — classified as 4 deaths, 39 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 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 49 reports, in the reporter's own words as published by the FDA.

• DeathMay 25, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 50 MM ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY 9.5 YEARS LATER WITH A RUPTURED ANEURYSM. IT WAS NOTED THAT THE PATIENT HAD A FALL AT THEIR HOME 3 DAYS BEFORE. TOTAL OCCLUSION OF THE RIGHT ILIAC LIMB, NOTED AS THE IPSILATERAL LIMB OF THE BIFURCATE WAS ALSO IDENTIFIED ON THE CT SCAN. AN ENDOLEAK WAS IDENTIFIED AND WAS SUSPECTED TO BE A TYPE III FABRIC ENDOLEAK. A 28 AUI STENT GRAFT WAS THEN IMPLANTED VIA THE LEFT SIDE BUT THE ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN ATTEMPTED TO ACCESS THE RIGHT LIMB BY CUTTING DOWN ON THE COMMON FEMORAL BUT WERE UNABLE TO PASS A WIRE UP THE LIMB SO NO THEY COULD NOT PERFORM ANY TREATMENT TO RESTORE FLOW. THE PRE-OPERATIVE CTA PERFORMED SHOWED THE RIGHT LIMB TOTALLY OCCLUDED , HOWEVER, THERE WAS SOME FLOW INTO THE RIGHT LIMB OBSERVED DURING THE PROCEDURAL ANGIOGRAM. IT WAS REPORTED THAT THE PATIENT EXPIRED ON THE SAME DAY. ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS ATTRIBUTED TO THE TYPE III ENDOLEAK FOLLOWING TRAUMA.

  Patient problems: Rupture

  MAUDE report 25268460 ↗
• MalfunctionMay 8, 2026Device Damaged Prior to Receipt by User; Material Deformation

  AN ENDURANT II LIMB ETLW1610C124E WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCUSLAR TREATMENT OF A 70MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE THE DELIVERY SYSTEM WAS OBSERVED TO BE BENT STRAIGHT OUT OF THE BOX. THE PRODUCT WAS REMOVED AND PLACED BACK INTO THE BOX, AND IT WAS NOT USED OR ATTEMPTED TO BE USED; THE PROCEDURE CONTINUED IMPLANTING A NON MDT GRAFT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE CAUSE WAS UNDETERMINED BUT IT WAS NOTED THAT SHIPPING DAMAGE COULD BE LIKELY AS THERE WAS A CREASE OBSERVED ON THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25120532 ↗
• InjurySep 18, 2025Obstruction of Flow; Obstruction of Flow

  AN ETLW1610C124E LIMB STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 38MM ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH LEG PAIN 3 WEEKS LATER. A CT SCAN REVEALED OCCLUSION OF THE LIMB STENT GRAFT. AN ELECTIVE FEM-FEM BYPASS WAS SCHEDULED; HOWEVER, THE PATIENT RETURNED TO THE HOSPITAL ONE WEEK LATER WITH WORSENING SYMPTOMS. THE FEM-FEM BYPASS WAS PERFORMED DURING THIS ADMISSION. PER THE PHYSICIAN, THE STENT OCCLUSION WAS ANATOMY RELATED, WITH THE STENT GRAFT NOTED TO BE SLIGHTLY KINKED DUE TO THE ANATOMY. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 23082541 ↗
• InjuryMar 13, 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 APPROX. 7 DAYS POST INDEX PROCEDURE, THAT THE LEFT LIMB ((B)(6)) STENT GRAFT HAD OCCLUDED, AND INTERVENTION WAS REQUIRED. NO OTHER STENT GRAFTS WERE OCCLUDED. THE PHYSICIAN WAS ABLE TO REPAIR THE LIMB OCCLUSION USING KISSING VBX STENTS IN THE DISTAL AORTA ON THE SAME DATE. THE CAUSE OF THE LIMB OCCLUSION WAS SUSPECTED TO BE DUE TO EITHER THE TIGHT DISTAL AORTA OR POSSIBLY THE PERCUTANEOUS CLOSURE DEVICE. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21592028 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ULCER. IT WAS REPORTED 1 YEAR, 5 MONTHS POST INDEX PROCEDURE THAT A PATIENT PRESENTED WITH A THROMBOSED LEFT LIMB (ETLW1610C124E), AND AN ASPIRATION MECHANICAL THROMBECTOMY WAS PERFORMED. FOLLOWING THE THROMBECTOMY, TWO LIMBS WERE IMPLANTED, ONE ON EACH SIDE, AND THE FLOW DIVIDER WAS RAISED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED BY THE HEALTHCARE PROFESSIONAL. THE EVENT WAS RESOLVED, AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21079086 ↗
• InjuryFeb 12, 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 THE ENDOVASCULAR TREATMENT OF A 50MM AAA. IT WAS REPORTED THAT APPROXIMATELY 3 WEEKS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH LEG PAIN AND THE PHYSICIAN CONFIRMED THAT THE ENDURANT LIMB WAS OCCLUDED. INTERVENTION WAS PERFORMED AND THE LEFT LIMB WAS DE-CLOTTED USING A NON MDT (PENUMBRA) CATHETER AND AN ADDITIONAL ENDURANT 16X10/24 LIMB WAS IMPLANTED ALONG WITH AN 8X59 BARE METAL BALLOON EXPANDABLE STENT IN THE LEFT COMMON ILIAC ARTERY. POST THE INTERVENTION THE LIMB WAS DE-CLOTTED AND THE FLOW WAS RESTORED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE AN OUTFLOW ISSUE WITH THE ARTERY'S SMALLER SIZE AND THE EXISTING STENT GRAFT. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 18684809 ↗
• DeathMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A RUPTURED AAA ON (B)(6) 2023.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT WAS NOTED TO HAVE CHALLENGING ACCESS VESSELS. A SHOCKWAVE LITHOPLASTY WAS USED AND THE MAIN BODY WAS  DEPLOYED. DURING REMOVAL OF THE DELIVERY SYSTEM THE SUPRARENAL STENT WAS STUCK AND BROUGHT INTO THE GRAFT. THE SUPRARENAL STENT WAS POINTING IN A HORIZONTAL ANGLE. AN IVUS PERFORMED  DEMONSTRATED A SEVERE INFOLD. A TYPE IA ENDOLEAK WAS ALSO NOTED. THE PHYSICIAN USED ENDOANCHORS AND A BALLOON TO ATTEMPT TO RESOLVE IT AND A NON MDT STENT WAS ALSO IMPLANTED.  IT WAS REPORTED THE ENDOANCHORS DID NOT RESOLVE THE TYPE IA ENDOLEAK. TWO ENDURANT LIMBS HAD ALSO BEEN IMPLANTED PRIOR TO THE PATIENTS DEATH. IT WAS REPORTED THE PATIENT SUBSEQUENTLY EXPIRED ON THE SAME DATE FROM THE RUPTURED ANEURYSM.  THE PATIENT EXPIRED DURING THE IMPLANT PROCEDURE THE CAUSE OF THE INFOLDING IS UNKNOWN PER THE PHYSICIAN NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Ruptured Aneurysm

  MAUDE report 16910061 ↗
• MalfunctionAug 25, 2022Leak/Splash; Defective Component; Leak/Splash; Defective Component

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 51MM ABDOMINAL AORTIC ANEURYSM. A RIGHT FEMORAL TO POPLITEAL BYPASS DUE TO PERIPHERAL VASCULAR DISEASE WITH CLAUDICATION. IT WAS REPORTED DURING THE INDEX PROCEDURE THE MAIN BODY ESBF2514C103E WAS IMPLANTED SUCCESSFULLY. (ETLW1610C124E S/N (B)(4)) WAS PLANNED TO BE IMPLANTED AS THE CONTRALATERAL LIMB. THE CONTRALATERAL GATE WAS CANULATED AND UNDER ANGIOGRAM MEASUREMENTS WERE TAKEN TO ASCERTAIN THE LENGTH NEEDED TO BRIDGE THE CONTRALATERAL SIDE OF THE MAIN BODY. THIS WAS DONE BY COUNTING THE MARKERS ON THE PIGTAIL FROM THE FLOW DIVIDER TO THE LEFT HYPOGASTRIC. IT WAS DEEMED THAT THE DISTANCE WAS 14CM (COUNTING THE FIRST MARKER AS ZERO). THE PHYSICIAN DID NOT WANT TO LAND ALL THE WAY TO THE LEFT HYPOGASTRIC ARTERY, AND WAS CONTENT TO LAND ABOUT THE 11 OR 12 CM MARKER. THE MODEL SIZE AND EXPIRY DATE OF ETLW1610C124E WAS CONFIRMED AND THE DEVICE WAS DELIVERED WHILE UTILIZING FLUOROSCOPY. WHEN ATTEMPTING TO LINE UP THE PROXIMAL MARKERS OF THE ETLW1610C124E IT WAS OBSERVED THAT THERE WAS ONLY ONE PROXIMAL AT THE EDGE OF THE GRAFT. THE SECOND MARKER WAS SEEN A COUPLEOF MILLIMETRES DISTAL TO THE PROX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293068 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II LIMB WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 48MM ABDOMINAL AORTIC ANEURYSM. MODERATE RIGHT AND LEFT ILIAC CALCIFICATION WAS NOTED. THE DIAMETER AT THE RIGHT PROXIMAL ILIAC WAS NOTED AS 8MM. IT WAS REPORTED 2 DAYS POST THE INDEX PROCEDURE WHILE PATIENT WAS AN INPATIENT IN REHAB RECOVERING FROM THE INDEX PROCEDURE, AN ACUTE ISCHEMIA WAS NOTED IN THE RIGHT LEG. THE PATIENT UNDERWENT A THROMBECTOMY AND STENTING OF THE RIGHT EXTERNAL ILIAC. A 23X14X103 EIIS ENDURANT BIFURCATED GRAFT WITH A 16X10X124 FOR THE LEFT ILIAC AND A 16X10X124 LIMB FOR THE RIGHT ILIAC WAS IMPLANTED. PER THE PHYSICIAN, THE CAUSE OF THE ISCHEMIA COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; Ischemia; Thrombosis/Thrombus

  MAUDE report 14216728 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A ENDURANT II LIMB WAS IMPLANTED DURING AN ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED APPROXIMATELY 6 MONTHS POST THE INDEX PROCEDURE FOLLOW-UP CT OBSERVED THAT THERE WAS OCCLUSION IN THE RIGHT LIMB. INTERVENTION WAS COMPLETED WHERE THE PHYSICIAN PERFORMED A CUTDOWN ON THE RIGHT AND PULLED THE CLOT OUT OF THE LIMB. A ETLW1610C156E LIMB WAS PLACED TO RELINE AND A 8X60 NON-MDT DEVICE WAS PLACED OUT OF THE DISTAL END OF THE STENT TO RESOLVE THE OCCLUSION. AS PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION WAS A RESULT OF THE PATIENT TAKING A LONG CAR JOURNEY AND NOT TAKING THE PRESCRIBED MEDICATION POST THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14191921 ↗
• InjuryDec 9, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE REPAIR OF A 100MM ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. IT WAS DISCOVERED THE PATIENT HAD A TYPE IA ENDOLEAK. THE LIMB HAD A NON-MDT (I CAST) BALLOON EXPANDABLE STENT THAT HAD PULLED OUT OF THE ENDURANT LIMB. THE PHYSICIAN THEN EXTENDED THE LIMB AND TO GAIN SEAL PLACED A CUFF TO RESOLVE THE TYPE IA ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO ANATOMY AS THE AORTA GREW AND ELONGATED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 12967812 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 35MM ABDOMINAL AORTIC ANEURYSM. THE EXTERNAL ILIAC AND LEFT SFA ARE OCCLUDED. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE PHYSICIAN STARTED WITH BI-LATERAL CUTDOWNS COMING FROM BELOW ON THE LEFT HOWEVER WAS NOT ABLE TO GET UP TO THE LEFT COMMON ILIAC. THE PHYSICIAN DECIDED TO COME UP AND OVER TO CROSS DOWN AND WAS ABLE TO GET A WIRE OUT THE LEFT COMMON FEMORAL WITH ACCESS ON BOTH SIDES TO THE AORTA. WHERE THE EXTERNAL ILIAC WAS OCCLUDED BALLOONING WITH A 5X10 AND 7X10 ANGIOPLASTY BALLOON WAS COMPLETED. THE GRAFTS WERE IMPLANTED AND ON THE LEFT SIDE AND EXTENDED WITH NON-MEDTRONIC STENTS. AFTER PLACING THE STENT GREAT FLOW OUT THE LEFT LIMB WAS OBSERVED. BOTH SIDES WERE BALLOONED WITH A RELIANT BALLOON. AFTER BALLOONING WITH THE RELIANT BALLOON THE LEFT LIMB WENT DOWN. A NON-MEDTRONIC BALLOON WAS USED TO PULL A CLOT OUT AND THE LIMB WAS RELINED WITH ANOTHER NON-MEDTRONIC STENT AND AN ADDITIONAL BALLOON EXPANDABLE STENT. AT THIS TIME THE LIMB HAD RESIDUAL CLOT BUT THE PHYSICIAN DECIDED TO STOP AND FOCUS ON THE LEG WHERE THE PROFUNDA WAS NOW OCCLUDED. THE PHYSICIAN USED A BALLOON TO P

  Patient problems: Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 12670787 ↗
• InjuryOct 4, 2021Obstruction of Flow; Obstruction of Flow

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 2 WEEKS POST THE INDEX PROCEDURE, WITH COMPLAINTS OF WEAKNESS/NUMBNESS IN THE LEFT LEG. A CT WAS PERFORMED WHICH REVEALED THERE A CLOT IN THE LEFT ILIAC LIMB ETLW1610C124E. IT WAS REPORTED  IT WAS AS THOUGH THE DISTAL PART OF THE GRAFT HAD COLLAPSED OCCLUDING THE FLOW. NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Muscle Weakness/Atrophy; Obstruction/Occlusion

  MAUDE report 12568044 ↗
• InjuryAug 31, 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 AN ENDOVASCULAR PROCEDURE. 11 DAYS POST PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH LEFT LIMB OCCLUSION. THROMBECTOMY WAS PERFORMED AND THE LIMB WAS EVALUATED WITH IVUS. THERE APPEARED TO BE A STENOSIS IN THE LIMB WHICH WAS REINFORCED WITH BILATERAL STENTS. PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion; Stenosis; Thrombosis/Thrombus

  MAUDE report 12391606 ↗
• MalfunctionApr 7, 2021Leak/Splash; Leak/Splash

  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 APPROXIMATELY 1 YEAR LATER, THE DATE THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL, AN ENDOLEAK TYPE 1B FROM THE LEFT COMMON ILIAC ARTERY WAS NOTED ON ETLW1610C124E AND AN ENDOLEAK TYPE 1A ON THE ESBF2814C103E WAS NOTED BY CT. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627697 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 43 MONTHS POST INDEX PROCEDURE, A CT WAS PERFORMED, WHERE IT WAS NOTED THAT THE RIGHT ILIAC LIMB WAS OCCLUDED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS ANATOMY RELATED, DUE TO ATHEROSCLEROTIC DISEASE IN THE EXTERNAL ILIAC. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11484623 ↗
• InjurySep 9, 2020Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 MONTHS POST INDEX PROCEDURE, THE PATENT PRESENTED EMERGENTLY WITH COLD LEG AND A THROMBOSED LIMB. PHYSICIAN OPENED IT UP WITH MECHANICAL THROMBOLYSIS. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Occlusion

  MAUDE report 10506988 ↗
• InjurySep 2, 2020Adverse 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 A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 45 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, UPON COMPETITION OF THE AAA, IT WAS NOTICED THAT THE PATIENT'S RIGHT SIDE FOOT WAS PALE AND THE PULSES WAS DIMINISHED. THE PHYSICIAN THAN DECIDED TO OPEN THE RIGHT GROIN, WHICH WAS CLOSED WITH A NON-MEDTRONIC CLOSURE DEVICE. UPON OPENING, THE PHYSICIAN NOTICED THAT THE POSTERIOR PLAQUE WAS LIFTED BY THE NON-MEDTRONIC CLOSURE DEVICE AND OCCLUDED THE RIGHT LEG. IT WAS REPORTED THAT A ENDARTERECTOMY WAS PERFORMED. IT WAS STATED THAT AN ANGIOGRAM WAS ALSO PERFORMED AND IT WAS NOTED THAT THE PATIENT HAD A CHRONIC OCCLUSION OF THE SFA. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Diminished Pulse Pressure; Occlusion

  MAUDE report 10481636 ↗
• InjuryAug 20, 2020Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  A ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED HOURS AFTER THE PROCEDURE, DURING A CT, THAT THE LIMB ETLW1610C124E HAD OCCLUDED. INTERVENTION WAS PERFORMED AND THE PATIENT HAD A FEM-FEM BYPASS COMPLETED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 10431163 ↗
• InjuryAug 19, 2020Malposition of Device; Malposition of Device

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER THE ENDURANT LIMB ETLW1610C124E WAS IMPLANTED, THE PHYSICIAN WAS NOT SATISFIED WITH THE POSITION WHERE IT WAS IMPLANTED SO DECIDED TO EXTEND WITH AN ILIAC EXTENSION DISTALLY. AN HELI-FX ENDOANCHORING SYSTEM WAS ALSO USED IN THIS PROCEDURE. WHEN THE APPLIER WAS BEING USED, THE FORWARD BUTTON WAS PRESSED WHICH ADVANCED THE ENDOANCHOR HALF WAY, BEFORE THE ENDOANCHOR HAD FULLY RELEASED HALF WAY, THE BACK BUTTON WAS THEN PRESSED AND THE APPLIER JAMMED AND THE ENDOANCHOR WOULDN'T GO BACK INTO THE APPLIER. IT WAS ALSO REPORTED THAT ONE ENDOANCHOR HAD BEEN DEPLOYED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENTS WAS USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10424416 ↗
• InjuryApr 27, 2020Adverse 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 THE ENDOVASCULAR TREATMENT OF A 42MM ABDOMINAL AORTIC ANEURYSM. ONE DAY PREVIOUSLY THE PATIENT HAD A RIGHT FEMORAL ENDARTERECTOMY PERFORMED. THE EVAR PROCEDURE REPORTEDLY WENT WELL AND THE PATIENT WAS DISCHARGED THE NEXT DAY. POST-OPERATIVELY NINE DAYS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH LEG PAIN AND WEAKNESS. THE PATIENT HAD WEAK PULSES. A CT WAS PERFORMED WHICH SHOWED A LIMB OCCLUSION. THE IMAGES REVEALED THAT THE RIGHT ENDURANT LIMB IS SEVERELY COMPRESSED THROUGH THE DISTAL AORTA. IT WAS NOTED THE DISTAL AORTIC MEASURED ONLY 16 MM IN DIAMETER. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS THE RIGHT LIMB BEING COMPRESSED THROUGH THE DISTAL AORTA. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Occlusion; Pain; Weakness

  MAUDE report 10000147 ↗
• MalfunctionMar 24, 2020Material Deformation; Material Deformation

  AN ENDURANT II LIMB WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE DEVICE'S PACKAGE WAS OPENED. WHEN THE DEVICE WAS STARTING TO BE PREPPED FOR THE PROCEDURE IT WAS NOTED THAT THE GREY HANDLE WAS CRACKED. ANOTHER ENDURANT LIMB WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS THE DEVICE WAS BROKEN WHEN ITS PACKAGE WAS OPENED. IT WAS REPORTED THERE WAS NO DAMAGE TO THE EXTERIOR SHIPPING BOX OR DEVICE'S BOX. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9871777 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW UP APPROXIMATELY TWO MONTHS LATER, IT WAS NOTED THAT THE LEFT STENT GRAFT LIMB (V29541842) WAS OCCLUDED. A SECONDARY REVASCULARIZATION PROCEDURE WAS CARRIED OUT ON TO TREAT THE OCCLUSION. A THROMBECTOMY WAS CARRIED OUT, THE STENT GRAFT LIMB WAS BALLOONED, AND AN ADDITIONAL ENDURANT II STENT GRAFT LIMB ETLW1610C124 WAS IMPLANTED. AS PER THE PHYSICIAN THE CAUSE CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 9685793 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 78 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CLAUDICATION SYMPTOMS WHEN THEY RETURNED FOR FOLLOW UP 4 MONTHS LATER. AN ULTRASOUND SHOWED LEFT LIMB OCCLUSION AND AN ANGIO CARRIED OUT ALSO VERIFIED THE OCCLUSION. A WIRE WAS ATTEMPTED TO BE PASSED INTO THE LIMB RETROGRADE AS WELL AS ANTEGRADE WITHOUT SUCCESS. THE ANGIO SHOWED A PATENT RIGHT AND LEFT HYPOGASTRIC WITH COLLATERAL FLOW AND THERE WAS FLOW IN THE LOWER EXTREMITIES. THE PHYSICIAN OPTED TO NOT PROCEED WITH INTERVENTION BUT TO FOLLOW THE PATIENT FOR THE MOMENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY. THE PHYSICIAN FELT THAT THE DISTAL END OF THE LEFT LIMB WAS AT A TORTUOUS PART OF THE COMMON ILIAC ARTERY CAUSING FLOW ISSUES THAT DID NOT SHOW UP IN THE INITIAL COMPLETION ANGIO OR THE ONE MONTH FOLLOW UP. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Claudication; Occlusion

  MAUDE report 9464893 ↗
• InjurySep 10, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TYPE IB ENDOLEAK APPEARED TO BE COMING FROM THE ILIAC DILATING AROUND THE VESSEL.

  Patient problems: Injury

  MAUDE report 8981083 ↗

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-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-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