Endurant® II ETBF2513C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00613994991249), received between May 9, 2017 and Sep 18, 2023 — classified as 1 death, 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (15 reports).

2 FDA recall records name this device's identifier, 1 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 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 ↗

2. Feb 27, 2017Terminated

   Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.

   Z-1543-2017 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 67MM AAA.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER THE STENT GRAFTS WERE IMPLANTED, AN ANGIOGRAM WAS PERFORMED WHICH SHOWED A TYPE IA ENDOLEAK. AN ENDURANT CUFF AND ENDOANCHORS WERE THEN IMPLANTED AS TREATMENT AND THE TYPE IA ENDOLEAK RESOLVED.  PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17763170 ↗
• InjuryDec 9, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM AND ENDURANT CUFF WERE IMPLANTED IN A PATIENT .  1 YEAR AND 7 MONTHS LATER, THE PATIENT PHONED TECHNICAL SERVICES REPORTING THAT THEY HAD UNDERWENT SURGERY A COUPLE OF MONTHS PRIOR. THE PATIENT REPORTED THAT A PART OF INFECTED MESH WAS REMOVED BUT THE PATIENT DID NOT KNOW WAS THIS PART OF THE MEDTRONIC STENT GRAFT OR FROM SOMETHING ELSE.  THE PATIENT ALSO DISCLOSED THAT THEY HAD AN ENDOLEAK AFTER THE STENT GRAFT IMPLANT, WHICH HAS SINCE SUBSIDED.  IT WAS CONFIRMED VIA THE SALES REP THAT THE ENDURANT STENT GRAFT WAS IMPLANTED TO TREAT AN AAA. DURING THE INDEX PROCEDURE, THERE WAS A TYPE IA ENDOLEAK NOTED AND THE ENDURANT CUFF WAS IMPLANTED AS TREATMENT. THIS RESOLVED THE ENDOLEAK AND FOLLOW-UP SCANS PERFORMED SINCE HAVE CONFIRMED THE TYPE I ENDOLEAK WAS RESOLVED. THE PATIENT HAS ALSO HAD OTHER PROCEDURES DONE THAT ARE NOT AAA/MEDTRONIC RELATED. THE PROCEDURE THE PATIENT REPORTED TO TECHNICAL SERVICES IS AN ABDOMINAL HERNIA REPAIR THAT HAD GOTTEN INFECTED. THIS MESH HAS BEEN REMOVED SINCE AND A COLOSTOMY PROCEDURE WAS DONE. NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15949116 ↗
• DeathJan 7, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR A 70MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 9 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY. A TYPE IA ENDOLEAK WAS IDENTIFIED WHICH HAD CAUSED THE ANEURYSM TO RUPTURE. THE PHYSICIAN NOTED THAT THERE WAS APPROXIMATELY 8MM BETWEEN THE GRAFT AND LOWEST RENAL AND ELECTED TO PLACE A 25 X 49 ENDURANT CUFF. FINAL ANGIOGRAM REVEALED THE PRESENCE OF A SMALL ENDOLEAK BUT THE PHYSICIAN FELT THE PRESSURE STABILIZED ENOUGH TO END PROCEDURE AND SEND THE PATIENT TO RECOVERY. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS DUE TO ANATOMY. THE PHYSICIAN SUSPECTED THAT THE GRAFT HAD EITHER MIGRATED 10MM DISTAL OR THE GRAFT WAS PLACED AT THAT LOCATION ORIGINALLY BUT REGARDLESS OF THE POSITION, DISEASE PROGRESSION CREATED THE TYPE IA ENDOLEAK RESULTING IN THE RUPTURE. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 13189751 ↗
• InjuryOct 4, 2021Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT, IDENTIFIED A TYPE IB ENDOLEAK. IT WAS NOTED THE LEFT ILIAC LIMB WAS IN THE SAC WITH 3CMS OF ILIAC TO SEAL. THE RIGHT ILIAC LIMB HAD ALSO PULLED BACK BUT THERE WAS STILL SEAL. THE PHYSICIAN DECIDED TO EXTEND BOTH ILIAC LIMBS. FIRST AFTER GAINING ACCESS, THE LEFT ILIAC LIMB WAS EXTENDED BY  PLACING A 16X20X82 ILIAC EXTENSION FROM THE BIFURCATED GRAFT TO JUST ABOVE THE INTERNAL ILIAC IN THE LEFT COMMON ILIAC ARTERY. THE LIMB WAS THEN BALLOONED USING A RELIANT BALLOON. THEN ON THE RIGHT ILIAC LIMB, THE PHYSICIAN  PLACED A 20X20X82 EXTENSION IN THE RIGHT LIMB AND EXTENDED TO JUST ABOUT THE RIGHT INTERNAL ILIAC IN THE COMMON ILIAC ARTERY. THE LIMB WAS THEN BALLOONED. AN ANGIOGRAM WAS PERFORMED WHICH SHOWED THE ENDOLEAK WAS RESOLVED. THE PROCEDURE WAS THEN COMPLETED.  AS PER THE PHYSICIAN THE CAUSE OF THE IB ENDOLEAK WAS ANEURYSM REFORMATION AND ILIAC EXPANSION.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12567013 ↗
• InjuryOct 21, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 66MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON (B)(6) 2020 APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY AND WAS DIAGNOSED WITH A TYPE IA ENDOLEAK WITH RUPTURE. OPEN REPAIR AAA WAS COMPLETED WHERE THE MAIN BODY STENT GRAFT WITHOUT SUPRARENAL STENTS WAS EXPLANTED AND A NON MDT STENT GRAFT WAS IMPLANTED TO RESOLVE THE EVENT. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK AND RUPTURE IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 10711052 ↗
• MalfunctionSep 17, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 77 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 37 MONTHS POST INDEX PROCEDURE, ANEURYSM ENLARGEMENT AND A POSSIBLE TYPE 1A/ TYPE 2 ENDOLEAK WAS NOTED BY CT. IT WAS STATED THAT DURING THE INDEX PROCEDURE, PROXIMAL ASPECT OR THE GRAFT WAS DEPLOYED LOW, AS PER THE ORIGINAL CASE PLAN. AS PER THE PHYSICIAN, CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED

  Patient problems: Aneurysm; Injury

  MAUDE report 10545782 ↗
• InjuryMar 30, 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 THAT A CT PERFORMED TWO YEARS AND SIX MONTHS LATER SHOWED A TYPE IA ENDOLEAK WAS PRESENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 9898027 ↗
• InjuryMar 23, 2020Device Damaged by Another Device; Device Damaged by Another Device

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 53MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW-UP FOUR AND A HALF MONTHS LATER THAT THE PATIENT COMPLAINED OF BUTTOCK AND LEFT THIGH CLAUDICATION. A CT WAS COMPLETED WHICH REVEALED A COMPRESSED LEFT LIMB ETLW1613124E FROM PRESSURE EXERTED BY THE RIGHT CONTRALATERAL LIMB OF THE MAIN BODY BIFURCATE STENT GRAFT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS THE RIGHT LIMB COMPRESSING THE LEFT LIMB. IT WAS REPORTED THAT THE PATIENT'S ANKLE-BR ACHIAL INDEX (ABI) REDUCED FROM 1.0 TO 0.3 WITH THE BUTTOCK AND THIGH CLAUDICATION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Claudication; Occlusion

  MAUDE report 9864838 ↗
• InjuryNov 25, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT SCAN CONDUCTED APPROXIMATELY 6 YEARS POST IMPLANT SHOWED A SUSPECTED ENDOLEAK. AN ANGIOGRAM WAS PREFORMED APPROXIMATELY 6 WEEKS LATER, WHICH CONFIRMED THE PRESENCE OF A HOLE IN THE BIFURCATED GRAFT AT THE BIFURCATION. A SECONDARY PROCEDURE WAS PERFORMED WHERE AUI DEVICE ETUF25C102E WAS PLACED ON THE RIGHT AND EXTENDED INTO THE RIGHT ILIAC WITH A LIMB ETLW1613C93E. THE PHYSICIAN THEN PLACED A TALENT OCCLUDER OCL20US INTO THE LEFT ILIAC LIMB OF THE GRAFT TO OCCLUDE THE LEFT ILIAC. A FINAL ANGIOGRAM WAS PREFORMED AND CONFIRMED THE LEAK HAD RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS REPORTED TO BE FINE.

  Patient problems: Injury

  MAUDE report 9368246 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY TWO YEARS AND NINE MONTHS LATER WITH A TYPE IB ENDOLEAK AND ANEURYSM EXPANSION. A SECONDARY PROCEDURE WAS CARRIED OUT AND THE STENT GRAFT LIMBS EXTENDED BILATERALLY INTO THE EXTERNAL ILIAC ARTERIES TO RESOLVE THE TYPE IB ENDOLEAKS. AS PER FILM EVALUATION; THE TYPE IB ENDOLEAK WAS ON THE RIGHT IPSI LIMB AND THAT THIS SIDE WAS OCCLUDED AS FAR AS THE BIFURCATION GATE. THE LIMB ETLW1624C124E WHICH WAS EXTENDED ON THE RIGHT AND HAS MIGRATED WITH A TYPE IB ENDOLEAK AND THE CONTRA LIMB ON THE LEFT (ETLW1620C156E) IS 100 % OCCLUDED AND ALSO MAY HAVE MIGRATED ALTHOUGH THERE WAS NO ENDOLEAK EVIDENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT¿S ANATOMY. THERE WAS INADEQUATE SEAL IN THE COMMON ILIAC ARTERIES CAUSING THE TYPE IB ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 9133528 ↗
• InjuryJul 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY FIVE YEARS LATER WITH OCCLUSIVE PAIN. A CT SCAN SHOWED TOTAL GRAFT OCCLUSION UP TO THE LEVEL OF THE RENAL ARTERIES. THE GRAFT WAS EXPLANTED ON THE SAME DAY AND AN AORTO-BI-FEM REPAIR CARRIED OUT TO RESTORE DISTAL PERFUSION. 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: Occlusion; Pain

  MAUDE report 8793102 ↗
• InjuryJun 4, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE PROCEDURE THE LENGTH FROM THE RENAL ARTERIES TO THE AORTIC BIFURCATION WAS SHORTER THAN EXPECTED. IT WAS NOTED THAT THERE WAS INSUFFICIENT ROOM TO DEPLOY THE GATE IN THE ANEURYSM ONCE THE STENT GRAFT WAS DEPLOYED TO THE FLOW DIVIDER. AN AUI WAS IMPLANTED AND A FEM-FEM BYPASS CARRIED OUT TO RESOLVE THE EVENT. AN ENDURANT CUFF ETCF2828C49E WAS ALSO IMPLANTED DURING THE PROCEDURE TO EXTEND TO THE LOWEST RENAL ARTERY. IT WAS REPORTED THE CORRECT SIZE BIFURCATED STENT GRAFT HAD BEEN SELECTED AND IMAGING HAD NOT SUGGESTED THAT THE STENT GRAFT WOULD DEPLOY LOW. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO A SHORTER RENAL TO BIFURCATION LENGTH THAT ANTICIPATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8665673 ↗
• InjuryMay 1, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AN INTERVENTION PROCEDURE WAS CARRIED OUT ON AN UNKNOWN DATE FOR A TYPE III ENDOLEAK. ONYX WAS USED TO FILL THE ENDOLEAK VIA DIRECT PUNCTURE INTO THE ANEURYSM SAC OUTSIDE OF THE STENT GRAFT. IT WAS REPORTED THAT A SMALL AMOUNT OF ONYX MIGRATED OUT OF A HOLE OR DEFECT IN THE STENT GRAFT TO THE LUMEN OF THE AORTA AND MIGRATED TO THE POPLITEAL ARTERY. THE PHYSICIAN WAS ABLE TO REMOVE ALL OF THE MIGRATED ONYX IN THE POPLITEAL ARTERY WITH SUCTION DURING THE PROCEDURE AND THE ONYX SEALED THE HOLE IN THE STENT GRAFT. THE ENDOLEAK WAS REPORTED TO HAVE RESOLVED. IT WAS REPORTED THAT THE LEAKAGE OF THE ONYX WAS SEEN OCCURRING INTO THE IPSILATERAL LIMB OF THE STENT GRAFT AND AS THERE WAS NO OVERLAP OF GRAFT COMPONENTS ON THE SIDE OF THE OBSERVED LEAKAGE IT WAS CONCLUDED THAT A HOLE IN THE GRAFT MATERIAL ALLOWED THIS TO HAPPEN. THE PHYSICIAN ALSO REVIEWED THE INITIAL ANGIOGRAMS AND NOTED THAT THE TYPE III LEAK WAS PRESENT AT THE TIME OF THE INDEX PROCEDURE. IT WAS REPORTED THAT IT WAS MISTAKENLY THOUGHT TO HAVE BEEN A TYPE IV ENDOLEAK AT THE TIME. AS

  Patient problems: Injury

  MAUDE report 8568180 ↗
• InjuryJan 29, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. 8 ENDOANCHORS WERE ALSO IMPLANTED PROXIMALLY DURING THE PROCEDURE IN A CLOCKWISE FASHION FOR THE TREATMENT OF A TYPE IA ENDOLEAK. A NON-MDT VIABHAN BALLOON EXPANDABLE STENT WAS ALSO IMPLANTED TO THE LEVEL OF THE ILIAC BIFURCATION ON THE LEFT DURING THE PROCEDURE. A CT SCAN CARRIED OUT THE FOLLOWING DAY SHOWED THERE WAS NO ENDOLEAK PRESENT AND THE PATIENT WAS DISCHARGED. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS IN FINE.

  Patient problems: Injury

  MAUDE report 8284920 ↗
• InjuryDec 20, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60 MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2012. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP VISIT APPROXIMATELY SIX YEARS LATER, ANEURYSM ENLARGEMENT WAS NOTED. A CT WAS PERFORMED WITH NO VISIBLE ENDOLEAK, HOWEVER ADEQUATE PROXIMAL SEAL WAS QUESTIONABLE. THE PROXIMAL EDGE OF THE DEVICE WAS APPROXIMATELY 7 MM FROM THE LOWEST RENAL ARTERY AND THE INFRARENAL NECK APPEARED TO BE DILATED GREATER THAN THE DIAMETER OF THE STENT GRAFT. AN INTERVENTION WAS CARRIED OUT, WITH AN ETCF3232C49E PROXIMAL EXTENSION CUFF IMPLANTED ALONG WITH HELI-FX ENDOANCHORS. THE EVENT WAS RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DISEASE PROGRESSION OF THE PROXIMAL LANDING ZONE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 8183761 ↗
• InjurySep 19, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 95MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY AND A CT SCAN IDENTIFIED A CONTAINED RUPTURE WITH AN INFECTED AAA AND INFECTED STENT GRAFT. THE STENT GRAFTS WERE EXPLANTED. PER THE PHYSICIAN UPON IMPLANT DURING THE ORIGINAL INDEX PROCEDURE IT WAS SUSPECTED THE PATIENT HAD A TYPE IA ENDOLEAK, A TYPE II ENDOLEAK AND A POSSIBLE TEAR IN THE LEFT LIMB OF THE GRAFT DUE TO CALCIUM HOWEVER WAS NOT FOLLOWED UP SINCE IMPLANT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Rupture; Unspecified Infection

  MAUDE report 7888569 ↗
• InjuryJun 5, 2018Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 53MM ABDOMINAL AORTIC ANEURYSM. THE DIAMETER OF THE AORTIC BIFURCATION WAS NOTED AS 21MM. THE PROXIMAL NECK DIAMETER OF THE RIGHT EXTERNAL ILIAC MEASURED 10MM, 78MM IN LENGTH AND THE DISTAL NECK DIAMETER NOTED AS 11MM. THE LCIA WAS OBSERVED TO BE TORTUOUS. IT WAS REPORTED THAT A CT SCAN CARRIED OUT APPROXIMATELY A YEAR LATER SHOWED THAT THE RIGHT LIMB WAS OCCLUDED. THE PHYSICIAN ATTRIBUTED THE CAUSE OF THE EVENT TO POSSIBLE CRUSHING/NARROWING OF THE LIMB NEAR THE DISTAL AORTA. THE EVENT IS NOT RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Injury; Occlusion

  MAUDE report 7569232 ↗
• InjuryJan 16, 2018Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD A VERY TORTUOUS ILIAC WITH A 90 DEGREE BEND. BECAUSE OF THIS, THE PHYSICIAN DECIDED TO EXTEND THE BIFURCATED STENT GRAFT DURING THE INDEX PROCEDURE, USING A LIMB. IT WAS REPORTED THAT DURING FOLLOW-UP, IT WAS NOTED THAT THE BIFURCATION STENT GRAFT AND THE LEFT LIMB WERE OCCLUDED. THE PHYSICIAN TREATED THE OCCLUSION BY IMPLANTATION OF A STAINLESS-STEEL STENT AND REMOVAL OF THE CLOT. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS ANATOMY RELATED, DUE TO THE TORTUOUS ILIAC. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 7192977 ↗
• InjuryJan 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2013. IT WAS REPORTED THAT DURING A FOLLOW UP CT, THAT THE ANEURYSM HAD ENLARGED. THE DEVICE DOES NOT APPEAR TO HAVE AN ENDOLEAK BUT THE PHYSICIAN WOULD PREFER TO EXPLANT THE STENT GRAFT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE CONFIRMED. AN INTERVENTION IS PLANNED TO REMOVE THE STENT GRAFT SYSTEM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 7185145 ↗
• InjuryOct 2, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 58MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE INFRARENAL NECK WAS 23MM IN LENGTH, 19.8 - 21.2MM IN DIAMETER AT 10MM BELOW THE RENAL ARTERIES AND 22.5MM AT 20MM BELOW THE RENAL ARTERIES. IT WAS REPORTED THAT THE STENT GRAFT WAS IMPLANTED WITHOUT ISSUE. THE FINAL ANGIOGRAM WAS PERFORMED INDICATING A TYPE IA ENDOLEAK. AN ENDURANT CUFF AND HELI-FX ENDOANCHORS WERE IMPLANTED. THE ENDOLEAK IMPROVED BUT DID NOT COMPLETELY RESOLVE. THE PROCEDURE TIME WAS OVER 4HRS AND CONTRAST USED IN THE PROCEDURE WAS HIGH. THE PHYSICIAN ELECTED TO WAIT 30 DAYS AND SEE WHAT THE CT SHOWS. NO FURTHER INTERVENTION WAS PERFORMED. THE CT SHOWED ECCENTRIC CALCIUM DEPOSITS WITHIN THE INFRARENAL TARGET AREA; HOWEVER, PER THE PHYSICIAN THE CAUSE OF THE EVENT IS CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury

  MAUDE report 6907613 ↗
• InjuryJun 27, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE BOWEL SURGERIES PERFORMED AND ALSO HAD EXTENSIVE DENTAL PROCEDURES. THE PATIENT PRESENTED WITH ABDOMINAL PAIN. A CT REVEALED THAT THE ABDOMINAL AORTIC ANEURYSM APPEARED TO THE INFLAMMATORY. THE PHYSICIAN HAD THE RADIOLOGIST PERCUTANEOUS OBTAIN A BLOOD CULTURE FROM THE AAA SAC, WHICH WAS POSITIVE FOR VARIOUS MICROBES. THE PATIENT RECEIVED A PIC-LINE TO TREAT THE INFECTION/MICROBS. THE PATIENT RETURNED SIX WEEKS LATER FOR A FOLLOW UP CT WHICH REVEALED AN UNKNOWN ENDOLEAK. THE PHYSICIAN PERFORMED AN AX-BI-FEM TO BYPASS THE INFECTED AAA, AND SCHEDULED EXPLANTING AT OF THE ENDURANT STENT GRAFT THE FOLLOWING DAY. THE PHYSICIAN EXPLANTED THE STENT GRAFT. UPON EXPLANT THE PHYSICIAN NOTED THAT THE UNKNOWN ENDOLEAK WAS A TYPE III FABRIC ENDOLEAK CAUSED DURING THE PERCUTANEOUS STICK TO OBTAIN THE BLOOD CULTURE. THE PHYSICIAN DOES NOT KNOW THE EXACT CAUSE OF THE EVENT HOWEVER THE INFECTION WAS MOST LIKELY RELATED TO THE PATIENT¿S ANATOMY; EITHER THE BOWEL SURGERIES OR THE DENTAL PROCEDURES. NO ADDITIONAL CLINICAL SEQUELAE WERE R

  Patient problems: Pain; Unspecified Infection

  MAUDE report 6672171 ↗
• InjuryMay 9, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.4 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THERE WAS A TYPE IA ENDOLEAK SEEN AT IMPLANT. HELI-FX ENDOANCHORS WERE IMPLANTED TO TREAT THE ENDOLEAK. THE PHYSICIAN INVESTIGATOR BELIEVED THAT THE EVENT WAS CAUSED BY A LACK OF COMPLETE PROXIMAL SEAL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6555734 ↗

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 i
• 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