Endurant® II ETTF3636C70ERecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00613994991515), received between Jan 20, 2017 and Sep 10, 2025 — classified as 1 death, 12 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (19 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Leak/Splash; Leak/Splash

  AN ETBF2816C166E STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A TYPE IA ENDOLEAK WAS OBSERVED ON FOLLOW-UP CT TAKEN APPROXIMATELY 12 YEARS AND 11 MONTHS POST INDEX PROCEDURE. INTERVENTION WAS PERFORMED ON THE FOLLOWING DAY, DURING WHICH A CUFF WAS IMPLANTED FOLLOWED BY BILATERAL RENAL ARTERY SNORKELS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO DISEASE PROGRESSION OF THE AORTIC NECK. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED. THE PHYSICIAN CONFIRMED THAT THE ENDOLEAK REMAINED UNRESOLVED FOLLOWING THE INTERVENTION WITH AN ETTF3636C70E / (B)(6). FURTHER FOLLOW-UP IS UNKNOWN AT THIS TIME.

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

  MAUDE report 23013387 ↗
• MalfunctionJun 7, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2022. IT WAS REPORTED THAT, DURING THE INDEX PROCEDURE, POST DEPLOYMENT IMAGING REVEALED TYPE IA ENDOLEAK. THE ENDOLEAK WAS ADDRESSED BY PLACING A 36/49 PROXIMAL CUFF AND 7 HELIFX ENDOANCHORS IN THE PROXIMAL NECK AREA. IT WAS REPORTED APPROXIMATELY 6 WEEKS POST THE INDEX PROCEDURE FOLLOW UP CT SHOWED A TYPE IA ENDOLEAK. THE PATIENT THEN PRESENTED EMERGENTLY SYMPTOMATIC OF THE TYPE IA ENDOLEAK. THE ANEURYSM MEASURED 60MM. INTERVENTION WAS THEN PERFORMED ON THE SAME DATE. AS THE ONLY TREATMENT OPTION THE PHYSICIAN THEN IMPLANTED AN ENDURANT EXTENSION CUFF ETTF3636C70E AND AN ADDITIONAL 6 ENDOANCHORS. THE TYPE IA ENDOLEAK IMPROVED BUT THERE WAS STILL LATE FILLING OBSERVED. THE PHYSICIAN WAS HOPEFUL THAT UPON REVERSAL OF THE PATIENTS HEPARIN THE TYPE IA WOULD RESOLVE. THE CAUSE OF THE ENDOLEAK IS BELIEVED TO BE DISEASE PROGRESSION OF THE PROXIMAL NECK. PER PHYSICIAN, IT IS BELIEVED THAT THE ANATOMY CONTRIBUTED TO THE TYPE IA ENDOLEAK DUE TO THE SHORT AND WIDE PROXIMAL LANDING ZONE. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482830 ↗
• MalfunctionSep 28, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT EXTENSION CUFF (ETTF3636C70E) AND A VALIANT NAVION STENT GRAFT (VNMF3434C97TU) WAS IMPLANTED DURING THE TREATMENT OF A 65MM ANEURYSM . IT WAS REPORTED DURING FOLLOW-UP CT IMAGING TAKEN, THE PATIENTS CT IMAGE REVEALED THE PROXIMAL AND DISTAL STENT GRAFTS LACK OF APPOSITION TO THE AORTA / SEAL ZONES. PER THE PHYSICIAN THE CAUSE OF THE STENT GRAFTS LACK OF APPOSITION WAS DUE TO DISEASE PROGRESSION OF THE AORTA. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17832088 ↗
• DeathJul 18, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM AND FOUR VALIANT NAVION (B)(6) STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A ANEURYSM ON THE (B)(6) OF (B)(6) 2019. A VALIANT (B)(6) STENT GRAFT WAS ALSO IMPLANTED 3 MONTHS LATER AND ANOTHER VALIANT GRAFT (B)(6) SUBSEQUENTLY IMPLANTED APPROXIMATELY 8 MONTHS POST THE INDEX PROCEDURE. IT WAS REPORTED APPROXIMATELY 9 MONTHS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED A TYPE IIIA ENDOLEAK WAS NOTED AT THE ABDOMINAL AORTIC STENT WHICH EXTENDS SUPERIORLY INTO THE DISTAL THORACIC AORTA. 9.5X7.8CM. CT AT 12 MONTHS SHOWED THERE WAS A PATENT ENDOVASCULAR STENT WHICH EXTENDS FROM THE DISTAL AORTIC ARCH INTO THE INFRARENAL ABDOMINAL AORTA, THERE IS A PERSISTENT LARGE TYPE III EL OF THE ABDOMINAL AORTIC STENT WHICH EXTENDS SUPERIORLY INTO THE DISTAL THORACIC AORTA, STABLE IN SIZE COMPARED TO PREVIOUS IMAGES. 8.4X7.0CM. INTERVENTION WAS THEN PERFORMED WHERE EMBOLIZATION WITH COILING WAS PERFORMED. A CT POST INTERVENTION APPROXIMATELY 16 MONTHS POST THE INDEX PROCEDURE SHOWED A NEW TYPE I ENDOLEAK ORIGINATING AT THE LEVEL OF THE PROXIMAL THORACIC ENDOGRAFT. THE PREVIOUS TYPE III ENDOLEAK WENT FROM 8.5CM TO 9.6CM. EMBOLIZATION WAS

  Patient problems: Cardiac Arrest

  MAUDE report 17340469 ↗
• MalfunctionJun 9, 2023Leak/Splash; Leak/Splash

  AN ENDURANT AORTIC EXTENSION WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA .  IT WAS REPORTED ON THE DATE OF A CT , IT WAS NOTED THE AORTIC EXTENSION HAS LOST SEAL AND APPOSITION.  PER THE PHYSICIAN THE CAUSE OF THE LOSS OF SEAL IS DISEASE PROGRESSION.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097352 ↗
• InjuryApr 17, 2023Fracture; Leak/Splash; Fracture; Leak/Splash

  AN ENDURANT CUFF WAS IMPLANTED DURING AND UNKNOWN ENDOVASCULAR PROCEDURE ON (B)(6)2023. IT WAS REPORTED DURING THE INDEX PROCEDURE, A POSSIBLE TYPE IA ENDOLEAK WAS SUSPECTED. 1 HELI-FX ENDOANCHOR WAS IMPLANTED AFTER WHICH DUE TO DIFFICULTIES IMPLANTING ANY FURTHER ENDOANCHORS THE PROCEDURE WAS ENDED WITHOUT ANY FURTHER INTERVENTION. PER THE PHYSICIAN THE CAUSE OF THE POSSIBLE ENDOLEAK COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 16750243 ↗
• MalfunctionNov 2, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ENDURANT II AORTIC EXTENSION WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM .  IT WAS REPORTED DURING THE PROCEDURE, THE DEVICE WAS BROUGHT TO THE OR IN THE PACKAGING. THE PACKAGING AND BOX WERE OPENED, THE STERILE PACKAGING WAS OPENED WITH NO IRREGULAR ISSUES NOTED. THE DEVICE WAS FLUSHED AND PREPPED BUT AFTER THE DEVICE WAS REMOVED FROM THE WHITE PLASTIC TRAY, IT WAS NOTICED THAT THE BACK PART OF THE DEVICE WAS CRACKED COMPLETELY THROUGH. IT WAS SAID THE CRACK WAS LOCATED ALL THE WAY AROUND WHERE THE BACK END WHEEL'S PROXIMAL THREAD MEETS THE SOLID PLASTIC PART OF THE DEVICE. IT WAS STILL ATTACHED BY THE GUIDEWIRE LUMEN, SO IT WAS STILL ONE UNIT. IT WAS SAID THERE WERE NO VISIBLE IMPACTED AREAS OR SOMEWHERE WHERE IT COULD BE SEEN WHAT CAUSED THE CRACK. THE DEVICE WAS NEEDED FOR A LIFE-SAVING TREATMENT SO ITS USE WAS CONTINUED, THE STENT GRAFT WAS IMPLANTED WITHOUT ISSUE.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713235 ↗
• InjurySep 12, 2022Material Deformation; Material Deformation

  ENDURANT II EXTENSION CUFFS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM AAA.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, USING ULTRASOUND THE PHYSICIAN ACCESSED THE RIGHT COMMON FEMORAL ARTERY WITH A MICRO PUNCTURE. A 5FR SHEATH WAS USED TO DILATE THE TRACK THEN REMOVED, TWO NON MDT CLOSURE SYSTEM DEVICES WERE DEPLOYED WITHOUT ISSUE AND A 8FR SHEATH WAS PLACED. THE PHYSICIAN THEN ACCESSED THE LEFT COMMON FEMORAL ARTERY AND PLACED A 5FR SHEATH. USING A STIFF GUIDEWIRE, A CATHETER WAS USED TO GAIN ACCESS TO THE MID TO PROXIMAL DESCENDING THORACIC AORTA FROM THE RIGHT ACCESS SITE THEN THE  CATHETER WAS REMOVED. A STIFF GLIDE WIRE AND OMNI FLUSH WAS ADVANCED TO THE SUPRARENAL AORTA. THE 9FR SHEATH WAS REMOVED AND REPLACED WITH THE ETTF2828C70E DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS ADVANCED WITHOUT ISSUE TO THE INFRA RENAL AORTA. AN ANGIOGRAM WAS PREFORMED FROM THE OMNI FLUSH, AND THE RENAL ARTERIES AND AORTIC BIFURCATION WERE IDENTIFIED. THE ETTF2828C70E WAS DEPLOYED WITHOUT ISSUE AND THE DELIVERY SYSTEM WAS REMOVED AND REPLACED BY A ETTF3636C70E DELIVERY SYSTEM.  THE 36X36X70 DELIVERY SYSTEM WAS ADVANCED TO THE LEVEL OF THE RENAL ARTERIES WITHOUT ISSUE. ANOTHER ANG

  Patient problems: Insufficient Information

  MAUDE report 15400561 ↗
• MalfunctionOct 16, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP, OVER EIGHT YEARS LATER. A TYPE I ENDOLEAK WAS REPORTED DUE TO NECK DILATION. INTERVENTION WAS PERFORMED ON THE SAME DATE, A ENDURANT 36X70 AORTIC CUFF WAS IMPLANTED ALONG WITH NON MDT BALLOON EXPANDABLE STENT BILATERALLY AS A SNORKEL, AND THE CUFF WAS PLACED DISTALLY TOWARDS THE SMA TO TRY, AND RESOLVE THE ENDOLEAK. ON FINAL ANGIOGRAM, A GUTTER ENDOLEAK STILL REMAINED. 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: No Consequences Or Impact To Patient

  MAUDE report 10689141 ↗
• MalfunctionOct 9, 2020Leak/Splash; Leak/Splash

  AN ANEURX ABDOMINAL STENT GRAFT WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT DURING A FOLLOW-UP, APPROXIMATELY 159 MONTHS POST INDEX PROCEDURE, IT WAS NOTED THAT THE ANEURX ABDOMINAL STENT GRAFT HAD MIGRATED, WHICH RESULTED IN A TYPE 1A ENDOLEAK AND ANEURYSM EXPANSION. THE PHYSICIAN IMPLANTED AN ENDURANT ETTF3636C70E TO THE LEVEL OF THE NATIVE LEFT RENAL TO ATTEMPT TO TREAT THE EVENT, HOWEVER THE TYPE I ENDOLEAK WAS NOT RESOLVED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS ANATOMY, DUE TO AORTIC NECK DILATATION NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10656498 ↗
• InjuryJun 24, 2020Leak/Splash; Leak/Splash

  AN ANEURX STENT GRAFT SYSTEM BFXCH2816165 WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2009. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT DURING A FOLLOW-UP APPROXIMATELY 1 WEEK LATER, THE PHYSICIAN NOTICED THAT THE ANEURX STENT GRAFT HAD MIGRATED DUE TO THE AORTIC NECK EXPANSION WHERE THE NECK MEASURES 28 MM AT THE RENALS AND 15 MM BELOW IT WAS 32 MM WITH A PROXIMAL TYPE IA ENDOLEAK PRESENT. AFTER DOING AN ANGIOGRAM THERE WAS 8+ CM'S FROM THE RENAL ARTERIES TO THE BIFURCATION OF THE PREVIOUSLY IMPLANTED ANEURX STENT GRAFT. IT WAS DECIDED TO TREAT THE PATIENT WITH ENDURANT CUFFS. A 32/32/49 ENDURANT CUFF WAS PLACED FIRST FOLLOWED BY A 36/36/70 ENDURANT CUFF TO REACH THE RENAL ARTERIES. FOUR APTUS ANCHORING PINS WERE THEN PLACED IN THE PROXIMAL PORTION OF THE 36/36/70 CUFF. AFTER ANGIO THE PROXIMAL PART WAS SEALED BUT IT APPEARED THAT THERE WAS INSUFFICIENT OVERLAP BETWEEN THE CUFFS AND THE PREVIOUS STENT GRAFT. IT WAS CONFIRMED THERE WAS NO ENDOLEAK BETWEEN THE ENDURANT CUFFS JUST NOT ENOUGH OVERLAP. A THIRD 36/36/49 CUFF WAS THEN PLACED AT THE BIFURCATION OF THE ANEURX STEN

  Patient problems: Injury

  MAUDE report 10188287 ↗
• InjuryMay 21, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 100MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY FIVE YEARS LATER WITH HYPERTENSION AND ABDOMINAL PAIN. IT WAS REPORTED THAT THERE APPEARED TO BE APPEARED TO BE A TYPE IA ENDOLEAK AND IT APPEARED THE SUPRARENAL FIXATION WAS NOT ATTACHED TO THE STENT GRAFT FABRIC. A SECONDARY PROCEDURE WAS CARRIED OUT THE NEXT DAY. AN ENDURANT II CUFF WAS IMPLANTED UP TO THE LEVEL OF THE RENAL ARTERIES. ANGIOGRAM SHOWED THAT THERE STILL APPEARED TO BE A TYPE IA ENDOLEAK SO 10 ENDOANCHORS WERE ALSO IMPLANTED AND ANOTHER ANGIOGRAM SHOWED THAT THE ENDOLEAK APPEARED TO BE RESOLVED. 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: Injury

  MAUDE report 10078308 ↗
• InjuryJun 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 CL

  Patient problems: Injury

  MAUDE report 7568395 ↗
• InjuryMar 29, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 3.5 YEARS POST INDEX PROCEDURE A CT WAS PERFORMED REVEALING A A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO PERFORM SURGERY TO SOLVE THE ENDOLEAK. AFTER ANGIOGRAM IT WAS DETERMINED THAT THERE WAS 7CM FROM THE GRAFT BIFURCATION TO THE SMA AND THE TYPE IA ENDOLEAK. AS THE PATIENT WAS ON DIALYSIS, THE PHYSICIAN WAS ABLE TO COVER BOTH RENAL ARTERIES WITH A 36X36X70 AORTIC CUFF WHICH WAS PLACED INSIDE THE PREVIOUS IMPLANTED BIFURCATE AT THE LEVEL OF THE SMA. THE CUFF WAS THEN BALLOONED USING A RELIANT BALLOON; HOWEVER, AFTER ANGIOGRAM THE ENDOLEAK WAS STILL VISIBLE. THE PHYSICIAN DECIDED THEN TO PLACE ENDOANCHORS INSIDE THE CUFF BUT AFTER PLACING 3 ENDOANCHORS THE HELI-FX APPLIER FROZE AND WOULDN'T WORK. A NEW HELI-FX APPLIER WAS OPENED AND A FURTHER 16 ENDOANCHORS WERE PLACED. AFTER THIS THE ENDOLEAK WAS RESOLVED AND THE CASE WAS COMPLETED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO A LARGE REVERSE CONE NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7380643 ↗
• InjurySep 13, 2017Leak/Splash; Leak/Splash

  A TALENT AAA AND ANEURX STENT GRAFT SYSTEMS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT PATIENT PRESENTED EMERGENTLY. A RECENT CT REVEALED THAT THE TALENT STENT GRAFT HAS A PROXIMAL TYPE I ENDOLEAK AND THE ANUERX STENT GRAFT HAS A DISTAL TYPE I ENDOLEAK IN THE RIGHT LIMB. THE ANEURYSM IS CURRENTLY 6.5 CM IN DIAMETER. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT 36X36X70 AORTIC CUFF HOWEVER THE PROXIMAL TYPE I ENDOLEAK WAS STILL PRESENT. TEN HELI-FX APTUS ENDOANCHORS WERE IMPLANTED. THE PROXIMAL TYPE I ENDOLEAK APPEARED TO BE 90% RESOLVED. THERE WAS 15MM OF LENGTH FROM THE EXISTING DISTAL ANUERX ILIAC LIMB TO HYPOGASTRIC ARTERY. THE PHYSICIAN DECIDED TO EXTEND THE STENT GRAFTS INTO EXTERNAL ILIAC ARTERY (EIA). ANOTHER MANUFACTURER¿S PLUG WAS IMPLANTED IN THE RIGHT HYPOGASTRIC ARTERY AND AN ENDURANT 16X10X124 WAS IMPLANTED INTO RT EIA. FINAL ANGIO CONFIRMED RESOLUTION OF DISTAL TYPE I ENDOLEAK. THERE WAS SLIGHT BLUSH PRESENT FROM T PROXIMAL TYPE I ENDOLEAK, HOWEVER THE PHYSICIAN DECIDED TO STOP, REVERSE HEPARIN AND WAIT FOR 30-DAY FU CT. THE PHYSICIAN STATED THAT THE CAUSES OF THE EVENTS WERE RELATED TO THE PATIENT¿

  Patient problems: Injury

  MAUDE report 6860926 ↗
• InjuryJun 30, 2017Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT SCAN REVEALED A TYPE IA ENDOLEAK. IT WAS ALSO THOUGHT THAT THE SUPRARENAL STENTS MAY HAVE FRACTURED. TWO OF THE SUPRARENAL STENTS WERE STILL ATTACHED TO THE GRAFT IN THE PROXIMAL ANEURYSM AND THE REMAINING WERE IN THE PROXIMAL NECK NEAR THE RENAL ARTERIES. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT II AORTIC CUFF. HOWEVER, THE AORTIC CUFF WAS IMPLANTED APPROXIMATELY 1 CM DISTAL TO THE INTENDED LOCATION AND THE PROXIMAL TYPE I ENDOLEAK REMAINED. THE PHYSICIAN THEN ELECTED TO IMPLANT AN ADDITIONAL AORTIC CUFF PROXIMALLY AND LANDED AT THE LEVEL OF THE RENAL ARTERY. AN ANGIOGRAM THE REVEALED THAT THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. A TYPE II ENDOLEAK WAS OBSERVED AT THE LUMBAR ARTERY. THE PHYSICIAN THEN ELECTED TO IMPLANT FOUR HELI-FX ENDOANCHORS TO SECURE THE AORTIC CUFF TO THE EXISTING TALENT STENT GRAFT AS A PROPHYLACTIC TO PREVENT POSSIBLE MIGRATION OF THE TALENT STENT GRAFT. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT WAS NOTED BY THE PHYSICIAN THAT THE CAUSE OF THE SLIGHT TYPE IA ENDOLEAK AFT

  Patient problems: Injury

  MAUDE report 6681631 ↗
• InjuryMay 18, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A PATIENT PRESENTED WITH BACK PAIN AND LOW BLOOD PRESSURE, BUT WAS IN STABLE CONDITION. THE PHYSICIAN STATED THAT IT WAS NOT CAUSED BY THE PREVIOUS ENDURANT STENT GRAFT BUT THE AORTA ABOVE THE RENAL ARTERIES HAD EXPANDED AND POSSIBLY RUPTURED, BUT WAS CONTAINED. THE FILMS WERE REVIEWED AND THE PHYSICIAN DECIDED TO IMPLANT AN ENDURANT AORTIC CUFF ABOVE THE RENAL ARTERY BUT BELOW THE SUPERIOR MESENTERIC ARTERY. THIS WAS DONE SUCCESSFULLY WITH AN ENDURANT 36 X 36 X 70 AORTIC CUFF. AN ANGIOGRAM WAS THEN PERFORMED AND THERE WAS CONTRAST GETTING AROUND THE STENT GRAFT PROXIMALLY BECAUSE THE GRAFT WASN'T LONG ENOUGH TO REACH THE SEAL ZONE. THE PHYSICIAN DECIDED TO CANNULATE THE SMA COMING FROM THE BRACHIAL ARTERY. ANOTHER MANUFACTURER¿S COVERED STENT WAS ADVANCED INTO THE SMA UP TO THE LEVEL OF THE CELIAC ARTERY. ANOTHER ENDURANT 36 X 36 X 49 CUFF WAS THEN IMPLANTED TO THE LEVEL OF THE OTHER MANUFACTURER¿S COVERED STENT AND THE CELIAC ARTERY. BOTH WERE DEPLOYED SIMULTANEOUSLY AND A SNORKEL WAS CREATED. THE ENDURANT CUFF WAS THEN BALLOONED USING A

  Patient problems: Injury

  MAUDE report 6575831 ↗
• InjuryApr 3, 2017Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT, PER THE PHYSICIAN, THE CAUSE FOR THE RESIDUAL TYPE IA ENDOLEAK AFTER THE SECONDARY INTERVENTION WAS DUE TO A SHORT REVERSE FUNNEL NECK.

  Patient problems: Injury

  MAUDE report 6455349 ↗
• InjuryMar 30, 2017Leak/Splash; Leak/Splash

  AN ANEURX STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE ANEURX STENT GRAFT HAS MIGRATED DISTALLY WITH A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT AORTIC CUFF. THE MIGRATION AND TYPE I ENDOLEAK WERE RESOLVED. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY. THE CT REVEALED THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK AND A CONTAINED ANEURYSM RUPTURE. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT AORTIC CUFF, SNORKEL THE RENAL ARTERIES AND IMPLANT APTUS ENDOANCHORS. THREE APTUS ENDOANCHORS WERE SUCCESSFULLY IMPLANTED IN THE PATIENT HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO LOAD THE 4TH ENDOANCHOR IN THE HELI-FX APPLIER THERE WAS A DOUBLE BEEP SOUND AND THE ENDOANCHOR WOULD NOT LOAD. THE PHYSICIAN CHANGED TO ANOTHER HELI-FX APPLIER AND THE SAME EXACT EVENT OCCURRED. THE FINAL ANGIOGRAM REVEALED THAT THE PROXIMAL TYPE I ENDOLEAK WAS NOT RESOLVED. THE PATIENT IS BEING EVALUATED FOR OPEN REPAIR. PER THE PHYSICIAN, THE CAUSE OF THE STENT GRAFT MIGRATION, PROXIMAL TYPE I ENDOLEAK AND ANEURYSM RUPTURE WERE RELATED TO PATIENT ANATOMY OF DISEASE PROGRESSION AND THE CAUSE OF THE HELI-FX

  Patient problems: Injury

  MAUDE report 6446561 ↗
• MalfunctionMar 16, 2017Leak/Splash; Leak/Splash

  A TALENT AAA STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR ENDOVASCULAR TREATMENT OF A 10 CM MAX DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A POST-OPERATIVE CT SCAN REVEALED BIFURCATE STENT GRAFT HAD MIGRATED DOWNWARD, RESULTING IN A PROXIMAL TYPE I ENDOLEAK. THE PATIENT RECEIVED TREATMENT. THE PHYSICIAN IMPLANTED AN ENDURANT AORTIC CUFF AND APTUS ENDOANCHORS TO OBTAIN SEAL. IMAGING DONE AT THE END OF THE PROCEDURE STILL SHOWED A MINOR PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED NOT TO PERFORM ANY ADDITIONAL TREATMENT. PER THE PHYSICIAN, THE CAUSE OF STENT GRAFT MIGRATION LEADING TO PROXIMAL TYPE I ENDOLEAK WAS MOST LIKELY DUE TO PATIENT'S ANATOMY, INFRARENAL AORTIC NECK DILATATION. PER THE PHYSICIAN, THE CAUSE OF THE RESIDUAL TYPE I ENDOLEAK, AFTER THE AORTIC CUFF WAS IMPLANTED, WAS DUE TO THE PATIENT ANATOMY OF A SHORT INFRARENAL AORTIC NECK AND THE AMOUNT OF HEPARIN THAT WAS USED DURING THE PROCEDURE. THE PHYSICIAN BELIEVED THE RESIDUAL PROXIMAL TYPE I ENDOLEAK WOULD SELF-RESOLVE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6411728 ↗
• InjuryJan 20, 2017Leak/Splash; Leak/Splash

  A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT, APPROXIMATELY SIX YEARS AND NINE MONTHS POST INDEX PROCEDURE THE TALENT STENT GRAFT HAD MIGRATED AND HAD A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT AORTIC CUFF AND EIGHT APTUS ENDOANCHORS AS PART OF THE PLANNED PROCEDURE. THE PROXIMAL TYPE I ENDOLEAK WAS REDUCED BY APPROXIMATELY 50% TO 60% AND THE PROCEDURE WAS COMPLETED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION. IN ADDITION, THE PHYSICIAN ATTRIBUTED THE PERSISTENT TYPE IA ENDOLEAK DUE TO THE GRAFT NOT BEING ABLE TO REACH THE AORTIC WALL DUE TO THE MIGRATED POSITION OF THE TALENT STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury

  MAUDE report 6266790 ↗

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-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