Endurant® II ETBF3616C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00613994991034), received between Jan 30, 2017 and Mar 11, 2025 — classified as 4 deaths, 30 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (30 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2025Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT THE PATIENT CALLED TECHNICAL SERVICES APPROXIMATELY 11 YEARS AND 5 MONTHS POST-INDEX PROCEDURE AND REPORTED THAT THERE WERE LEAKS FOUND TWICE IN THE STENT GRAFTS AND INTERVENTION HAD BEEN CARRIED OUT TO REPAIR THE ENDOLEAKS. NO CAUSE WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21570948 ↗
• InjuryFeb 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT WAS TREATED FOR A 55MM ABDOMINAL AORTIC ANEURYSM WITH AN ENDURANT II STENT GRAFT SYSTEM. APPROX. 11 YEARS, 4 MONTHS, POST INDEX PROCEDURE, A FOLLOW UP CT IMAGING REVEALED A PROXIMAL TYPE IA ENDOLEAK AND A DISTAL TYPE IB ENDOLEAK, ATTRIBUTED TO ANEURYSMAL DEGENERATION. INTERVENTION WAS PERFORMED ON THE FOLLOWING DAY WHERE A VALIANT CAPTIVIA VAMF3838C100TU STENT GRAFT WAS DEPLOYED AT THE LEVEL OF THE CELIAC ARTERY. LASER FENESTRATION WAS CARRIED OUT IN BOTH RENAL ARTERIES AND THE SUPERIOR MESENTERIC ARTERY , FOLLOWED BY PLACEMENT OF AN ENDURANT LIMB ETLW1620C146 ON THE LEFT AND AN ETLW1624C146E ON THE RIGHT LIMB, EXTENDING BOTH TO THE HYPOGASTRIC ARTERIES. THE PATIENT WAS REPORTED TO HAVE DONE WELL AND WAS DISCHARGED THE FOLLOWING DAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21411882 ↗
• InjuryDec 3, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A FOLLOW-UP FOR A PATIENT TREATED FOR AN ANEURYSM WITH THE USE OF TWO STENT GRAFTS, A TYPE IB ENDOLEAK AND A POSSIBLE TYPE IA ENDOLEAK WERE IDENTIFIED FOR EACH STENT GRAFT MODEL. THE EVENT WAS DISCOVERED THROUGH A COMPUTED TOMOGRAPHY SCAN. THE CAUSE OF THE EVENT REMAINS UNKNOWN, AND THE STENT GRAFTS REMAIN IMPLANTED.

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

  MAUDE report 20831491 ↗
• InjuryMar 12, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  AN ENDURANT II STENT GRAFT (ETBF3616C145E) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE, THE PATIENT WAS TRANSFERRED FROM ANOTHER HOSPITAL. CT IMAGING REVEALED THAT THE SUPRARENAL STENTS HAD SEPARATED FROM THE ENDURANT II STENT GRAFT, LEADING TO THE RUPTURE OF THE ANEURYSM. A TYPE IA ENDOLEAK WAS PRESENT. INTERVENTION WAS PREFORMED, AND 3 ENDURANT CUFFS (ETCF3636C49E) WERE IMPLANTED TO REPAIR THE RUPTURE. TREATMENT WAS SUCCESSFULLY COMPLETED. PER THE PHYSICIAN THE CAUSE OF THE RUPTURE AND SUPRARENAL STENT SEPARATION WAS ATTRIBUTED TO DEVICE FAILURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT FINE.

  Patient problems: Rupture

  MAUDE report 18884008 ↗
• InjuryMar 27, 2023Leak/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 APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE VIA PATIENT SERVIES THAT A NOTE ON A OPERATIVE REPORT NOTED THAT THE ENDURANT STENT GRAFTS WERE EXPLANTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE. THE FOLLOWING INFORMATION WAS NOTED IN THE REPORT: ON AN UNKNOWN DATE THE YEAR OF THE INDEX PROCEDURE THE PATIENT WAS EXPERIENCING SIGNIFICANT CLAUDICATION IN THE RIGHT LOWER EXTREMITY. APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE THE PATIENT UNDERWENT A LEFT TO RIGHT FEM-FEM BYPASS DUE TO A RIGHT ILIAC LIMB OCCLUSION AND IMPLANT OF A NON MDT GRAFT. FURTHER SURVEILLANCE STUDY FOUND SIGNIFICANT INCREASE IN THE ANEURYSM SAC DIAMETER FROM 80MM TO 100MM. THE CTA WAS SUGGESTIVE OF A TYPE IA AND POSSIBLE TYPE IB ENDOLEAK. THE PATIENT WAS NOT A CANDIDATE FOR FURTHER ENDOVASCULAR INTERVENTION AND APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE, THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFT SYSTEM AND PLACE A HAND SEWN GRAFT. DURING THE EXPLANT PROCEDURE, 2 SMALL SEROSAL TEARS OCCURRED WHILE THE PHYSICIAN WAS REMOVING ADHESIONS USING CAUTERY AND SHAR

  Patient problems: Obstruction/Occlusion; Pain; Vascular Dissection

  MAUDE report 16617571 ↗
• DeathJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOUR VALIANT CAPTIVIA STENT GRAFTS AND AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A >90MM TAAA. IT WAS REPORTED THAT 2 DAYS LATER THE PATIENT DIED. THE CAUSE OF DEATH IS UNKNOWN BUT THE PHYSICIAN STATED IT WAS POSSIBLY THE ASCENDING THORACIC OR A CARDIAC ISSUE. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 16240558 ↗
• InjuryApr 27, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 80MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED TO THE ER WITH ABDOMINAL PAIN. CTA DEMONSTRATED A TYPE III ENDOLEAKS BETWEEN THE MAIN BODY AND IPSILATERAL LIMB. A 1616124 LIMB WAS BRIDGED BETWEEN THE MAIN BODY AND THE IPSILATERAL LIMB. PER PHYSICIAN, THE CAUSE OF THE TYPE IIIA ENDOLEAK IS MOST LIKELY DUE TO MORPHOLOGY CHANGES WHICH LEAD TO INCREASED TORTUOSITY AND DISEASE PROGRESSION IN BOTH COMMON ILIACS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain; Insufficient Information

  MAUDE report 14218519 ↗
• DeathDec 15, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE IN A POST IMPLANT ANGIOPLASTY THE PATIENTS AORTA RUPTURED. AN ENDURANT 36X16X145 WAS IMMEDIATELY PLACED BELOW MAIN RENAL ARTERIES AND ABOUT 3.5 CM'S ABOVE THE PREVIOUSLY PLACED MAIN BODY GRAFT (28X16X103) WHICH WAS PLACED LOW TO SAVE TWO ACCESSORYRENAL ARTERIES. THE CONTRA LIMB WAS CANNULATED AND AN ADDITIONAL CONTRA LIMB PLACED TO EXCLUDE AN ENDOLEAK. IT APPEARED THAT THE ENDOLEAK WAS RESOLVED HOWEVER, THE BLOOD PRESSURE DID NOT GET BACK TO NORMAL. A 28X49 AORTIC CUFF WAS EXTENDED PROXIMAL AND THE ENDOLEAK WAS RESOLVED. IT APPEARED THE RENAL ARTERIES WERE MOSTLY COVERED. THE PATIENT WAS TRANSFERRED OUT OF THE ANGIO SUITE TO ICU AND EXPIRED 5 DAYS POST THE INDEX PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE RUPTURE AND DEATH IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

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

  MAUDE report 13008348 ↗
• InjuryDec 9, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE REPAIR OF A 100MM ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY OVER 5 YEARS LATER WITH BACK PAIN. IT WAS DISCOVERED THE PATIENT HAD A TYPE IA ENDOLEAK. THE LIMB HAD A NON-MDT BALLOON EXPANDABLE STENT THAT HAD PULLED OUT OF THE ENDURANT LIMB. THE PHYSICIAN THEN EXTENDED THE LIMB AND TO GAIN SEAL PLACED A CUFF TO RESOLVE THE TYPE IA ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO ANATOMY AS THE AORTA GREW AND ELONGATED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 12967723 ↗
• InjuryNov 1, 2021Fracture; Leak/Splash; Fracture; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM .  IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED FOR A TYPE 1A ENDOLEAK  DUE TO NECK DILATATION/ENLARGEMENT WHEN  A FRACTURE OF THE SUPRA RENAL STENT WAS IDENTIFIED. THE PATIENT RECEIVED TREATMENT  AND THE ANEURYSM WAS COILED.  AS PER THE PHYSICIAN, THE CAUSE OF THE SUPRA RENAL  STENT FRACTURE CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12727633 ↗
• InjuryJul 7, 2021Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE AAA. AN MRI AND CT SCAN WAS TAKEN APPROX..6 YEARS AND 10 MONTHS LATER FOR A SEPARATE MEDICAL ISSUE AND IT WAS REPORTED ENDOGRAFT MIGRATION WAS OBSERVED. THE CT SCAN REVEALED THAT THE AORTIC NECK AT RENAL ARTERIES NOW MEASURES 45MM. THE ENDOGRAFT HAS MIGRATED 40MM INTO THE AORTIC SAC AND THERE IS A TYPE 1 ENDO LEAK WITH A AAA MEASURING 100MM IT WAS ALSO REPORTED THE PATIENT WAS ASYMPTOMATIC PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS NECK DILATION DUE TO ANATOMY NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED

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

  MAUDE report 12126619 ↗
• InjuryMay 24, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 67MM AAA ON (B)(6) 2017. APPROX. 3 YEARS AND 10 MONTH POST IMPLANT, THE PATIENT PRESENTED WITH SEVERE ABDOMINAL AND BACK PAIN. CT SHOWED A TYPE IA WITH RUPTURE. INTERVENTION WAS PERFORMED WHERE AN AORTIC CUFF AND ENDOANCHORS WERE IMPLANTED AT THE LEVEL OF THE SMA AND RENALS TO RESOLVE THE EVENT PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS PATIENT ANATOMY, WHERE THE PROXIMAL NECK HAD DILATED. IT HAD BEEN REPORTED THAT THE PT HAD A SEVERE PROXIMAL NECK ANGULATION. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Pain; Rupture

  MAUDE report 11869505 ↗
• InjuryMay 21, 2020Leak/Splash; Migration or Expulsion of Device; Detachment of Device or Device Component; Leak/Splash; Migration or Expulsion of Device; Detachment of Device or Device Component

  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: High Blood Pressure/ Hypertension; Pain

  MAUDE report 10078300 ↗
• DeathOct 16, 2019Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of 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 THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY FOUR YEARS LATER WITH A CONTAINED ANEURYSM RUPTURE. A CT SCAN SHOWED A TYPE IA ENDOLEAK. A NON-MDT (GORE) CUFF WAS IMPLANTED TO ADDRESS THE ENDOLEAK, ALONG WITH ENDOANCHORS. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO DECOMPRESS THE ABDOMINAL COMPARTMENT, AND IN DOING SO THE RETROPERITONEAL CAVITY GAVE WAY. AFTER MUCH EFFORT TO SAVE THE PATIENT IT WAS REPORTED THAT THE PATIENT DIED. IT WAS REPORTED THAT A POSSIBLE TYPE IIIA ENDOLEAK WAS NOTED AFTER OPENING THE ANEURYSM SAC PERI-MORTEM. AS PER THE PHYSICIAN, THE CAUSE OF THE TYPE IA ENDOLEAK WAS EITHER STENT GRAFT MIGRATION OR AORTIC DILATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT HAS EXPIRED.

  Patient problems: Death; Rupture

  MAUDE report 9197050 ↗
• InjuryOct 15, 2019Difficult to Remove; Difficult to Remove

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED TO REPAIR AN ENDOLEAK IN A NON-MEDTRONIC STENT GRAFT. AFTER DEPLOYMENT OF THE ENDURANT II BIFURCATE, THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE. THE PHYSICIAN HAD DEPLOYED THE GATE, THE END OF THE IPSI-LATERAL LIMB AND THE SUPRA-RENAL STENTS, BUT WHILE REMOVING THE DELIVERY SYSTEM THEY ENCOUNTERED RESISTANCE. IT WAS NOTED THAT THE DELIVERY SYSTEM AND GRAFT WERE NOT NEAR THE RENAL ARTERIES AND THE NOSE-CONE WAS DOWN INSIDE THE NON-MEDTRONIC STENT GRAFT. THE PHYSICIAN CONFIRMED THAT THE IPSILATERAL LUNDERQUIST WIRE WAS NOT TRAPPED INSIDE THE CAGE OF THE NON-MEDTRONIC STENT GRAFT. THE ENDURANT II STENT GRAFT WAS COMPRESSED DOWN INSIDE THE NON-MEDTRONIC STENT GRAFT NEAR THE DISTAL AORTA AND IN THE PROXIMAL RIGHT COMMON ILIAC ARTERY. THE DELIVERY SYSTEM COULD NO LONGER BE ADVANCED OR WITHDRAWN, AND THE NOSE CONE COULD NOT BE RECAPTURED. THE PATIENT WAS THEN CONVERTED TO AN OPEN REPAIR AND THE ENDURANT II STENT GRAFT WAS EXPLANTED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WA

  Patient problems: Injury

  MAUDE report 9191965 ↗
• InjuryAug 20, 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 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED ADDITIONAL TREATMENT. IT WAS REPORTED THAT THE PATIENT DIED 7 MONTHS POST IMPLANTATION FROM RESPIRATORY FAILURE. AUTOPSY SHOWED THAT THE SUPRA RENAL FIXATION OF THE BIFURCATED STENT GRAFT HAD ERODED THROUGH THE AORTA. THE STENT GRAFT WAS EXPLANTED DURING THE AUTOPSY. AS PER THE PHYSICIAN, THE CAUSE OF THE EROSION THROUGH THE AORTA WAS UNKNOWN. THE PHYSICIAN ALSO REPORTED THAT THE EROSION OF THE STENT GRAFT THROUGH THE AORTA WAS NOT RELATED TO THE RESPIRATORY FAILURE AND DEATH. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 8909351 ↗
• InjuryAug 19, 2019Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 62 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE NOSE CONE OF THE DELIVERY SYSTEM BECAME DETACHED. IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THE NOSE CONE WAS COMPROMISED DURING RE-SHEATHING OF THE STENT GRAFT, AND THAT IT POTENTIALLY BECAME KINKED AT THAT POINT. THE PHYSICIAN THEN TRAPPED THE DETACHED NOSE CONE WITH A THORACIC STENT GRAFT WHICH RESOLVED THE EVENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 8906044 ↗
• InjuryAug 13, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 80 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE DIAMETER OF THE AORTA AT THE RENAL ARTERY WAS 32 MM, AND THE LENGTH OF THE PROXIMAL AORTIC NECK WAS 15 MM. THERE WAS MINIMAL ANGULATION AND VESSEL CALCIFICATION PRESENT, HOWEVER THERE WAS SIGNIFICANT VESSEL TORTUOSITY. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS NOTED. A CUFF WAS PLACED THE FOLLOWING DAY AS TREATMENT, WHICH RESOLVED THE ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8887178 ↗
• InjuryJun 19, 2019Leak/Splash; Leak/Splash

  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 WHEN THE PATIENT RETURNED FOR FOLLOW UP APPROXIMATELY FOUR YEARS LATER AN UNKNOWN ENDOLEAK WAS OBSERVED. THE ENDOLEAK WAS REPORTED TO START JUST ABOVE THE FLOW DIVIDER OF THE MAIN BIFURCATED STENT GRAFT. AN ANGIOGRAM WAS CARRIED OUT AND IT WAS BELIEVED THAT THESE IMAGES RULED OUT A TYPE III ENDOLEAK AND THE ENDOLEAK WAS BELIEVED TO BE A TYPE I. A SECONDARY INTERVENTION PROCEDURE WAS CARRIED OUT, WHERE THE MAIN BIFURCATED STENT GRAFT WAS RELINED WITH AN ENDURANT II CUFF AND ENDOANCHORS WERE PLACED AT THE PROXIMAL EDGE OF THE EXISTING MAIN BIFURCATED STENT GRAFT. THE EVENT WAS REPORTED TO NOT BE RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Injury

  MAUDE report 8712162 ↗
• InjuryJan 31, 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 APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENT WITH PAIN. A CT REVEALED A TYPE IA ENDOLEAK. EMERGENCY INTERVENTION WAS COMPLETED WITH THE INSERTION OF AN ENDURANT AORTIC CUFF AND BILATERAL RENAL STENTS AND THE ENDOLEAK WAS CONFIRMED AS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO ANATOMY RELATED DUE TO DISEASE PROGRESSION WITH ANEURYSM SIZE INCREASED TO 60MM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 8292088 ↗
• InjuryJan 14, 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 65MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. AT IMPLANT, THE PROXIMAL AORTIC NECK DIAMETER WAS 20-23-31-36MM AND 15MM IN LENGTH. THE NECK ANGULATION WAS 74 DEGREES. HELI-FX ENDOANCHORS WERE PROPHYLACTICALLY IMPLANTED DURING THE INDEX PROCEDURE. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND HYPOTENSION. ANEURYSM RUPTURE WAS CONFIRMED. SURGICAL INTERVENTION WAS COMPLETED HOWEVER THE PATIENT EXPIRED DUE TO THE RUPTURED AORTIC ANEURYSM ONE DAY POST THE INTERVENTION. PER THE INVESTIGATOR THE CAUSE OF THE EVENT WAS RELATED TO THE ENDOGRAFT DEVICE.

  Patient problems: Abdominal Pain; Death; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 8243521 ↗
• MalfunctionJan 10, 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 ON AN UNKNOWN DATE A CT REVEALED ANEURYSM EXPANSION AND A TYPE I ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8235776 ↗
• InjuryNov 19, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM DIAMETER ABDOMINAL AORTIC ANEURYSM WITH SHORT NECK INDICATION. IT WAS ALSO REPORTED THAT ENDOANCHORS WERE IMPLANTED ON AN UNKNOWN DATE POST THE INDEX PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS POST-INDEX PROCEDURE A FOLLOW UP CT REVEALED A MODERATE TYPE IA ENDOLEAK AND IT WAS REPORTED THE ANEURYSM WAS UP TO 2MM BELOW THE LEVEL OF THE LOWEST RENAL ARTERY. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO DISEASE PROGRESSION WITH NECK DILATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 8084387 ↗
• MalfunctionSep 27, 2018Adverse 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 ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE ON (B)(6) 2012. IT WAS REPORTED THAT ON APPROXIMATELY SIX YEARS LATER THE PATIENT CONTACT TECHNICAL SERVICES TO STATE THAT APPROXIMATELY FIVE MONTHS PREVIOUSLY, THE STENT GRAFT IN HIS LEFT ILIAC HAD CLOSED OFF AND HE ALSO REPORTED THAT HIS LEG TIRES WHEN WALKING VERY SHORT DISTANCES OR IF ELEVATION CHANGED.

  Patient problems: No Consequences Or Impact To Patient; Occlusion

  MAUDE report 7913825 ↗
• MalfunctionSep 25, 2018Leak/Splash; Leak/Splash

  A HELI-FX ENDOANCHORING SYSTEM WAS USED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 70MM RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PATIENT PREVIOUSLY HAD AN ENDURANT II STENT GRAFT SYSTEM IMPLANTED APPROXIMATELY THREE MONTHS EARLIER AND THE ENDOANCHORS WERE IMPLANTED TO TREAT NECK DILATION. IN ADDITIONAL TO THE ENDOANCHORS, TWO 16X13X93 ENDURANT II STENT GRAFT LIMBS WERE ALSO IMPLANTED. IT WAS REPORTED THAT A TYPE III ENDOLEAK OF THE LEFT ILIAC LIMB AT THE OVERLAP OF THE STENT GRAFTS WAS NOTED ON A FOLLOW UP ULTRASOUND CARRIED OUT ON (B)(6) 2015. THE ENDOLEAK RESOLVED AND THE PATIENT RECOVERED WITHOUT TREATMENT. PER THE INVESTIGATOR THE CAUSE OF THE EVENT IS NOT RELATED TO THE PROCEDURE OR DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. MEDICAL HISTORY; TOBACCO (PAST), HYPERTENSION, HYPERLIPIDEMIA, MI, PCI, COPD, RENAL DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7905510 ↗

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-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-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