Endurant® II ETLW1616C156E (UDI 00643169467668)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00643169467668), received between May 4, 2017 and May 27, 2026 — classified as 4 deaths, 25 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 70MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 9 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY. CT CONFIRMED THAT THE RIGHT ILIAC LIMB HAD PULLED OUT OF THE RIGHT ILIAC ARTERY. THE PHYSICIAN NOTED THAT THERE WAS SOME SORT OF TRAUMA TO THE PATIENT THAT MAY HAVE CAUSED IT SINCE PREVIOUS FOLLOW UP CT'S HAD ALL BEEN NORMAL BUT WAS UNSURE. INTERVENTION WAS COMPLETED WHERE THE RIGHT LIMB WAS RELINED. ENDURANT ILIAC LIMBS 16-16/124 AND A 16-16/93 ILIAC LIMB WERE IMPLANTED AND RESOLVED THE ENDOEAK. THE CAUSE WAS UNDETERMINED BUT POSSIBLE TRAUMA MAY HAVE CONTRIBUTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 25298689 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ETLW1616C156E STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 25MM LEFT COMMON ILIAC ANEURYSM. IT WAS REPORTED THAT DISEASE PROGRESSION IN THE LEFT COMMON ILIAC ARTERY WAS IDENTIFIED ON THE DATE THE PATIENT RETURNED FOR FOLLOW-UP APPROXIMATELY 10 YEARS POST-INDEX PROCEDURE, WITH NO ENDOLEAK OBSERVED ON ANGIOGRAPHY. EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY WAS PERFORMED THE NEXT DAY, AND THE STENT GRAFT WAS EXTENDED INTO THE LEFT EXTERNAL ILIAC ARTERY USING ETLW1613C124E. THE EVENT WAS REPORTED AS RESOLVED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm expansion

  MAUDE report 25147501 ↗
• InjuryNov 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT WITH A 60 MM ANEURYSM WHO PREVIOUSLY RECEIVED A STENT GRAFT ETLW1616C156E ENDUR II LIMB UNDERWENT FOLLOW-UP CT ANGIOGRAPHY, WHICH REVEALED A LARGE ENDOLEAK WITH SAC ENLARGEMENT. DURING EVALUATION AND REPAIR, A TYPE IIIB  ENDOLEAK WAS IDENTIFIED IN THE LEFT ILIAC LIMB, ALONG WITH A TYPE II ENDOLEAK FROM THE INTERNAL ILIAC , ILIO-LUMBAR AND LUMBAR ARTERIES. A HOLE/DEFECT IN THE GRAFT FABRIC WAS NOTED AS THE CAUSE OF THE TYPE IIIB ENDOLEAK. THE FOLLOWING DAY, THE TYPE II ENDOLEAK WAS TREATED WITH EMBOLIZATION, AND A NEW ETLW1616124E STENT GRAFT WAS PLACED TO REPAIR THE TYPE IIIB ENDOLEAK IN THE LEFT ILIAC LIMB. IT WAS NOTED THAT CONTRAST INJECTION WAS MADE AFTER THE TYPE II ENDOLEAK WAS TREATED WITH EMBOLIZATION AND PRIOR TO STENT GRAFT DEPLOYMENT OVER THE SUSPECTED HOLE/DEFECT TO CONFIRM THE TYPE IIIB ENDOLEAK. THE EVENT WAS RESOLVED. PER THE PHYSICIAN, THERE WAS MINIMAL CALCIFICATION PRESENT ALTHOUGH IT WAS SAID THIS COULD HAVE BEEN A POSSIBLE CONTRIBUTORY FACTOR TO THE TYPE IIIB ENDOLEAK . NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm expansion

  MAUDE report 23614672 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROX. 25 DAYS POST INDEX PROCEDURE, CT IMAGING IDENTIFIED WHAT APPEARS TO BE A RIGHT COMMON ILIAC ARTERY (RCIA) LIMB OCCLUSION DUE TO THE TIGHT DISTAL AORTA WHICH EXTENDED TO THE FLOW DIVIDER. INTERVENTION WAS PERFORMED AND A THROMBECTOMY DEVICE WAS PLACED TO CREATE A CHANNEL FOLLOWED BY THE IMPLANT OF ANOTHER LIMB TO OPEN THE LUMEN. BILATERAL NON-MDT STENTS WERE PLACED THROUGH THE DISTAL AORTA. THERE WERE NO KINKS IN THE STENT GRAFT. PER THE PHYSICIAN THE CAUSE OF THE (RCIA) OCCLUSION WAS DUE TO ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21941455 ↗
• MalfunctionMay 15, 2024Defective Component; Positioning Problem; Defective Component; Positioning Problem

  AN ENDURANT LIMB (ETLW1616C156E / V30982663) WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 52MM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL RENAL ARTERY DIAMETER MEASURED 23MM, WITH A 34MM NECK LENGTH. MILD CALCIFICATION AND MODERATE THROMBUS WAS OBSERVED IN THE PROXIMAL NECK. MILD BILATERAL ILIAC WAS PRESENT. IT WAS REPORTED DURING THE INDEX PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING ETLW1616C156E IN THE CONTRALATERAL LEFT ILIAC. THE PHYSICIAN REMOVED THE DEVICE AND NOTICED THAT THE NOSE CONE HAD COME OFF THE SHAFT OF THE GRAFT CREATING A"LIP." THE DELIVERY SYSTEM WAS REMOVED AND REPLACED IT WITH AN 11FR SHEATH TO SEE TRACKABILITY. IT ADVANCED WITH NO ISSUES. THE PHYSICIAN TRIED THE DEVICE AGAIN AND GOT RESISTANCE. AFTER SOME TIME TYING IT WAS DECIDED IT WAS NOT SAFE TO KEEP FORCING THIS DEVICE. THE DEVICE WAS SWAPPED OUT THE DEVICE FOR ANOTHER ENDURANT LIMB WITH THE SAME DIMENSIONS 16X16X156 AND THAT DEVICE ADVANCED WITHOUT ISSUE. THE PHYSICIAN BELIEVES THE NOSE CONE WAS NOT FLUSH TO THE GRAFT AND THE LIP IT CREATED CAUSED THE ISSUE. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320663 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS NOTED THAT THE ANEURYSM WAS A SMALLER SACCULAR ANEURYSM AT AORTIC BIFURCATION. THE PROXIMAL DIAMETER OF THE LEFT CIA WAS NOTED AS 16-14MM AND 64MM IN LENGTH. THE ACCESS DIAMETER AT THE COMMON ILIAC WAS NOTED AS 10MM. THERE WAS MILD RIGHT AND LEFT ILIAC CALCIFICATION NOTED. IT WAS REPORTED THAT THE INDEX PROCEDURE WAS COMPLETED WITH GOOD POST-ANGIO RESULTS, HOWEVER WHEN THE PATIENT WAS IN RECOVERY THEY LOST PULSES IN THEIR LEFT FOOT. THE PATIENT WAS BROUGHT TO IR SUITE AND THE LEFT LIMB (ETLW1616C156E) WAS FOUND TO BE OCCLUDED. 2 NON-MDT STENTS WERE PLACED TO RESTORE THE BLOOD FLOW. PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION WAS POSSIBLY ANATOMY RELATED DUE TO THE TORTUOSITY OF THE PROXIMAL LEFT COMMON ILIAC. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18737059 ↗
• InjuryJan 5, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 53MM AAA. IT WAS NOTED THAT THE DIAMETER OF THE AORTA AT THE RENAL ARTERY WAS 30MM, THE LENGTH OF THE PROXIMAL NECK WAS 49MM, THE DEGREE OF ANGULATION WAS 10 DEGREES AND THERE WAS MILD VESSEL TORTUOSITY. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PROCEDURE WENT WELL FROM START TO FINISH WITH NO COMPLICATIONS. DURING THE FINAL ANGIOGRAM AN ENDOLEAK WAS OBSERVED. IT WAS OBSERED THAT THE LIMB ON THE LEFT SIDE WAS DEPLOYED BEHIND THE GATE LEADING TO A TYPE IIIA ENDOLEAK. THE PHYSICIAN ASSUMED THAT THE GATE HAD BEEN CANNULATED BY SPINNING THE PIGTAIL CATHETER AT THE PROXIMAL PORTION OF THE GRAFT. THE PHYSICIAN THEN ACCESSED THE LEFT COMMON ILIAC WITH A .014 WIRE ALONG THE SIDE OF THE GRAFT AND GOT INTO THE AAA SAC. THE GATE WAS CANNULATED AND CONFIRMED VIA INTRAVASCULAR ULTRASOUND. A NEW 16X16X156 ENDURANT LIMB WAS INSERTED ALONG SIDE THE EXISTING STENT GRAFT FROM THE GATE TO JUST ABOVE THE HYPOGASTRIC ARTERY WITH NO DIFFICULTY. AN 11MMX79MM NON-MDT (VBX) STENT WAS USED TO PROVIDE MORE RADIAL FORCE WITH THE LEFT GRAFT AND DILATED WITH A 14MM BALLOON. THE FINAL ANGIOGRAM SHOWED A GOOD RESUL

  Patient problems: Insufficient Information

  MAUDE report 18452894 ↗
• InjuryJul 3, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT LIMB WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 56MM AAA . IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN SHOWED ANEURYSM ENLARGEMENT TO 103MM AND A TYPE IB ENDOLEAK IN THE LEFT LIMB. PER THE PHYSICIAN IT IS BELIEVED THE PROGRESSION IN THE ILIAC WAS CAUSED BY A TYPE II ENDOLEAK. NINE DAYS LATER THE PHYSICIAN COILED SEVERAL BRANCHES IN THE SAC TO REPAIR THE TYPE II ENDOLEAK. THE PHYSICIAN THEN EXTENDED INTO THE LEFT EXTERNAL ILIAC ARTERY WITH AN ENDURANT LIMB TO REPAIR THE TYPE IB ENDOELAK. THE PHYSICIAN DID NOT VISUALIZE WHETHER THE RIGHT HYPO WAS OCCLUDED OR NOT DURING THE FOLLOW UP PROCEDURE AND DIDN¿T FEEL THAT THE ENDURANT GRAFT PLACED ABOVE IT WOULD HAVE CAUSED THE ISSUE IF THERE WAS ONE. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS DISEASE PROGRESSION. NO ADDITIONAL  CLINICAL SEQUELAE WERE PROVIDED IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17245051 ↗
• DeathJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 67MM RUPTURED ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY ON THE DATE WITH A RUPTURED ANEURYSM. THE PATIENT'S BLOOD PRESSURE WAS 50/30. THE PATIENT HAD A PREVIOUS NON-MEDTRONIC STENT GRAFT IMPLANTED THAT WAS LEAKING DUE TO FABRIC TEAR, LEADING TO BLOOD LOSS AND ANEURYSM RUPTURE. THE ENDURANT STENT GRAFTS WERE IMPLANTED TO SUCCESSFULLY RELINE THE NON-MEDTRONIC GRAFT WITHOUT ANY ENDOLEAKS OBSERVED. THE PATIENT WAS TAKEN TO ICU AFTER THE SURGERY AND DIED LATER ON THE SAME DAY. PER THE PHYSICIAN, THE PATIENT WAS TOO SICK TO SURVIVE THE EVENT. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO BLOOD LOSS. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS EXPIRED.

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

  MAUDE report 17160452 ↗
• InjuryMar 14, 2023Adverse 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 ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED AAA . IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY. IT WAS NOTED THAT THE PATIENTS LEFT ENDURANT LIMB ETLW1616C156E HAD THROMBOSED. THE PHYSICIAN BROUGHT THE PATIENT FOR INTERVENTION. AN ATTEMPT WAS MADE TO OPEN THE LIMB WITH A BALLOON AND A NON MDT STENT WAS THEN PLACED WITHIN THE LIMB. POST DILATION WAS THEN PERFORMED WITH A XXL BALLOON. ANOTHER STENT WAS THEN PLACED FROM THE DISTAL LIMB TO THE PROXIMAL LEFT EXTERNAL ILIAC ARTERY. THE LIMB AND EXTERNAL ILIAC ARTERY OCCLUDED AGAIN DURING THE PROCEDURE.  THE PHYSICIAN THEN PERFORMED A FEM-FEM BYPASS TO REVASCULARIZE THE LEFT LOWER EXTREMITY.  PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNKNOWN.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16536322 ↗
• MalfunctionOct 14, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 130MM ABDOMINAL AORTIC ANEURYSM  IT WAS REPORTED THAT CT CARRIED OUT IDENTIFIED BILATERAL TYPE IB ENDOLEAKS. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS DUE TO ANATOMY AND DISEASE PROGRESSION.  NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606981 ↗
• InjurySep 26, 2022Adverse 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 63X61 AAA AND 55 RCIA. EMBOLIZATION OF RIGHT INTERNAL ILIAC ARTERY AND EXTENSION OF LIMB INTO EXTERNAL ILIAC ARTERY WAS ALSO PERFORMED.  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH A COLD RIGHT LEG. A CT SCAN PERFORMED SHOWED A RIGHT ILIAC LIMB OCCLUSION. THE CT SCAN ALSO SHOWED THE PATIENT DID NOT HAVE ANY FLOW IN EITHER OF HIS LEGS WITH ANEURYSMAL DISEASE THROUGHOUT BOTH LEGS. NO INTERVENTION WAS PERFORMED AS THE PATIENT WAS NOT GIVEN CARDIAC CLEARANCE FOR SURGERY.  PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION IS NO OUTFLOW. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15484441 ↗
• InjuryAug 31, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER THE STENT GRAFTS WERE IMPLANTED,  A FINAL ANGIOGRAM WAS PERFORMED. AN ENDOLEAK WAS NOTED. THE PHYSICIAN PLACED SHEATHS UP EACH LIMB <(>&<)> DID A RETROGRADE SHOT TO IDENTIFY WHICH LIMB THE ENDOLEAK WAS COMING FROM. IT WAS IDENTIFIED THAT THE LEFT LIMB ETLW1616C156E CONTAINED THE ENDOLEAK. INTERVENTION WAS PERFORMED AND THE PHYSICIAN RELINED THE LIMB WITH 1616124 LIMB AND THE ENDOLEAK RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK CAN NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15327963 ↗
• InjuryAug 30, 2022Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT IIS BIFURCATED STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED 73X81MM ABDOMINAL AORTIC ANEURYSM ON THE (B)(6) 2022.  IT WAS REPORTED THE PATIENT THAT DURING THE INDEX PROCEDURE THE PHYSICIAN PLACED ADDITIONAL LIMBS DUE TO INADEQUATE OVERLAP ZONES. THE PHYSICIAN WAS UNSURE IF THERE WAS A VISIBLE TYPE III OR NOT, BUT IT WAS NOTED THAT THE MARKERS WERE LINED INCORRECTLY IN THE OVERLAP ZONE BETWEEN ETLW1616C156E (SN (B)(4)) AND ETLW1624C124E ((B)(4)), SO THE PHYSICIAN RELINED THE AREA TO THE RECOMMENDED OVERLAP PER THE IFU. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IV ENDOLEAK IN THE BIFURCATED STENT GRAFT. IT WAS NOTED THAT THE PATIENT WAS GIVEN 6000 UNITS OF HEPARIN DURING CASE. THE PATIENT LEFT THE OR. THE PATIENT THEN BECAME UNSTABLE AND WAS RETURNED TO THE OR WHERE THE PHYSICIAN IMPLANTED A NON-MDT GRAFT INSIDE THE MAINBODY STENT GRAFT. THE ENDOLEAK WAS STILL OBSERVED SO THE PHYSICIAN CONVERTED TO AN OPEN REPAIR AND THE ENDURANT STENT GRAFT WAS EXPLANTED.  AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15319089 ↗
• DeathMar 8, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC FUSIFORM ANEURYSM. DURING THE INDEX PROCEDURE 2 ENDURANT LIMBS (ETLW1616C156E & ETLW1624C156E) WERE IMPLANTED. AN ADDITIONAL ENDURANT LIMB (ETLW1616C199E) WAS IMPLANTED BRIDGING THE VALIANT GRAFT AND VISCERAL BYPASS OF THE IPSILATERAL LIMB OF THE BIFURCATED DEVICE WAS COMPLETED. 2 NON MDT STENTS WERE IMPLANTED IN THE LEIA AND POST DILATED WITH A NON MDT BALLOON. THE MAX AORTIC DIAMETER WAS NOTED AS 107MM; THE ANEURYSM SIZE WAS NOTED TO HAVE HAD INCREASED WITH THE STENT GRAFT NOTED AS PATENT. A TYPE II ENDOLEAK WAS OBSERVED AND A TYPE IIIA ENDOLEAK WAS OBSERVED AT THE SMA WITH A DISCONNECTION FROM THE MANIFOLD. NON MDT STENTS WERE IMPLANTED FROM THE MANIFOLD TO THE SMA FOR THE DISCONNECTION IT WAS REPORTED A FOLLOW-UP CT IDENTIFIED A TYPE II ENDOLEAK. THE PATIENT WAS HEMODYNAMICALLY UNSTABLE AND WAS ADMITTED WITH A POSSIBLE GRAFT INFECTION AND ANAEMIA. AN MRA DEMONSTRATED AN INCREASED SIZE OF THE ANEURYSM SAC AND A TYPE IIIA ENDOLEAK AT THE SMA . THE IMAGE SHOWED A DISCONNECTION FROM THE MANIFOLD. THE INFECTION LED TO SEPSIS AND MULTI-ORGAN FAILURE AND EVENTUAL DEATH. AS PER THE PHYSICI

  Patient problems: Anemia; Sepsis; Unspecified Infection

  MAUDE report 13692247 ↗
• MalfunctionDec 9, 2021Use of Device Problem; Use of Device Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED DURING THE PROCEDURE THAT THE PHYSICIAN REQUESTED AN ENDURANT LIMB. THE LIMB WAS PULLED FROM THE FACILITY'S OWN STOCK AND WAS IMPLANTED. UPON REGISTRATION OF THE DEVICE THE MEDTRONIC PERSONNEL DISCOVERED THAT THE ENDURANT LIMB WAS EXPIRED AND ALERTED THE PHYSICIAN. IT WAS STATED THAT THE DEVICE COULD NOT BE REGISTERED TO THE PATIENT DUE TO THE EXCEEDED SHELF LIFE. THERE IS NO ADVERSE PATIENT OUTCOME ASSOCIATED WITH THIS EVENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO FAILURE OR MISMANAGEMENT OF OWNED INVENTORY LEVELS PRIOR TO PROCEDURE AND FAILURE TO PERFORM DATING CHECK OF THE DEVICE BEFORE IMPLANT. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967489 ↗
• InjuryDec 8, 2021Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED FOR THE TREATMENT OF A SUSPECTED TYPE III ENDOLEAK IN A PREVIOUSLY IMPLANTED NON MDT STENT GRAFT. THE PATIENT WAS ORIGINALLY TREATED FOR A 60MM RIGHT COMMON ILIAC A AAA ON AN UNKNOWN DATE. IT WAS REPORTED DURING THE PROCEDURE AFTER THE ENTIRE NON MDT STENT WAS RELIGNED DURING BALLOONING THE RELIANT BALLOON BURST. ON FINAL ANGIO THE SUSPECTED TYPE III ENDOLEAK WAS OBSERVED AGAIN. AFTER FURTHER DIAGNOSTIC TESTING THE PHYSICIAN DECIDED TO RELINE THE 16X16X156 LIMB WITH A 16X16X124 LIMB IN THE SAME AREA ON THE RIGHT SIDE. THE ENDOLEAK IMPROVED BUT REMAINED AND WAS NOW SUSPECTED TO BE A TYPE II ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK MAY HAVE BEEN DUE TO THE NON MDT STENTS USED TO SNORKEL INTO LEFT HYPO DURING THE INITIAL IMPLANT OF THE NON MDT DEVICE. IT IS BELIEVED THAT THE BALLOON BURST BECAUSE A NON-MEDTRONIC STENT WAS USED IN A PREVIOUS IMPLANTED NON-MEDTRONIC GRAFT WHICH TORE THROUGH FABRIC LEADING TO BALLOON TO BURST DURING THE RELINING OF THIS GRAFT WITH MEDTRONIC STENTS. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12959358 ↗
• InjuryFeb 15, 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 70MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY AND IT WAS IDENTIFIED THAT THE ENDURANT LIMB ETLW1616C156E HAD PULLED OUT OF THE ILIAC ARTERY CAUSING ANEURYSM ENLARGEMENT LEADING TO A IB ENDOLEAK AND ANEURYSM RUPTURE. INTERVENTION WAS PERFORMED ON THE SAME DATE, AN OPEN REPAIR WAS COMMENCED. THE ILIAC ARTERY WAS DISSECTED OUT AND AN END TO END ANA STOMOSES WAS DONE FROM THE DISTAL END OF THE LIMB AND THE LEFT COMMON ILIAC. THIS RESOLVED THE EVENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND A TORTUOUS ECTATIC ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 11327172 ↗
• DeathAug 12, 2020Adverse 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 A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 55+ MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AT THE END OF THE INDEX PROCEDURE, DURING BALLOONING OF THE STENT GRAFT THE DISTALOR THE PROXIMAL RIGHT ILIAC ARTERY WAS RUPTURED. IT WAS REPORTED THAT THE PHYSICIAN QUICKLY IMPLANTED A ETLW1616C124E LIMB FROM INSIDE THE PREVIOUSLY IMPLANTED ETLW1624C124E, ACROSS THE INTERNAL ILIAC AND INTO THE RIGHT EXTERNAL ARTERY, WHERE THE PHYSICIAN BELIEVED TO BE THE DISRUPTION. ANOTHER ANGIOGRAM WAS PERFORMED AND SOME RUPTURE WAS STILL NOTED. THE PHYSICIAN THEN DECIDED TO IMPLANT A ETLW1620C156E IT THE HIGHER AND LOWER END ON THE PREVIOUSLY IMPLANTED STENT GRAFT. FINAL ANGIOGRAM WAS PERFORMED WITH NO ADDITIONAL EVIDENCE OF RUPTURED ARTERY. AS PER THE PHYSICIAN, CAUSE OF THE EVENT CANNOT BE DETERMINED. IT WAS FURTHER REPORTED THE PATIENT PRESENTED WITH PAIN AND HYPERTENSION APPROXIMATELY 2 WEEKS POST INDEX PROCEDURE. A CT SCAN SHOWED SOME FLUID/OLD BLOOD IN ABDOMINAL BUT NO DEFINITIVE RUPTURE WAS SEEN. A POSSIBLE TYPE II ENDOLEAK WAS OBSERVED. IT WAS DECIDED TO EXPLANT THE STENT GRAFT SYSTEM TO FURTHER EXPLORE THE CAUSE OF THE HYPERT

  Patient problems: Death

  MAUDE report 10398707 ↗
• InjuryJul 13, 2020Adverse 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 58 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 6 WEEKS POST INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL. CT WAS PERFORMED AND A LIMB OCCLUSION WAS NOTED. IT WAS STATED THAT THE EVENT WAS TREATED WITH EMBOLECTOMY AND THE STENT GRAFT WAS EXTENDED INTO THE EXTERNAL ILIAC ARTERY. THE EVENT IS RESOLVED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS ANATOMY. IT WAS STATED THAT THE END OF THE GRAFT WAS POINTING AT THE WALL OF THE ARTERY. THE PHYSICIAN BELIEVES THAT THIS HAPPENED ONCE THE SHAPE OF THE ILIAC ARTERY WENT BACK TO NORMAL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Occlusion

  MAUDE report 10263221 ↗
• InjuryMay 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 56MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY FIFTY-SEVEN DAYS LATER WITH LEFT LOWER EXTREMITY AND HIP PAIN. A CT CONFIRMED A LEFT LIMB OCCLUSION. INTERVENTION WAS PERFORMED AND THE PATIENT WAS TAKEN TO THE OR, WHERE AN EMBOLECTOMY WAS COMPLETED AND THE LIMB WAS RELINED WITH ANOTHER LIMB LANDING IN THE EXTERNAL ILIAC ARTERY. THIS RESOLVED THE EVENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY. IT WAS REPORTED THAT THERE WAS A SHORT TORTUOUS COMMON ILIAC ARTERY. AFTER THE COMMON ILIAC ARTERY TOOK THE ORIGINAL TORTUOSITY, THE DISTAL EDGE OF THE LIMB WAS POINTED AT THE HYPOGASTRIC. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Occlusion; Pain

  MAUDE report 10085040 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT AS A PROXIMAL EXTENSION, FOR THE ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM. THE MID TO DISTAL DESCENDING THORACIC AORTA MEASURING 80MM AT ITS GREATEST DIMENSION. THE PATIENT WAS ALSO TREATED FOR A INFRARENAL AND EXTERNAL ANEURYSM MEASURING 60MM AT ITS GREATEST DIMENSION. THE CASE WAS A PHYSICIAN SPONSORED IDE. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DEVICE WAS IMPLANTED SUCCESSFULLY. HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, IT BECAME CAUGHT ON A SUPRARENAL STENT AND WAS KINKED. THIS WAS RESOLVED BY BALLOONING THE STENT GRAFT AND RELINING IT WITH ANOTHER NAVION DEVICE. THE INVESTIGATOR ASSESSED THE CAUSE OF THE EVENT WAS POSSIBLE DUE TO BE AN OPERATOR ERROR AND NOT A DEVICE MALFUNCTION. IT WAS REPORTED THAT AN ADDITIONAL VALIANT NAVION STENT GRAFT AND TWO ENDURANT II STENT GRAFT LIMBS WERE ALSO IMPLANTED DURING THE PROCEDURE. THREE ADVERSE EVENTS HAVE BEEN FURTHER REPORTED: INTRA-ABDOMINAL HEMORRHAGE WHICH IS CONFIRMED AS RESOLVED WITH SEQUELAE, ACUTE KIDNEY INJURY WHICH IS REPORTED AS ONGOING AND LEFT KIDNEY INFARCT WHICH IS ALSO ONGOING. PER THE INVESTIGATOR THE CAUSE OF THESE ADVERSE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Renal Failure

  MAUDE report 9456832 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD PRE-EXISTING DISTAL AORTIC NARROWING WITH CALCIFICATION. IT WAS REPORTED THAT THE PATIENT PRESENTED ONE WEEK POST THE INDEX PROCEDURE WITH LEG PAIN, AND AN OCCLUDED LIMB WAS IDENTIFIED ON CT SCAN. A THROMBECTOMY WITH IVUS AND PTA WAS CARRIED OUT TO RESOLVE THE OCCLUSION. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE PATIENTS NARROW CALCIFIED DISTAL AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion; Pain

  MAUDE report 9004051 ↗
• MalfunctionMar 21, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 140MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AN ENDURANT STENT GRAFT SYSTEM WAS USED TO RELINE A PREVIOUSLY IMPLANTED NON MDT STENT GRAFT TO TREAT A TYPE IIIB ENDOLEAK. TWO ENDURANT II LIMBS (ETLW1616C156E AND ETLW1613C93E) WERE IMPLANTED ON THE RIGHT SIDE. THE ETLW1613C93E WAS IMPLANTED AS AN EXTENSION INSIDE THE ETLW1616C156E. THE RELINING TREATMENT APPEARED SUCCESSFULLY AS PER THE IMAGING DURING AND POST PROCEDURE. IT WAS NOTED THAT A FOLLOW UP CT THREE DAYS POST IMPLANT SHOWED THAT THE RIGHT CONTRA LIMB (ETLW1616C156E) WAS NOT WITHIN THE GATE OF THE MAIN BODY AND THIS CAUSED THE PREVIOUS ENDOLEAK TO CONTINUE. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR TREATMENT OF A GI BLEED. IT WAS NOTED THAT THE PATIENT HAS NOT AND WILL NOT RECEIVE TREATMENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8439891 ↗
• InjuryOct 15, 2018Malposition of Device; Malposition of Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55M DIAMETER ABDOMINAL AORTIC ANEURYSM. DURING THE INDEX PROCEDURE, IT WAS REPORTED THAT BOTH OF THE STENT GRAFT LIMBS WERE IMPLANTED IN THE IPSILATERAL SIDE. THE PROCEDURE WAS THEN CONVERTED TO AN OPEN REPAIR AND THE STENT GRAFTS WERE EXPLANTED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7965213 ↗

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-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-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 aortoili
• Z-2135-2021 · Jun 7, 2021 · Open, Classified
  Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infra
• Z-1543-2017 · Feb 27, 2017 · Terminated
  Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166