Endurant® II ETLW1613C93E (UDI 00643169467682)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00643169467682), received between Dec 22, 2016 and Feb 9, 2026 — classified as 3 deaths, 20 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Fracture; Material Deformation

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE STENT GRAFT ENDUR II LIMB WAS FOUND TO BE BROKEN WHEN REMOVED FROM THE BOX. IT WAS NOTED THAT THE DEVICE WAS TAKEN FROM TRUNK STOCK AND THE REP OBSERVED THAT THE TAPE ADHESIVE WAS ALREADY REMOVED. A CREASE WAS OBSERVED IN THE OUTER BOX AT THE LEVEL OF THE CATHETER, WHILE NO DAMAGE WAS NOTED IN THE BOX AT THE LEVEL OF THE HANDLE. THE TRAY APPEARED UNDAMAGED. THE DEVICE WAS DISCARDED AND A REPLACEMENT LIMB WAS USED, ALLOWING THE CASE TO PROCEED AS NORMAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289563 ↗
• InjuryDec 15, 2025Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion 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 23800983 ↗
• MalfunctionNov 18, 2024Material Deformation; Material Deformation

  AN ENDURANT II LIMB WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 57MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE DELIVERY SYSTEM WAS REMOVED FROM ITS PACKAGING AND WAS FOUND TO BE DAMAGED, AS A SIGNIFICANT BEND WAS IDENTIFIED IN THE MIDDLE OF THE DELIVERY SYSTEM. NO EXTRA FORCE WAS USED TO REMOVE THE DEVICE FROM PACKAGING. THE PACKAGING ITSELF WAS NOT DAMAGED AND WAS NOTED TO BE SEALED WHEN TAKEN OFF THE SHELF. DUE TO THE SEVERITY OF THE BEND, THE DEVICE WAS DEEMED UNUSABLE. THE ENDURANT II STENT GRAFT LIMB DID NOT COME INTO CONTACT WITH THE PATIENT AND WAS DISCARDED. A REPLACEMENT DEVICE WAS OPENED AND SUCCESSFULLY IMPLANTED. THE PATIENT WAS TREATED WITH A 28X14X012 AUI AND 16X13X82 LIMB EXTENSION PER THE PHYSICIAN THE CAUSE OF THE DAMAGED DELIVERY SYSTEM IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE P ATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705464 ↗
• InjurySep 12, 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 AAA. IT WAS REPORTED APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN AND A TYPE IA ENDOLEAK WAS IDENTIFIED. THE PATIENT WAS TAKEN TO THE OR AND A NON-MDT STENT WAS IMPLANTED HOWEVER THE ENDOLEAK REMAINED. IT WAS NOTED BY THE PHYSICIAN THAT THE AORTIC NECK WAS MEASURING 12-13MM IN DIAMETER AND 10MM IN LENGTH AND SO THE ENDURANT STENT GRAFT WAS CONSTRAINED AND THE PROXIMAL SEALING STENT COULD NOT FULLY OPEN AS THE GRAFT WAS OVERSIZED IN RELATION TO THE PATIENT¿S ANATOMY. THE PROXIMAL ENDOLEAK REMAINED AFTER THE NON-MDT STENT WAS IMPLANTED. THE PHYSICIAN DID NOT FEEL A GOOD ENDOVASCULAR OPTION EXISTED GIVEN HOW SMALL THE AORTA WAS AT THE RENAL LEVEL AND AN OPEN REPAIR WAS PERFORMED ON WHERE THE ENDOGRAFT WAS EXPLANTED, WITH THE EXCEPTION OF THE SUPRARENAL STENT AND THE MOST PROXIMAL ASPECT OF THE GRAFT WHERE THE ENDOANCHORS WERE IN PLACE. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS DUE TO OVERSIZING. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 20198256 ↗
• MalfunctionJul 9, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ENDURANT II STENT GRAFT LIMB (ETLW1613C93E) WAS INTENDED TO BE IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED VIA TECHNICAL SERVICES ON 18-JUN-2024, AN EMAIL FROM MDT REPRESENTATIVE, STATED THAT THE ENDURANT II STENT GRAFT LIMB (B)(6) WAS SCRAPPED. ADDITIONAL COMMENTS INDICATED: "OPEN, NOT USED: FULL CHARGE / OPEN NOT USED / CUSTOMER / DEVICE WAS DAMAGED UPON IMPLANT." IT WAS CONFIRMED THE BOX WAS SEALED WHEN TAKEN OFF THE SHELF. IT WAS NOTED THAT THE DEVICE WAS KINKED AT THE TAPERED TIP AND GRAFT COVER TRANSITION. IT WAS REPORTED THAT THE TAPERED TIP AND GRAFT COVER TRANSITION WAS CAUGHT ON THE PATIENT'S SKIN AT INSERTION SITE. ONLY THE TAPERED TIP ENTERED THE PATIENT. THE PHYSICIAN WAS HOLDING DEVICE AT THE BACK OF THE DELIVERY SYSTEM UPON INSERTION INSTEAD OF CLOSER TO THE PROXIMAL END FOR MORE LEVERAGE. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM AND THEN USED A HEMOSTAT TO SPREAD THE SKIN FOR A BETTER TRANSITION AND ADVANCED A NEW DEVICE WITHOUT ISSUE. IT WAS CONFIRMED THAT THE DELIVERY SYSTEM KINKED UPON INSERTION INTO THE PATIENT. THERE WAS NO CALCIFICATION, THE ISSUE WAS USER/PROCEDURE RELATED. IT WAS SAID THE PHYSICIAN DID NOT HAVE APPROPRIATE LEVERAGE UP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19701758 ↗
• InjuryMay 23, 2024Malposition of Device; Malposition of Device

  AN ENDURANT II STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2024. THE AORTIC NECK WAS WIDE, SHORT AND CONICAL. BILATERAL DISSECTIONS IN COMMON ILIACS WERE NOTED WITH A PAU PROXIMAL TO THE RIGHT HYPOGASTRIC.  IT WAS REPORTED DURING THE INDEX PROCEDURE, ETLW1616C93E WAS MEASURED BUT DUE TO ANGULATION AND TORTUOSITY THE LIMB LANDED SHORT OF MARKERS. AN ADDITIONAL LIMB WAS PLACED AND THE PROCEDURE COMPLETED SUCCESSFULLY. PER THE PHYSICIAN THE CAUSE WAS ANATOMY RELATED DUE TO TORTUOSITY.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 19380497 ↗
• MalfunctionMar 26, 2024Material Deformation; Material Deformation

  AN ENDURANT LIMB (ETLW1613C93E); WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, UPON OPENING THE PACKAGING OF THE ENDURANT II STENT GRAFT, THE DELIVERY SYSTEM WAS FOUND TO BE DAMAGED. THE LARGE BLUE WHEEL ON THE DEVICE WAS DAMAGED. THE STENT GRAFT DID NOT COME INTO CONTACT WITH THE PATIENT, AND THE DEVICE WAS NOT IMPLANTED. A REPLACEMENT DEVICE WAS OPENED AND IMPLANTED SUCCESSFULLY. PER THE PHYSICIAN THE CAUSE OF THE DAMAGED DELIVERY SYSTEM IS UNDETERMINED. ITS UNKNOWN IF THE OUTER PACKAGING HAD ANY DAMAGE FROM S HIPPING. THE BOX WAS SEALED WHEN TAKEN OFF THE SHELF.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977116 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 52MM AAA .  IT WAS REPORTED ON THE DATE ON THE CT, A LEFT LIMB OCCLUSION WAS NOTED  WITH THROMBUS EVIDENT IN THE RIGHT LIMB ALSO.  PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY AND A NARROWING IN PART OF THE RIGHT COMMON ILIAC ARTERY.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16635138 ↗
• InjuryMar 24, 2022Adverse 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 57MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON APPROXIMATELY 3 WEEKS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY DUE TO CLAUDICATION IN THE LEFT L EG. IMAGING DEMONSTRATED SUSPECTED INFOLDING ABOVE THE FLOW DIVIDER IN THE MAIN BODY WITH LEFT LIMB THROMBOSIS. INTERVENTION WAS COMPLETED WERE THROMBECTOMIES, IMPLANT OF A NON MDT STENT AND A FEM-FEM BYPASS WAS PERFORMED TO REPAIR THE FLOW DEFECT. IT WAS NOTED THE PATIENT RECLOTTED DURING THE INTERVENTION AND WHILE AN ATTEMPT WAS MADE TO PRESS OUT THE INFOLDING IT REMAINED IN THE MAIN BODY. PER PHYSICIAN, THE CAUSE OF THE INFOLDING IS UNDETERMINED. THE CAUSE OF THE LEFT LIMB THROMBOSIS WAS POSSIBLY DUE TO THE INFOLDING IN THE MAIN BODY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 13887681 ↗
• InjuryMar 23, 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 GRAFT AND THREE ENDURANT II LIMBS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A FOLLOW-UP CT SCAN OVER 4 YEARS , A TYPE IA ENDOLEAK AND A SUSPECTED TYPE IB ENDOLEAK WERE FOUND BY THE RADIOLOGY. 4 DAYS LATER , THE PATIENT RETURNED TO THE OR FOR SECONDARY INTERVENTION TO TREAT THE TYPE IA LEAK AND EXTEND THE DISTAL SEAL IN THE RCIA. A 28MM PROXIMAL CUFF WAS DEPLOYED AT THE FLOOR OF THE RIGHT RENAL, THUS EXTENDING THE PROXIMAL SEAL BY 5 TO 7 MM. NEXT, A 16 ¿ 20¿82 FLARED ILIAC LIMB WAS DEPLOYED ON THE RIGHT SIDE TO EXTEND THE DISTAL SEAL BY 1.5 TO 2 CM, ALL THE WAY TO THE RIGHT COMMON ILIAC BIFURCATION. AFTER BALLOONING THE PROXIMAL AND DISTAL SEAL ZONES AS WELL AS OVERLAPPED SEGMENTS, THE INITIAL COMPLETION ANGIOGRAM SHOWED A BRISK TYPE IA LEAK ON THE LEFT LATERAL ASPECT OF THE GRAFT. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED 10 ENDOANCHORS CIRCUMFERENTIALLY AT THE TOP OF THE AORTIC CUFF, SPECIFICALLY PLACING 7 ANCHORS IN THE LEFT ANTERIOR AND LEFT POSTERIOR QUADRANTS. A SECOND COMPLETION ANGIOGRAM WAS PERFORMED WHICH CONFIRMED COMPLETE RESOLUTION OF THE TYPE IA LEAK. THE CAUSE OF THE TYP

  Patient problems: Insufficient Information

  MAUDE report 13868755 ↗
• DeathNov 3, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED ON DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 75MM ABDOMINAL AORTIC ANE URYSM ON THE. IT WAS REPORTED OVER 2 YEARS LATER DURING A CT THAT THERE WAS LIMB SEPARATION TYPE 3 ENDOLEAK OBSERVED INVOLVING THE LIMB ETLW1613C93E. AS PER THEY PHYSICIAN  THE CAUSE OF THE EVENT WAS DUE TO ANATOMY AS A RESULT OF TORTUOUS ANATOMY WITH MINIMAL OVERLAP. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 12745946 ↗
• InjuryJul 7, 2021Adverse 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 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON THE DATE OF THE CT, A OCCLUDED LEFT LIMB WAS OBSERVED. IT WAS ALSO NOTED THERE WAS A SUSPECTED IIIB ENDOLEAK ABOVE THE FLOW DIVIDER. INTERVENTION WAS PERFORMED 4 DAYS LATER, AN AUI STENT GRAFT WAS IMPLANTED AND A FEMORAL-FEMORAL BYPASS WAS PERFORMED. THE EVENT RESO LVED. AS PER THE PHYSICIAN THE CAUSE OF THE LIMB OCCLUSION WAS DISTAL STENOSIS IN THE LEFT COMMON ILIAC ARTERY. THE CAUSE OF THE IIIB ENDOLEAK COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12128205 ↗
• DeathFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II ABDOMINAL STENT GRAFTS WAS IMPLANTED IN AN ENDOVASCULAR PROCEDURE FOR A PATIENT. IT WAS REPORTED THAT THE PATIENT EXPIRED THREE DAYS AFTER THE PROCEDURE. IT WAS CONFIRMED THAT NO INFORMATION REGARDING THE PATIENT'S DEATH IS AVAILABLE. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Death

  MAUDE report 9676948 ↗
• InjuryDec 10, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AN OCCLUSION OF THE ETLW1613C93E LIMB WAS NOTED. THE PATIENT WAS TREATED FOR THROMBOSIS USING A PTA AND NON-MEDTRONIC BALLOON. THE OCCLUSION WAS THEN RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE OCCLUSION WAS POSSIBLY INADEQUATE DILATION OF THE LIMB. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 9444503 ↗
• MalfunctionNov 22, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 51MM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK DIAMETER MEASURED 19-21MM WITH A NECK LENGTH OF 30MM. THE DIAMETER AT THE LEVEL OF THE AORTIC BIFURCATION MEASURED 31MM. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE STENT GRAFT SYSTEM WAS IMPLANTED, FINAL ANGIOGRAM SHOWED THAT THE BIFURCATED GRAFT WAS PARTIALLY COVERING THE LEFT RENAL ARTERY. ADDITIONALLY, AN ENDOLEAK WAS APPRECIATED AT THE LEVEL OF THE CONTRA-LATERAL GATE. THE PHYSICIAN FELT THE ENDOLEAK COULD BE JUNCTIONAL RELATED AND RE-BALLOONED THE OVERLAPPING SEGMENT OF THE CONTRA-LATERAL LIMB. A REPEAT ANGIOGRAM DEMONSTRATED PERSISTENT ENDOLEAK AT THE SAME LEVEL SO THE PHYSICIAN DECIDED TO RE-EVALUATE AT LATER DATE. AN ADDITIONAL ANGIOGRAM WAS PERFORMED TO CONFIRM THE PROXIMAL LOCATION OF THE STENT GRAFT. THE LEFT RENAL ARTERY WAS FILLING BUT WAS PARTIALLY COVERED SO THE PHYSICIAN ELECTED TO IMPLANT A 7X20MM BALLOON EXPANDABLE STENT. A FINAL ANGIOGRAM DEMONSTRATED GROSS PATENCY OF THE LEFT RENAL ARTERY AND THE PROCEDURE WAS COMPLETED. PER THE PHYSICIAN THE CAUSE OF THE RENAL OCCLUSION WAS DUE TO USER ERROR. THE CAU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9361672 ↗
• MalfunctionJun 17, 2019Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 46 MM DIAMETER ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2019. THE PATIENT HAD A CONICAL NECK OF LENGTH 40 MM AND DIAMETER 20-23 MM. MILD CALCIFICATION AND THROMBUS WAS PRESENT IN THE NECK. THE DIAMETERS OF THE LEFT AND RIGHT ILIAC ARTERIES WERE 11-16 MM AND 11-12 MM, RESPECTIVELY. MILD CALCIFICATION WAS PRESENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE EVAR WAS PERFORMED IN TYPICAL FASHION. UPON THE COMPLETION ANGIOGRAM, AN ENDOLEAK WAS OBSERVED. AFTER PERFORMING ADDITIONAL ANGIOGRAPHY, THE PHYSICIAN FELT THAT THE LEAK WAS A TYPE III. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED AN ADDITIONAL LIMB (B)(4) INTO THE EXISTING LEFT LIMB (B)(4), HOWEVER THE ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN THEN IMPLANTED AN ADDITIONAL LIMB (B)(4) WITHIN THE EXISTING RIGHT LIMB (B)(4), HOWEVER THE ANGIOGRAPHY SHOWED THAT THE ENDOLEAK PERSISTED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED 6 HELI-FX ENDOANCHORS. ANGIOGRAPHY THEN SHOWED A REDUCED ENDOLEAK COMPARED TO THE PREVIOUS ANGIOGRAMS. THE PHYSICIAN THEN DECIDED TO END THE PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703034 ↗
• InjuryMar 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II LIMB WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ISOLATED DILATION OF THE RIGHT ILIAC ARTERY. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH LEG PAIN. A CT ANGIOGRAM SHOWED THE STENT GRAFT LIMB WAS OCCLUDED. A THROMBECTOMY OF THE STENT GRAFT WAS CARRIED OUT ON ALONG WITH THE ENDOVASCULAR REPAIR OF THE PATIENT¿S ABDOMINAL AORTIC ANEURYSM. AN ANGIO-JET THROMBECTOMY DEVICE WAS USED TO REMOVE THE ACUTE THROMBUS AND AN ENDURANT IIS BIFURCATED STENT GRAFT WAS PLACED AT THE LOWEST RIGHT ACCESSORY RENAL ARTERY. THE INDWELLING STENT GRAFT WAS THEN MARRIED TO THE BIFURCATED STENT GRAFT WITH ANOTHER 16X 13 LIMB. A 16X16 LIMB WAS ALSO PLACED FROM THE BIFURCATED STENT GRAFT TO THE LEFT COMMON ILIAC ARTERY. THE STENT GRAFT WAS BALLOONED AND NO ENDOLEAK WAS PRESENT ON THE POST IMPLANTATION ANGIOGRAM. THE EVENT WAS REPORTED TO BE RESOLVED. AS PER THE PHYSICIAN, THE PATIENT STOPPED TAKING THEIR BLOOD THINNING MEDICATION AND THIS LED TO THE OCCLUSION OF THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion; Pain

  MAUDE report 8389483 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 35X43 MM PENETRATING ATHEROSCLEROTIC ULCER (PAU). IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY 2 WEEKS POST THE INDEX PROCEDURE WITH AN OCCLUDED LEFT LIMB THAT APPEARED TO BE COMPROMISED AT THE AORTIC BIFURCATION. A THROMBECTOMY WAS CARRIED OUT AND THE BIFURCATION WAS STENTED BILATERALLY AND THE LEFT ILIAC LIMB WAS RELINED WITH A 16X10X124 DEVICE. THE EVENT WAS CONFIRMED TO BE RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO PATIENT ANATOMY DUE TO A TIGHT BIFURCATION.

  Patient problems: Injury; Obstruction/Occlusion; Occlusion

  MAUDE report 8207759 ↗
• InjuryOct 24, 2018Adverse 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 AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED ON AN UNKNOWN DATE A NON-MDT STENT WAS PLACED IN THE STENT GRAFT LIMB ETLW1613C93E ON AN UNKNOWN DATE AS THERE WAS NARROWING OF THE STENT DUE TO THE ANATOMY OF THE COMMON ILIAC. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Occlusion

  MAUDE report 7998938 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN OCCLUDED STENT GRAFT TWO MONTHS LATER AND THERE WAS STENOSIS OF BOTH ILIAC ARTERIES. THE STENOSIS WHICH WAS DISTAL TO THE RIGHT SIDE OF THE STENT GRAFT WAS BELIEVED TO HAVE CAUSED CLOTTING OF THE STENT GRAFT. INTERVENTION WAS CARRIED OUT WHERE THE PHYSICIAN ATTEMPTED TO REMOVE AS MUCH AS THE CLOTTING AS POSSIBLE. HOWEVER, THE LEFT ILIAC WAS STILL NOT FULLY PATENT AND SO THE PHYSICIAN CONVERTED TO A FEM-FEM BYPASS AND AN AUI WAS IMPLANTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 7925074 ↗
• InjuryJan 18, 2018Occlusion Within Device; Occlusion Within Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 6.1CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD AN OCCLUSION WHICH EXTENDED FROM THE RIGHT LIMB UP INTO THE BIFURCATION DEVICE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS ANATOMY RELATED CAUSED BY CALCIFIED ARTERIES WITH POOR OUTFLOW. THE PATIENT RECEIVED TREATMENT WITH LIMB THROMBECTOMY AND STENT PLACEMENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 7203314 ↗
• InjuryDec 20, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER WITH A COLD LEG. CT PERFORMED REVEALED AN OCCLUSION OF THE PATIENTS RIGHT IPSILATERAL STENT GRAFT LIMB AND REDUCED FLOW DIAMETER IN THE CONTRALATERAL LEFT GRAFT LIMB. ADDITIONALLY, CONSIDERABLE THROMBUS BUILD-UP WAS NOTED IN THE AORTIC SECTION OF THE BIFURCATED PIECE. ON THE SAME DATE, A THROMBECTOMY WAS PERFORMED ON THE PATIENT¿S CONTRALATERAL LIMB TO REMOVE THE CLOT AND A STENT WAS ALSO PLACED IN THAT AREA TO IMPROVE FLOW ON THAT SIDE. A FEM-FEM BYPASS WAS PERFORMED TO RESTORE FLOW TO THE PATIENTS RIGHT LOWER EXTREMITY. IT WAS NOTED THAT THE PATIENT HAS ALSO BEEN PRESCRIBED ANTI-COAGULANTS TO DISSOLVE AND RETARD CLOTTING. THE TREATMENT PERFORMED RESOLVED THE ISSUE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO HYPER-COAGULOPATHY AND POLYCYTHEMIA OF THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 7132844 ↗
• InjuryDec 1, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 25MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY 6 DAYS POST INDEX PROCEDURE WITH A DEVICE LIMB OCCLUSION. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS DUE TO THE BALLOONS USED DURING THE INDEX PROCEDURE NOT BEING INFLATED SIMULTANEOUSLY. A THROMBECTOMY WAS PERFORMED AND METAL STENT PLACED TO TREAT THE OCCLUSION, WHICH RESOLVED THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 7074030 ↗
• InjuryOct 2, 2017Leak/Splash; Occlusion Within Device; Leak/Splash; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY. THE NON-CONTRASTED CT DEMONSTRATED A THORACOABDOMINAL ANEURYSM THAT HAD PROGRESSED BELOW THE RENAL ARTERIES. THERE WAS NO VISUAL EVIDENCE OF ENDOLEAKS SINCE THERE WAS NO CONTRAST WITH THE CT SCAN. THERE WAS AN ENDURANT BIFURCATED GRAFT WITH APTUS ENDOANCHORS IN ADDITION TO THE ILIAC LIMBS IMPLANTED. THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFT. IT WAS REPORTED DURING THE EXPLANT PROCEDURE, THAT THERE WAS NO APPARENT RUPTURE PROXIMALLY AND THE SUPRARENAL ANCHOR PINS REMAINED ENGAGED IN THE AORTA AND THE PROXIMAL SEAL ZONE OF THE STENT GRAFT APPEARED TO BE SITTING IN THROMBUS. THE LEFT ILIAC LIMB WAS OCCLUDED BUT THE ILIAC WAS PATENT AND A DISTAL TYPE I ENDOLEAK THAT WAS BACK BLEEDING IN TO THE ANEURYSM SAC, RESULTING IN ANEURYSM RUPTURE. THERE WAS ALSO SOME LIQUIFIED THROMBUS OUTSIDE OF THE ANEURYSM IN THIS AREA WHERE THE LIKELY ANEURYSM RUPTURE OCCURRED, MOST LIKELY A CONTAINED RUPTURE. THE CONVERSION TO AN OPEN SURGICAL REPAIR WAS SUCCESSFUL. PER THE PHYSICIAN, THE CAUSE OF THE CONTAINED RUPTURE WAS DUE

  Patient problems: Occlusion; Rupture

  MAUDE report 6907582 ↗
• InjuryAug 18, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.6 CM ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT THERE WAS MILD CALCIFICATION AND MINIMAL TORTUOSITY AT IMPLANT. IT WAS REPORTED THAT A TYPE IB WAS SEEN ON AN ANGIOGRAM. IT WAS ALSO NOTED THAT RADIOLOGY OBSERVED MULTIPLE LUMBAR ARTERIES THAT WERE PATENT AND FILLING THE SAC. THE LEFT HYPOGASTRIC ARTERY WAS COILED AND A 16X10X124 ENDURANT II LIMB WAS IMPLANTED TO EXTEND INTO THE LEFT EXTERNAL ILIAC. THIS REPORTEDLY RESOLVED THE TYPE IB ENDOLEAK. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DUE TO UNDERSIZING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6803104 ↗

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-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