Endurant® II ETUF3214C102ERecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169232617), received between Jan 24, 2017 and Oct 15, 2024 — classified as 8 deaths, 12 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 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 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 ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2024Difficult to Remove; Difficult to Remove

  AN ENDURANT II AUI WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN 50MM ABDOMINAL AORTIC ANEURYSM REPAIR. IT WAS REPORTED DURING THE PROCEDURE, THE ENDURANT II AUI STENT GRAFT WAS USED DUE TO AN OCCLUDED ILIAC ARTERY AND A PRIOR FEM-FEM BYPASS. THE STENT GRAFT WAS DEPLOYED WITH NO ISSUES. THE DELIVERY SYSTEM WAS POSITIONED PROXIMALLY TO RECAPTURE THE SPINDLE WITHOUT ANY PROBLEMS. HOWEVER, THE DELIVERY SYSTEM COULD NOT BE MOVED DISTALLY DURING REMOVAL AND APPEARED TO BE STUCK. IT WAS CONFIRMED THAT SUPRARENAL STENTING WAS NOT THE CAUSE OF THE STICKING. THE PATIENT WAS TREATED WITH THE ENDURANT II AUI STENT GRAFT AND LIMBS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO ENDOLEAK OBSERVED. PER THE PHYSICIAN THE CAUSE OF THE REMOVAL DIFFICULTIES UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450673 ↗
• InjuryJun 9, 2022Difficult to Insert; Difficult to Remove; Device Damaged by Another Device; Difficult to Insert; Difficult to Remove; Device Damaged by Another Device

  AN ENDURANT AUI DEVICE WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A SMALL ABDOMINAL AORTIC ANEURYSM AND OCCLUSIVE DISEASE. THE AORTIC NECK WAS NOTED TO MEASURE 40MM IN LENGTH. THE DIAMETER OF THE AORTA AT THE LEVEL OF THE RENAL ARTERY MEASURED 38MM. THERE WAS NO OVERT  ANGULATION NOTED AND MILD TORTUOSITY AND CALCIFICATION WERE REPORTED.  THE PATIENT HAD TIGHT ACCESS ANATOMY WITH AN EXISTING 7X40 SELF EXPANDING STENT IN THE LEFT EXTERNAL ILIAC ARTERY. IT WAS REPORTED DURING THE INDEX PROCEDURE  THE ENDURANT AUI STENT GRAFT WAS ADVANCED WITH DIFFICULTY THROUGH THE SELF EXPANDING STENT, BUT IT WAS DEPLOYED WITHOUT ISSUE. WHEN REMOVING THE DELIVERY SYSTEM, THE SELF EXPANDING STENT CAME OUT OF THE PATIENT ON THE DELIVERY SYSTEM. THERE WERE NOT PATIENT INJURIES AND A 16/10/124 LIMB WAS PLACED IN THE SEGMENT WHERE THE SELF EXPANDING STENT WAS REMOVED TO STABILIZE THE LEFT EXTERNAL ILIAC ARTERY. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS CAUSED BY TIGHT VASCULAR ACCESS AND PRESENCE OF THE SELF EXPANDING STENT.  NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 14641927 ↗
• DeathMay 6, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II AUI WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A RUPTURED 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE THE AUI WAS SUCCESSFULLY IMPLANTED ALONG WITH 2 ENDURANT LIMBS AS ILIAC EXTENSION TO SEAL THE DISTAL END OF THE AUI GRAFT. A POSSIBLE TYPE IA ENDOLEAK WAS OBSERVED. DUE TO LACK OF INVENTORY NO FURTHER DEVICES WERE AVAILABLE FOR IMPLANT. IT WAS REPORTED THE PATIENT DID NOT RECOVER AND EXPIRED. DUE TO SHOCK THE RUPTURED ABDOMINAL AORTIC ANEURYSM.  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK IS UNDETERMINED. THE CAUSE OF DEATH WAS DUE TO SHOCK FROM THE RUPTURED AAA. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Insufficient Information; Rupture; Shock

  MAUDE report 14302874 ↗
• DeathDec 14, 2021Malposition of Device; Malposition of Device

  AN ENDURAT AUI STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR TREATMENT OF A 52MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE THAT AFTER THE DEPLOYMENT OF THE AUI GRAFT AND AN ENDURANT LIMB THE FINAL ANGIOGRAPHY SHOWED THE AUI DEVICE WAS APPROXIMATELY 2CM HIGHER THAN THE INTENDED LANDING ZONE BELOW THE RENALS AND THE DEVICE WAS NOW COVERING THE BOTH RENAL ARTERIES. THE PHYSICIAN ELECTED TO OPEN THE PATIENT AND PARTIALLY EXPLANT THE GRAFT COVERING THE RENAL ARTERIES AND SEW A GRAFT FROM THE RENAL TO THE RIGHT ILIAC ARTERY. ONE DAY POST THE INDEX PROCEDURE IT WAS REPORTED THE PATIENT EXPIRED. AS PER THE PHYSICIAN THE CAUSE OF THE INACCURATE DELIVERY AND OCCLUSION COULD NOT BE DETERMINED. THE CAUSE OF DEATH WAS RELATED TO DIC. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Disseminated Intravascular Coagulation (DIC); Obstruction/Occlusion

  MAUDE report 13002628 ↗
• DeathJun 16, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; 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 12006945 ↗
• DeathMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT AUI AND STENT GRAFT LIMB WAS IMPLANTED ALONG WITH A TALENT OCCLUDER IN AN EMERGENCY PROCEDURE ALONG WITH A FEM-FEM BYPASS FOR THE TREATMENT OF A RUPTURED AAA. IT WAS REPORTED THE PATIENT EXPIRED POST PROCEDURE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY. NO ADDITIONAL CLINICAL SEQUALAE AND THE PATIENT IS EXPIRED

  Patient problems: Insufficient Information

  MAUDE report 11581145 ↗
• InjuryMar 9, 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 55 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A CT APPROXIMATELY 45 MONTHS POST INDEX PROCEDURE, IT WAS NOTED THAT THERE WAS NO BLOOD FLOW THROUGH THE AUI AND THE LIMB. A THROMBOSED STENT GRAFT WAS NOTICED. A STENT GRAFT WAS IMPLANTED ON THE NEXT DAY. THE EVENT IS RESOLVED AND THE BLOOD FLOW WAS RESTORED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11445526 ↗
• InjuryOct 15, 2019Leak/Splash; Leak/Splash

  AN ENDURANT AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 90MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE AUI STENT AND FEM- FEM BY PASS WAS COMPLETED A TYPE IA ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN RE-BALLOONED WITH A RELIANT BALLOON. THE PHYSICIAN THEN ELECTED TO IMPLANT 10 HELI-FX ENDOANCHORS AND WHILE THE ENDOLEAK IMPROVED IT WAS NOT FULLY RESOLVED. THE PROCEDURE WAS COMPLETED AT THIS TIME. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS ANATOMY RELATED DUE TO AN ANGULATED INFRARENAL NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 9191742 ↗
• MalfunctionSep 23, 2019Leak/Splash; Device Damaged by Another Device; Leak/Splash; Device Damaged by Another Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED THAT PATIENT HAD ANEURYSM GROWTH WITHOUT EVIDENCE OF ANY ENDOLEAK. AN INTERVENTION PROCEDURE WAS CARRIED OUT APPROXIMATELY FOURS YEARS AND NINE MONTHS LATER AND AN ENDURANT STENT GRAFT CUFF ETCF3232C49E, ENDURANT STENT GRAFT LIMB ETLW1620C93E AND ENDURANT STENT GRAFT LIMB ETLW1613C93E WERE IMPLANTED IN THE PATIENT AS TREATMENT. IT WAS REPORTED THAT NO ENDOLEAK WAS SEEN DURING THE PROCEDURE. THE PATIENT THEN PRESENTED WITH ABDOMINAL PAIN APPROXIMATELY ONE MONTH LATER AND CT SHOWED AN ENDOLEAK THAT APPEARED TO ORIGINATE ABOVE THE FLOW DIVIDER OF THE ORIGINAL BIFURCATED STENT GRAFT. THE GENERAL AREA OF THE ENDOLEAK WAS CONFIRMED BY ANGIO DURING AN INTERVENTION PROCEDURE CARRIED OUT THE FOLLOWING DAY. IT WAS REPORTED THAT AN ENDURANT AUI DEVICE WAS IMPLANTED AS TREATMENT. IT WAS ALSO REPORTED THAT BALLOONING WAS THEN CARRIED OUT WITH A RELIANT BALLOON, HOWEVER THE RELIANT BALLOON BURST WHEN IN THE AREA ABOVE THE FLOW DIVIDER. FURTHER ANGIO SHOWED THAT CONTRAST APPEARED TO BE LEAKING INTO THE ORIGINAL BIFURCATED STENT GRAFT AND INTO THE ANEURYSM S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9104226 ↗
• DeathJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II AUI AND ENDURANT II STENT GRAFT LIMB WERE IMPLANTED IN A PATIENT FOR AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED BY THE PATIENT'S WIFE, VIA TECHNICAL SERVICES, THAT THE PATIENT DIED FOLLOWING THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT HAS EXPIRED.

  Patient problems: Death

  MAUDE report 8239185 ↗
• InjuryJan 7, 2019Difficult or Delayed Positioning; Activation, Positioning or Separation Problem; Device Damaged by Another Device; Difficult or Delayed Positioning; Activation, Positioning or Separation Problem; Device Damaged by Another Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 68MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, WHILE ADVANCING THE DELIVERY SYSTEM, THE PHYSICIAN HAD SOME RESISTANCE. AFTER BALLOONING THE EXTERNAL ILIAC WHERE A STENT WAS IN PLACE AND DILATING WITH 16 AND 20FR DILATORS THE PHYSICIAN PLACED A 20 FRENCH SHEATH INTO THE DISTAL AORTA AND PLACED THE AUI THROUGH IT. AFTER IMAGING, THE STENT GRAFT WAS DEPLOYED AND IT WAS ATTEMPTED TO RELEASE THE SUPRA RENAL STENTS BUT THEY DIDN¿T OPEN EVEN AFTER USE OF A BALLOON IN BETWEEN THE BARE METAL. IT WAS DECIDED TO EXPLANT AND CONVERT TO AN OPEN PROCEDURE. ON REMOVAL OF THE STENT GRAFT AND DELIVERY SYSTEM IT WAS IDENTIFIED THAT THE STENT FROM THE ILIAC HAD DISPLACED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE DISPLACED ILIAC STENT PREVENTING THE SUPRA RENAL STENTS FROM OPENING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8222490 ↗
• InjuryJul 20, 2018Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 61MM DIAMETER ABDOMINAL AORTIC ANEURYSM. DURING THE INDEX PROCEDURE, IT WAS REPORTED THAT, A TYPE IA ENDOLEAK WAS NOTED DURING THE FINAL AORTOGRAM AFTER THE IMPLANTATION OF THE DEVICE. THE PATIENT RECEIVED 8 ENDOANCHORS IMPLANTED CIRCUMFERENTIALLY, FOLLOWED BY A BALLOON EXPANDED NON-MDT STENT; BUT THE ENDOLEAK PERSISTED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Injury

  MAUDE report 7705653 ↗
• InjuryDec 7, 2017Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. FINAL ANGIOGRAM SHOWED A SUCCESSFUL EVAR. HOWEVER, IT WAS REPORTED THAT, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDEWIRE FROM THE MAIN BODY SIDE (LEFT) SOME RESISTANCE WAS ENCOUNTERED. WHEN FLUOROSCOPIC IMAGING WAS RE-ESTABLISHED, THE BIFURCATED STENT GRAFT WAS NO LONGER IN ITS ORIGINAL POSITION BUT WAS SITTING IN THE AAA SAC. IT WAS REPORTED THAT A SECONDARY INTERVENTION WAS PERFORMED THREE DAYS LATER TO TREAT MALPOSITION OF THE ENDURANT STENT GRAFT. DURING THE RE-INTERVENTION AN ENDURANT AUI AND ENDURANT LIMB EXTENSION WERE IMPLANTED AND A LEFT TO RIGHT FEM-FEM BYPASS PERFORMED. IT WAS REPORTED THAT POST THE IMPLANT OF THE AUI A TYPE IA ENDOLEAK WAS OBSERVED. TEN (10) APTUS ENDOANCHORS WERE IMPLANTED. IT WAS REPORTED THAT THE TYPE IA ENDOLEAK WAS RESOLVED WITH NO FOLLOW UP NECESSARY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7094681 ↗
• DeathNov 14, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 73MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL LANDING ZONE WAS 18MM IN LENGTH AND A DIAMETER OF 27MM WITH FOCAL CALCIFICATION ON THE RIGHT ANTERIOR AORTIC WALL THAT WAS APPROXIMATELY 4MM DISTAL TO THE LOWEST RENAL ARTERY. THE RIGHT PROXIMAL COMMON ILIAC WAS CHRONICALLY OCCLUSIVE. THE LEFT COMMON ILIAC DIAMETER RANGED FROM 12-14MM WITH MODERATE CALCIFICATION. ACCESS WAS HEAVILY CALCIFIED. THE ENDURANT AUI WAS IMPLANTED AT THE LEVEL OF THE LOWEST RENAL ARTERY. IT WAS REPORTED THAT POST IMPLANT ANGIOGRAM REVEALED A TYPE IA ENDOLEAK. ADDITIONAL POST IMPLANT DILATATION WAS PERFORMED WITH A RELIANT BALLOON WHICH DID NOT RESOLVE THE ENDOLEAK. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED 8 ENDOANCHORS CIRCUMFERENTIAL BUT PRIMARILY FOCUSED ON THE PATIENTS RIGHT ANTERIOR WALL; HOWEVER, THE ENDOLEAK WAS NOT RESOLVED. AN ADDITIONAL 12 ENDOANCHORS WERE SUCCESSFULLY IMPLANTED; HOWEVER, THE TYPE IA ENDOLEAK WAS STILL PERSISTENT. DUE TO A REDUCTION OF THE ENDOLEAK FROM THE INITIAL POST IMPLANT ARTERIOGRAM, THE PHYSICIAN DECIDED TO END THE PROCEDURE AND MONITOR THE SITUATION WITH A FOLLOW UP CT

  Patient problems: Injury

  MAUDE report 7028122 ↗
• InjuryMay 25, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. APTUS ENDOANCHORS WERE USED DURING THE PROCEDURE. THE PROXIMAL AORTIC NECK MEASURED 4 MM IN LENGTH. DURING THE INDEX PROCEDURE, AFTER THE ENDURANT II AUI WAS IMPLANTED, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. THE PHYSICIAN ELECTED TO IMPLANT HELI-FX ENDOANCHORS. HOWEVER, MIDWAY THROUGH DEPLOYMENT OF THE CASSETTE, THE BLUE LIGHT OF THE APPLIER TURNED ON AND THE APPLIER COULD NO LONGER BE USED. A NEW APPLIER WAS OPENED AND THE APPLICATION OF THE HELI-FX ENDOANCHORS WAS COMPLETED. THE PROXIMAL TYPE I ENDOLEAK HAD DECREASED BUT WAS STILL PERSISTENT. THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE WITHOUT ADDITIONAL INTERVENTION AND TO MONITOR THE ENDOLEAK ON FOLLOW-UP SCANS. PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK WAS DUE TO THE PATIENT ANATOMY OF A SHORT PROXIMAL AORTIC NECK. PER THE PHYSICIAN, THE CAUSE OF THE BLUE LIGHT ERROR ON THE HELI-FX APPLIER WAS RELATED TO THE DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6592956 ↗
• InjuryMay 23, 2017Malposition of Device; Device Damaged by Another Device; Malposition of Device; Device Damaged by Another Device

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT A 5.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE THE PHYSICIAN ELECTED TO PERFORM A SNORKELING OF THE RENAL ARTERIES. THE ENDURANT AUI WAS IMPLANTED (INTENTIONALLY OVERSIZED, TO ACCOMMODATE THE SNORKELING PROCEDURE) AND ANOTHER MANUFACTURER¿S STENT GRAFT WAS INSERTED INTO THE RENAL ARTERY FOR SNORKELING AND DEPLOYED. THE PATIENT HAS THREE RENAL ARTERIES; TWO MAIN RENAL ARTERIES AND AN ACCESSORY RENAL ARTERY ON THE LEFT SIDE DISTAL TO THE LEFT MAIN RENAL ARTERY. THE PHYSICIAN SNORKELED THE LEFT ACCESSORY RENAL ARTERY. UPON REMOVAL OF ANOTHER MANUFACTURER¿S SHEATH, THE SHEATH COVER WAS CAUGHT ON THE ENDURANT AUI SUPRARENAL ANCHORING PIN. THE PHYSICIAN PULLED ON THE SHEATH TO RELEASE IT, AND THE ENDURANT AUI WAS PULLED PROXIMALLY, COVERING ALL THREE RENAL ARTERIES. AFTER FAILED ATTEMPTS TO BRING THE AUI MORE DISTAL AND FAILED ATTEMPTS TO CANNULATE THE RENAL ARTERIES WITH A WIRE FOR STENTING, THE PHYSICIAN COMPLETED DEPLOYMENT OF THE AUI DISTAL EXTENSION. UPON REMOVAL OF THE OTHER MANUFACTURER¿S SHEATH IT WAS NOTED THAT A PIECE OF THE OTHER MA

  Patient problems: Occlusion; Renal Failure

  MAUDE report 6586525 ↗
• DeathMay 19, 2017Adverse 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 PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 67 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 30 MM IN LENGTH, 24 ¿ 27 MM IN DIAMETER FROM PROXIMAL TO DISTAL. THE AORTIC BIFURCATION IS 35 MM IN DIAMETER. THE RIGHT ILIAC IS 18 ¿ 33 MM IN DIAMETER FROM PROXIMAL TO DISTAL. THE LEFT ILIAC IS 24 ¿ 17 ¿ 16 FROM PROXIMAL TO DISTAL. THE RIGHT EXTERNAL ILIAC IS 11 MM AND THE LEFT IS 7 MM. IT WAS REPORTED THAT THERE WAS NO ISSUES RELATED TO THE STENT GRAFT; HOWEVER, THE PATIENT HAD BLEEDING FORM THE VENA CAVA. THE PATIENT EXPIRED BEFORE LEAVING THE OR FROM BLEEDING COMPLICATIONS FROM AN ADJUNCTIVE SURGICAL PROCEDURE AND LIGATION OF THE RCIA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Blood Loss; Death

  MAUDE report 6579897 ↗
• InjuryMay 10, 2017Malposition of Device; Malposition of Device

  AN ENDURANT II AUI STENT GRAFT SYSTEM AND A TALENT OCCLUDER WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.7 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS REPORTED AS VERY TIGHT AND CALCIFIED AORTIC BIFURCATION. THE RIGHT ILIAC ARTERY MEASURED BETWEEN 6 MM AND 7 MM IN DIAMETER. THE LEFT ILIAC ARTERY MEASURED FROM BETWEEN 4 MM AND 5 MM IN DIAMETER TO BETWEEN 5 MM AND 6 MM IN DIAMETER. THE PROXIMAL AORTIC NECK MEASURED 24 MM IN DIAMETER. THERE WAS SEVERE LEFT ILIAC CALCIFICATION. THERE WAS MODERATE TO SEVERE RIGHT ILIAC CALCIFICATION. THERE WAS MILD CALCIFICATION AT THE PROXIMAL AORTIC NECK. THE PATIENT HAD A WIDE AND CONICAL PROXIMAL AORTIC NECK. THE LEFT RENAL ARTERY WAS THE LOWEST RENAL ARTERY AND THE RIGHT RENAL ARTERY WAS ATROPHIC. IT WAS REPORTED THAT ENDURANT AUI WAS ADVANCED UP TO THE LEFT RENAL STENT. THE ENDURANT AUI WAS INITIALLY DEPLOYED AND IMPLANTED AT THE INTENDED LANDING ZONE. HOWEVER, WHEN THE DELIVERY SYSTEM WAS BEING REMOVED THERE WERE DIFFICULTIES REMOVING THE DELIVERY SYSTEM. THE GRAFT COVER WAS BELOW THE AREA OF CALCIFIED/TIGHT AORTA AND THE SPINDLE AND TAPER TIP COULD NOT BE RETRACTED BACK TO THE GRAFT COVER. THE PHYSICI

  Patient problems: Perforation of Vessels

  MAUDE report 6557382 ↗
• InjuryApr 17, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT CT IMAGING DISCOVERED A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT AORTIC CUFF PROXIMAL TO THE AUI AND INTENTIONALLY COVERED THE RENAL ARTERIES IN ORDER TO GAIN MORE SEAL. THERE WAS A SLIGHT PROXIMAL TYPE I ENDOLEAK AFTER THE AORTIC CUFF PLACEMENT. THE PHYSICIAN ELECTED TO IMPLANT EIGHT HELI-FX ENDOANCHORS AND THE ENDOLEAK WAS RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE INITIAL TYPE I ENDOLEAK COULD NOT BE DETERMINED. THE PHYSICIAN DETERMINED THAT THE CAUSE OF THE PERSISTENT TYPE I ENDOLEAK, AFTER THE CUFF WAS IMPLANTED, WAS DUE TO AORTIC ANGULATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6498803 ↗
• MalfunctionMar 29, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT ENDOVASCULAR TREATMENT OF A 7 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE ENDURANT AUI WAS ADVANCED TO THE INTENDED LANDING ZONE, THE PHYSICIAN TURNED THE BACK END BLUE WHEEL HOWEVER THE SUPRARENAL STRUTS WOULD NOT DEPLOY. THE PHYSICIAN WAS ABLE TO DISASSEMBLE THE DELIVERY CATHETER AND SUCCESSFULLY DEPLOYED THE STENT GRAFT AT THE INTENDED LOCATION. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS RELATED TO THE PATIENT¿S ANATOMY OF VERY ANGULATED AORTIC NECK, 90 DEGREE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6443245 ↗
• InjuryMar 23, 2017Leak/Splash; Difficult To Position; Malposition of Device; Leak/Splash; Difficult To Position; Malposition of Device

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR ENDOVASCULAR TREATMENT OF A 5.5 CM MAX DIAMETER ABDOMINAL AORTIC ANEURYSM. THE VESSELS WERE HIGHLY CALCIFIED. PRIOR TO THE INDEX PROCEDURE, THE RIGHT COMMON ILIAC ARTERY WAS OCCLUDED WITH COILS. THE PATIENT HAS A BARE METAL STENT FROM AN UNKNOWN MANUFACTURER IMPLANTED IN THE LEFT COMMON ILIAC ARTERY. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A CUT DOWN WAS PERFORMED IN THE RIGHT ARM, AND A 5 FR SHEATH WAS INSERTED INTO THE RIGHT BRACHIAL ARTERY PERCUTANEOUSLY. A GUIDEWIRE AND A PIGTAIL CATHETER WERE INSERTED INTO THE INFRARENAL AORTA. A CUT DOWN IN THE LEFT COMMON FEMORAL ARTERY WAS PERFORMED. THE PHYSICIAN DILATED THE VESSEL WITH A 8X40 MM PTA BALLOON. THE PHYSICIAN THEN ATTEMPTED TO INSERT THE AUI DELIVERY SYSTEM THROUGH THE LEFT FEMORAL ARTERY BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN IMPLANTED A 9X50 MM COVERED STENT FROM ANOTHER MANUFACTURER INTO THE LEFT EXTERNAL ILIAC ARTERY AND POST DILATED WITH A 9 MM BALLOON. THE PHYSICIAN ATTEMPTED TO INSERT THE ENDURANT AUI DELIVERY SYSTEM AGAIN BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN IMPLANTED A 10 MM COVER STENT FROM ANOTHER MANUFACTURER INTO THE PREVIOUSLY

  Patient problems: Occlusion

  MAUDE report 6428460 ↗
• DeathFeb 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR ENDOVASCULAR TREATMENT OF A 70 MM MAX DIAMETER RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK DIAMETER MEASURED ~ 22-27 MM. THERE WAS MINIMAL AORTIC NECK ANGULATION. THE VESSEL WAS MILDLY CALCIFIED. IT WAS REPORTED THE PATIENT WAS FULLY CODED BEFORE ARRIVING TO THE OPERATING ROOM. A CHEST COMPRESSION WAS DONE DURING THE IMPLANT PROCEDURE. DURING THE CHEST COMPRESSION, THE GUIDEWIRE ON THE CONTRALATERAL SIDE PUNCTURED THE ARTERY AND WAS SUBINTIMAL. AS A RESULT, THE PHYSICIAN WAS UNABLE TO CANNULATE THE GATE OF THE BIFURCATE. THE PATIENT RECEIVED TREATMENT. THE PHYSICIAN IMPLANTED AN ENDURANT AUI STENT GRAFT AND AN OCCLUDER; HOWEVER, THE EVENT DID NOT RESOLVE AND THE PATIENT EXPIRED. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS DUE TO THE PRE-OPERATIVE RUPTURED ANEURYSM AND THE AMOUNT OF BLOOD LOSS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Blood Loss; Death

  MAUDE report 6348080 ↗
• InjuryJan 24, 2017Leak/Splash; Difficult to Remove; Malposition of Device; Device Damaged by Another Device; Leak/Splash; Difficult to Remove; Malposition of Device; Device Damaged by Another Device

  AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT PRESENTED EMERGENTLY. AN ENDURANT STENT GRAFT WAS IMPLANTED DURING INTERVENTION. IT WAS REPORTED THAT ANEURX STENT GRAFT HAD MIGRATED DISTALLY INTO THE ANEURYSM SAC LANDING PERPENDICULARLY RESULTING IN A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ADVANCED A 32X14X102 ENDURANT AUI THROUGH THE RIGHT LIMB OF THE PREVIOUSLY IMPLANTED ANEURX STENT GRAFT POSITIONING THE DEVICE JUST BELOW THE LEFT RENAL ARTERY. HOWEVER, DURING THE RECAPTURING OF THE NOSE CONE, THE ENDURANT AUI DEVICE MOVED PROXIMAL COVERING THE LEFT RENAL ARTERY. THE PHYSICIAN CANNULATED THE LEFT RENAL ARTERY, BUT THEN THE WIRE CAME OUT DURING REPOSITIONING OF ANOTHER MANUFACTURER¿S CATHETER. DURING THE ADVANCING OF THE CATHETER UP THROUGH THE RIGHT LIMB INTO THE ENDURANT AUI DEVICE, THE SHEATH IMPINGED THE DISTAL AREA OF THE ENDURANT AUI DEVICE. THE PHYSICIAN GAINED ACCESS VIA THE LEFT BRACHIAL ARTERY, ADVANCING A GUIDEWIRE DOWN THROUGH THE AORTA, THROUGH THE ENDURANT AUI AND SNARED THE GUIDE WIRE THROUGH THE RIGHT GROIN. A RELIANT BALLOON WAS ADVANCED INTO THE DISTAL PART OF THE ENDURANT AUI A

  Patient problems: Occlusion; Renal Failure

  MAUDE report 6274659 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100021. One submission often covers many models, so check the product and lot details in each record.

• Z-0291-2022 · Oct 15, 2021 · Open, Classified
  Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT G
• Z-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-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-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-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