Endurant® II ETLW1628C124E (UDI 00643169467453)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00643169467453), received between Feb 6, 2017 and May 19, 2025 — classified as 3 deaths, 15 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (15 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ANEURYSM ENLARGEMENT OCCURRED BELOW THE EXISTING ILIAC LIMB ETLW1628C124E, ASSOCIATED WITH DISEASE PROGRESSION OF THE ILIAC ARTERY. THE PATIENT WAS TREATED FOR A 50MM ANEURYSM. INITIALLY, IT WAS PLANNED TO EXTEND TO THE EXTERNAL ILIAC WITH THE ENDURANT STENT GRAFT. DURING THIS PROCEDURE, A 12 FRENCH NON-MEDTRONIC DILATOR FROM THEIR SHEATH COULD NOT TRACK THROUGH FEMORAL OVER 2 DIFFERENT TYPES OF GUIDEWIRES DUE TO SIGNIFICANT VESSEL TORTUOSITY. THE PHYSICIAN DECIDED TO ABORT THE INTERVENTION AND BROUGHT PATIENT BACK NEXT DAY AND USE NON-MEDTRONIC STENTS (GORE VBX)) VIA BRACHIAL ACCESS. STENTS. SUCCESSFUL TREATMENT WAS ACHIEVED USING A NON-MDT STENT GRAFT DELIVERED FROM ARM BRACHIAL ACCESS, BRIDGING OR TELESCOPING INTO THE ILIAC LIMB DOWN TO THE RIGHT EXTERNAL ILIAC ARTERY. THE RESOLUTION OF THE EVENT INVOLVED THE USE OF FOUR OVERLAPPING NON-MDT (VBX) STENTS.

  Patient problems: Aneurysm expansion

  MAUDE report 22042235 ↗
• InjuryMar 28, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A FOLLOW-UP VISIT, A TYPE IB ENDOLEAK WAS OBSERVED IN THE RIGHT ILIAC OF A PATIENT WHO HAD PREVIOUSLY RECEIVED A STENT GRAFT ETLW1628C124E ENDUR II LIMB. THE PATIENT WAS TREATED FOR TYPE 1B WITH A PROCEDURE INVOLVING COIL AND EXTENSION INTO THE COMMON ILIAC. THE HEALTHCARE PROFESSIONAL IDENTIFIED DISEASE PROGRESSION AS THE CAUSE OF THE EVENT. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 21718402 ↗
• DeathJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE . THE PATIENT HAD AN EXISTING VALIANT CAPTIVA AND ENDURANT IIS STENT GRAFT SYSTEM IMPLANTED SIX MONTHS EARLIER. IT WAS REPORTED THAT CORELAB REVIEW OF A CT TAKEN ON THE SAME DATE SHOWED A IA AND IIIA ENDOLEAKS INVOLVING THE VALIANT NAVION. THERE WAS NO FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION OBSERVED. THE MAXIMUM AORTIC DIAMETER WAS 96.8MM. IT WAS NOTED THAT THE VALIANT NAVION WAS FAILING TO SEAL WITH THE OTHER DEVICES. THE SITE COULD NOT CONFIRM WHICH DEVICE THE NAVION HAS LOST SEAL AGAINST. IT IS UNKNOWN IF THERE WERE INTERVENTIONS PERFORMED TO TREAT THE ENDOLEAKS. NO CAUSE WAS PROVIDED. IT WAS REPORTED THE PATIENT EXPIRED THE SAME YEAR. NO CAUSE OF DEATH WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED

  Patient problems: Insufficient Information

  MAUDE report 21263113 ↗
• InjuryJul 4, 2024Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 52MM AAA. THE DIAMETER AT IMPLANT OF THE AORTA AT THE RENAL ARTERY WAS 28MM AND THE LENGTH OF THE PROXIMAL AORTIC NECK WAS 25MM. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE, ANGIOGRAM IDENTIFIED A IB ENDOLEAK. INTERVENTION WAS PERFORMED WHERE THE LIMB WAS EXTENDED INTO THE EXTERNAL ILIAC WITH COILING OF THE HYPOGASTRIC ARTERY RESOLVING THE ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS ANATOMY RELATED DUE TO DEGENERATION AROUND THE LIMB. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 19675014 ↗
• InjuryJan 18, 2022Leak/Splash; Leak/Splash

  AN ENDURANT LIMB WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 90MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY. A TYPE IB WAS IDENTIFIED IN THE LEFT LIMB (ETLW1628C124E). INTERVENTION WAS COMPLETED WHERE THE PHYSICIAN EXTENDED THE LEFT LIMB TO THE LEFT EXTERNAL ILIAC USING A 16/16/156 LIMB FROM THE FLOW DIVIDER, THEN EXTENDING INTO THE LEFT EXTERNAL ILIAC WITH A 16/16/93 LIMB AND BALLOONED WITH A RELIANT. THE ENDOLEAK WAS RESOLVED AND PATIENT WAS DOING WELL AFTER THE PROCEDURE.   AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE PATIENTS ANATOMY AS A RESULT OF CONTINUED DISEASE PROGRESSION OF THE COMMON ILIAC ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13279173 ↗
• MalfunctionDec 2, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM .2 ENDURANT LIMBS WERE THEN IMPLANTED AROUND 5 YEARS LATER . IT WAS REPORTED DURING A FOLLOW UP CT ANOTHER 2 YEARS LATER, THAT THE LIMB ETLW1628C124E THAT HAD PREVIOUSLY BEEN PLACED IN THE LEFT COMMON ILIAC ARTERY HAD PULLED BACK SLIGHTLY AND WAS NOW IN THE DISTAL PORTION OF THE RIGHT COMMON ILIAC ARTERY AND IT WAS NOTED THAT THE ARTERY IS DILATING. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 12916237 ↗
• InjuryJan 21, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 83MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON THE DATE OF THE CT, IT WAS FOUND THE ILIAC LIMB ETLW1628C124E HAD LOST SEAL AND A IB ENDOLEAK HAD OCCURRED. INTERVENTION WAS PERFORMED AND AN AUI STENT GRAFT WAS IMPLANTED. THIS RESOLVED THE IB ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11207086 ↗
• InjuryNov 10, 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 62MM ABDOMINAL AORTIC ANEURYSM. BILATERAL COMMON FEMORAL ARTERY ANEURYSMS WERE NOTED (19RCFA &14LCFA).THE LEFT HYPO WAS OCCLUDED. THE RIGHT HYPO WAS NOTED AS NARROW PROXIMALLY (14MM) AND ANEURYSMAL DISTALLY. IT WAS REPORTED ONE MONTH POST THE INDEX PROCEDURE, FOLLOW UP CT DEMONSTRATED A FOCAL RIGHT ILIAC LIMB OCCLUSION CONTAINED IN ETLW1 628C124E. PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion; Occlusion

  MAUDE report 10815546 ↗
• InjuryAug 27, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 62MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON THE DATE OF A CT, JUST OVER FOUR YEARS LATER, THAT IT WAS NOTED THERE WAS ANEURYSM ENLARGEMENT WITHOUT AN APPARENT ENDOLEAK. TWELVE DAYS LATER, INTERVENTION WAS PERFORMED AND IT WAS THOUGHT THERE WAS AN ENDOLEAK POSSIBLY COMING FROM THE RIGHT ILIAC ETLW1628C124E LIMB. THE PHYSICIAN EXTENDED THIS LIMB WITH A NON MDT ILIAC LIMB. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 10458831 ↗
• MalfunctionApr 27, 2020Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT PERFORMED JUST OVER TWO YEARS LATER SHOWED A TYPE III ENDOLEAK. AS PER THE PHYSICIAN IT IS THOUGHT THAT THE LIMB ETLW1628C124E HAS SEPARATED FROM THE MAIN BODY STENT GRAFT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; No Consequences Or Impact To Patient

  MAUDE report 10001496 ↗
• InjuryMar 18, 2020Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 75MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH PAIN APPROXIMATELY THREE YEARS AND THREE MONTHS LATER AND CT SHOWED AN ENDOLEAK AND INCREASE IN ANEURYSM SIZE. AFTER RULING OUT A TYPE II ENDOLEAK THE PATIENT WAS BROUGHT TO THE OPERATING ROOM WHERE THE GRAFT WAS ASSESSED. A TYPE III ENDOLEAK WAS OBSERVED FROM THE LEFT SIDE FROM THE STENT GRAFT LIMBS (B)(4). THERE WAS NO LEAK ON THE RIGHT SIDE. AN ADDITIONAL STENT GRAFT LIMB ETLW1616C156E WAS PLACED AT THE FLOW DIVIDER AND EXTENDED TO THE FLARED PORTION OF THE 28MM LIMB ON THE LEFT SIDE. AFTER BALLOONING, A FINAL ANGIOGRAM SHOWED THAT THE ENDOLEAK HAD 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: Pain

  MAUDE report 9847370 ↗
• MalfunctionDec 11, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT CUFF AND LIMB WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN ENDOLEAK. THE PATIENT HAD AN ANUERX STENT GRAFT SYSTEM PREVIOUSLY IMPLANTED, ON AN UNKNOWN DATE APPROXIMATELY 8 YEARS EARLIER. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN UNKNOWN ENDOLEAK APPROXIMATELY 8 YEARS POST IMPLANT OF THE ANEURX STENT GRAFT SYSTEM. TWO WEEKS LATER, THE PHYSICIAN DID MULTIPLE INJECTIONS, HOWEVER WAS NOT ABLE TO REPRODUCE THE ENDOLEAK. THE PHYSICIAN STATED THAT THEY SAW A DEFECT IN THE RIGHT LIMB OF THE ANEURX STENT GRAFT. THE ETLW1628C124E ENDURANT LIMB WAS THEN IMPLANTED AS TREATMENT. THE ENDOLEAK WAS NOT RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE CONFIRMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9449483 ↗
• MalfunctionJul 29, 2019Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 70 M ABDOMINAL AORTIC ANEURYSM. A FOLLOW UP CT APPROXIMATELY TWO YEARS LATER SHOWED THE BILATERAL LIMBS PULLED UP INTO THE ANEURYSM AND A SEVERE TYPE IB ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS PATIENT ANATOMY. IT WAS REPORTED THAT THE ILIACS WERE ECTATIC AT THE TIME OF IMPLANT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8836307 ↗
• InjuryJun 5, 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 ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM SIZE AT THE LEFT ILIAC WAS NOTED AS 25MM. IT WAS REPORTED POST THE INDEX PROCEDURE THE PATIENTS BP DROPPED AND THE PATIENT COMPLAINED OF LEFT LOWER BACK PAIN. A CT DEMONSTRATED A LARGE AMOUNT OF BLOOD SURROUNDING THE LEFT EXTERNAL ILIAC ARTERY. THE PATIENT WAS BROUGHT BACK TO THE OR AND AN EMERGENCY VESSEL REPAIR WAS COMPLETED. A FINAL ANGIOGRAM OF THE LEFT EXTERNAL ILIAC WAS PERFORMED AND SHOWED NO SIGNS OF RUPTURE FROM THE ILIAC OR ENDOGRAFT. THE RETROPERITONEAL BLEED WAS DECOMPRESSED AND THE PATIENT MAINTAINED BP AND HEART RATE AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE SOURCE OF THE EVENT WAS NOT AN ILIAC OR AORTIC ANEURYSM RUPTURE. THE CAUSE OF THE BLOOD LOSS WAS FROM THE ACCESS SITE DUE TO FAILED PRECLOSURE DEVICES. IT WAS REPORTED THERE WAS NO ISSUE WITH ANY OF THE MEDTRONIC STENT GRAFTS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Blood Loss; Low Blood Pressure/ Hypotension; Pain

  MAUDE report 8669627 ↗
• InjuryDec 20, 2018Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 75MM ABDOMINAL AORTIC ANEURYSM RUPTURE. IT WAS REPORTED THERE WAS A TYPE IB ENDOLEAK NOTED FROM THE RIGHT COMMON ILIAC ARTERY AFTER BALLOONING AND FINAL ANGIOGRAM WAS CARRIED OUT. IT WAS ATTEMPTED TO COIL THE HYPOGASTRIC ARTERY TO EXTEND A LIMB DOWN INTO THE RIGHT EXTERNAL ARTERY, HOWEVER THE WIRE COULD NOT GET THROUGH THE ANATOMY AND AFTER MULTIPLE ATTEMPTS A CONVERSION TO OPEN REPAIR WAS CARRIED OUT. THE EVENT IS REPORTED TO NOT BE RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO PATIENT ANATOMY DUE TO AN ILIAC ANEURYSM THAT COMMUNICATED WITH THE ABDOMINAL ANEURYSM AND THE HYPOGASTRIC ARTERY NEEDED TO BE OCCLUDED IN ORDER TO CONTINUE TO SEAL ANEURYSM BY EXTENDING DOWN IN THE RIGHT EXTERNAL ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Injury

  MAUDE report 8183736 ↗
• InjuryDec 18, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 110 MM PREVIOUSLY RUPTURED ABDOMINAL AORTIC ANEURYSM. IT IS REPORTED THAT APPROXIMATELY 1 YEAR 10 MONTHS POST IMPLANT THE PATIENT PRESENTED EMERGENTLY. THE ANEURYSM HAD INCREASED IN SIZE TO 130MM AND TWO TYPE IIIA SEPARATION AND ONE TYPE IB ENDOLEAKS WERE NOTED. IT IS REPORTED THAT THERE WAS DISSOCIATION OF THE ETLW1616C93E FROM THE FINAL FLARED PIECES PLACED IN THE RCIA, WITH FILLING OF THE ANEURYSM SAC NOTED. THE PATIENT RECEIVED TREATMENT ON THE SAME DAY, WITH A LIMB IMPLANTED AS A BRIDGE ACROSS THE TYPE III LEAK FROM THE FLOW DIVIDER DOWN INTO THE PREVIOUSLY IMPLANTED FLARED LIMB. AN ETLW1616C156E LIMB WAS INTENDED TO BE IMPLANTED INITIALLY, HOWEVER THE DEVICE WOULD NOT TRACK THROUGH THE TORTUOUS ANATOMY AND SO A ETLW1616C93E WAS IMPLANTED SUCCESSFULLY INSTEAD. THREE 16X16 LIMBS WERE IMPLANTED IN TOTAL DUE TO THE LONG AND TORTUOUS ANATOMY. SEAL WAS OBTAINED AND THE EVENT WAS RESOLVED. A TYPE IB LEAK FROM THE ETLW1628C124E LIMB WAS ALSO FILLING THE ANEURYSM. ETLW1613C124E WAS PLACED OVER THE LIIA AND INTO THE LEIA TO OBTAIN SEAL. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENTS WERE

  Patient problems: Injury

  MAUDE report 8173184 ↗
• InjuryMay 17, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. HOWEVER IT WAS REPORTED THAT, DURING A FOLLOW UP CT PERFORMED APPROXIMATELY 1 YEAR AND 4 MONTHS POST INDEX PROCEDURE, A TYPE IB ENDO LEAK WAS OBSERVED IN THE RIGHT ILIAC LIMB. INTERVENTION WAS PERFORMED WHERE AN ENDURANT LIMB ALONG WITH ANOTHER MANUFACTURERS' DEVICE WERE IMPLANTED AND THE ENDOLEAK WAS CONFIRMED AS RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION OF THE RIGHT ILIAC. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7521434 ↗
• InjuryJan 10, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON CT PERFORMED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THAT THE PATIENT DEVELOPED A RIGHT COMMON ILIAC ANEURYSM THAT THREATENS THE PRIOR EVAR SEAL OF THE ENDURANT LIMB IN THAT COMMON ILIAC. IT WAS NOTED THAT THE ILIAC ANEURYSM HAS PROGRESSED TO THE POINT WHERE THERE IS NO WALL APPOSITION IN THE COMMON ILIAC, ONLY MURAL THROMBUS IS CURRENTLY ¿SEALING¿ THE RIGHT LIMB. THE CAUSE OF THE EVENT HAS BEEN DETERMINED AS DISEASE PROGRESSION IN THE ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7177739 ↗
• DeathNov 1, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD 3 DUPLEX ULTRASOUNDS AFTER THE INITIAL IMPLANT AT 3-MONTH INTERVALS, ALL SHOWING THE ANEURYSM STABLE AT PRE-OPERATIVE SIZE OF 55MM. HOWEVER, IT WAS REPORTED THAT DUPLEX ULTRASOUND PERFORMED APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE SHOWED AAA GROWTH TO 67MM. THE PHYSICIAN SENT THE PATIENT FOR CT WHICH SHOWED A TYPE 2 LEAK FROM THE IMA. COILING OF THE IMA WAS PERFORMED APPROXIMATELY 14 MONTHS POST IMPLANTATION AND RESOLVED THE TYPE II ENDOLEAK. A CT PERFORMED APPROXIMATELY 18 MONTHS POST INDEX PROCEDURE SHOWED THE IMA WAS SEALED WITH NO LEAKS. FURTHER ULTRASOUND PERFORMED APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE SHOWED A POSSIBLE ANEURYSM ENLARGEMENT BUT NO LEAK. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 27 MONTHS POST INDEX PROCEDURE WITH BACK PAIN. WHILE CT WAS BEING PERFORMED THE ANEURYSM RUPTURED AND THE PATIENT ARRESTED AND DIED. THE PHYSICIAN BELIEVED THE DEATH WAS POSSIBLY CAUSED BY THE ANEURYSM IN THE PATIENT'S LEFT COMMON ILIAC THAT THE FLARED LIMB WAS ON. THE PHYSICIAN BELIEVED THAT THE ANEURYSM

  Patient problems: Aneurysm; Cardiac Arrest; Death; Pain; Rupture

  MAUDE report 6992655 ↗
• DeathJun 14, 2017Leak/Splash; Device Damaged by Another Device; Leak/Splash; Device Damaged by Another Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A PRE-OPERATIVELY RUPTURED 67MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PATIENT PRESENTED INTO THE EMERGENCY ROOM WITH AN ABDOMINAL AORTIC RUPTURE. THE PATIENT WAS TAKEN TO THE OR AS THE PATIENT HAD LOW BLOOD PRESSURE. THE PHYSICIAN STARTED THE OPERATION USING AN ENDURANT AUI AND ENDURANT LIMB UP THE RIGHT SIDE WITH AN OCCLUDER ON THE LEFT. IT WAS REPORTED THAT ON THE FINAL ANGIOGRAM THE DEVICE WAS A LITTLE LOW SO AN ENDURANT CUFF WAS PLACED. THE IMAGE OF THE FINAL ANGIOGRAM BEFORE THE CUFF WAS PLACED SHOWED ADEQUATE OVERLAP BETWEEN THE AUI AND THE LIMB; HOWEVER, AFTER THE CUFF WAS PLACED, INADEQUATE OVERLAP WAS SEEN BUT UNFORTUNATELY NOT NOTICED BY THE PHYSICIAN. UPON PULLING OUT THE STIFF WIRE IT ALLOWED A COMPLETE DISUNION BETWEEN THE AUI AND THE LIMB. UNFORTUNATELY, THE TWO PIECES WERE SEPARATED IN A FASHION THAT WOULD HAVE MADE IT IMPOSSIBLE TO RECONNECT THEM WITHIN THE ANEURYSM. THE PHYSICIAN DECIDED TO OPEN THE PATIENT UP AND CONVERT TO OPEN SURGICAL REPAIR WITH A BIFURCATED OPEN SURGICAL GRAFT. THE AUI AND CUFF WERE ALL REMOVED FROM THE NECK AND AN OPEN GRAFT WAS SEWN INT

  Patient problems: Death

  MAUDE report 6640469 ↗
• InjuryMar 6, 2017Adverse 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. THE PROXIMAL AORTIC NECK WAS SEVERELY ANGULATED. IT WAS REPORTED THAT DURING THE IMPLANT OF THE ENDURANT STENT GRAFT IT WAS VERY DIFFICULT TO SEE THE ORIGIN OF THE RIGHT RENAL ARTERY WHICH WAS THE LOWEST ARTERY. DURING THE PROCEDURE MULTIPLE INJECTIONS ATTEMPTING TO VISUALIZE THE RIGHT RENAL ARTERY ORIGIN HOWEVER WERE UNABLE TO SEE THE ORIGIN BUT SAW A DOUBLE DENSITY WHICH THE PHYSICIAN THOUGHT WAS THE RIGHT RENAL ARTERY. THE ENDURANT STENT GRAFT WAS DEPLOYED WITH NO PROBLEMS. THE CONTRALATERAL GATE WAS CANNULATED AND A MARKER PIGTAIL CATHETER CONFIRMED THE RIGHT RENAL WAS FILING. THE ANGIOGRAM SHOWED THE RENAL FILLING. THE PHYSICIAN THEN USED ANOTHER MANUFACTURER¿S BALLOON TO MODEL THE ENDURANT STENT GRAFT. UPON THE FINAL ANGIOGRAM THE RIGHT RENAL WAS NOT FILLING AND DEMONSTRATED THAT THE RIGHT RENAL ARTERY WAS COVERED/OCCLUDED. THERE WERE NO ENDOLEAKS SEEN. THE LEFT ARM WAS PREPPED AND ANOTHER MANUFACTURER¿S 6 FRENCH SHEATH WAS INSERTED TO THE LEVEL OF THE RENAL ARTERIES. THE PHYSICIAN WAS ABLE TO GET THE OTHER MANUFACTURER¿S 6 FRENCH SHEATH BEHIND THE ENDU

  Patient problems: Stroke/CVA

  MAUDE report 6382109 ↗
• InjuryFeb 6, 2017Leak/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 A 64 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THERE WAS A TYPE IA ENDOLEAK ON THE LEFT PROXIMAL SIDE AND THE GRAFT WAS DOWN 15MM. IT WAS ALSO REPORTED THAT THE RIGHT LIMB DID NOT HAVE PURCHASE AND THERE WAS 35MM BEFORE THE INTERNAL ILIAC TAKE OFF. THE RIGHT LIMB WAS DETERMINED TO HAVE MIGRATED AND THE RIGHT STENT GRAFT LIMB WAS OBSERVED TO HAVE A DISTAL TYPE I ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK WAS DUE TO THE PATIENT ANATOMY OF PROXIMAL AORTIC NECK ANGULATION. PER THE PHYSICIAN, THE CAUSE OF THE DISTAL TYPE I ENDOLEAK AND MIGRATION OF THE RIGHT LIMB WAS DUE TO DILATION OF THE RIGHT COMMON ILIAC ARTERY THAT WAS ANEURYSMAL AND HAD A SHORT PURCHASE FLARE. THE PHYSICIAN ELECTED TO IMPLANT A RIGHT ILIAC STENT GRAFT THAT EXTENDED TO THE RIGHT HYPOGASTRIC ARTERY AND THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. THE PHYSICIAN THEN ELECTED TO IMPLANT AN AORTIC CUFF. HOWEVER, THE AORTIC CUFF WAS DEPLOYED TOO LOW DUE TO BEING DEPLOYED WITHOUT A PARALLAX CORRECTION. THE PHYSICIAN ELECTED TO DEPLOY AN ADDITIONAL AORTIC CUFF PROXIMALLY BUT THE SECOND AORTIC CUFF

  Patient problems: Injury

  MAUDE report 6306038 ↗

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-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-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-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