Endurant® IIs ESBF3214C103E (UDI 00643169439962)Recalls & reported problems

Summary

The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 00643169439962), received between Dec 5, 2016 and Aug 25, 2026 — classified as 19 deaths, 107 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (97 reports).

2 FDA recall records name this device's identifier, 2 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 18, 2026.

Recalls naming this device

1. Dec 21, 2021Class IIOpen, Classified

   Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.

   Z-0657-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Jun 7, 2021Class IIOpen, Classified

   During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

   Z-2136-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 173 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Material Deformation

  It was reported that during the index procedure to treat a 55 mm abdominal aortic aneurysm, an Endurant IIs stent graft delivery system kinked at the mid-shaft during implantation. The aortic diameter at the renal artery was 27 mm, the proximal aortic neck length was 35 mm, and the neck had 10 degrees of angulation. The iliac anatomy was calcific and tortuous, and force was required to deliver the system. The physician was not comfortable continuing to use the kinked delivery system. The original device was not implanted, and was replaced with a new device. The replacement device was delivered without difficulty using a non-Medtronic 20 Fr sheath. Theevent was resolved. The Endurant IIs was prepared and used in accordance with the instructions for use (IFU), and no damage was noted to the device prior to insertion into the patient. According to the physician, the cause of the event was anatomy-related due to calcific and tortuous vessels. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50426220 ↗
• MalfunctionApr 27, 2026Material Deformation

  AN ESBF3214C103E STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK DIAMETER MEASURED 28 MM. IT WAS REPORTED THAT AFTER DEPLOYMENT OF ALL STENT GRAFT COMPONENTS, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED THROUGH THE GRAFT TO CONFIRM THE ABSENCE OF OCCLUSIONS. WHILE ADVANCING THROUGH THE LEFT ILIAC LIMB AND THE TOP OF THE GATE NEAR THE FLOW DIVIDER, A KINK CONSISTENT WITH STENT GRAFT INFOLDING WAS OBSERVED. TOUCH-UP WITH A RELIANT BALLOON WAS ATTEMPTED USING SUSTAINED INFLATION; HOWEVER, FOLLOW-UP IVUS DEMONSTRATED MINIMAL CHANGE, DESPITE MULTIPLE INFLATIONS. BILATERAL 16MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOONS WERE THEN USED IN AN ATTEMPT TO CORRECT THE ISSUE. SUBSEQUENT IVUS ASSESSMENT SHOWED IMPROVEMENT, ALTHOUGH A SMALL INFOLD REMAINED. NO VISIBLE REDUCTION IN BLOOD FLOW WAS OBSERVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY-RELATED. A BEND IN THE PROXIMAL NECK WAS PRESENT AND THE INFOLDING WAS OBSERVED AT THE POINT WHERE THE ANATOMY TAPERED DOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24996869 ↗
• InjuryApr 15, 2026Device Damaged by Another Device; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDEX ENDOVASCULAR PROCEDURE TO TREAT A 45 MM ABDOMINAL AORTIC ANEURYSM, AN ENDURANT II/IIS STENT GRAFT SYSTEM (ESBF3214C103E WITH ETLW1616C93E AND ETLW1620C93E) WAS IMPLANTED SUCCESSFULLY AND ENDO-ANCHORS WERE THEN DEPLOYED. FIVE ENDO-ANCHORS WERE IMPLANTED SUCCESSFULLY; HOWEVER, DURING DEPLOYMENT OF THE SIXTH ENDO-ANCHOR, THE ANCHOR WAS REPORTED TO NOT BE ENGAGED WITH THE GRAFT FABRIC OR ARTERIAL WALL WHEN DEPLOYED. THE ENDO-ANCHOR MIGRATED ABOVE THE SUPRARENAL STENTS OF ESBF3214C103E. THE PHYSICIAN REMOVED THE ENDO-ANCHOR DELIVERY SYSTEM, INSERTED THE DILATOR OF A 16 FR SHEATH, AND ADVANCED THE 16 FR SHEATH PROXIMAL TO THE SUPRARENAL STENTS OF ESBF3214C103E OVER A STIFF 0.035-INCH GUIDEWIRE, THEN REMOVED THE DILATOR. A GOOSE-NECK STYLE SNARE WAS INSERTED TO ATTEMPT TO SNARE THE UNFIXED ENDO-ANCHOR. DURING THIS MANEUVER THE 16 FR SHEATH AND SNARE WERE PULLED DOWN INTO THE GRAFT, AFTER WHICH THE SNARE BECAME TANGLED WITH THE SUPRARENAL STENTS OF ESBF3214C103E. THE PHYSICIAN ATTEMPTED UNSUCCESSFULLY TO FREE THE SNARE AND THEN CONVERTED TO AN OPEN SURGICAL REPAIR OF THE ABDOMINAL ANEURYSM. THE ESBF3214C103E, ETLW1616C93E, ETLW1620C93E, AND SA-85 ENDO-A

  Patient problems: Insufficient Information

  MAUDE report 24881295 ↗
• DeathMar 25, 2026Malposition of Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 54MM ABDOMINAL AORTIC ANEURYSM. PRE-OP PLANNING SHOWED THE PROXIMAL RENAL DIAMETER AS 26-28MM WITH A SHORT NECK LENGTH OF 10MM. MILD PROXIMAL CALCIFICATION WAS NOTED. MODERATE BILATERAL ILIAC CALCIFICATION WAS ALSO SEEN. IT WAS REPORTED DURING THE INDEX PROCEDURE, ESBF3214C103E WAS LANDED AT THE CELIAC ARTERY BELIEVING IT WAS THE RENAL ARTERIES. IT WAS FIXED BY DOING A BILATERAL RENAL BYPASS AND A RETROGRADE STENT OF SMA AND THE PROCEDURE WAS COMPLETED. THE PATIENT STATUS POST PROCEDURE WAS REPORTED AS ALIVE WITH NO INJURY. PER THE PHYSICIAN THE CAUSE WAS DUE TO USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Metabolic Acidosis; Obstruction/Occlusion

  MAUDE report 24685750 ↗
• MalfunctionNov 27, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT WITH A 70 MM ANEURYSM WHO HAD RECEIVED A STENT GRAFT ESBF3214C103E ENDUR IIS BIF WAS FOUND TO HAVE A TYPE 1A ENDOLEAK DUE TO DISEASE PROGRESSION, AS IDENTIFIED BY CT. THE CAUSE OF THE EVENT WAS ATTRIBUTED TO THE PATIENT'S ANATOMY. THE PLAN IS TO PLACE AN EXTENSION CUFF WITH ENDOANCHORS TO ADDRESS THE ENDOLEAK AT AN UNKNOWN FUTURE DATE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23666061 ↗
• MalfunctionNov 26, 2025Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR USING THE STENT GRAFT ESBF3214C103E ENDUR IIS BIF TO TREAT AN 83MM ANEURYSM, A TYPE 1A ENDOLEAK WAS OBSERVED ON THE FINAL ANGIOGRAM. THE BIFURCATED GRAFT'S PROXIMAL EDGE WAS POSITIONED 4MM DISTAL TO THE INTENDED PROXIMAL LOCATION. MINIMAL IMPROVEMENT IN THE LEAK WAS NOTED AFTER RE-BALLOONING THE PROXIMAL GRAFT EDGE. NO FURTHER INTERVENTION WAS PERFORMED OR PLANNED AT THAT TIME, AND FOLLOW-UP IMAGING WAS SCHEDULED. THE ANATOMY, SPECIFICALLY ANGULATION, WAS IDENTIFIED AS A CONTRIBUTING FACTOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655612 ↗
• MalfunctionOct 22, 2025Material Deformation; Material Deformation

  AN ESBF3214C103E STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60.5MM AAA. IT WAS REPORTED THAT A CT SCAN TAKEN A OVER A MONTH LATER SHOWED POSSIBLE INFOLDING OF THE STENT GRAFT. THERE WAS NO EVIDENCE OF A IA ENDOLEAK OR OTHER COMPLICATIONS. THE HEALTHCARE PROFESSIONAL INDICATED THAT THE CAUSE OF THE EVENT WAS OVERSIZING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355645 ↗
• InjuryOct 20, 2025Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 90MM AAA. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY TO ER APPROXIMATELY 3 YEAR LATER WITH ABDOMINAL PAIN. A CT PERFORMED SHOWED A IA ENDOLEAK. AS INTERVENTION THE PHYSICIAN IMPLANTED AN ENDURANT II AORTIC EXTENSION AND THREE ENDOANCHORS, RESOLVING THE ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE IA ENDOLEAK WAS ANATOMY AND AORTIC NECK DILATION. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Pain

  MAUDE report 23334943 ↗
• InjuryOct 20, 2025Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 56MM AAA. IT WAS REPORTED THE PATIENT RETURNED FOR FOLLOW-UP 6 WEEKS LATER, AND A CTA PERFORMED REVEALED A TYPE IA ENDOLEAK WITH INFOLDING OF THE MAIN BODY. PER THE PHYSICIAN THE CAUSE OF THE EVENTS WAS OVERSIZING. IT WAS NOTED THE DEVICE SIZING SELECTION WAS BASED OFF PRE-IMPLANT SIZING AND NECK MORPHOLOGY (WIDE AND CONICAL). NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 23334876 ↗
• InjuryOct 16, 2025Leak/Splash; Material Deformation; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Material Deformation; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. OVER A MONTH LATER, STENT GRAFT STENOSIS WAS OBSERVED. THE SPONSOR ASSESSED THE STENOSIS AS POSSIBLY RELATED TO PROCEDURE AND RELATED TO DEVICE. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 23311059 ↗
• DeathOct 15, 2025Adverse 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 51.1MM AAA.  FIVE DAYS LATER THE PATIENT WAS REPORTED TO HAVE ABDOMINAL PAIN AND FOLLOWING A CT SCAN IT IS UNDERSTOOD THE PATIENT UNDERWENT AN EX PLORATORY LAPAROTOMY TO CHECK FOR POSSIBLE ISCHEMIC COLITIS. THE RELATIONSHIP OF THE CONDITION TO THE ENDURANT STENT GRAFTS IS UNKNOWN. IT WAS REPORTED THE PATIENT HAS ALSO BEEN SCHEDULED TO HAVE THEIR SMA STENTED. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Colitis; Ischemia; Pain

  MAUDE report 23277784 ↗
• InjuryAug 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE INVOLVING THE IMPLANTATION OF AND ENDURANT IIS STENT GRAFT SYSTEM (ESBF3214C103E, ETLW1616C146E AND ETLW1616C124E) AS PART OF A POST-MARKET STUDY. DURING THE PROCEDURE, A TYPE I ENDOLEAK WAS IDENTIFIED. TO ADDRESS THE ENDOLEAK, ENDOANCHORS WERE DEPLOYED AT THE PROXIMAL SEAL ZONE. THE SPONSOR ASSESSED THE ENDOLEAK AS RELATED TO THE DEVICE AND PROCEDURE. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 22838329 ↗
• MalfunctionJun 24, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING A REVISION OF A FAILED NON-MEDTRONIC (ENDOLOGIX AFX) STENT GRAFT FOR AN ABDOMINAL AORTIC ANEURYSM REPAIR, THE STENT GRAFT ESBF3214C103E ENDUR IIS BIF DELIVERY SYSTEM EXHIBITED SIGNIFICANT MISALIGNMENT OF THE "BLUE DOT" MARKER ON THE HANDLE WITH THE GATE ORIENTATION AS INDICATED BY THE "E" MARKER UNDER LIVE FLUOROSCOPY. AFTER GAINING BILATERAL FEMORAL ACCESS AND ADVANCING THE MAIN BODY DEVICE DELIVERY SYSTEM TO THE PLANNED LANDING ZONE IN THE INFRARENAL AORTA, THE MISALIGNMENT WAS IDENTIFIED. THE DELIVERY SYSTEM WAS REMOVED AND FURTHER EXAMINED UNDER DIRECT VISUALIZATION AND LIVE FLUOROSCOPY. TO BETTER UNDERSTAND THE APPARENT DISCREPANCY THAT EXISTED BETWEEN THE 'BLUE DOT" AND "E" MARKERS, THE DELIVERY SYSTEM WAS ROTATED UNDER FLUOROSCOPY. IT WAS DETERMINED THAT THE TWO MARKERS WERE OFF BY MORE THAN 90 DEGREES. THE DELIVERY SYSTEM WAS REMOVED UNDEPLOYED DUE TO THE RISK OF IMPROPER GATE ORIENTATION POTENTIALLY CAUSING SEVERE COMPLICATIONS. A SECOND MAIN BODY DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE AS PLANNED WITH NO COMPLICATIONS. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22317867 ↗
• InjuryApr 28, 2025Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT A COMPUTED TOMOGRAPHY REVEALED A TYPE IA ENDOLEAK DUE TO A PROXIMAL INFOLDING ASSOCIATED WITH THE STENT GRAFT E SBF3214C103E ENDUR IIS BIF. THE PATIENT WAS TREATED FOR AN 57MM ABDOMINAL AORTIC ANEURYSM. INTERVENTION WAS PERFORMED 17 DAYS LATER WHERE A NON-MEDTRONIC STENT WAS IMPLANTED AND FIXED THE INFOLDING. PER THE PHYSICIAN, THERE WAS STENT GRAFT OVERSIZING THAT COULD HAVE CAUSED THE INFOLDING. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 21916629 ↗
• DeathApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDEX PROCEDURE INVOLVING THE HELI-FX ENDOSYSTEM AND AN ENDURANTIIS, A RUPTURE WAS SUSPECTED WHEN THE NON-MEDTRONIC WIRE APPEARED TO DEFLECT OUTSIDE THE AORTIC LUMEN UPON REMOVAL OF THE HELI-FX GUIDE. PRE-OPERATIVELY THE DIAMETER OF THE AORTA AT THE RENAL ARTERY MEASURED 26MM WHILE THE LENGTH OF THE PROXIMAL AORTIC NECK WAS 9MM. MODERATE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. THE PROCEDURE INITIALLY INVOLVED THE SUCCESSFUL PLACEMENT OF A 32MM BIFURCATED DEVICE AND 16X16MM DIAMETER LIMBS, ALONG WITH SIX ENDOANCHORS DUE TO THE PATIENT'S SHORT AND CONICAL NECK ANATOMY. A SELECTIVE ANGIOGRAM WAS PERFORMED, AND NO RUPTURE LEAKS WERE IDENTIFIED AT THAT TIME. HOWEVER, APPROXIMATELY ONE HOUR LATER, THE PATIENT WAS REPORTED TO BE UNSTABLE, PROMPTING ANOTHER ANGIOGRAM WHICH REVEALED A TEAR ABOVE THE LEFT RENAL ARTERY. THE LEFT RENAL ARTERY WAS EMBOLIZED VIA BRACHIAL APPROACH AND COVERED WITH A 32X32X49MM AORTIC CUFF, WHILE THE RIGHT RENAL ARTERY WAS STENTED AND "SNORKELED" BEHIND A 36X36X49MM AORTIC CUFF, MAINTAINING BLOOD FLOW THROUGH THE STENT. THE PATIENT RECEIVED THREE UNITS OF BLOOD AND WAS TRANSFERRED TO CRITICAL CARE. MULTIPLE S

  Patient problems: Stroke/CVA

  MAUDE report 21760702 ↗
• InjuryMar 28, 2025Malposition of Device; Material Deformation; Positioning Problem; Malposition of Device; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING AN EMERGENT PROCEDURE FOR AN IMPENDING RUPTURE OF A 64 MM ABDOMINAL AORTIC ANEURYSM, AN ENDURANT IIS STENT GRAFT SYSTEM WAS USED. THE PATIENT PRESENTED WITH SEVERE ABDOMINAL AND BACK PAIN, AND A COMPUTED TOMOGRAPHY SCAN REVEALED AN IMPENDING RUPTURE OF THE ANEURYSM. THERE WAS A SIGNIFICANT SHELF OF CALCIUM AT THE OSTIUM OF THE RIGHT RENAL ARTERY, AND THE LEFT RENAL ARTERY WAS NOT FUNCTIONAL. DURING THE DEPLOYMENT OF THE BIFURCATE STENT GRAFT, THERE WAS DIFFICULTY IN GETTING THE RIGHT SIDE OF THE GRAFT TO DESCEND PROPERLY DUE TO THE CALCIFICATION, RESULTING IN PARTIAL COVERAGE OF THE RIGHT RENAL ARTERY. A 7 X 17 NON-MDT STENT WAS PLACED, AND SUBSEQUENT IMAGING SHOWED THE RIGHT RENAL ARTERY FILLED WITHOUT ISSUES. A DOUBLE BARREL APPEARANCE WAS NOTED IN THE MAIN BODY PORTION OF THE GRAFT, INDICATING INFOLDING OF THE DISTAL MAIN BODY. THE GRAFT WAS RE-BALLOONED, AND NO ENDOLEAK WAS OBSERVED. THE CAUSE OF THE INFOLDING COULD NOT BE DETERMINED PER THE PHYSICIAN. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS DISCHARGED FROM HOSPITAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21719916 ↗
• MalfunctionDec 10, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN 6 WEEKS LATER SHOWED STENT GRAFT STENOSIS AT THE LEFT LIMB AND STENT GRAFT KINKING ON THE LEFT LIMB. THERE WAS NO IMPACT TO THE PATIENT. THE SPONSOR ASSESSED THE EVENT AS RELATED TO THE DEVICE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20890777 ↗
• MalfunctionNov 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLEGED ISSUE OF AN ENDOLEAK TYPE IB AT THE LEFT LIMB FOLLOWING THE IMPLANTATION OF A STENT GRAFT. THE STENT GRAFT USED WAS THE ESBF3214C103E ENDUR IIS BIF. THE ASSESSMENT BY THE SPONSOR INDICATED A POSSIBLE RELATION TO THE DEVICE AND PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT INJURY OR IMPAIRMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20809478 ↗
• MalfunctionNov 18, 2024Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED THAT A  FOLLOW UP CT FROM AN UNKNOWN DATE IDENTIFIED A TYPE IA ENDOLEAK.  PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK IS BELIEVED TO BE DISEASE PROGRESSION.  NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20703622 ↗
• InjuryNov 5, 2024Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation; Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 63MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE CONTRALATERAL LIMB (B)(6) APPEARED TO BE CRIMPED ON THE HYPOTUBE AT THE MID-SECTION. THE DEPLOYMENT STEPS WERE FOLLOWED AS OUTLINED IN THE IFU. THERE WAS NO RESISTANCE WHEN ADVANCING THE DEVICE OVER THE GUIDEWIRE. DEPLOYMENT DIFFICULTIES WERE ENCOUNTERED, RESULTING IN THE DELIVERY SYSTEM GETTING STUCK INSIDE THE PATIENT. THE STENT GRAFT WAS FULLY DEPLOYED AND EXPANDED EXCEPT IN THE 2-3CM CONSTRAINED SECTION. THE DELIVERY SYSTEM WAS PHYSICALLY MANIPULATED/ROTATED DURING THE PROCEDURE IN AN ATTEMPT TO OPEN UP THE LIMB IN ORDER TO REMOVE THE DELIVERY SYSTEM FROM THE PATIENT. ADDITIONALLY, THE LIMB WAS DISTORTED / ¿BUNCHED¿ DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE GRAFT COVER OF THE DELIVERY SYSTEM UPWARDS IN AN ATTEMPT TO RESOLVE THE ISSUE/REMOVE THE DELIVERY SYSTEM. THERE WAS NO VISIBLE DAMAGE TO THE DELIVERY SYSTEM OR PACKAGING OF (B)(6) PRIOR TO UNBOXING. THE PHYSICIAN CONVERTED TO OPEN REPAIR AND EXPLANTED THE ENTIRE ENDURANT IIS STENT GRAFT SYSTEM. A DACRON AORTIC/BIFURCATED GRAFT WAS THEN

  Patient problems: Insufficient Information

  MAUDE report 20608456 ↗
• MalfunctionOct 29, 2024Difficult to Remove; Difficult to Remove

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 50MM AAA . IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PHYSICIAN EXPERIENCED RESISTANCE WHEN REMOVING THE ENDURANT DELIVERY SYSTEM FROM THE BODY POST DEPLOYMENT. THE PHYSICIAN HAD TO USE FORCE TO REMOVE THE DELIVERY SYSTEM FROM THE RIGHT COMMON FEMORAL ARTERY AND THE DELIVERY SYSTEM WAS SEVERELY DAMAGED FROM THE REMOVAL PROCESS. THE PATIENT APPEARED TO HAVE A MILD HEMATOMA WHICH RESOLVED UPON THE COMPLETION OF THE PROCEDURE. THE PHYSICIAN COMPLETED THE PROCEDURE AND OBTAINED HEMOSTASIS OF THE RIGHT COMMON FEMORAL ARTERY USING A NON-MEDTRONIC CLOSURE DEVICE . THE DELIVERY SYSTEM WAS INSPECTED AND APPEARED NORMAL BEFORE USE. NO DEPLOYMENT ISSUES REPORTED. PER THE PHYSICIAN, THE CAUSE OF HE REMOVAL DIFFICULTIES IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20555169 ↗
• InjuryOct 17, 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 A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY DUE TO A GRAFT INFECTION FROM AN AO RTODUODENAL FISTULA. OPEN SURGERY WAS COMPLETED WHERE THE INFECTED GRAFT WAS EXPLANTED AND REPLACED WITH A NON-MDT STENT GRAFT. PER THE PHYSICIAN THE CAUSE OF THE INFECTION WAS ANATOMY RELATED CAUSED BY AN AORTODUODENAL FISTULA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 20470988 ↗
• InjurySep 5, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60 MM AAA. IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN ALMOST NINE YEARS LATER SHOWED A IA ENDOLEAK. INTERVENTION WAS PERFORMED A NON-MDT WAS IMPLANTED AND THE SMA AND BOTH RENAL ARTERIES WERE FENESTRATED AND STENTED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 20145586 ↗
• InjuryJun 27, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON AN UNKNOWN DATE, A FOLLOW UP CT SCAN REVEALED THAT THE PATIENT HAD A TYPE IA ENDOLEAK. INTERVENTION WAS PERFORMED APPROX. 7 YEARS, 5 MONTHS POST INDEX PROCEDURE, THE PATIENT WAS TREATED WITH A FENESTRATED REPAIR. THE PHYSICIAN IMPLANTED TWO ENDURANT II ILIAC LIMB EXTENSIONS (ETEW2020C82E) TO BRIDGE FROM FLOW DIVIDER INTO THE FENESTRATED CUFF DUE TO MISMATCHED COMPONENT SIZES. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS NOT DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 19624568 ↗
• MalfunctionMay 14, 2024Leak/Splash; Activation, Positioning or Separation Problem; Device Damaged by Another Device; Leak/Splash; Activation, Positioning or Separation Problem; Device Damaged by Another Device

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 80MM AAA. IT WAS NOTED THAT PATIENT ANATOMY WAS OUTSIDE THE IFU BUT THE ANEURYSM HAD GROWN SIGNIFICANTLY AND THE PATIENT WAS NOT AN OPEN CANDIDATE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE BIFURCATE DELIVERY SYSTEM COULD NOT BE RETRACTED OUT THROUGH THE DEPLOYED STENT GRAFT DUE TO A SIGNIFICANTLY ANGULATED PROXIMAL SEAL ZONE. AS A RESULT, THE DELIVERY SYSTEM PULLED THE GRAFT INTO THE ANEURYSM SAC AND THE SEAL WAS LOST. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO THE PATIENT'S VERY ANGULATED NECK AND VERY POOR IMAGING.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309242 ↗

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-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-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