Endurant® II ETUF2814C102E (UDI 00643169232594)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00643169232594), received between Feb 15, 2017 and May 25, 2026 — classified as 8 deaths, 22 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (14 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. Oct 15, 2021Class IIOpen, Classified

   Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

   Z-0291-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 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: Insufficient Information

  MAUDE report 25268828 ↗
• InjuryMay 18, 2026Difficult to Remove; Device Damaged by Another Device

  IT WAS REPORTED THAT AN ENDURANT II AUI STENT GRAFT WAS USED DURING AN INITIAL PROCEDURE TO TREAT A 55 MM ABDOMINAL AORTIC ANEURYSM WITH PLANNED DEPLOYMENT OF A 28 AUI WITH A 10 MM LIMB EXTENSION TO THE RIGHT COMMON ILIAC ARTERY IN A PATIENT WITH A PRE-EXISTING OCCLUDED LEFT COMMON ILIAC ARTERY AND A PREVIOUSLY PLACED RIGHT COMMON ILIAC ARTERY STENT. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE RIGHT ILIAC STENT WAS PRE-DILATED WITH A 9 MM ANGIOPLASTY BALLOON, AND THE 28 AUI WAS ADVANCED AND SUCCESSFULLY DEPLOYED. IT WAS NOTED THAT THE DEVICE WAS INSPECTED UPON OPENING WITH NO ISSUES NOTED AND THE INSTRUCTIONS FOR USE WERE FOLLOWED DURING DEPLOYMENT. DURING RE-SHEATHING, THE DELIVERY SYSTEM BECAME STUCK ON THE PROXIMAL SEGMENT OF THE PRE-EXISTING ILIAC STENT, AND THE ILIAC STENT WAS PULLED BACK DURING ATTEMPTED RE-SHEATHING, CAUSING A BEND IN THE ILIAC STENT. THE PHYSICIAN WAS UNABLE TO REMOVE THE DELIVERY SYSTEM ACROSS THE BENT ILIAC STENT. AXILLARY ACCESS WAS OBTAINED AND A WIRE, CATHETER, AND BALLOON WERE ADVANCED FROM ABOVE IN AN ATTEMPT TO CROSS THE ILIAC STENT AND OPEN IT, BUT THIS WAS UNSUCCESSFUL. THE PATIENT WAS TRANSPORTED TO ANOTHER HOSPITAL FOR CONTINUATION OF CARE.

  Patient problems: Insufficient Information

  MAUDE report 25197398 ↗
• MalfunctionMar 2, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE TO TREAT A 55MM ANEURYSM WITH THE STENT GRAFT ETUF2814C102E ENDUR II AUI. AFTER THE STENT GRAFT WAS DEPLOYED WHEN ATTEMPTING TO RECAPTURE, THE NOSE CONE WOULD NOT RECAPTURE. FOLLOWING THE IFU THE DEVICE WAS OPENED HOWEVER THE DEVICE WOULD STILL NOT RECAPTURE THE NOSE CONE. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DEVICE RELATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483564 ↗
• MalfunctionMay 10, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ENDURANT II AUI STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 90MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE ENDURANT II AUI STENT GRAFT DELIVERY SYSTEM KINKED AT THE MIDDLE DURING DELIVERY DUE TO SEVERE CALCIFICATION. THE DELIVERY SYSTEM AND GRAFT WERE WITHDRAWN AND A REPLACEMENT ENDURANT II AUI STENT GRAFT (V30978245) WAS IMPLANTED, AND TREATMENT WAS COMPLETE. IT WAS CONFIRMED THE DEVICE WAS INSPECTED BEFORE USE AND NO ISSUES WERE OBSERVED. PER THE PHYSICIAN THE CAUSE OF THE KINK IN THE DEVICE¿S DELIVERY SYSTEM WAS ANATOMY-RELATED DUE TO THE SEVERE CALCIFICATION OF THE PATIENT¿S AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19284250 ↗
• InjuryJul 28, 2023Adverse 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 55MM AAA . IT WAS NOTED THE PATIENT HAD A CHRONIC OCCLUDED RIGHT SUPERFICIAL FEMORAL ARTERY. THE RIGHT HYPOGASTRIC WAS COILED DURING THE EVAR. A RIGHT ENDARTERECTOMY WAS PERFORMED AFTER THE COMPLETION OF THE EVAR. IT WAS REPORTED POST -OPERATIVELY JUST AFTER MIDNIGHT , THE PATIENT WAS NOTED TO HAVE AN ABSENT DISTAL PULSE IN THE RIGHT LEG. THE PATIENT WAS TAKEN TO OR WHERE A THROMBECTOMY WAS PERFORMED AS TREATMENT.  PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION WAS ANATOMY AND THE PHYSICIAN STATED THAT THE GRAFT GOT OCCLUDED FROM THE DISTAL PROFUNDA AND THE ENDARTERECTOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17412646 ↗
• InjuryJul 20, 2023Leak/Splash; Leak/Splash

  AN ENDURANT AUI STENT GRAFT AND ENDURANT LIMB WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. AN ENDURANT II CUFF WAS IMPLANTED APPROXIMATELY 2 YEARS LATER FOR AN UNKNOWN REASON. THE MAX AORTIC DIAMETER AT 2 YEARS WAS NOTED AS 75MM X 81MM. IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE, FOLLOW-UP CT SHOWED AN UNKNOWN ENDOLEAK. IT WAS ALSO NOTED THAT THE DISTAL RIGHT LIMB APPEARS TO HAVE LOST APPOSITION TO THE WALL OF THE RIGHT COMMON ILIAC ARTERY. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED WILL BE MONITORED.

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

  MAUDE report 17359628 ↗
• DeathMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED EMERGENTLY IN THE ENDOVASCULAR TREATMENT OF A RUPTURED AAA .  IT WAS REPORTED THAT DURING THE PROCEDURE, THE AUI AND LIMBS WERE IMPLANTED IN AN EFFORT TO CONTAIN THE RUPTURE BUT THE PATIENT SUCCUMBED TO THE BLOOD LOSS AND EXPIRED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16917801 ↗
• InjuryApr 3, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 80MM AAA.  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY OVER FOUR YEARS LATER WITH STOMACH PAIN. A CTA WAS PERFORMED WHICH SHOWED A POSSIBLE TYPE IIIA ENDOLEAK BETWEEN THE ENDURANT  AUI STENT GRAFT AND ENDURANT LIMB.  ON THE SAME DATE A ENDURANT LIMB ETLW1616C124E WAS IMPLANTED TO CORRECT THE ENDOLEAK AND THE ALLEGED EVENT RESOLVED.  PER THE PHYSICIAN THE CAUSE OF THE IIIA ENDOLEAK COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 16662153 ↗
• DeathJan 23, 2023Adverse 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 A ENDOVASCULAR PROCEDURE .  IT WAS REPORTED VIA THE PATIENTS DAUGHTER, THROUGH PATIENT REGISTRATION SERVICES, THAT THE PATIENT PASSED AWAY DURING THE INDEX PROCEDURE.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 16222876 ↗
• InjuryNov 10, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 39MM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK DIAMETER WAS NOTED AS 23MM WITH NECK LENGTH 20MM. MILD PROXIMAL NECK CALCIFICATION WAS NOTED. IT WAS REPORTED ON THE DAY AFTER THE INDEX PROCEDURE THE PATIENT WAS NOT PASSING URINE. FOLLOW UP CT IDENTIFIED COVERED RENALS AND PARTIAL COVERAGE OF THE SMA. PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION IS UNDETERMINED. IT WAS NOTED THAT THE PHYSICIANS THOUGHT THEY WERE AT THE INTENDED LANDING ZONE. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15769942 ↗
• MalfunctionOct 28, 2022Leak/Splash; Leak/Splash

  AN ANNEURX STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 56MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 21 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT SHOWED A TYPE IA ENDOLEAK ON THE RIGHT ANTERIOR ASPECT OF THE AORTA. THE GRAFT WAS 15MM BELOW THE LOWEST RENAL AND THE AORTA HAD DILATED TO THE SIZE OF THE IMPLANTED GRAFT. INTERVENTION WAS PERFORMED ON (B)(6) 2022. ETUF2814C102E (B)(4) WAS USED TO EXTEND UP TO THE LOWEST RENAL EXTENDING INTO THE LEFT ILIAC LIMB OF THE PREVIOUS GRAFT. THE RIGHT LIMB WAS OCCLUDED USING AN 18MM NON MDT PLUG AND A FEM-FEM BYPASS WAS PERFORMED. THERE WAS STILL A SMALL TYPE IA ENDOLEAK AT THE END OF THE PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS ANATOMY RELATED DUE TO NORMAL DISEASE PROGRESSION CAUSING THE ENLARGEMENT OF THE AORTA OVER 21 YEARS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15689716 ↗
• InjurySep 13, 2022Device Damaged by Another Device; Device Damaged by Another Device

  AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM AAA. THE PROXIMAL AORTIC NECK DIAMETER WAS NOTED AS 22MM AND 25MM IN LENGTH IT WAS REPORTED THAT DURING THE PROCEDURE, THAT DURING DEPLOYMENT, THE STENT GOT CAUGHT IN A PREVIOUSLY PLACED ILIAC STENT GRAFT. THE PHYSICIAN THEN BALLOONED AND BROKE A PART OF THE STENT TO FREE THE STENT AND DELIVERY SYSTEM, AND THE GRAFT WAS IMPLANTED.  IT WAS REPORTED THE PATIENTS RIGHT RENAL ARTERY WAS COVERED AND THE PATIENT HAD EXCESSIVE RADIATION EXPOSURE OF 2 HOURS.  PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND THE PREVIOUSLY PLACED ILIAC STENT.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion; Renal Failure

  MAUDE report 15409520 ↗
• InjurySep 5, 2022Adverse 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 AAA.  IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE, THE PATIENT HAD THEIR ENDURANT STENT GRAFTS EXPLANTED DUE TO AN OCCLUDED LEFT ILIAC ARTERY AND LEFT LEG CLAUDICATION. IT WAS SAID THE PATIENT HAS A FAILED FEM-FEM BYPASS AND THE PHYSICIAN THOUGHT THEY SHOULD HAVE HAD AN AORTA BIFEM PROCEDURE TO AN AUI. THERE WAS NO PROBLEM WITH THE STENT GRAFT. THE DEVICE WAS EXPLANTED AND AN OPEN AORTO-BIFEM SURGERY WAS PERFORMED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED BUT NOTED NOT GRAFT RELATED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 15354711 ↗
• InjuryJun 27, 2022Adverse 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 ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE CASE PLAN WAS TO IMPLANT AN AUI WITH EXTENSION DOWN THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT ONLY HAD ONE ACCESS SITE AND DUE TO THIS, THE PHYSICIAN WAS NOT ABLE  TO CONFIRM EXACTLY WHERE THE DEVICE WAS DEPLOYING AFTER TAKING THE ORIGINAL ANGIOGRAM BEFORE LOCKING IN THE DEVICE. THE PROCEDURE CONTINUED AS NORMAL BUT IT WAS ONLY NOTED ONCE THE FINAL ANGIOGRAM WAS BEING TAKEN, THAT THE PATIENTS RENAL ARTERIES WERE COVERED WITH STENT GRAFT FABRIC.  THE PHYSICIAN THEN ELECTED TO CONVERT THE PATIENT TO OPEN REPAIR TO EXPLANT THE PROXIMAL PORTION OF THE STENT GRAFT. THIS WAS COMPLETED WITHOUT ISSUE.  PER THE PHYSICIAN  THE CAUSE OF THE EVENT IS UNCLEAR, THE PHYSICIAN WAS NOT AWARE OF THE C - ARM OR TABLE MOVING DURING DEPLOYMENT.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14827671 ↗
• InjuryJun 15, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II AUI WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. A SHORT, CONICAL, ANGLED AORTIC NECK WAS NOTED. IT WAS REPORTED DURING THE INDEX PROCEDURE THE FABRIC LINE OF THE AUI GRAFT WAS DEPLOYED RIGHT BELOW THE LOWEST RENAL ARTERY AND THE GRAFT EXTENDED INTO THE RIGHT COMMON ILIAC. UPON THE FINAL ANGIOGRAM A LARGE TYPE IA ENDOLEAK WAS OBSERVED. MULTIPLE BALLOON INFLATIONS DID NOT RESOLVE THE ENDOLEAK. THE PHYSICIAN WAS MADE AWARE OF THE OPTION OF ENDOANCHOR PLACEMENT TO HELP RESOLVE THE ENDOLEAK BUT DECLINED THAT OPTION. THE PHYSICIAN COMPLETED A "SNORKEL" REPAIR, EXTENDING STENTS FROM THE RENAL ARTERY NORTH PARALLEL TO A 32MM AORTIC CUFF LANDING BOTH PROXIMALLY BELOW THE LEVEL OF THE SMA. AN ANGIOGRAM SHOWED THAT THE TYPE IA ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN THEN DECIDED TO COMPLETE THE PROCEDURE, REVERSE THE HEPARIN AND DO A FOLLOW UP SCAN.  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS DUE TO THE PATIENTS ANATOMY AS A RESULT OF A S SHORT, CONICAL, ANGLED NECK WHICH WAS NOT ADEQUATE FOR A GOOD SEAL. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 14692920 ↗
• MalfunctionMar 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ENDURANT II AUI STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED 78MM ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, WHEN THE PACKAGE WAS OPENED IT WAS OBSERVED THAT THE DELIVERY SYSTEM WAS BROKEN INTO TWO PIECES. THE PROCEDURE WAS COMPLETED WITH A ANOTHER REPLACEMENT DEVICE. PER THE PHYSICIAN, THE CAUSE OF THE DETACHMENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13658328 ↗
• MalfunctionFeb 24, 2022Defective Device; Defective Device

  AN ENDURANT AUI STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE STENT GRAFT WAS IMPLANTED WITH NO ADVERSE EVENTS, ISSUES OR ENDOLEAKS NOTED. POST THE INDEX PROCEDURE WHEN THE DEVICE WAS SCANNED FOR REGISTRATION IT WAS FLAGGED THAT THE IMPLANTED GRAFT THAT WAS PART OF A PRODUCT HOLD WITH ADVICE NOT TO IMPLANT AND TO SEGREGATE. THERE WAS NO CONSEQUENCE TO THE PATIENT. THE CAUSE OF THE EVENT WAS DETERMINED AS USER ERROR - THIS DEVICE WAS NOT STORED IN THE ALLOCATED AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13589898 ↗
• DeathJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED DURING THE EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED AFTER THE PATIENT WAS TRANSFERRED TO THE OR AND BEFORE THE STENT WAS IMPLANTED THE PATIENT¿S STATUS CHANGED; THE PATIENT BECAME UNRESPONSIVE WITHOUT PULSES. IT WAS DETERMINED THE PATIENT AAA HAD RUPTURED AND CPR WAS STARTED. AFTER A DISCUSSION BETWEEN THE PHYSICIAN AND THE ANESTHESIOLOGIST IT WAS DETERMINED THE PATIENT NEEDED HIS AORTA CONTROLLED. THE PHYSICIAN CUT DOWN OVER THE COMMON FEMORAL ARTERY AND PLACED A BALLOON IN THE PATIENT¿S THORACIC AORTA HOWEVER THE PATIENT DID NOT RECOVER FROM THE OCCLUSION AND CPR WAS CONTINUED. THE PHYSICIAN THEN ELECTED TO PLACE AN AUI IN THE PATIENT¿S INFRARENAL AORTA AND EXTENDED TO THE EXTERNAL ILIAC ARTERY EXCLUDING THE ANEURYSM. UNFORTUNATELY, CPR WAS STOPPED, AND THE PATIENT WAS UNABLE TO BE RESITUATED, AFTER A CONSULTATION BETWEEN THE PHYSICIAN AND THE ANESTHESIOLOGIST THE PROCEDURE AND ALL RESITUATING ACTIVITIES WERE COMPLETED. THE PATIENT EXPIRED SHORTY AFTER. AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS CARDIAC RELATED SURROUNDING AN ABDOMINAL AORTIC ANEURYSM RUPTURE. DUE TO THE PATIENTS FRAGIL

  Patient problems: Cardiac Arrest

  MAUDE report 13236234 ↗
• InjuryNov 10, 2021Leak/Splash; Leak/Splash

  AN ANNURRX STENT GRAFT SYSTEM WAS IMPLANTED FOR AN UNKNOWN ENDOVASCULAR PROCEDURE AN ENDURANT CUFF WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE UNDER 2 YEARS LATER FOR MIGRATION OF THE ORIGINAL ANEURX GRAFT. A NON MDT STENT GRAFT WAS IMPLANTED TO RELINE THE GRAFTS A FURTHER 5 YEARS LATER. AN ENDURANT AUI STENT GRAFT SYSTEM WAS IMPLANTED FOR AN UNKNOWN ENDOVASCULAR PROCEDURE ANOTHER YEAR LATER. IT WAS REPORTED FROM THE PATIENT VIA TECHNICAL SERVICES THAT THE PATIENTS STENT GRAFTS WERE LEAKING AGAIN EARLY THIS YEAR AND WERE REMOVED . PER THE PHYSICIAN NO DEVICE DEFICIENCY WAS IDENTIFIED AND THE ORIGIN OR SUBTYPE OF THE ENDOEAK WAS NOT CONFIRMED. AN EXPLANT PROCEDURE WAS CONFIRMED TO HAVE TAKEN PLACE. PER THE PHYSICIAN THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 12785509 ↗
• DeathOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED  FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. AN ENDURANT II AUI STENT GRAFT WAS ALSO IMPLANTED ON THE SAME DATE. IT WAS REPORTED DURING THAT THE PATIENT EXPIRED ON THE SAME DAY OF THE INDEX PROCEDURE. THE CAUSE OF DEATH WAS NOTED AS CARDIOPULMONARY. THE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 12632279 ↗
• InjuryJul 13, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE AAA. APPROXIMATELY 36 MONTHS POST PROCEDURE THE PATIENT RETURNED FOR FOLLOW UP. A TYPE IA & IB ENDOLEAK WAS OBSERVED ON CT, IT WAS ALSO REPORTED THE PATIENTS ANEURYSM WAS 110MM. PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 12158965 ↗
• InjuryJun 30, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 74 MM ABDOMINAL AORTIC ANEURYSM. PATIENT HAD AN OCCLUDED REIA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A NON-MEDTRONIC DEVICE WAS PLACED IN THE RCIA, AND AN ENDURANT AUI WAS PLACED AT THE INFRARENAL AORTA WITH A ENDURANT LIMB EXTENSION. BALLOONING WAS PERFORMED TWICE, HOWEVER AN ENDOLEAK TYPE 1A WAS OBSERVED. THE PHYSICIAN THEN DECIDED TO PUT 10 HELI-FX ENDOANCHORS AND AFTER ANGIOGRAM TYPE 1A LEAK WAS LESS BUT NOT RESOLVED. ADDITIONAL 10 HELI-FX ENDOANCHORS WERE PLACED, BUT ENDOLEAK TYPE 1A WAS STILL PRESENT. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 12091615 ↗
• DeathFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANEURX BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM ON AN UNKNOWN DATE. IT WAS REPORTED 15 YEARS LATER, THE PATIENT PRESENTED WITH A RUPTURED ANEURYSM. A CT IDENTIFIED A TYPE III ENDOLEAK ROUGHLY 3-4CM FROM THE PROXIMAL EDGE OF THE GRAFT. INTERVENTION WAS PERFORMED AN ENDURANT AUI STENT GRAFT WAS IMPLANTED. WHILE EXTENDING THIS WITH A 16X16X93MM ENDURANT LIMB IT WAS SAID THAT DURING ITS DEPLOYMENT, THE PATIENTS BLOOD PRESSURE DROPPED AND THE PATIENT WENT INTO CARDIAC ARREST. CHEST COMPRESSIONS WERE COMMENCED BUT THE PATIENT EXPIRED. THE PATIENT EXPIRED DUE TO THE RUPTURED ANEURYSM. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 11292230 ↗
• InjuryOct 2, 2020Difficult to Remove; Difficult to Remove

  AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM ON THE (B)(6) 2020. A NON MDT STENT GRAFT WAS ATTEMPTED TO BE IMPLANTED BUT FAILED DUE TO AN OCCLUDED LEFT ILIAC AND THE PHYSICIAN ELECTED TO IMPLANT THE AUI. IT WAS REPORTED DURING THE INDEX PROCEDURE THE ENDURANT AUI WAS IMPLANTED WITH AN ENDURANT LIMB EXTENSION (ETLW1616C124E V29886412)) INTO THE RIGHT ILIAC ARTERY. DURING REMOVAL OF THE AUI DELIVERY SYSTEM, THE PHYSICIAN DID NOT CLOSE THE NOSE CONE COMPLETELY AND SOME PLAQUES WERE PULLED OUT SUBSEQUENTLY BREAKING SOME OF THE PROGLIDE STITCHES. THE EXTENSION WAS THEN IMPLANTED AND A FEM FEM BYPASS COMPLETED. FINAL ANGIOGRAM WAS PERFORMED SHOWING NO ENDOLEAKS, BLOCKAGES AND NO EXTRAVASATION FROM THE RIGHT EXTERNAL ILIAC. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10618484 ↗
• InjuryMay 26, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THAT ON FINAL ANGIOGRAM A IA ENDOLEAK WAS PRESENT. INTERVENTION WAS PERFORMED AND THE PHYSICIAN IMPLANTED EIGHT ENDOANCHORS. ANOTHER ANGIOGRAM WAS PERFORMED AND THE IA ENDOLEAK REMAIN ED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 10086628 ↗

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-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