Endurant® II ETUF3614C102ERecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00643169232631), received between Feb 20, 2017 and Dec 15, 2025 — classified as 16 deaths, 16 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (17 reports).

2 FDA recall records name this device's identifier, 2 still open.

5 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.

Recalls naming this device

1. Dec 21, 2021Class IIOpen, Classified

   Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.

   Z-0657-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Jun 7, 2021Class IIOpen, Classified

   During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

   Z-2135-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• DeathDec 15, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE TO TREAT A 57.5MM ANEURYSM, THE STENT GRAFT ETUF3614C102E ENDUR II AUI WAS UNABLE TO ADVANCE THROUGH THE RIGHT COMMON ILIAC ARTERY. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED. THE ANATOMY WAS NOTED TO INCLUDE SEVERELY DISEASED VESSELS. THE PATIENT SUBSEQUENTLY DIED APPROXIMATELY TWO WEEKS LATER, WITH THE CAUSE OF DEATH UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23801026 ↗
• DeathDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS SYMPTOMATIC FOR MULTIPLE PENETRATING AORTIC ULCERS AND WAS IMPLANTED WITH MULTIPLE ENDOGRAFTS, INCLUDING THREE VALIANT CAPTIVIA STENT GRAFTS ( VAMF3636C200TU , TWO VAMF3636C150TU) AND AN ENDURANT AUI STENT GRAFT SYSTEM (ETUF3614C102E, ETLW1613C146E). THE PHYSICIAN CONCLUDED THE PROCEDURE WITH A FEM-FEM BYPASS WHICH WAS NOT PLANNED PRE-OPERATIVELY. IT WAS SAID THAT THE FEM-FEM BYPASS WAS PERFORMED BECAUSE THERE WAS EXCESSIVE OVER SIZING WITH THE VAMF3636C200TU STENT GRAFT DIAMETER. THE STENT GRAFT INFOLDED AND RIGHT ILIAC VESSEL OCCLUSION OCCURRED. THE OCCLUSION WAS DESCRIBED AS NOT THROMBUS-RELATED. THE PATIENT DIED POST OPERATIVELY, BUT THE CAUSE OF DEATH AND DATE OF DEATH ARE UNKNOWN. THE PATIENT'S CONDITION IN THE IMMEDIATE POST-OPERATIVE IS UNKNOWN. THE PATIENT DEATH WAS ASSESSED BY THE PHYSICIAN AS RELATED TO THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23690810 ↗
• InjuryJun 18, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE FOR TREATMENT OF A LARGE ABDOMINAL AORTIC ANEURYSM (80.1MM X 58.5MM), A STENT GRAFT ETUF3614C102E ENDUR II AUI WAS PLACED IN A PATIENT WITH A HISTORY OF AORTA-BY-FEM BYPASS AND RIGHT TO LEFT FEM-FEM BYPASS. A PSEUDOANEURYSM WAS PRESENT AT THE PROXIMAL ANASTOMOSIS PRIOR TO THE PROCEDURE. THE DISTAL PORTION OF THE GRAFT WAS POSITIONED IN THE MOST PROXIMAL ANASTOMOSIS OF THE AORTA-BY-FEM, WHERE THE TIP CAPTURE MECHANISM BECAME STUCK DURING ATTEMPTED RETRIEVAL AND REMAKING OF THE DEVICE. THE GRAFT COVER WAS DAMAGED DURING THESE ATTEMPTS, CAUSING FURTHER ISSUES AT BOTH THE PROXIMAL AND DISTAL ANASTOMOSES. AN OPEN SURGICAL CUTDOWN TO THE PROXIMAL ANASTOMOSIS AND BYPASS GRAFT WAS PERFORMED, AND INTERNAL PHYSICAL MANIPULATION WAS ATTEMPTED TO FREE THE TIP CAPTURE, BUT THIS WAS UNSUCCESSFUL. A SUBSEQUENT CUTDOWN ONTO THE BYPASS GRAFT ALLOWED THE TIP CAPTURE TO BE RELEASED. UPON FURTHER ATTEMPTS TO REMAKE THE DEVICE, IT WAS DISCOVERED THAT THE GRAFT COVER WAS DAMAGED AND WOULD NOT ALLOW FULL RECAPTURE OF THE TIP. THE DEVICE WAS THEN PULLED THROUGH THE BYPASS, BECOMING STUCK AT THE DISTAL ANASTOMOSIS, NECESSITATING AN ADDITIONAL GROIN ACCESS CUT

  Patient problems: Insufficient Information

  MAUDE report 22273949 ↗
• InjuryAug 22, 2024Leak/Splash; Leak/Splash

  AN ENDURANT II AUI STENT GRAFT (ETUF3614C102E) AND ENDURANT II LIMB (ETLW1613C93E) WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROX. 8 YEARS AND 8 MONTHS POST INDEX PROCEDURE THAT FOLLOW-UP CT IMAGING REVEALED A TYPE IA ENDOLEAK. INTERVENTION WAS PERFORMED, DURING WHICH AN ENDURANT II AUI STENT GRAFT (ETUF3214C102E) AND AN ADDITIONAL ENDURANT II LIMB EXTENSION (ETLW1616C124E) WERE IMPLANTED. THE PHYSICIAN POSITIONED THE DEVICE HIGHER IN THE ANATOMY, SEALING JUST BELOW THE CELIAC ARTERY, WHICH COVERED THE SUPERIOR MESENTERIC ARTERY (SMA) AND BOTH RENAL ARTERIES. THE PHYSICIAN THEN LASERED THROUGH THE ENDURANT II AUI AND PLACED STENTS INTO THE SMA AND RENAL ARTERIES TO RESTORE BLOOD FLOW. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS ANATOMY RELATED DUE TO SEVERE PROXIMAL AORTIC NECK ANGLE AND A LARGE TAPERED PROXIMAL NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 20030357 ↗
• DeathMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. IMAGING SHOWED A SUSPECTED TYPE IIIB ENDOLEAK ORIGINATING FROM THE PREVIOUSLY PLACED BIFURCATE GRAFT. INTERVENTION WAS PERFORMED WHERE AN ENDURANT AUI AND ENDURANT EXTENSION CUFF WERE IMPLANTED WHICH RESOLVED THE ENDOLEAK. NO ENDOLEAK WAS VISUALIZED ON ANGIOGRAM AFTER PLACEMENT OF THE AUI GRAFT. IT WAS REPORTED THE PATIENT EXPIRED ON AN UNKNOWN DATE FOLLOWING THE AORTIC RUPTURE. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE III ENDOLEAK COULD NOT BE DETERMINED. IT IS BELIEVED THE ENDOLEAK CAUSED THE ANEURYSM RUPTURE.

  Patient problems: Insufficient Information; Rupture

  MAUDE report 18995995 ↗
• DeathSep 26, 2023Difficult to Remove; Difficult to Remove

  AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED 105MM AAA. IT WAS REPORTED THAT DURING AN EMERGENCY PROCEDURE AFTER THE STENT GRAFT WAS DEPLOYED THE PHYSICIAN WAS UNABLE TO REMOVE THE DELIVERY SYSTEM. THE PATIENT EXPIRED THE DAY AFTER THE INDEX PROCEDURE DUE TO A RUPTURED ANEURYSM. PER THE PHYSICIAN THE CAUSE OF THE REMOVAL DIFFICULTIES WAS ANATOMY RELATED. IT WAS NOTED THAT THE PATIENT HAD A SEVERELY ANGLED NECK AND POOR ACCESS. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Rupture

  MAUDE report 17815940 ↗
• DeathOct 26, 2022Leak/Splash; Difficult to Remove; Leak/Splash; Difficult to Remove

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF AN UNKNOWN SIZE. IT WAS REPORTED APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF ANEURYSM RUPTURE AND IT WAS DISCOVERED THE PATIENT HAD A LATE TYPE IB ENDOLEAK. THE PHYSICIAN IMPLANTED A LIMB EXTENSION ON THE PATIENT'S RIGHT ILIAC ARTERY. FOUR DAYS LATER, THE PATIENT PRESENTED EMERGENTLY AGAIN WITH RUPTURE SYMPTOMS AND AN LATE TYPE IB WAS DISCOVERED ON THE PATIENT'S LEFT ILIAC ARTERY. A 36 AUI STENT GRAFT WAS PLACED AND EXTENDED WITH A 16 X13X156 LIMB. AFTER AUI WAS DEPLOYED WHILE REMOVING THE DELIVERY SYSTEM, NOSE CONE WAS CAUGHT ON SUPER RENAL STENTS. DELIVERY SYSTEM WAS REPOSITIONED AND REMOVED. GRAFTS WERE BALLOONED AND A DIAGNOSTIC ANGIOGRAPHY WAS PERFORMED AND SHOWED SATISFACTORY RESULTS. THE PHYSICIANS BEGAN TO PERFORM FEMORAL TO FEMORAL BYPASS SURGERY. THE PATIENT BEGAN CODING AND CPR WAS PERFORMED FOR 6 MINUTES WHEN TIME OF DEATH WAS CALLED. PER THE PHYSICIAN, THE CAUSE OF THE TYPE IB ENDOLEAK WAS DUE TO ILIAC DILATATION. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Cardiac Arrest; Rupture

  MAUDE report 15672101 ↗
• DeathApr 26, 2022Malposition of Device; Malposition of Device

  AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF 54 MM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK DIAMETER WAS NOTED AS 27 MM AND 60 MM IN LENGTH WITH MILD THROMBUS REPORTED. SEVERE RIGHT AND LEFT ILIAC CALCIFICATION WAS NOTED. IT WAS REPORTED DURING THE INDEX PROCEDURE, DURING DEPLOYMENT OF THE AUI GRAFT THE PHYSICIAN DID NOT FOLLOW IFU INSTRUCTIONS AND PULL THE GRAFT DOWN BELOW THE VIABLE RIGHT RENAL ARTERY. BEFORE BALLOONING WAS COMPLETED AN ANGIOGRAM WAS PERFORMED TO VISUALIZE THE RIGHT RENAL ARTERY. THE RIGHT RENAL ARTERY FILLED BUT SHOWED THAT THE ORIFICE WAS COVERED. THE SMA WHICH WAS 5 MM PROXIMAL TO THE RIGHT RENAL ARTERY WAS OPEN. AN ATTEMPT TO GET INTO THE RENAL ARTERY FROM THE LEFT ARM BRACHIAL APPROACH WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO ABORT THE ENDOVASCULAR OPTION AND CONVERT TO AN OPEN AAA AORTIC REPAIR THE NEXT DAY. THE ETUF3614C102E WAS EXPLANTED AND AN AORTA BI-FEM GRAFT WAS SEWN TO THE EXISTING ENDURANT LIMB. IT WAS REPORTED THE PATIENT EXPIRED ON THE DAY OF THE OPEN REPAIR. PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION WAS DUE TO USER ERROR AND IN REFERENCE TO THE DEATH IT WAS NOTED THAT THE PATIENT WAS TOO FRAIL TO SUR

  Patient problems: Obstruction/Occlusion

  MAUDE report 14207958 ↗
• InjuryJan 17, 2022Positioning Problem; Positioning Problem

  AN ENDURANT II AUI STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 60.5MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE THAT THE PHYSICIAN CUT DOWN OVER THE LEFT COMMON FEMORAL ARTERY AND ACCESSED THE VESSEL WITH AN 18G NEEDLE AND A NON-MDT WIRE. THE NON-MDT DEVICE WIRE WAS ABLE TO BE ADVANCED TO THE MID COMMON ILIAC ARTERY, A 7FR SHEATH WAS ADVANCED INTO THE VASCULAR ANATOMY. THE PHYSICIAN WAS ABLE TO NAVIGATE THROUGH THE SEVERE CALCIUM OF THE LEFT ILIAC ARTERY. AN ANGIOGRAM OF THE INFRARENAL AORTA SHOWED THE RIGHT COMMON ILIAC ARTERY WAS OCCLUDED. THE PHYSICIAN DECIDED TO PLACE AN AUI DEVICE FROM THE LEFT COMMON ILIAC ARTERY. A STIFF WIRE WAS PLACED INTO THE PATIENT¿S ANATOMY THEN THE VESSEL WAS DILATED BY USING 12FR, 14FR, AND 16FR SHEATHS. ONCE THE 16FR SHEATH WAS REMOVED IT WAS REPLACED BY THE 36MM AUI.  WHILE ADVANCING THE AUI THE DELIVERY SYSTEM ADVANCED TO THE PROXIMAL COMMON ILIAC ARTERY THE C-ARM X RAY UNIT FAILED AND HAD TO BE REPLACED WITH A FUNCTIONAL UNIT. DURING THE PROCESS OF REPLACING THE X RAY C-ARM UNIT, THE STIFF WIRE WAS PULLED DOWN INTO THE PATIENT¿S ANEURYSM. THE WIRE WAS UNABLE TO BE RE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Perforation of Vessels

  MAUDE report 13265314 ↗
• DeathJan 4, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE.  IT WAS REPORTED VIA TECHNICAL SERVICES THAT THE PATIENT EXPIRED ON THE DATE OF INDEX PROCEDURE.  NO CAUSE FOR THE EVENT HAS BEEN PROVIDED.   NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 13150337 ↗
• InjuryJun 14, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ENDOLEAK TYPE 2A CAUSED BY A TALENT AORTIC STENT. APPROXIMATELY 64 POST PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH BACK PAIN. ABDOMINAL ULTRASOUND WAS PERFORMED, WHERE AN ENDOLEAK TYPE 1A WAS NOTED. THE EVENT WAS TREATED WITH THE IMPLANTATION OF 10 APTUS ENDOANCHORS PLACED INTO THE ENDURANT AUI IN THE AORTIC NECK. THE EVENT WAS RESOLVED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY POSSIBLY DUE TO AORTIC DILATION. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 11991586 ↗
• DeathJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED IN THE EMERGENT TREATMENT OF A RUPTURED UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE RUPTURE WAS REPAIRED BUT THE PATIENT DID NOT SURVIVE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Rupture

  MAUDE report 11990020 ↗
• InjuryApr 22, 2021Migration or Expulsion of Device; Obstruction of Flow; Migration or Expulsion of Device; Obstruction of Flow

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 100 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 47 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO ER WITH COMPLAINTS OF CLAUDICATION AND DIFFICULTY WALKING. IT WAS STATED THAT THE PHYSICIAN FELT THAT THE ORIGINAL ENDURANT II AUI STENT GRAFT PREVIOUSLY IMPLANTED HAD ¿SLIPPED¿ A FEW MM AND APPEARED TO CREATE A KINK BETWEEN THE DISTAL END OF THE TAPER AND THE AUI LIMB. ON THE SAME DAY, THROMBECTOMY AND ANGIOPLASTY WAS PERFORMED AND AN ADDITIONAL ETUF3614C102E WAS IMPLANTED TWO DAYS LATER RESULTING IN BRISK BLOOD FLOW AND PALPABLE DISTAL PULSES UPON COMPLETION. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11711967 ↗
• InjuryApr 22, 2021Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN AAA . APPROX 5 WEEKS POST IMPLANT, IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY TO THE ED WITH SYMPTOMS CONSISTENT OF A RUPTURED AAA. A CT SHOWED A POSSIBLE CONTAINED RUPTURED AAA WAS IDENTIFIED. INTERVENTION WAS PERFORMED ON THE SAME DATE WHERE AN ENDURANT 36MM AORTIC EXTENSION WAS IMPLANTED AND THE EVENT WAS RESOLVED. THE CAUSE OF THE EVENT PER THE PHYSICIAN WAS DUE TO AN ENDOLEAK, SUBTYPE UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 11711886 ↗
• InjuryMar 23, 2021Leak/Splash; Difficult to Remove; Leak/Splash; Difficult to Remove

  AN ENDURANT AUI STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 52 MM ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE ACCESS WAS SMALL AND IT WAS DIFFICULTY TO REMOVE THE DEVICE FROM THE INTENDED LANDING ZONE. FINAL ANGIOGRAPHY WAS PERFORMED WHERE IT SHOWED AN ENDOLEAK TYPE 1A. AN ETCF3636C49E CUFF WAS THEN IMPLANTED, HOWEVER WHEN THE PHYSICIAN WAS REMOVING THE DEVICE, A RUPTURE OF THE EXTERNAL ILIAC ARTERY OCCUR. IT WAS STATED THAT A ETLW1610C156E WAS IMPLANTED TO REPAIR THE RUPTURED EXTERNAL ILIAC ARTERY. FINAL ANGIOGRAM SHOWED THAT THE TYPE 1A ENDOLEAK WAS RESOLVED. THE CAUSE OF THE EVENT AS PER THE PHYSICIAN, WAS ANATOMY DUE TO A SMALL CALCIFIED ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11555372 ↗
• DeathNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 51MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT EXPIRED DUE TO A MYOCARDIAL INFRACTION THE FOLLOWING DAY. AS PER THE PHYSICIAN THE DEATH WAS NOT PRODUCT RELATED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Death

  MAUDE report 10792682 ↗
• InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 223MM THORACIC AORTIC DISSECTION. IT WAS NOTED THAT THE DEVICE WAS IMPLANTED FROM THE LSA TO THE MID DESCENDING THORACIC AORTA. IT WAS REPORTED THAT POST-OPERATIVELY, AFTER CSF DRAINAGE WAS REMOVED A WEEK LATER, THE PHYSICIAN STATED THAT THEY RE-ESTABLISHED ANOTHER CSF DRAIN BUT THE PATIENT HAD PARAPLEGIA SYMPTOMS. IT WAS NOTED THAT THE INDEX PROCEDURE WAS PERFORMED WITHOUT ISSUE AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED BUT THAT THE PATIENT HAD AN EXISTING AUI AND FEM-FEM AND THE PHYSICIAN THOUGHT THAT HAVING THE PREVIOUS AAA REPAIR MAY HAVE CONTRIBUTED TO THE PARAPLEGIA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Paraplegia

  MAUDE report 10218250 ↗
• InjuryJun 15, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A > 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY 1 YEAR AND 9 MONTHS LATER. A IB ENDOLEAK WAS OBSERVED. IT WAS NOTED THAT THE LEAK DEVELOPED BECAUSE AT THE TIME OF THE AUI IMPLANTATION, THERE WAS NO LIMB EXTENSIONS IMPLANTED. INTERVENTION WAS PERFORMED ON THE SAME DATE. TWO LIMB EXTENSIONS WERE IMPLANTED TO EXTEND FROM THE AUI TO EXTERNAL LEFT AND RIGHT ILIAC ARTERIES AND THE ENDOLEAK RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CANT BE DETERMINED BUT WAS MENTIONED TO BE DUE TO NOT IMPLANTING STENT GRAFT LIMBS INITIALLY. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10152468 ↗
• InjuryDec 11, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAS A VERY SMALL ACCESS ANATOMY AND A PREVIOUSLY IMPLANTED BARE METAL STENT IN THE RIGHT COMMON ILIAC ARTERY. IT WAS REPORTED THAT THE DEVICE WAS INITIALLY UNABLE TO BE PASSED DUE TO THE VESSEL SIZE AND DISEASE. A SERIES OF DILATIONS WERE PERFORMED THROUGHOUT THE ACCESS VESSEL, BUT THE DEVICE STILL WOULD NOT PASS. IN THE PROCESS OF DILATING AND TRYING TO ADVANCE THE DELIVERY SYSTEM THE RIGHT FEMORAL ARTERY RUPTURED. THE RUPTURE WAS REPAIRED. A DIFFERENT DEVICE WAS THEN USED AND WAS ABLE TO BE PASSED SUCCESSFULLY. THE ANEURYSM WAS SUCCESSFULLY TREATED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 9451007 ↗
• DeathJun 6, 2019Leak/Splash; Leak/Splash

  A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 11 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH A RUPTURED ABDOMINAL ANEURYSM. CT REVEALED THE TALENT GRAFT HAD MIGRATED DOWN FROM THE RENALS WITH THE RUPTURE NOTED AT THE PROXIMAL END OF THE GRAFT. INTERVENTION WAS COMPLETED WHERE THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT AUI GRAFT. THE PROCEDURE WAS PERFORMED UNDER SHORT NECK INDICATION. A TYPE IA ENDOLEAK WAS THEN OBSERVED. HELI-FX ENDOANCHORS WERE IMPLANTED HOWEVER THE ENDOLEAK REMAINED. A OCCLUDER WAS IMPLANTED ON THE LEFT AND AN ENDURANT LIMB (ETLW1624C124E) ON THE RIGHT. IT WAS REPORTED THE PHYSICIAN COULD NOT ACHIEVE A SEAL PROXIMALLY AND DECIDED TO IMPLANT A NON MDT NON AORTIC CUFF PROXIMALLY TO THE ENDURANT AUI. THE CUFF DID NOT LAND WHERE EXPECTED. THE PHYSICIAN SUSPECTED A JUNCTIONAL LEAK AND IMPLANTED AN ADDITIONAL CUFF COVERING THE LEFT RENAL. ON THE FINAL RUN, THE TYPE IA ENDOLEAK WAS STILL OBSERVED. A FEM-FEM WAS THEN PERFORMED. IT WAS THEN REPORTED THE PATIENT EXPIRED. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK AND MIGRATION ARE UNDETE

  Patient problems: Death; Rupture

  MAUDE report 8673824 ↗
• InjuryMay 28, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 59MM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK DIAMETER MEASURES 26-32MM AND 10MM IN LENGTH. THE PROXIMAL NECK WAS NOTED AS SHORT WIDE AND CONCIAL WITH MODERATE CALCIFICATION AND THROMBUS PRESENT. IT WAS REPORTED DURING THE INDEX PROCEDURE, AFTER THE AUI STENT WAS IMPLANTED A COMPLETION ANGIOGRAM IDENTIFIED A TYPE IA ENDOLEAK. THERE APPEARED TO BE APPROXIMATELY 5-8MM OF PROXIMAL NECK THAT COULD BE GAINED WITH A PROXIMAL EXTENSION SO THE PHYSICIAN ELECTED TO DEPLOY A PROXIMAL AORTIC EXTENSION JUST BELOW RENAL ARTERIES. A SECOND ANGIOGRAM DEMONSTRATED THE TYPE IA ENDOLEAK REMAINED. 4 HELIX-FX ENDOANCHORS WERE THEN PLACED IN THE PROXIMAL SEAL ZONE. A FINAL COMPLETION ANGIOGRAM WAS PERFORMED DEMONSTRATING A REDUCED AND DELAYED TYPE IA ENDOLEAK. THE PHYSICIAN DECIDED TO END THE PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 8645979 ↗
• InjuryMay 20, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. TORTUOUS ANATOMY WAS NOTED. THE PROCEDURE WAS CARRIED OUT FOR SHORT NECK INDICATION. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE AUI DEVICE WAS IMPLANTED, THE DEVICE CAUGHT ON THE ILIAC DURING REMOVAL CAUSING A RUPTURE. IT WAS NOTED THE DEVICE WAS KINKED ON REMOVAL. THE AREA OF RUPTURE WAS RELINED AND THE EVENT CONFIRMED AS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO CHALLENGING ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 8623076 ↗
• MalfunctionJun 14, 2018Leak/Splash; Leak/Splash

  A TALENT 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 IN PAIN APPROXIMATELY 8 YEARS POST THE INDEX PROCEDURE. A CT REVEALED AN UNKNOWN ENDOLEAK APPEARING MOST PROMINENT AT THE LEVEL OF THE UNSUPPORTED SEGMENT OF THE RIGHT LIMB. IT WAS NOTED THAT THE EFFECTIVENESS/LENGTH OF THE PROXIMAL SEAL AS WELL AS THE DISTAL RIGHT LIMB SEAL WOULD SUGGEST THAT THESE AREAS ARE COMPROMISED AND MAY BE THE SOURCE OF THE LEAK. RADIOLOGY HAS READ THE PATIENT CT AND CONCLUDED A TYPE III ENDOLEAK. INTERVENTION WAS COMPLETED AND A CLASSIC ANGIOGRAM WAS DONE WHERE THE PHYSICIANS AGREED THIS WAS A TYPE III ENDOLEAK AT THE LEVEL OF THE UNSUPPORTED SEGMENT. A 36MM AUI WAS IMPLANTED AND EXTENDED WITH A 20MM FLARED LIMB. A SMALL ENDOLEAK AT FINAL RUN WAS OBSERVED THAT THE PHYSICIANS FELT WOULD RESOLVE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7600335 ↗
• MalfunctionJun 5, 2018Leak/Splash; Leak/Splash

  AN ANUERX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. AN ENDURANT II CUFF WAS ALSO IMPLANTED APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE FOR A SUSPECTED STENT GRAFT MIGRATION AND TYPE IA ENDOLEAK. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 12 YEARS POST THE INDEX PROCEDURE WITH ABDOMINAL PAIN. A CT SHOWED A TYPE III ENDOLEAK BETWEEN THE CUFF AND BIFURCATED STENT GRAFT. THE PHYSICIAN REPORTED THE CAUSE OF THE EVENT TO BE RELATED TO PATIENT ANATOMY AND REPORTED THERE WAS A MORPHOLOGY CHANGE DUE TO ANGULATION BETWEEN THE NECK AND EXISTING BIFURCATED STENT GRAFT. IT WAS REPORTED THAT THE CURRENT DIAMETER OF THE AORTA AT THE RENAL ARTERY WAS 35 MM, THE CURRENT LENGTH OF THE PROXIMAL AORTIC NECK WAS 5MM, AND THE DEGREE OF ANGULATION WAS 50. THE PATIENT WAS TREATED WITH AN ENDURANT II ABDOMINAL TUBE, AN ENDURANT II LIMB EXTENSION, SEVEN ENDOANCHORS AND A RELIANT BALLOON. A NON-MDT PLUG WAS ALSO IMPLANTED IN THE PATIENT AND A FEM-FEM BYPASS CARRIED OUT. EITHER A TYPE IA OR TYPE II ENDOLEAK WAS NOTED ON THE FINAL ANGIOGRAM. THE EVENT WAS REPORTED TO HAVE BEEN RESOLVED. NO ADDITIONAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7568396 ↗
• DeathMar 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED UNKNOWN DIAMETER ABDOMINAL AORTIC ANEURYSM AND SUBSEQUENT IMPLANTATION OF ANOTHER ANEURX STENT GRAFT AND ENDURANT STENT GRAFT WAS ALSO PERFORMED. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS RECEIVING TREATMENT WITH THE ATTEMPTED IMPLANTATION OF AN AUI DEVICE BUT THEN EXPIRED DURING THIS PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO MIGRATION OF THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death

  MAUDE report 7353720 ↗

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, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• 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-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