ENDURANTRecalls & reported problems across all models

We found 46 models of ENDURANT by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 169 adverse event reports in the FDA's MAUDE database, received between Jan 30, 2017 and May 1, 2026 — classified as 11 deaths, 136 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (135 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ENDURANT problems

ENDURANT models

46 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ENDURANT® ENBF3216C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  15 reports
• ENDURANT® ENBF2816C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  13 reports
• ENDURANT® ENBF3616C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death11 reports
• ENDURANT® ENBF3216C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  11 reports
• ENDURANT® ENBF3616C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death7 reports
• ENDURANT® ENBF2816C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death7 reports
• ENDURANT® ENLW1620C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  6 reports
• ENDURANT® ENBF2516C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death6 reports
• ENDURANT® ENLW1624C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• ENDURANT® ENLW1624C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• ENDURANT® ENLW1620C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• ENDURANT® ENLW1613C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• ENDURANT® ENBF2516C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• ENDURANT® ENBF2513C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death5 reports
• ENDURANT® ENBF2313C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• ENDURANT® ENBF3620C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• ENDURANT® ENLW1616C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 reports
• ENDURANT® ENEW2020C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 reports
• ENDURANT® ENCF3232C49E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death3 reports
• ENDURANT® ENBF2316C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• ENDURANT® ENBF2820C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• ENDURANT® ENLW1616C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• ENDURANT® ENLW1616C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• ENDURANT® ENLW1613C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death2 reports
• ENDURANT® ENEW2424C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• ENDURANT® ENLW1628C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• ENDURANT® ENBF2813C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death2 reports
• ENDURANT® ENBF2813C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death2 reports
• ENDURANT® ENBF3620C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• ENDURANT® ENBF3220C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• ENDURANT® ENBF3216C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• ENDURANT® ENBF2820C166E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• ENDURANT® ENLW1628C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• ENDURANT® ENLW1628C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• ENDURANT® ENLW1620C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• ENDURANT® ENLW1613C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• ENDURANT® ENLW1610C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death1 report
• ENDURANT® ENLW1610C93E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• ENDURANT® ENTF3636C70E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death1 report
• ENDURANT® ENCF2525C49E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• ENDURANT® ENEW2828C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• ENDURANT® ENEW1313C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• ENDURANT® ENEW1010C82E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• ENDURANT® ENBF2516C124E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• ENDURANT® ENBF2513C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• ENDURANT® ENBF3220C145E

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report

Recent ENDURANT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT A PATIENT REPRESENTATIVE CONTACTED TECHNICAL SERVICES APPROXIMATELY 14 YEARS LATER AND STATED THAT THE PATIENT EXPERIENCED AN ENDOLEAK THAT WAS REPAIRED 4 MONTHS PREVIOUSLY WITH AN ENDURANT CUFF. SUBSEQUENT INFORMATION RECEIVED CONFIRMED THAT THE ENDOLEAK WAS A TYPE IA INVOLVING THE ENDURANT BIFURCATED GRAFT. THE ENDOLEAK DID NOT RESOLVE FOLLOWING CUFF IMPLANTATION; THEREFORE, SIX ENDOANCHORS WERE PLACED, RESULTING IN A REDUCTION OF THE ENDOLEAK. THE PHYSICIAN LATER CONFIRMED THAT THE ENDOLEAK WAS FULLY RESOLVED ON FOLLOW-UP IMAGING. LACK OF WALL APPOSITION WAS NOTED IN THE LEFT LIMB; HOWEVER, NO TYPE IB ENDOLEAK WAS IDENTIFIED. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE TYPE IA ENDOLEAK WAS PROGRESSIVE DILATION OF THE AORTA SINCE THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS DOING WELL.

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

  MAUDE report 25054506 ↗
• MalfunctionMar 30, 2026Fracture; Leak/Splash; Migration or Expulsion of Device; Detachment of Device or Device Component

  AN ENBF3216C166E STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS NOTED THAT THE PATIENT IS NOW BEING FOLLOWED UP BY A PHYSICIAN WHO WAS NOT THE INITIAL IMPLANTER. IT WAS REPORTED APPROXIMATELY 15 YEARS POST THE INDEX PROCEDURE, FOLLOW-UP CT SHOWED A IA ENDOLEAK WITH ANEURYSM SAC EXPANSION. REVIEW OF THE CT AGAIN 2 DAYS LATER DETERMINED THAT THE SUPRARENAL STENT HAD BECOME DETACHED FROM THE MAIN BODY AND THE MAIN BODY HAD MIGRATED AWAY FROM THE RENAL ARTERIES WITH A IA ENDOLEAK PRESENT. THE PHYSICIAN PLANS TO DISCUSS FURTHER TREATMENT OPTIONS. PER THE PHYSICIAN THE CAUSE OF THE DETACHED STENT AND TYPE IA ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm expansion

  MAUDE report 24711190 ↗
• InjuryDec 22, 2025Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60MM AAA. THE DIAMETER OF THE AORTA AT THE RENAL ARTERY WAS 28MM. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL APPROXIMATELY 14 YEARS AND 9 MONTHS LATER WITH PAIN AND ENDOLEAKS WERE IDENTIFIED. A TYPE IA ENDOLEAK WAS ASSOCIATED WITH THE ENBF2513C145E AND A TYPE IB WAS ASSOCIATED WITH THE ENLW1613C124E LIMB. INTERVENTION WAS PERFORMED ON THE SAME DATE AND AN ENDURANT CUFF AND ENDURANT II LIMB STENT GRAFT WERE IMPLANTED TO REPAIR THE ENDOLEAKS. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ATTRIBUTED TO DISEASE PROGRESSION OVER A 14 YEAR PERIOD. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 23861839 ↗
• InjuryDec 22, 2025Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60MM AAA ON . THE DIAMETER OF THE AORTA AT THE RENAL ARTERY WAS 28MM.IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL APPROXIMATELY 14 YEARS AND 9 MONTHS LATER WITH PAIN AND ENDOLEAKS WERE IDENTIFIED. A TYPE IA ENDOLEAK WAS ASSOCIATED WITH THE ENBF2513C145E AND A TYPE IB WAS ASSOCIATED WITH THE ENLW1613C124E LIMB. INTERVENTION WAS PERFORMED ON THE SAME DATE AND AN ENDURANT CUFF AND ENDURANT II LIMB STENT GRAFT WERE IMPLANTED TO REPAIR THE ENDOLEAKS. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ATTRIBUTED TO DISEASE PROGRESSION OVER A 14 YEAR PERIOD. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 23861835 ↗
• InjuryJan 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A TYPE IB OCCURRED IN AN ENDURANT II LIMB WHICH WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60MM ANEURYSM. ANOTHER ENDURANT LIMB WAS PLACED DURING THE PROCEDURE AS INTERVENTION. THE CAUSE OF THE EVENT WAS ATTRIBUTED TO DISEASE PROGRESSION AND VESSEL TORTUOSITY. THE EVENT WAS DISCOVERED WHEN THE PATIENT PRESENTED EMERGENTLY. THE ISSUE WAS RESOLVED, AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: Insufficient Information

  MAUDE report 21065749 ↗
• InjuryDec 10, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT WAS TREATED FOR AN ANEURYSM USING A ENDURANT STENT GRAFT SYSTEM. APPROX. 13 YEARS, 4 MONTHS POST INDEX PROCEDURE A COMPUTED TOMOGRAPHY CONDUCTED WITHOUT CONTRAST DUE TO THE PATIENT'S POOR KIDNEY FUNCTION, REVEALED A TYPE IB ENDOLEAK. THE PHYSICIAN'S FINDINGS WERE BASED ON WHAT APPEARED TO BE NON-OPPOSED LIMBS OBSERVED IN THE IMAGING. THE HEALTHCARE PROFESSIONAL IDENTIFIED ANATOMY AND DISEASE PROGRESSION AS THE CAUSE OF THE EVENT. IT WAS CONFIRMED THAT THERE WERE NO ALLEGATIONS OR ISSUES RELATED TO THE TWO ENDURANT CUFFS IMPLANTED DURING THE INITIAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20890670 ↗
• InjuryNov 6, 2024Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED A FOLLOW UP CT SCAN CONDUCTED APPTOX. 13 YEARS, 6 MONTHS POST INDEX PROCEDURE, REVEALED A SUSPECTED ENDOLEAK BUT IT WAS NOT CONFIRMED. THE PHYSICIAN SCHEDULED AN EXPLORATORY ANGIOGRAM 18 DAYS LATER WHICH IDENTIFIED A SUSPECTED TYPE IB ENDOLEAK ON THE LEFT ILIAC ENDURANT LIMB. INTERVENTION WAS PERFORMED ON THE SAME DAY AND A ENDURANT (ETLW1620C93E) LIMB EXTENSION WAS IMPLANTED TO ADDRESS THE ENDOLEAK FIX THE LEAK, EFFECTIVELY RESOLVING IT. PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK WAS ANATOMY RELATED DUE THE LEFT ILIAC ENLARGING OVER TIME EXCEEDING THE ORIGINAL STENT DIAMETER SINCE THE INITIAL IMPLANTATION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 20619647 ↗
• InjuryMay 3, 2024Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM AND AN ANEURX LIMB WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 14 YEARS POST THE INDEX PROCEDURE, THAT THE PATIENT PRESENTED EMERGENTLY EXPERIENCING ABDOMINAL PAIN. A CT SCAN REVEALED A TYPE IA ENDOLEAK WITH A 96MM ABDOMINAL AORTIC ANEURYSM. INTERVENTION WAS PERFORMED, AND AN ENDURANT II/IIS CUFF (ETCF3636C49E) WAS PLACED IN THE RIGHT RENAL ARTERY. THE LEFT RENAL ARTERY WAS COVERED, AND THE RIGHT RENAL WAS STENTED. A FINAL ANGIOGRAM WAS CONDUCTED, AND THE TYPE IA ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS ANATOMY RELATED DUE TO THE PATIENTS AORTIC NECK DILATATION COMPROMISING THE SEAL OF THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain

  MAUDE report 19243522 ↗
• MalfunctionFeb 9, 2024Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM AND ANEURX ILIAC LIMB WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS REPORTED APPROXIMATELY 13 YEARS POST THE INDEX PROCEDURE, THE PATIENT RANG TECHNICAL SERVICES AND SAID THAT ONE OF THE STENT GRAFTS WAS LEAKING. THE PATIENT IS UNSURE WHICH GRAFT BUT KNOWS THAT IT WAS IMPLANTED IN 2011. THE PATIENT STATED THAT THE ANEURYSM HAS GROWN FROM 50MM TO 80MM ON A RECENT CT. THE PATIENT DID NOT REPORT ANY SYMPTOMS. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 18675634 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 106MM AAA. IT WAS REPORTED THAT A CT WAS TAKEN APPROXIMATELY 13 YEARS POST THE INDEX PROCEDURE SHOWED A TYPE IA ENDOLEAK. IT WAS NOTED THAT THE PATIENT HAD A NON-MDT CUFF AND LIMBS PRESENT WITHIN THE ENDURANT GRAFT WHICH WERE IMPLANTED ON AN UNKNOWN DATE. THE ENDURANT STENT GRAFTS AND NON-MDT STENT GRAFTS WERE EXPLANTED. THE PATIENTS CONDITION IS POST THE EXPLANT PROCEDURE WAS NOTED AS ALIVE AND WELL. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS ANATOMY RELATED AND DUE TO AORTIC NECK DEGENERATION. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 18650670 ↗
• InjuryFeb 6, 2024Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 106MM AAA. IT WAS REPORTED THAT A CT WAS TAKEN APPROXIMATELY 13 YEARS POST THE INDEX PROCEDURE SHOWED A TYPE IA ENDOLEAK. IT WAS NOTED THAT THE PATIENT HAD A NON-MDT CUFF AND LIMBS PRESENT WITHIN THE ENDURANT GRAFT WHICH WERE IMPLANTED ON AN UNKNOWN DATE. THE ENDURANT STENT GRAFTS AND NON-MDT STENT GRAFTS WERE EXPLANTED. THE PATIENTS CONDITION IS POST THE EXPLANT PROCEDURE WAS NOTED AS ALIVE AND WELL. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS ANATOMY RELATED AND DUE TO AORTIC NECK DEGENERATION. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 18650650 ↗
• InjuryJan 12, 2024Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED AAA. IT WAS REPORTED THE PATIENT PRESENTED TO ER, A CT WAS PERFORMED WHICH SHOWED BLOOD IN THE ABDOMEN DIAGNOSED AS A ANEURYSM RUPTURE AND ALSO AN ENDOLEAK. THE ENDOLEAK WAS THOUGHT TO BE TYPE II OR TYPE III ENDOLEAK. THE PATIENT WAS TRANSFERRED TO A SURGICAL HYBRID THEATRE TO PERFORMED A ANGIOGRAM. AFTER SEVERAL IMAGES AND VIEWPOINTS WERE COMPLETED, IT WAS THOUGHT THAT A POSSIBLE AREA OF CONTRAST WAS SEEN OUTSIDE THE STENT AND WITHIN THE ABDOMINAL SAC. THE AREA OF THE GRAFT WAS THE IPSILATERAL SIDE (RCIA) OF THE MAIN BODY BIFURCATE. THIS AREA WAS THEN RELINED WITH A 16X16X82 STENT GRAFT. FOLLOW-UP IMAGING WAS PERFORMED AND CONTRAST WAS NO LONGER FEEDING INTO THE SAC. OTHER IMAGING COULD NOT FIND ANY OTHER LEAKS. PER THE PHYSICIAN THE CAUSE OF THE SUSPECTED TYPE III ENDOLEAK COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL "SEQUELAE" WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 18501114 ↗
• MalfunctionDec 6, 2023Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55 X 57MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 12 YEARS POST THE PROCEDURE, FOLLOW UP CT SCAN REVEALED A POSSIBLE TYPE III ENDOLEAK LOCATED IN THE DISTAL AORTA, HOWEVER IT IS UNCLEAR WHICH ILIAC LIMB CONTAINED THE AFFECTED. IT WAS NOTED THE PATIENT IS ASYMPTOMATIC. PER THE PHYSICIAN THE CAUSE OF THE SUSPECTED TYPE III ENDOLEAK IS DUE TO A HOLE WORN IN THE GRAFT. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18272701 ↗
• InjuryApr 11, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE, ENDURANT AORTIC EXTENSION AND LIMBS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 65MM AAA. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW-UP AT 10 YEARS POST-IMPLANT WHERE A TYPE III ENDOLEAK WAS NOTED IN THE LEFT ILIAC ARTERY AT THE OVERLAP OF AN ENDURANT LIMB ETLW1624C93E AND THE ENEW2828C82E  CUFF. INTERVENTION WAS CARRIED OUT 3 DAYS LATER WHERE AN ILIAC EXTENSION LIMB ( SNV31076806) WAS PLACED TO CORRECT THE TYPE IIIA ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY AND ALSO OFF LABEL USE OF THE ENDURANT CUFF IN THE ILIAC ARTERY.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16711464 ↗
• MalfunctionFeb 22, 2023Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA .  A CTA WAS PERFORMED , WHICH IDENTIFIED A PROXIMAL TYPE IA ENDOLEAK AND BILATERAL TYPE IB ENDOLEAKS.  PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS  IS DISEASE PROGRESSION.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416417 ↗

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