Endurant® II ETCF3232C49ERecalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00613994991454), received between Dec 2, 2016 and Feb 27, 2026 — classified as 7 deaths, 30 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (31 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Dec 21, 2021Open, 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Difficult to Insert; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE FOR TREATMENT OF AN ANEURYSM, THE ETCF3232C49E STENT GRAFT COULD NOT BE FLUSHED AND GUIDEWIRES WERE UNABLE NOT PASS THROUGH THE DEVICE'S LUMEN. THE DEVICE WAS RETRIEVED FROM A VEHICLE ON A VERY COLD DAY, AND IT WAS SUSPECTED THAT THE IT MAY HAVE FROZEN WHEN SALINE WAS PUSHED THROUGH. THE PATIENT RECEIVED TREATMENT WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466567 ↗
• DeathApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDEX PROCEDURE INVOLVING THE HELI-FX ENDOSYSTEM AND A N ENDURANT IIS, A RUPTURE WAS SUSPECTED WHEN THE NON-MEDTRONIC WIRE APPEARED TO DEFLECT OUTSIDE THE AORTIC LUMEN UPON REMOVAL OF THE HELI-FX GUIDE. PRE-OPERATIVELY THE DIAMETER OF THE AORTA AT THE RENAL ARTERY MEASURED 26MM WHILE THE LENGTH OF THE PROXIMAL AORTIC NECK WAS 9MM. MODERATE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. THE PROCEDURE INITIALLY INVOLVED THE SUCCESSFUL PLACEMENT OF A 32MM BIFURCATED DEVICE AND 16X16MM DIAMETER LIMBS, ALONG WITH SIX ENDOANCHORS DUE TO THE PATIENT'S SHORT AND CONICAL NECK ANATOMY. A SELECTIVE ANGIOGRAM WAS PERFORMED, AND NO RUPTURE LEAKS WERE IDENTIFIED AT THAT TIME. HOWEVER, APPROXIMATELY ONE HOUR LATER, THE PATIENT WAS REPORTED TO BE UNSTABLE, PROMPTING ANOTHER ANGIOGRAM WHICH REVEALED A TEAR ABOVE THE LEFT RENAL ARTERY. THE LEFT RENAL ARTERY WAS EMBOLIZED VIA BRACHIAL APPROACH AND COVERED WITH A 32X32X49MM AORTIC CUFF, WHILE THE RIGHT RENAL ARTERY WAS STENTED AND "SNORKELED" BEHIND A 36X36X49MM AORTIC CUFF, MAINTAINING BLOOD FLOW THROUGH THE STENT. THE PATIENT RECEIVED THREE UNITS OF BLOOD AND WAS TRANSFERRED TO CRITICAL CARE. MULTIPLE

  Patient problems: Stroke/CVA

  MAUDE report 21760739 ↗
• InjuryFeb 19, 2025Leak/Splash; Migration or Expulsion of Device; Material Deformation; Leak/Splash; Migration or Expulsion of Device; Material Deformation

  AN ANEURX STENT GRAFT SYSTEM ( YRECXC22375,YRBRHXC2615135,ILXC161685 AND ILXC1616115) WAS IMPLANTED FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM . APPROXIMATELY 1 YEAR AND 10 MONTHS LATER TWO ADDITIONAL ANEURX LIMB STENT GRAFTS (ILXC161685 AND IEXC202055) WERE IMPLANTED. THE REASON FOR IMPLANTATION OF THESE TWO LIMBS IS NOT KNOWN. TWO ENDURANT II STENT GRAFT CUFFS WERE IMPLANTED TO TREAT MIGRATED AND AN ENDOLEAK OF THE ANEURX STENT GRAFT EIGHTEEN YEARS LATER. IT WAS SAID THE BIFURCATE STENT GRAFT HAD FALLEN INTO THE ANEURYSM SAC. THE DATE WHEN THE MIGRATION AND ENDOLEAK WERE FIRST IDENTIFIED IS UNKNOWN BUT IT WAS SAID THE PATIENT HAD PRESENTED TO THE HOSPITAL SYMPTOMATIC WITH PAIN. THE PHYSICIAN WAS ABLE TO STABILIZE THE PATIENT WITH THE IMPLANT OF THE ENDURANT CUFFS. PER THE PHYSICIAN THE FIRST CUFF WAS IMPLANTED AND IT APPEARED THE PROXIMAL FIXATION WAS INVERTED. IT WAS ASSUMED THAT'S WHY THE SECOND CUFF WAS ADDED BUT THIS WAS NOT CONFIRMED. IT WAS REPORTED DURING A FOLLOW-UP THE PATIENT WAS FOUND TO HAVE A TYPE IIIA ENDOLEAK WHERE THE TWO ENDURANT CUFFS HAVE DISCONNECTED. PER THE PHYSICIAN THE CAUSE OF THE TYPE IIIA ENDOLEAK WAS NOT DETERMINED. NO ADDITIONAL CLINICAL SEQUEL

  Patient problems: Insufficient Information; Pain

  MAUDE report 21409776 ↗
• InjuryAug 14, 2023Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device

  AN ENDURANT CUFF AND AORTIC EXTENSION WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM AAA. IT WAS NOTED THAT AT IMPLANT THE DIAMETER OF THE AORTA AT THE RENAL ARTERY WAS 26MM, THE LENGTH OF THE PROXIMAL AORTIC NECK WAS 15MM, THE DEGREE OF ANGULATION WAS LESS THAN 60 DEGREES AND THERE WAS MILD VESSEL TORTUOSITY PRESENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE POST DEPLOYMENT OF ETCF3232C49E, THE DELIVERY SYSTEM WOULDN'T MOVE PROXIMALLY OR DISTALLY WHEN TRYING TO REMOVE IT. THE TWO STENT GRAFTS WERE EXPLANTED ON THE SAME DATE VIA OPEN ANEURYSM REPAIR. PER THE PHYSICIAN THE CAUSE OF THE REMOVAL DIFFICULTIES IS UNDETERMINED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17539828 ↗
• InjuryMay 10, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA.  IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TO THE ER WITH BACK PAIN. A CT SCAN WAS PERFORMED WHICH SHOWED THE GRAFT HAD MIGRATED A FEW MILLIMETERS AND THE NECK HAD CONTINUED TO GROW CAUSING A TYPE IA ENDOLEAK. NO RUPTURE WAS NOTED. INTERVENTION WAS PERFORMED AND AFTER THE FIRST ANGIOGRAM THE PHYSICIAN  DETERMINED THAT THERE WAS ABOUT 8MM OF SEAL ZONE ABOVE THE GRAFT TO THE LEVEL OF THE LOWEST RENAL ARTERY. THE TYPE IA ENDOLEAK WAS OBSERVED. AN 32X32X49 ENDURANT CUFF WAS PLACED INSIDE THE PREVIOUS PLACED GRAFT TO THE LEVEL OF THE LOWER(RIGHT) RENAL ARTERY. AFTER IMPLANTED THE ENDURANT CUFF, A RELIANT BALLOON WAS USED. THE PHYSICIAN THE PLACED 10 ENDOANCHORS AROUND THE PROXIMAL PORTION OF THE CUFF. AFTER THE ENDOANCHORS WERE PLACED, ANOTHER ANGIOGRAM WAS PERFORMED. THERE WAS STILL A SLIGHT TYPE IA ENDOLEAK SO THE PHYSICIAN IMPLANTED 9 MORE ENDOANCHORS. ANOTHER ANGIOGRAM SHOWED THE ENDOLEAK WAS RESOLVED. THE PROCEDURE WAS COMPLETED.  THE CAUSE OF THE ENDOLEAK WAS THAT CONTINUED GROWTH OF THE AORTIC NECK.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16901878 ↗
• MalfunctionApr 11, 2023Device Damaged by Another Device; Device Damaged by Another Device

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED  IN THE ENDOVASCULAR TREATMENT OF A 53MM AAA.  IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW-UP , A TYPE IA ENDOLEAK WAS DIAGNOSED.  ON THE SAME DATE , INTERVENTION WAS PERFORMED. THE PHYSICIAN FIRST IMPLANTED A NON MDT CUFF FOLLOWED BY AN ENDURANT CUFF AND ENDOANCHORS. THE PATIENT HAD PRIOR NON MDT STENTS PLACED IN THE LIMBS OF THE EXISTING GRAFT. DURING THE ADVANCEMENT OF ONE OF THE DEVICES, ONE OF THE NON MDT STENTS WAS UNKNOWINGLY PUSHED PROXIMALLY AND WAS TRAPPED BY THE SUPRARENAL FIXATION ON THE ENDURANT CUFF AFTER IT WAS DEPLOYED. THIS DID NOT AFFECT THE DEPLOYMENT OF THE ENDURANT CUFF OR CAUSE IT TO BE IMPLANTED OUTSIDE OF THE INTENDED AREA. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK CAN NOT BE DETERMINED. THE CAUSE OF THE ISSUE WITH THE ENDURANT CUFF TRAPPING A STENT BY ITS SUPRARENAL FIXATION IS USER ERROR. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16713811 ↗
• MalfunctionOct 14, 2022Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM .  IT WAS REPORTED THAT A CT CARRIED OUT 6 MONTHS LATER IDENTIFIED A PROXIMAL TYPE 1A ENDOLEAK WITHOUT ANEURYSM GROWTH. A 32 MEDTRONIC CUFF AND ENDOANCHORS WERE IMPLANTED ON THE SAME DATE, BUT A SMALL LEAK REMAINED. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS  ANATOMY DUE TO A CONICAL NECK.  NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607107 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II AORTIC EXTENSION WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE.  IT WAS REPORTED VIA THE PATIENT THAT APPROXIMATELY 21 MONTHS POST IMPLANT THAT THE STENT GRAFT HAD RUPTURED AND BLOOD WAS COMING OUT.  NO CAUSE OF THE EVENT WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Rupture; Unspecified Infection

  MAUDE report 14842079 ↗
• MalfunctionJun 15, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II AUI WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. A 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14692941 ↗
• DeathMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED URGENTLY. CT SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK AND EVIDENCE THAT THE GRAFT WAS IMPLANTED 1CM LOW. THE PHYSICIAN CARRIED OUT A SUCCESSFUL LEFT RENAL CHIMNEY AND AN ENDURANT AORTIC CUFF PLACEMENT AT LEVEL OF THE SMA. IT WAS REPORTED THE PATIENT EXPIRED AFTER THE INTERVENTION. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK IS UNDETERMINED. THE CAUSE OF DEATH WAS AS A RESULT OF THE RUPTURED ABDOMINAL AORTIC ANEURYSM.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Rupture

  MAUDE report 14434769 ↗
• DeathMar 31, 2022Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  AN ANEURX BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF 50MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED ON THE DATE OF A CT , A LEFT ILIAC LIMB OCCLUSION WAS NOTED. IT WAS SAID THE TOP OF THE GRAFT LOOKED TO HAVE MIGRATED WELL BELOW THE RENAL ARTERIES. THE PATIENT WAS EXPERIENCING LEG ISCHEMIA. THE CURRENT ANEURYSM DIAMETER IS NOTED AS 64MM. IT WAS REPORTED THAT AN INTERVENTION TOOK PLACE . AN ENDURANT AUI AND CUFF WAS IMPLANTED LANDING AT THE LEFT LOWEST RENAL ARTERY AND EXTENDED OUT WITH A ENDURANT 16 X16X 56 LIMB INTO THE EXISTING RIGHT ILIAC LIMB, THEN PROCEEDED WITH A FEM-FEM BYPASS. THE PHYSICIAN WAS UNABLE TO DETERMINE IF ONLY MAIN BODY OR LIMBS CHANGED POSITION WITH MIGRATION. IT WAS REPORTED THAT THE PATIENT WENT TO A HOSPICE THE FOLLOWING MONTH AND IS NOW DECEASED. THE EXACT DATE OF DEATH IS UNKNOWN. PER THE PHYSICIAN, THE CAUSE OF DEATH IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED. *ADDITIONAL INFORMATION RECEIVED 14-MAR-2022: IT WAS REPORTED THAT THE PATIENT WENT TO HOSPICE IN (B)(6) AND IS NOW DECEASED. THE EXACT DATE OF DEATH IS UNKNOWN. *ADDITIONAL INFORMATION RECEIVED 15-MAR-2022: PER THE PHYSICI

  Patient problems: Aneurysm; Insufficient Information; Ischemia; Obstruction/Occlusion

  MAUDE report 13962502 ↗
• MalfunctionMar 24, 2022Migration or Expulsion of Device; Difficult to Remove; Malposition of Device; Device Damaged by Another Device; Material Deformation; Migration or Expulsion of Device; Difficult to Remove; Malposition of Device; Device Damaged by Another Device; Material Deformation

  AN ENDURANT II STENT GRAFT AND AORTIC CUFF WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 75MM ABDOMINAL AORTIC ANEURYSM. THE GRAFT WAS USED IN CONJUNCTION WITH A PARALLEL GRAFT TO PRESERVE PERFUSION TO THE RENAL ARTERIES. THE PROXIMAL NECK DIAMETER WAS NOTED AS 27MM WITH A SHORT ANGLED CONICAL NECK (9MM). MILD NECK CALCIFICATION AND THROMBUS WAS NOTED WITH MODERATE CALCIFICATION TO THE RIGHT AND LEFT ILIACS REPORTED. IT WAS REPORTED DURING THE INDEX PROCEDURE WHILE RETRIEVING THE NOSE CONE A BARE SPRING BECAME CAUGHT AND CAUSED THE GRAFT TO SLIP DOWN APPROXIMATELY 3MM. AN AORTIC CUFF WAS IMPLANTED HOWEVER THE SAME INCIDENT OCCURRED BUT IN THIS CASE THE BARE SPRING FLIPPED INTO THE NECK. BALLOONING WAS COMPLETED IN AN ATTEMPT TO FLIP BACK INTO POSITION. POST BALLOONING REVEALED NO FLOW LIMITATIONS. VISUALIZATIONS WERE POOR IN TRYING TO DETERMINE IF THE BARE SPRING RETURNED. ANGIOGRAM REVEALED NO FLOW IMPEDIMENT THEREFORE NO FURTHER ACTION WAS TAKEN AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO A SHORT NECK WITH SEVERE ILIAC ANGULATION. IT WAS ALSO NOTED THAT THE PHYSICIAN WAS AGGRESSIVE WHEN RETRACTING THE NOSE CONE THROUGH THE BARE STRUT AFTER DEPLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13888749 ↗
• MalfunctionMar 23, 2022Malposition of Device; Material Deformation; Malposition of Device; Material Deformation

  AN ENDURANT II AORTIC EXTENSION WAS IMPLANTED TO TREAT A TYPE IA ENDOLEAK ON AN UNKNOWN STENT GRAFT ON A 57MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEPLOYMENT WAS SUCCESSFUL. AFTER DEPLOYMENT, DURING REMOVAL OF THE DELIVERY SYSTEM, THE GRAFT WAS PULLED DOWN INTO THE EXISTING GRAFTS MAIN BODY/ IPSILATERAL GATE AND THE DEVICE BECAME MISSHAPEN. IT WAS ALSO NOTED THAT THE AORTIC NECK WAS SHORT. THE PATIENT REMAINED STABLE, AND THE PHYSICIAN DECIDED TO END THE SURGERY. PER PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO USER ERROR. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13857397 ↗
• InjuryMar 23, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 68.5MM X 64 ABDOMINAL AORTIC ANEURYSM. AN ENDURANT CUFF AND LIMB WERE THEN IMPLANTED PRESUMABLY FOR THE TREATMENT OF A TYPE IA ENDOLEAK OVER 6 YEARS LATER. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY TO HOSPITAL NEARLY 3 MONTHS LATER, AFTER BEING FOUND UNCONSCIOUS ON THE FLOOR. A CT SHOWED A LARGE RUPTURED ABDOMINAL AORTIC ANEURYSM AND WHAT APPEARED TO BE A TYPE IA ENDOLEAK. THE PATIENT WAS TAKEN URGENTLY TO OR FOR CONVERSION TO OPEN REPAIR. IT WAS NOTED AT THIS TIME IN THE PATIENT¿S HISTORY THAT THE PATIENTS RIGHT KIDNEY WAS NOT FUNCTIONAL AS IT WAS TOTALLY ATRETIC AND THE LEFT RENAL ARTERY IS STENOTIC AND JAILED WITH 2 SUPRARENAL EXTENSIONS FROM THE ENDOGRAFT AND THE NEW PROXIMAL EXTENSION. ON THE RIGHT SIDE, THE INTERNAL ILIAC ARTERY IS COILED BECAUSE OF A COMMON ILIAC ANEURYSM AND THE STENT GRAFT EXTENDS INTO THE EXTERNAL ILIAC ARTERY. THERE WAS A VERY LARGE HEMATOMA ANTERIORLY AND IN THE RIGHT RETRO PERITONEUM . IT WAS SAID THE PATIENT PROBABLY HAD A STENT INSERTED INTO THE LEFT ANTERIOR DESCENDING ARTERY AROUND THE TIME OF THE EVAR. DURING THE OPEN CONVERSION

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Ischemia; Rupture

  MAUDE report 13856226 ↗
• InjuryJan 26, 2022Malposition of Device; Malposition of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 69MM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK DIAMETER MEASURED 24-23MM AND 18 MM IN LENGTH. MILD CALCIFICATION WAS NOTED AT THE RIGHT AND LEFT ILIAC. THE CELIAC WAS NOTED AS ANEURYSMAL AT ITS ORIGIN, BOTH RENAL ORIGINS WERE OBSERVED TO BE DILATED WITH A LEFT HYPO ANEURYSM WHICH APPEARED TO BE OCCLUDED PROXIMALLY. IT WAS REPORTED DURING THE INDEX PROCEDURE THAT A TYPE IA ENDOLEAK WAS OBSERVED AFTER IMPLANTING THE INITIAL GRAFT IN A HIGHLY TORTUOUS NECK. FIVE ENDOANCHORS WERE IMPLANTED BUT THE ENDOLEAK REMAINED. THE PHYSICIAN ELECTED TO PLACE A CUFF ON THE RIGHT SIDE WHERE IT APPEARED THE ENDOLEAK WAS OCCURRING FROM. AFTER PLACEMENT BOTH RENAL ARTERIES WERE PARTIALLY COVERED. THE PHYSICIAN WAS ABLE TO GET INTO EACH RENAL ARTERY WITH A WIRE BUT UNABLE TO EASILY ADVANCE THE WIRE. THE PHYSICIAN CARRIED OUT A PROCEDURE TO PRESERVE THE PATIENTS RENAL FUNCTION. THE GRAFT WAS PARTIALLY EXPLANTED AND TIED INTO THE LIMBS. THE LIMBS AND SUPRARENAL PARTS WERE LEFT IN. THE PHYSICIAN REPORTED THE PATIENT WAS DOING FINE POST OP WITH URINE OUTPUT PRESENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO T

  Patient problems: Obstruction/Occlusion

  MAUDE report 13359926 ↗
• InjuryJan 7, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AN ENDURANT II AORTIC EXTENSION STENT GRAFT WAS IMPLANTED DURING A CHEVAR PROCEDURE FOR THE TREATMENT OF AN 84MM X 80MM ABDOMINAL AORTIC ANEURYSM AND TYPE IA ENDOLEAK. IT WAS REPORTED DURING THE INDEX PROCEDURE THAT THE DEVICE DEPLOYED AS NORMAL, THE DEVICE WAS ADVANCED AND BACK WHEEL WAS CLOSED, THE DELIVERY SYSTEM WAS PULLED BELOW THE SUPRA RENAL FIXATION AND THE PHYSICIAN RE-MADE THE DELIVERY SYSTEM BY DOING THE GREY TO BLUE MOTION. AT THAT TIME IT WAS NOTICED THAT THE BACK WHEEL HAD POPPED OFF DEVICE. UPON REMOVAL OF DEVICE, THE PHYSICIANS HAD A HARD TIME REMOVING THE DELIVERY SYSTEM. ONCE THE DELIVERY SYSTEM WAS REMOVED IT WAS NOTED THAT THE TAPERED TIP HAD COME DETACHED AND WAS STILL IN THE PATIENT BODY. AT THAT TIME THE PHYSICIAN MADE THE DECISION TO DO A CUT DOWN ON THE FEMORAL ARTERY TO REMOVE THE TAPERED TIP AND REPAIR THE ARTERY. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT HAVING PREVIOUS REPAIRS IN THE FEMORAL ARTERY, CALCIFIED ANATOMY AND THE PATIENTS ADVANCED AGE WAS ALSO NOTED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13188946 ↗
• InjuryAug 26, 2021Leak/Splash; Leak/Splash

  ENDOANCHORS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 71MM ABDOMINAL AORTIC ANEURYSM. AN ENDURANT CUFF AND LEFT RENAL STENT WERE ALSO IMPLANTED DURING THE PROCEDURE. A NON-MDT (GORE EXCLUDER) STENT GRAFT SYSTEM WAS PREVIOUSLY IMPLANTED IN THE PATIENT 2 YEARS PRIOR AND THE ENDOANCHORS WERE IMPLANTED FOR THE TREATMENT OF A TYPE IA ENDOLEAK AND MIGRATION. APPROX.. 3.5 YEARS POST INDEX PROCEDURE, A POSSIBLE TYPE IA ENDOLEAK AT THE PROXIMAL STENT GRAFT WITH LACK OF APPOSITION TO THE POSTERIOR ASPECT WAS REPORTED. IT WAS ADDITIONALLY REPORTED THE PATIENT HAD BEEN CONTINUOUSLY LOSING WEIGHT WITH INTERMITTENT ABDOMINAL PAIN INTERVENTION WAS PERFORMED 2 MONTHS LATER WHERE AN ADDITIONAL 3 ENDOANCHORS WERE PLACED AT THE PROXIMAL EDGE OF THE STENT GRAFT. IT WAS REPORTED THE PROCEDURE WAS SUCCESSFUL THE SITE ASSESSED THE EVENT AS PROBABLY RELATED TO THE IMPLANTED ENDOGRAFT NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 12369836 ↗
• MalfunctionAug 25, 2021Leak/Splash; Leak/Splash

  AN ANEURX BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZED AAA . UNDER 13 YEARS LATER, AN ANGIOGRAM SHOWED A POSSIBLE TYPE IA ENDOLEAK. A CT WAS PERFORMED AFTERWARDS AND SHOWED THE IA ENDOLEAK AND THAT THE GRAFT HAD MIGRATED DISTALLY. IT WAS REPORTED INTERVENTION WAS PERFORMED WHERE AN ETUF3232C49E WAS IMPLANTED, IT WAS REPORTED THE ENDOLEAK WAS STILL PRESENT SO AN ADDITIONAL ETUF3232C49E WAS EXTENDED PROXIMALLY 4MM MORE TO THE LOWEST RENAL ARTERY. AFTER BALLOONING THERE WAS STILL A SMALL TYPE 1A ENDOLEAK. THE PHYSICIAN DECIDED TO STOP THE PROCEDURE. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS PATIENT ANATOMY DUE TO AN ANGLED NECK NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12364443 ↗
• InjuryAug 25, 2021Leak/Splash; Leak/Splash

  AN ANEURX BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZED AAA . UNDER 13 YEARS LATER, AN ANGIOGRAM SHOWED A POSSIBLE TYPE IA ENDOLEAK. A CT WAS PERFORMED AFTERWARDS AND SHOWED THE IA ENDOLEAK AND THAT THE GRAFT HAD MIGRATED DISTALLY. IT WAS REPORTED INTERVENTION WAS PERFORMED WHERE AN ETUF3232C49E WAS IMPLANTED, IT WAS REPORTED THE ENDOLEAK WAS STILL PRESENT SO AN ADDITIONAL ETUF3232C49E WAS EXTENDED PROXIMALLY 4MM MORE TO THE LOWEST RENAL ARTERY. AFTER BALLOONING THERE WAS STILL A SMALL TYPE 1A ENDOLEAK. THE PHYSICIAN DECIDED TO STOP THE PROCEDURE. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS PATIENT ANATOMY DUE TO AN ANGLED NECK NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 12364433 ↗
• DeathJun 16, 2021Adverse 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 PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 79 MM ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS HAVING AN URGENT EVAR FOR A SYMPTOMATIC AAA. THE PATIENT HAD A HEAVILY CALCIFIED DISTAL AORTA AND ILIAC AS WELL AS CALCIUM IN A HIGHLY ANGULATED NECK. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AUI AND LIMB WERE DEPLOYED BUT A LARGE TYPE 1A ENDOLEAK WAS NOTED. 15 ENDOANCHORS WERE IMPLANTED, BUT THE ENDOLEAK TYPE 1A PERSISTED. AN AORTIC CUFF WAS THEN PLACED MORE PROXIMALLY AND BALLOONED AGGRESSIVELY WITH A RELIANT BALLOON. NO ENDOLEAK WAS OBSERVED AFTER PLACEMENT OF THE CUFF. IT WAS STATED THAT ONCE THE RELIANT BALLOON WAS DEFLATED, PATIENTS' BLOOD PRESSURE IMMEDIATELY DROPPED. ANGIOGRAM WAS PERFORMED, WHERE NO ENDOLEAK WAS OBSERVED. HOWEVER EXTRAVASATION AROUND THE UPPER PART OF THE STENT GRAFT AND ABOVE THE STENT GRAFT WITH NO FLOW GOING INTO THE ANEURYSM WAS NOTED. THE BALLOON WAS PLACED SUPRA CELIAC WHICH STABILIZED THE PATIENT'S BLOOD PRESSURE. URGENT EXPLANT OF ENDURANT GRAFTS AND OPEN AORTO-BI FEM BYPASS WAS PERFORMED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. IT WAS REPORTED, THE PATIENT HAD MUL

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Rupture

  MAUDE report 12006993 ↗
• DeathApr 23, 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 PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A 67MM RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT WAS BECOMING UNSTABLE WHEN ARRIVING TO THEATRE, THE PHYSICIAN MANAGED TO SEAL THE ANEURYSM. IT WAS REPORTED THAT AS PER MANAGEMENT OF A RUPTURE PROTOCOL, THE MAIN BODY BIFURCATION WAS MOVED IN THE 12MM CONICAL NECK AND ONLY HALF OF THAT SEAL LENGTH WAS OBTAINED SEQUENTIALLY PRODUCING A SMALL TYPE IA ENDOLEAK. AN ENDURANT CUFF ALONG WITH 6 HELI-FX ENDOANCHORS WERE THEN IMPLANTED TO TREAT THE IA ENDOLEAK. IT WAS REPORTED THE PATIENT EXPIRED EARLY THE FOLLOWING DAY. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS CONSIDERED THAT THE PATIENT HAD ARRIVED TOO LATE INTO HOSPITAL AND THAT THE COAGULATION CASCADE WAS TOO FAR ALONG, WHEN AN EXPLORATORY LAPAROTOMY WAS PERFORMED FOR DECOMPRESSION OF THE ABDOMEN, A SEVERE DISEASED LIVER WAS ALSO OBSERVED. IT WAS REPORTED THE PHYSICIAN WAS HAPPY WITH THE PERFORMANCE OF THE STENT GRAFTS BUT IT WAS NOTED THAT THESE TYPES OF PATIENTS USUALLY DON'T RECOVER FROM THIS TYPE OF INSULT. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT HAS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 11715788 ↗
• MalfunctionMar 30, 2021Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55 MM ABDOMINAL AORTIC ANEURYSM. APPROX 9 YEARS AND 1 MONTH POST IMPLANT, AN ENDOLEAK TYPE 1A WAS OBSERVED. AN ENDURANT CUFF ETCF3232C49E AND AN ENDURANT LIMB ETLW16 16C156E WERE IMPLANTED ON THE (B)(6) 2021, BUT THE EVENT WAS NOT RESOLVED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS ANATOMY DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11589042 ↗
• MalfunctionSep 25, 2020Difficult or Delayed Positioning; Material Deformation; Difficult or Delayed Positioning; Material Deformation

  TALENT AND ANEURX STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR AN ENDOVASCULAR TREATMENT. AN ENDURANT LIMB WAS ADDITIONALLY IMPLANTED APPROXIMATELY 138 MONTHS POST INDEX PROCEDURE, AN ENDURANT II AORTIC CUFF EXTENSION WAS TO BE IMPLANTED TREATMENT OF A TYPE 1A ENDOLEAK . IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, IT WAS DIFFICULT TO POSITION TWO ENDURANT II AORTIC CUFF EXTENSIONS. IT WAS STATED THAT THE DEVICES BENT WHEN TRYING TO ACCESS. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY. IT WAS REPORTED THAT THE PATIENT HAD A HIGHLY TORTUROUS ANATOMY IN THE COMMON AND EXTERNAL ILIACS ARTERY. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10586248 ↗
• InjurySep 30, 2019Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK DIAMETER MEASURED 26.5MM AND 5MM IN LENGTH WITH 20 DEGREE ANGULATION NOTED. MODERATE VESSEL TORTUOSITY WAS NOTED IT WAS REPORTED DURING THE INDEX PROCEDURE WHILE THE ENDURANT CUFF WAS BEING DEPLOYED THE PHYSICIAN FOUND THE CUFF WAS RIDING UP PROXIMALLY. AFTER RELEASING THE TOP CAP THE PROXIMAL EDGE OF FABRIC AND SUPRARENAL STENTS WERE OBSERVED TO BE ALL MISALIGNED AND THE GRAFT HAD BEEN DEPLOYED MUCH HIGHER THAN EXPECTED. THE PHYSICIAN ELECTED TO CONVERT TO OPEN SURGERY AND EXPLANT THE GRAFT. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9133496 ↗
• InjuryJun 25, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II AORTIC CUFF AND 4 ENDURANT LIMBS WERE IMPLANTED IN AN UNKNOWN STENT GRAFT SYSTEM FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED 100MM ABDOMINAL AORTIC ANEURYSM WITH A TYPE IA ENDOLEAK. IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL EMERGENTLY. A PREVIOUS UNKNOWN STENT GRAFT WAS IMPLANTED IN THE PATIENT. CT REVEALED A RUPTURED AAA AND TYPE IA ENDOLEAK WITH EXTRAVASATION. THE PHYSICIAN REALIGNED THE UNKNOWN STENT GRAFT WITH THE ENDURANT II AORTIC CUFF AND 4 ENDURANT LIMBS HOWEVER THE TYPE IA ENDOLEAK REMAINED. ENDOANCHORS WERE THEN IMPLANTED TO GAIN SEAL HOWEVER THE TYPE IA ENDOLEAK PERSISTED. A REPEAT CT SHOWED EXTRAVASATION WITHIN THE AAA SAC, SO THE PHYSICIAN ELECTED TO CONVERT TO OPEN REPAIR AND SUTURED THE PROXIMAL PORTION OF GRAFT WITH SUCCESS. THE ENDOLEAK WAS CONFIRMED AS RESOLVED. THE PATIENT WAS REPORTED AS DOING WELL ONE DAY POST PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE RUPTURE AND TYPE IA ENDOLEAK WAS ANATOMY RELATED DUE TO INFRARENAL NECK DILATION. IT WAS REPORTED THAT THE EXTRAVASATION NOTED ON REPEAT CT WAS RELATED TO THE PRE-OP RUPTURE AND NOT RELATED TO THE MEDTRONIC DEVICES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS F

  Patient problems: Injury

  MAUDE report 8730047 ↗

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-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-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 aort
• 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 i
• 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