Endurant® II ETLW1620C156E (UDI 00643169467545)Recalls & reported problems
Medtronic, Inc. · STENT GRAFT ETLW1620C156E ENDUR II LIMB · Class 3 · Implant
All models of Endurant II (114)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169467545), received between Jan 11, 2017 and Sep 17, 2024 — classified as 14 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (5 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash5
- Adverse Event Without Identified Device or Use Problem2
- Malposition of Device2
- Material Deformation2
- Device Damaged by Another Device1
- Difficult to Insert1
- Kinked1
- Migration or Expulsion of Device1
Patient problems
- Injury7
- Occlusion3
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Obstruction/Occlusion2
- Thrombus1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2024Difficult to Insert; Difficult to Insert
AN ENDURANT II STENT GRAFT LIMB (B)(6) WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE DEVICE WAS PREPPED NORMALLY, BUT WHEN THE DEVICE WAS PLACED OVER THE WIRE IT WOULD NOT TRACK OVER THE WIRE. THE WIRE WOULD NOT GO THROUGH THE DEVICE. MULTIPLE ATTEMPTS WERE MADE TO PASS THE WIRE THROUGH THE DEVICE, BUT IT WAS BUT IT WAS UNSUCCESSFUL. A REPLACEMENT STENT GRAFT WAS IMPLANTED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETE. PER THE PHYSICIAN THE CAUSE OF THE DIFFICULTLY TO TRACK THE DEVICE WAS DEVICE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20235550 ↗MalfunctionJun 12, 2024Material Deformation; Material Deformation
AN ENDURANT II LIMB ETLW1620C156E WAS INTENDED TO BE IMPLANTED AS PART OF THE ENDOVASCULAR TREATMENT OF A 60MM AAA . IT WAS REPORTED THAT DURING THE PROCEDURE, UPON OPENING THE DEVICES PACKAGING, IT WAS NOTED THAT THE BACK END HANDLE WAS BROKEN. THE BOX ITSELF WAS IN PERFECT CONDITION. THE BOX AND INNER POUCH WERE COMPLETELY SEALED PRIOR TO OPENING. A DIFFERENT STENT GRAFT WAS THEN USED TO CONTINUE WITH THE PROCEDURE. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WAS NOT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19519721 ↗InjuryMar 25, 2024Malposition of Device; Malposition of Device
AN ENDURANT II LIMB (ETLW1620C156E / (B)(6)) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE ENDURANT II STENT GRAFT LIMB WAS DEPLOYED AND LANDED DISTALLY TOTHE INTENDED LANDING ZONE IN THE COMMON ILIAC ARTERY, COVERING THE INTERNAL ILIAC ARTERY. THE STENT GRAFT LIMB WAS DETERMINED TO BE IN AN ACCEPTABLE POSITION AND THE PROCEDURE WAS COMPLETED WITH NO EVIDENCE OF ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE INACCURATE DELIVERY IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.
Patient problems: Obstruction/Occlusion
MAUDE report 18970227 ↗InjuryNov 2, 2022Leak/Splash; Leak/Splash
AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 70MM ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED THAT OVER 6 AND A HALF YEARS LATER, THE PATIENT WAS BEING SEEN FOR FOLLOW-UP DUE TO CANCER TREATMENT. DURING THE CT, THE RADIOLOGIST NOTED THAT THE AAA HAD INCREASED AND ADDITIONAL IMAGING WAS REQUIRED TO DETERMINE WHAT WAS HAPPENING WITH THE PATIENTS AAA. AFTER ADDITIONAL IMAGING , IT WAS DETERMINED THAT THE PATIENT HAS A TYPE IA ENDOLEAK AND BILATERAL IB ENDOLEAKS. THE ANEURYSM HAS INCREASED TO 120MM FROM THE ORIGINAL SIZE OF 70MM. IT WAS NOTED THE BIFURCATE STENT GRAFT IS AT THE LEVEL OF THE RENAL ARTERIES. 3 DAYS LATER, A SECONDARY PROCEDURE WAS PERFORMED. A VAMF3636C100TU LOT #(B)(4)WAS PHYSICIAN MODIFIED WITH 2 FENESTRATIONS FOR THE CELIAC AND SMA. THE RIGHT AND LEFT RENAL WERE LASER FENESTRATED. AN NON MDT STENT WAS PLACED IN THE CELIAC. ANOTHER NON MDT STENT WAS PLACED IN THE SMA. MORE NON MDT STENTS WERE PLACED IN THE RIGHT AND LEFT RENAL ARTERIES. ETEW2828C82E LOT (B)(4) EXTENSION WAS PLACED ON THE RIGHT AND ETLW1628C156E LOT #(B)(4)EXTENSION WAS PLACED ON THE LEFT. PER THE PHYSICIAN FOR A CAUSE OF THE EVENT, IT WAS NOTED THAT T
Patient problems: Insufficient Information
MAUDE report 15714305 ↗InjuryOct 14, 2022Leak/Splash; Leak/Splash
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A AAA. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A TYPE 1B ENDOLEAK IN THE LCIA DUE TO DISEASE PROGRESSION AND THE ANEURYSM CONTINUING TO GROW DISTALLY. ETLW1620C156E WAS THE LIMB AFFECTED. THE LEFT INTERNAL ILIAC WAS EMBOLIZED AND BUILT DOWN INTO THE EXTERNAL ILIAC ARTERY WITH A 16X10X156 LIMB. THE ENDOLEAK RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND DISEASE PROGRESSION. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS FINE
Patient problems: Insufficient Information
MAUDE report 15606908 ↗InjuryFeb 16, 2021Adverse 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 THE ENDOVASCULAR TREATMENT OF A 70MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 1 MONTH POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL WITH A LEFT LEG PAIN. A CT WAS PERFORMED WHERE IT WAS NOTED THAT THE LEFT LIMB WAS OCCLUDED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS ANATOMY DUE TO SEVERE POSTERIOR ANGULATION. IT WAS STATED THAT THE STENT GRAFT WAS ENTERING INTO THE LEFT ILIAC DOVE BACK INTO THE PELVIS AND PINCHED THE LIMB. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.
Patient problems: Obstruction/Occlusion
MAUDE report 11332173 ↗InjuryAug 19, 2020Device Damaged by Another Device; Device Damaged by Another Device
AN ENDURANT IIS, ENDURANT LIMB AND VALIANT NAVION STENT GRAFT WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 80MM SYMPTOMATIC ABDOMINAL AORTIC ANEURYSM. IT WAS DECIDED PRE-EVAR THAT THE PATIENT WAS NOT A CANDIDATE FOR OPEN REPAIR THUS THE PHYSICIAN OPTED FOR OFF-LABEL TREATMENT OF THE LARGE SYMPTOMATIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THAT DUE TO THE PATIENTS VERY DIFFICULT ANATOMY AND THE C-ARM IMAGING, THE DELIVERY SYSTEM OF THE VALIANT NAVION STENT GRAFT GOT CAUGHT ON THE METAL STENTS ON TOP OF THE LIMB GRAFT. MANY ATTEMPTS WERE MADE TO DISLODGE THE DELIVERY SYSTEM BUT THIS PROVED UNSUCCESSFUL. OPEN CONVERSION WAS INITIATED AND ALL THE STENT GRAFTS WERE EXPLANTED, AND THE DELIVERY SYSTEM REMOVED. THE PATIENT WAS RECOVERING IN ICU CRITICAL CARE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY. IT WAS REPORTED THE INFRA-RENAL NECK ANGLE WAS GREATER THAN 90 DEGREES. WHEN THE ENDURANT WAS IMPLANTED, THE BEND AT THE AORTIC NECK WAS SO DRAMATIC THAT IT BENT THE GRAFT AT THE LEVEL OF FLOW DIVIDER, THUS EXPOSING THE SCALLOPED METAL STENTS ON THE LIMB. AS A RESULT , THE SPINDLE OF THE NAVION DELIVERY SYSTEM GOT STUCK ON THESE STENTS. NO ADDITIONAL CLI
Patient problems: Injury
MAUDE report 10425331 ↗InjuryJul 3, 2020Leak/Splash; Leak/Splash
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON ROUTINE FOLLOW-UP 15 MONTHS LATER, A IB ENDOLEAK WAS IDENTIFIED FROM THE RIGHT LIMB ETLW1620C156E DUE TO AN ANEURYSMAL RIGHT COMMON ILIAC ARTERY. INTERVENTION WAS PERFORMED THE NEXT DAY, THE RIGHT HYPOGASTRIC ARTERY WAS EMBOLIZED. THEN A 16X16X93 LIMB FOLLOWED BY 16X10X124 LIMB AND A 10X10X82 ILIAC EXTENSION WERE IMPLANTED WITHIN THE PROXIMAL RIGHT EXTERNAL ILIAC ARTERY. THIS RESOLVED THE ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AS THE RIGHT COMMON ILIAC ARTERY BECAME ANEURYSMAL. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 10229693 ↗InjuryJun 9, 2020Malposition of Device; Malposition of Device
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 53MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THAT THE ENDURANT II STENT GRAFT LIMB ETLW1620C156E COVERED THE RIGHT HYPOGASTRIC ARTERY. IT WAS REPORTED BY THE PHYSICIAN THAT IT APPEARED THE RIGHT HYPOGASTRIC ARTERY "TAKE OFF" WAS HIGHER THAN VISUALIZED ON ANGIOGRAM. INTERVENTION IS NOT PLANNED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT WILL BE MONITORED.
Patient problems: Occlusion
MAUDE report 10132022 ↗InjurySep 30, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY TWO YEARS AND NINE MONTHS LATER WITH A TYPE IB ENDOLEAK AND ANEURYSM EXPANSION. A SECONDARY PROCEDURE WAS CARRIED OUT AND THE STENT GRAFT LIMBS EXTENDED BILATERALLY INTO THE EXTERNAL ILIAC ARTERIES TO RESOLVE THE TYPE IB ENDOLEAKS. AS PER FILM EVALUATION; THE TYPE IB ENDOLEAK WAS ON THE RIGHT IPSI LIMB AND THAT THIS SIDE WAS OCCLUDED AS FAR AS THE BIFURCATION GATE. THE LIMB ETLW1624C124E WHICH WAS EXTENDED ON THE RIGHT AND HAS MIGRATED WITH A TYPE IB ENDOLEAK AND THE CONTRA LIMB ON THE LEFT (ETLW1620C156E) IS 100 % OCCLUDED AND ALSO MAY HAVE MIGRATED ALTHOUGH THERE WAS NO ENDOLEAK EVIDENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT¿S ANATOMY. THERE WAS INADEQUATE SEAL IN THE COMMON ILIAC ARTERIES CAUSING THE TYPE IB ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Occlusion
MAUDE report 9133510 ↗InjuryJan 10, 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 AN ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK DIAMETER MEASURES 23MM WITH A 40 DEGREE ANGULATION. MILD VESSEL TORTUOSITY WAS NOTED AT THE INDEX PROCEDURE. IT WAS REPORTED APPROXIMATELY 8 MONTHS POST THE INDEX PROCEDURE FOLLOW UP CT REVEALED THROMBUS IN THE RIGHT LIMB OF THE ENDURANT GRAFT. THE PHYSICIAN ELECTED TO INTERVENE BEFORE THE LIMB OCCLUDED COMPLETELY. IVUS DEMONSTRATED THE FOCAL THROMBUS IN THE MID RIGHT LIMB. THE LIMB WAS NOT STENOSED OR KINKED. INTERVENTION WAS COMPLETED WITH AN ADDITIONAL LIMB PLACED (V08108449) INSIDE THE EXISTING LIMB TO EXCLUDE THE THROMBUS. BALLOONING WAS THEN COMPLETED USING A RELIANT BALLOON. IVUS REVEALED THE THROMBUS WAS TRAPPED BETWEEN THE LIMBS AND THAT THE LIMB WAS ALMOST FULLY EXPANDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT DISCHARGED ON ANTICOAGULATION THERAPY. PER THE PHYSICIAN THE SOURCE OF THE THROMBUS IS UNKNOWN BUT SUSPECTS IT IS FROM THE HEART.
Patient problems: Injury; Thrombus
MAUDE report 8235744 ↗InjuryOct 18, 2017Material Deformation; Material Deformation
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.8 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS LEFT SIDE TORTUOUS ILIAC ARTERY. IT WAS REPORTED THAT FINAL ANGIOGRAM REVEALED THAT THERE WAS NARROWING/COMPRESSION IN THE LEFT ILIAC LIMB. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER MANUFACTURER¿S STENT, AND THE EVENT WAS RESOLVED. PER THE PHYSICIAN, THE CAUSES OF THE NARROWING/COMPRESSION OF THE ILIAC LIMB WAS DUE TO THE PATIENT¿S ANATOMY; TORTUOUS LEFT ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 6957300 ↗InjuryAug 29, 2017Leak/Splash; Leak/Splash
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE LEFT ILIAC ARTERY MEASURED 11-12-11 MM IN DIAMETER WITH MILD CALCIFICATION. THE RIGHT ILIAC ARTERY MEASURED 10-12-13 MM IN DIAMETER WITH MILD CALCIFICATION. THE DISTAL AORTA WAS APPROXIMATELY 20 MM IN DIAMETER IT WAS REPORTED THAT THE FINAL ANGIOGRAM SHOWED WHAT APPEARED TO BE A BLUSH IN THE RIGHT PROXIMAL COMMON ILIAC. THE PHYSICIAN STATED THERE WAS HEAVY CALCIFICATION IN THE PROXIMAL RIGHT COMMON ILIAC. A RELIANT BALLOON HAD BEEN USED IN THE SAME AREA AS THE LEAK WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THE PHYSICIAN STATED THAT THE EVENT IS ANATOMY RELATED (CALCIFICATION). ANOTHER ENDURANT II LIMB WAS IMPLANTED, RESOLVING THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 6827053 ↗InjuryJun 6, 2017Leak/Splash; Leak/Splash
AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8.0 CM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK ANGULATION OF APPROXIMATELY 60 DEGREES. IT WAS REPORTED THAT, WHEN THE PHYSICIAN BROUGHT THE PATIENT BACK TO THE OPERATING ROOM FOR A RIGHT ILIAC LIMB EXTENSION THE CTA SHOWED WHAT APPEARED TO BE A TYPE IB ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY. THE OR ANGIO CONFIRMED THE TYPE IB ENDOLEAK. THE DECISION WAS MADE TO IMPLANT AN ENDURANT STENT GRAFT AND THE ILIAC ENDOLEAK RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 6616415 ↗InjuryMar 10, 2017Kinked; Kinked
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 83 CM BY 8.8 CM MAX DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON A CT DONE APPROXIMATELY ONE YEAR AND EIGHT MONTHS POST INDEX PROCEDURE, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. THE ENDOLEAK APPEARED TO BE FEEDING THE RIGHT/POSTERIOR QUADRANT OF THE ANEURYSM SAC. THE PATIENT RECEIVED TREATMENT APPROXIMATELY 26 DAYS LATER. THE PHYSICIAN PERFORMED BILATERAL RENAL SNORKELING AND IMPLANTED A 32X32X70 ENDURANT AORTIC CUFF TO THE LEVEL OF THE SUPERIOR MESENTERIC ARTERY (SMA). AFTER IMPLANT OF THE ENDURANT AORTIC CUFF, THERE APPEARED TO BE INFOLDING AT THE SECOND STENT RING OF THE ENDURANT AORTIC CUFF. THE PHYSICIAN REMODELED THE CUFF WITH A BALLOON, AND THE INFOLDING WAS RESOLVED. FINAL ANGIOGRAM SHOWED THAT THE PROXIMAL TYPE I ENDOLEAK APPEARED TO HAVE RESOLVED. ADDITIONALLY, THE RIGHT STENT GRAFT LIMB APPEARED TO BE KINKED. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER MANUFACTURER'S STENT ACROSS THE KINK. NO DISTAL TYPE I ENDOLEAK WAS OBSERVED. PER THE PHYSICIAN, THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK WAS MOST LIKELY DUE TO PATIENT ANATOMY, DISEASE PROGRESSION. PER THE PHYSI
Patient problems: Injury
MAUDE report 6396047 ↗InjuryJan 11, 2017Occlusion Within Device; Occlusion Within Device
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 100 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT, TWENTY DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH OCCLUSION IN THE LEFT ILIAC ENDURANT II STENT GRAFT LIMB. ADDITIONALLY, THE ENDURANT II STENT GRAFT LIMB APPEARED TO BE KINKED. THE PHYSICIAN ELECTED TO GIVE THE PATIENT THROMBOLYTIC MEDICATION OVERNIGHT AND, THE FOLLOWING DAY, IMPLANTED ANOTHER MANUFACTURER¿S 14 MM BARE SELF-EXPANDING STENT IN THE ENDURANT II STENT GRAFT LIMB. AN ANGIOGRAM THEN REVEALED THAT THE ENDURANT II STENT GRAFT LIMB WAS COMPLETELY PATENT WITH BRISK FLOW AND THE EVENT WAS RESOLVED. PER THE PHYSICIAN'S STATEMENT THE CAUSE OF THE EVENT WAS DUE TO THE ANGLE IN WHICH THE ILIAC ENTERED THE AORTA, CAUSING THE KINK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Occlusion
MAUDE report 6244516 ↗
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-0290-2022 · Oct 15, 2021 · Open, ClassifiedEndurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
- Z-0291-2022 · Oct 15, 2021 · Open, ClassifiedEndurant 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, ClassifiedEndurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STEN
- Z-2136-2021 · Jun 7, 2021 · Open, ClassifiedMedtronic 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, ClassifiedEndurant 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 · TerminatedEndurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166
Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices
- Endurant® IIs ESBF2814C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls34 deaths254 reports
- Endurant® IIs ESBF3214C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls19 deaths173 reports
- Endurant® IIs ESBF3614C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall37 deaths214 reports
- Endurant® IIs ESBF2514C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls18 deaths136 reports
- Endurant® IIs ESBF2314C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls9 deaths60 reports
- RelayPro Thoracic Stent-Graft System 28-N4-34-154-34UBolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment3 recalls7 reports
- Vela Proximal Endograft System A34-34/C100-O20 VEndologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths152 reports
- Endurant® II ETCF2828C49EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls7 deaths44 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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