Endurant® II ETBF3216C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00613994990990), received between Jan 17, 2017 and Apr 25, 2025 — classified as 4 deaths, 32 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (20 reports).

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.

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.

• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM, TREATED WITH THE ENDURANT II STENT GRAFT SYSTEM, EXPERIENCED GROWTH OF THE ANEURYSM OVER THE LAST TWO YEARS TO A SIZE OF 68MM, SHOWING SIGNS OF RUPTURE. DURING FOLLOW-UP, ANGIOGRAPHY AND COMPUTED TOMOGRAPHY WERE CONDUCTED, REVEALING NO ENDOLEAKS. AS A PRECAUTION, INTERVENTION WAS PERFORMED WHERE MULTIPLE ANGIOGRAMS WITH CONTRAST SHOWED NO RUPTURE OR ENDOLEAKS. DUE TO THE ANEURYSM ENLARGEMENT, RELINING WAS PERFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE CAUSE OF THE ANEURYSM ENLARGEMENT COULD NOT BE DETERMINED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aneurysm

  MAUDE report 21907235 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 50MM AAA. IT WAS REPORTED APPROXIMATELY 2 MONTHS POST THE INDEX PROCEDURE; CT TAKEN ON (B)(6) 2024 SHOWED RIGHT SIDE LIMB OCCLUSION FROM THE FLOW DIVIDER DOWN. PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION IS NOT THOUGHT TO BE DEVICE RELATED AND DUE TO ANATOMY RELATED TO LIMITED OUTFLOW IN THE EXTERNAL AND ILIAC ARTERIES. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19980729 ↗
• InjuryJul 3, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. 6 ENDOANCHORS WERE ALSO IMPLANTED. IT WAS REPORTED THAT THE PATIENT RANG TECHNICAL SERVICES AND STATED THAT POST THE INDEX PROCEDURE, FOLLOWING THE IMPLANT OF THE ENDURANT STENT GRAFTS, THE BLOOD FLOW WAS KINKED AND WAS BEING PINCHED OFF DOWN TOWARDS THE LEG. THE PHYSICIAN IMPLANTED A RIGID METAL STENT AS INTERVENTION. IT WAS CONFIRMED VIA THE SALES REP THAT DURING THE INDEX PROCEDURE, A BALLOON EXPANDABLE STENT WAS IMPLANTED IN THE LEFT ILIAC LIMB SECONDARY TO STENOSIS . AT THE END OF THIS PROCEDURE A POSSIBLE TYPE II ENDOLEAK WAS NOTED. POST FOLLOW UP WITH VARIOUS IMAGE MODALITIES SHOWED A POSSIBLE TYPE II ENDOLEAK. THE ANEURYSM STAYED THE SAME SIZE UNTIL OVER SIX YEARS LATER WHERE A 1.5 CM INCREASE WAS THEN NOTED. AT THIS TIME THE PHYSICIAN SUSPECTED A TYPE 3 LEAK AT THE RIGHT ILIAC LIMBS VIA CT AND A TYPE 1A ENDOLEAK VIA ULTRASOUND SCAN. THE PHYSICIAN DISCUSSED POSSIBLE SURGERY WITH THE PATIENT BUT BECAUSE OF THE PATIENTS PARKINSON'S DISEASE, THE PATIENT DECIDED TO WAIT. 3 MONTHS LATER, REPEAT IMAGING HAD SHOWED A TYPE 1A ENDOLEAK ON CT AND SMALL INCREASE IN AAA DIAMETER. AN ANGIOGRAM

  Patient problems: Aneurysm; Obstruction/Occlusion

  MAUDE report 19664243 ↗
• MalfunctionApr 11, 2024Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT (ETBF3216C166E) AND ENDURANT LIMB (ETLW1616C124E) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN A BDOMINAL AORTIC ANEURYSM ON (B)(6) 2013. IT WAS REPORTED ON (B)(6) 2024, FOLLOW-UP IMAGING IDENTIFIED A TYPE IA ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087533 ↗
• InjuryMay 25, 2022Leak/Splash; Inadequacy of Device Shape and/or Size; Material Deformation; Leak/Splash; Inadequacy of Device Shape and/or Size; Material Deformation

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 60MM X 49MM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK DIAMETER WAS 25MM AND 35MM IN LENGTH. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE FOLLOW-UP CTA IDENTIFIED A TYPE IA ENDOLEAK AND INFOLDING OF THE BIFURCATED STENT GRAFT FROM THE TIP OF THE FABRIC TO THE FLOW DIVIDER WAS OBSERVED. THE PHYSICIAN IMPLANTED A NON-MDT STENT IN THE TRUNK OF THE BIFURCATED GRAFT TO GAIN GRAFT WALL APPOSITION ON THE (B)(6) 2022. THE TYPE IA AND INFOLDING WERE RESOLVED AS EVIDENCED BY IVUS AND ANGIOGRAPHY IMAGING AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS AS A RESULT OF OVERSIZING, THIS LED TO INFOLDING OF THE BIFURCATED GRAFT WHICH RESULTED IN THE TYPE IA ENDOLEAK.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 14494806 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOUR HELI-FX ENDOANCHORS AND AN ENDURANT II STENT GRAFT SYSTEM WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN 64.8MM ABDOMINAL AORTIC ANEURYSM AS PART OF AN ANCHOR STUDY. THE ENDOANCHORS WERE IMPLANTED FOR A 4-10MM PROXIMAL NECK. IT IS REPORTED THE PATIENT RETURNED FOR A CT WHERE TOTAL OCCLUSION OF THE LEFT LIMB OF THE ENDOGRAFT AND THROMBOSED LEFT LIMB OF THE ENDOVASCULAR  GRAFT WAS OBSERVED. THE PATIENT HAD REST PAIN AND SEVERE LIMITING CLAUDICATION IN THE LEFT. THE PHYSICIAN CARRIED OUT A FEM-FEM BYPASS AND LOWER EXTREMITY ARTERIAL INTERVENTION ON THE (B)(6) 2021. THE NEXT DAY THE PATIENT WAS AMBULATING WITH STRONG PERIPHERAL PULSES AND THE OCCLUSION WAS RESOLVED.  THE SITE ASSESSED THE STENT GRAFT OCCLUSION AS UNLIKELY RELATED TO THE DEVICE AND PROCEDURE. THE SPONSOR HAS ASSESSED THE STENT GRAFT OCCLUSION AS NOT RELATED TO THE DEVICE OR PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 14488089 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOUR HELI-FX ENDOANCHORS AND AN ENDURANT II STENT GRAFT SYSTEM WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN 64.8MM ABDOMINAL AORTIC ANEURYSM AS PART OF AN ANCHOR STUDY. THE ENDOANCHORS WERE IMPLANTED FOR A 4-10MM PROXIMAL NECK. IT WAS REPORTED THE PATIENT PRESENTED TO THE ED WITH RIGHT LOWER EXTREMITY PAIN AND COOLNESS/CRITICAL LIMB ISCHEMIA. THE CTA SHOWED ABRUPT OCCLUSION OF THE RIGHT COMMON FEMORAL ARTERY. THE PATIENT UNDERWENT EXPLORATION OF THE RIGHT GROIN AND OPEN EMBOLECTOMY OF THE RIGHT CFA, SFA AND PROFUNDA FEMORAL ARTERY. AS PER THE SITE THE EVENT IS POSSIBLY RELATED TO THE PROCEDURE. AS PER THE SPONSOR THE EVENT HAS BEEN ASSESSED AS NOT RELATED TO DEVICE OR PROCEDURE. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Ischemia; Obstruction/Occlusion; Pain; Stenosis

  MAUDE report 14488007 ↗
• DeathNov 29, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TO THE EMERGENCY ROOM WITH HEART ATTACK SYMPTOMS OVER 7 YEARS LATER. A CT WAS CARRIED OUT WHERE AN INCIDENTAL FINDING OF A TYPE IA ENDOLEAK WAS OBSERVED.  AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE PATIENTS OWN ANATOMY DUE TO POST-OP DISEASE PROGRESSION WITH AORTIC DILATION WHICH LED TO A FAILURE OF THE PROXIMAL SEAL ZONE.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 12882096 ↗
• InjuryOct 19, 2021Adverse 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 DURING A DE NOVO ENDOVASCULAR AAA PROCEDURE. IT WAS REPORTED APPROXIMATELY ONE MONTH LATER, THE PATIENT PRESENTED WITH LOWER BACK PAIN AND TENDERNESS. OVER THE NEXT FEW WEEKS THE PATIENT HAD SYMPTOMS OF FATIGUE WITH INTERMITTENT EPISODES OF FEVER, CHILLS AND JOIN ACHES AND APPROXIMATELY ONE MONTH LATER WAS READMITTED TO BE TREATED WITH IVAB FOR POTENTIAL STENT GRAFT INFECTION. THREE DAYS POST ADMISSION INTERVENTION WAS COMPLETED TO EXPLANT THE INFECTED AORTIC GRAFT. AN AORTA-BIFEMORAL GRAFT WAS THEN PLACED. CULTURES TAKEN DURING EXPLANT WERE CONFIRMED AS POSITIVE. THE INFECTION WAS CONFIRMED AS RESOLVED APPROXIMATELY ONE WEEK POST INTERVENTION. THE SITE HAS ASSESSED THE INFECTION AS HAVING A PROBABLE RELATIONSHIP TO AN UNDERLYING CONDITION OR DISEASE AND AS HAVING A CAUSAL RELATIONSHIP TO THE INDEX PROCEDURE AND A CAUSAL RELATIONSHIP TO THE ENDURANT DEVICE. THE SPONSOR HAS ASSESSED THE INFECTION AS POSSIBLE RELATED TO THE INDEX PROCEDURE AND PROBABLE RELATED TO THE ENDURANT DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Liver Failure; Pain; Renal Impairment; Unspecified Infection

  MAUDE report 12654907 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR AN ENDOVASCULAR TREATMENT IT WAS REPORTED A RELIANT BALLOON AND SENTRANT SHEATHS WERE ALSO USED DURING THE PROCEDURE. ONE MONTH POST IMPLANT, IT WAS REPORTED THE PATIENT EXPERIENCED LEFT ILIAC LIMB STENOSIS WITH POSSIBLE OCCLUSION OF THE RIGHT RENAL INTERVENTION WAS PERFORMED THE FOLLOWING DAY WHERE A NON MDT COVERED STENT WAS IMPLANTED WITH BALLOON DILATION TO RESOLVE THE EVENT. IT WAS REPORTED THE STENT WAS PATENT WITH EXCELLENT FLOW AND DISTAL PULSES BY THE END OF THE PROCEDURE. SITE ASSESSED THE LEFT LIMB STENOSIS AS POSSIBLY RELATED TO THE PROCEDURE AND CAUSALLY RELATED TO THE DEVICE SITE ASSESSED THE POSSIBLE RENAL OCCLUSION AS PROBABLY RELATED TO THE PROCEDURE NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12412781 ↗
• InjuryJul 15, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 67 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT WAS PERFORMED APPROXIMATELY 6 YEARS POST PROCEDURE, WHERE A POTENTIAL TYPE 1B ENDOLEAK WAS OBSERVED. AFTER REVIEW OF THE CT, THE 16X20X93 ON THE IPSILATERAL (RIGHT SIDE) WAS NOTED TO HAVE CONTRAST OUTSIDE OF LIMB AND FLOW NOTED IN THE ANEURYSM SAC. PHYSICIAN THEN DECIDED TO TAKE PATIENT TO SURGERY FOR FURTHER EVALUATION AND INTERVENTION. UPON FIRST ANGIOGRAM, DISTAL PORTION OF 16X20X93 NOTED IN PROXIMAL COMMON ILIAC AND CONTRAST FLOWING BACK INTO SAC. ADDITIONALLY, A SMALL TYPE 1A ENDOLEAK WAS NOTED AT THE NECK BELOW THE RENALS ARTERY, CONTRAST BLUSHING OUTSIDE OF GRAFT INTO SAC. PATIENT DID NOT PRESENT WITH ANY SIGNS OR SYMPTOMS OF A RUPTURE. IT WAS STATED THAT THE A 32X32X49 ABDOMINAL CUFF WAS PLACED DIRECTLY BELOW THE RENALS ARTERY. THE 16 X 20 X 93 LIMB ON THE IPSILATERAL SIDE WAS EXTENDED WITH A 16 X 10 X 124 INTO THE EXTERNAL ILIAC. DUE TO THE TORTUOSITY, A 13 X 10 NON-MEDTRONIC DEVICE WAS EXTENDED OUT OF THE 16 X 10 X 124. PER ANGIOGRAM, THE TYPE 1A AND TYPE 1B ENDOLEAK WERE RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF

  Patient problems: Insufficient Information

  MAUDE report 12174399 ↗
• InjuryApr 6, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 69MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED OVER 8 YEARS LATER, THE PATIENT PRESENTED WITH WHAT APPEARED AT FIRST TO BE A TYPE I OR TYPE II ENDOLEAK. INTERVENTION WAS PERFORMED AND INTRA-OPERATIVE IMAGING DETERMINED IT WAS A TYPE IIIB ENDOLEAK. A AORTIC CUFF AND BILATERAL LIMBS WERE IMPLANTED. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11618181 ↗
• DeathFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 57MM ABDOMINAL AORTIC ANEURYSM. ONE ENDOANCHOR WAS ALSO IMPLANTED IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT EXPERIENCED BLOOD PRESSURE FLUCTUATIONS DURING THE NORMAL COURSE OF THE EVAR CASE WHICH WERE BEING MANAGED BY ANESTHESIA. DURING ONE OF THE BLOOD PRESSURE DROPS THE PATIENT DID NOT RESPOND TO THE MANEUVERS BY ANESTHESIA. THE PATIENT ENTERED CARDIAC ARREST AND CHEST COMPRESSIONS WERE ADMINISTERED AND BLOOD TRANSFUSION WERE GIVEN. IT WAS STATED THAT A BALLOON WAS PLACED IN THE AORTA JUST ABOVE THE CELIAC ORIGINAND INFLATED TO PREVENT ANY POSSIBLE BLEEDING IN THE ABDOMINAL/PELVIC AREA. A CARDIOTHORACIC SURGEON WAS CALLED TO OPEN THE CHEST AND AFTER DOING SO DECLARED THE PATIENT DECEASED. IT WAS ALSO REPORTED THAT ALL DEVICES PERFORMED AS PER SPECIFICATION. AND THERE WAS NO KNOWN EVENT IN THE ABDOMINAL WORK AREA THAT WOULD HAVE CAUSED THE EVENT (BLOOD PRESSURE FLUCTUATION) AND CAUSE OF THE EVENT CANNOT BE DETERMINED. AS PER THE PHYSICIAN CAUSE OF THE DEATH WAS POSSIBLY DUE TO CARDIAC ARREST BUT THE CAUSE OF CARDIAC ARREST CAN NOT BE DETERMINED. NO ADDITIONAL CLI

  Patient problems: Cardiac Arrest

  MAUDE report 11284852 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM. INTERVENTION WAS PERFORMED ON THE SAME DATE, A FEM-FEM BYPASS WAS PERFORMED AND AN AUI STENT GRAFT IMPLANTED. THIS RESOLVED THE EVENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS A POSSIBLE TYPE IA OR TYPE II ENDOLEAK. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 11235611 ↗
• InjuryNov 11, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 100MM ABDOMINAL AORTIC ANEURYSM. THE PATIENT PRESENTED EMERGENTLY OVER FOUR AND A HALF YEARS WITH ABDOMINAL PAIN. A CT PERFORMED SHOWED AN ENLARGING ANEURYSM SAC OF 110MM WITH A TYPE IIIA ENDOLEAK BETWEEN THE BIFURCATE AND ENDURANT LIMB ETLW1613C82E. INTERVENTION WAS PERFORMED ON THE SAME DATE AND A 16X16X124 WAS IMPLANTED TO BRIDGE THE TYPE IIIA ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY. IT WAS NOTED IT WAS 100M ANEURYSM TO BEGIN WITH THAT STARTED TO REMODEL AND THE ANEURYSM ENLARGEMENT CAUSED THE LIMB TO PULL OUT OF THE BIFURCATE REPORTEDLY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10822078 ↗
• MalfunctionApr 8, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR REPAIR OF A 58MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE A LEAK WAS NOTED FROM AN APPARENT TEAR IN THE DEVICE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS A TEAR IN THE FABRIC. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDE AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9937661 ↗
• InjuryMar 26, 2020Leak/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 THE PATIENT HAD PREVIOUSLY BEEN TREATED WITH COILS FOR A TYPE II ENDOLEAK BUT THE ANEURYSM WAS STILL GROWING. CT APPROXIMATELY THREE YEARS POST THE INDEX PROCEDURE SHOWED POSSIBLE TYPE IB ENDOLEAK AT THE LEFT ILIAC SEAL ZONE. AN AORTOGRAM CONFIRMED THE PRESENCE OF A TYPE IB ENDOLEAK. AN ENDURANT II STENT GRAFT LIMB ETEW2020C82E WAS IMPLANTED AS TREATMENT INTO THE EXISTING BIFURCATED ISPSI LEG TO EXTEND TO THE HYPOGASTRIC ARTERY. BALLOONING WAS CARRIED OUT AND ANOTHER AORTOGRAM SHOWED THE ENDOLEAK HAD RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CAUSE WAS CONTINUED DILATATION OF THE COMMON ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9882258 ↗
• MalfunctionMar 9, 2020Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM, WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT 7 YEARS AND 1 MONTH LATER, THE PATIENT PRESENTED TO ER WITH SYMPTOMATIC BACK PAIN. A CT WAS PERFORMED AND A TYPE III ENDOLEAK WAS OBSERVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS THE TYPE III ENDOLEAK. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 9805830 ↗
• InjuryJan 7, 2020Migration or Expulsion of Device; 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 ON (B)(6) 2014. IT WAS REPORTED THAT CT FIVE YEARS POST THE INDEX PROCEDURE SHOWED A TYPE II ENDOLEAK (THAT WAS POSSIBLY A TYPE IA). IT WAS REPORTED THAT THERE WAS A LUMBAR ARTERY FILLING THE ANEURYSM SAC AND POSSIBLY A TYPE IA ENDOLEAK FROM NECK DILATION, AND POSSIBLE MIGRATION. AN AORTOGRAM APPROXIMATELY ONE MONTH LATER SHOWED A TYPE II ENDOLEAK AND THAT THE STENT GRAFT WAS 10MM FROM THE LEVEL OF THE LOWEST RENAL ARTERY. THERE WAS NO APPARENT TYPE IA ENDOLEAK. IT WAS REPORTED THAT THE STENT GRAFT HAD MIGRATED 3-4 MM BUT IT NOT THE CAUSE OF THE ENDOLEAK. THE ENDOLEAK WAS CONFIRMED TO BE A TYPE II CAUSED BY A LUMBAR ARTERY. THE TYPE II ENDOLEAK WAS TREATED BY CARRYING OUT COILING. AN ENDURANT II STENT GRAFT CUFF WAS THEN IMPLANTED UP TO THE LEVEL TO THE LOWEST RENAL AND 10 ENDOANCHORS WERE ALSO PLACED TO TREAT THE MIGRATION. AN AORTOGRAM CONFIRMED THE TYPE II ENDOLEAK HAD RESOLVED AND THERE WAS NO TYPE IA ENDOLEAK NOTED. THE CAUSE OF THE MIGRATION IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9557193 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 52MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY FOURTEEN DAYS LATER WITH A PULSELESS RIGHT FEMORAL ARTERY AND A CT AND ANGIOGRAM CONFIRMED A LIMB OCCLUSION. A SECONDARY PROCEDURE WAS CARRIED OUT AND ENDURANT AUI STENT GRAFT WAS IMPLANTED AND A FEMORAL-FEMORAL BYPASS CARRIED OUT WHICH RESOLVED THE OCCLUSION. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS PATIENT ANATOMY. THE PATIENT WAS REPORTED TO HAVE A LONG NARROW DISTAL AORTA WITH DIAMETERS OF 27-28-25. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 9551871 ↗
• InjuryMay 30, 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 OF UNKNOWN SIZE. IT WAS REPORTED THAT ON CT 2 MONTHS POST THE INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS OBSERVED IN THE PATIENT. INTERVENTION WAS PERFORMED WITH COILING OF THE ANEURYSM SAC AND IMPLANTATION OF AN ENDURANT CUFF UP TO THE LEVEL OF THE LEFT RENAL ARTERY. THE AREA WAS THEN BALLOONED USING A RELIANT BALLOON AND 12 HELI-FX ENDOANCHORS WERE IMPLANTED IN THE PROXIMAL PART OF THE CUFF. THIS RESOLVED THE ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO MIGRATION OF THE BIFURCATE TO 5MM BELOW THE LEVEL OF THE LOWEST RENAL. THE CAUSE OF THE MIGRATION WAS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8652888 ↗
• InjuryApr 30, 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 THE PATIENT HAD TREATMENT FOR A PERSISTENT TYPE IA ENODLEAK USING A NON MDT CUFF AND COILING. APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT DEMONSTRATED ANEURYSMAL DISEASE PROGRESSING TOWARD THE RENALS. THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFT SYSTEM. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8564224 ↗
• InjuryFeb 18, 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 ABDOMINAL AORTIC ANEURYSM. A VALIANT STENT GRAFT WAS ALSO IMPLANTED IN THE PATIENT APPROXIMATELY ONE MONTH LATER. IT WAS REPORTED A FOLLOW UP CT IDENTIFIED THORACOABDOMINAL ANEURYSM ENLARGEMENT AND A DISSECTION. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS DISEASE PROGRESSION. TWO ENDURANT LIMBS ETLW1616C93 AND ETLW1616C156E WERE IMPLANTED IN THE PATIENT DURING AN INTERVENTION PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED. MEDICAL HISTORY: DISSECTION, HYPERTENSION, OSA.

  Patient problems: Aneurysm; Intimal Dissection

  MAUDE report 8347001 ↗
• InjuryMay 16, 2018Kinked; Occlusion Within Device; Activation, Positioning or Separation Problem; Kinked; Occlusion Within Device; Activation, Positioning or Separation Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN CONDITION. IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE STENT GRAFT DIDN'T OPEN AND THAT THE PHYSICIAN HAS STATED THERE WAS A KINK IN IT. 5 DAYS AFTER THE INDEX PROCEDURE, THERE WAS NOT SUFFICIENT BLOOD FLOW TO THE PATIENTS LEFT LEG AND A FEM-FEM BYPASS WAS PERFORMED. IT WAS NOTED BY THE PATIENTS WIFE THAT BLOOD FLOW PROBLEMS TO THE PATIENTS LEGS CONTINUES, THE PATIENT IS NOT HEALING AND HAS AN INFECTION. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS NOT DOING WELL AS PER THE COMPLAINANT.

  Patient problems: Injury; Occlusion; Unspecified Infection

  MAUDE report 7518042 ↗
• InjuryMar 20, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 103MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A TYPE III FABRIC ENDOLEAK WAS NOTED IN THE BIFURCATE. IT WAS NOTED THAT THE PATIENT RECEIVED TREATMENT WITH A FEMORAL-FEMORAL BYPASS AND AUI CONVERSION, WITH LIMB EXTENSION AND ENDOANCHORS IMPLANTATION. THIS RESOLVED THE EVENT. AS PER THE PHYSICIAN, THE CAUSE OF THE TYPE III ENDOLEAK IS NOT DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7353464 ↗

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 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