Endurant® II ETLW1620C124E (UDI 00643169467552)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00643169467552), received between Mar 24, 2017 and Feb 17, 2026 — classified as 4 deaths, 35 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (26 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Leak/Splash

  IT WAS REPORTED THAT AN (B)(6) WAS USED DURING AN INITIAL REPAIR OF A 66 MM ABDOMINAL AORTIC ANEURYSM. A TYPE IB ENDOLEAK WAS IDENTIFIED ON IMAGING ALMOST TEN YEARS POST IMPLANT. THE CAUSE WAS ATTRIBUTED TO ANATOMY AND RIGHT COMMON ILIAC DILATATION. THE (B)(6) LIMB WAS EXTENDED WITH AN (B)(6) . NON-MEDTRONIC COILS WERE ALSO USED. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED, AND THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24362373 ↗
• InjuryJul 10, 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 A 57 MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2025. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE BIFURCATE STENT GRAFT LANDED A LITTLE LOWER THEN PLANNED, THEREFORE THE PHYSICIAN OPTED TO IMPLANTED AN ENDURANT II AORTIC EXTENSION TO COVER UP TO THE LOWEST RENAL ARTERY. IT WAS NOTED THAT ANATOMY PLAYED A ROLE IN THE INACCURATE DELIVERY AS THE NECK WAS CONICAL AND ALSO THE PHYSICIAN MAY HAVE LET THE STENT GRAFT COME DOWN A LITTLE BIT DURING THE DEPLOYMENT PROCESS. SEVERAL HOURS AFTER THE PROCEDURE, THE PATIENT DEVELOPED A COLD LEG AND IT WAS NOTED THAT THE LEFT ILIAC LIMB HAD THROMBOSED. IT WAS CONFIRMED THE LEFT LIMBS WERE 16-20/124, 16-13/124, AND 16-10/124 THAT WERE OCCLUDED INTERVENTION WAS PERFORMED ONE DAY POST THE INDEX PROCEDURE. BARE METAL STENTS AND A 16-16/124 ENDURANT ILIAC LIMB WERE USED TO RE-LINE THE LIMB, AND A NON-MDT CATHETER WAS USED TO REMOVE THE CLOT. THE HEALTHCARE PROFESSIONAL INDICATED THAT THE CAUSE OF THE EVENT WAS OVER-SIZING, THE PHYSICIAN FELT THE 16- 10 LIMB MAY HAVE BEEN SLIGHTLY OVERSIZED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22466580 ↗
• InjuryFeb 13, 2025Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RUPTURED ABDOMINAL AORTIC ANEURYSM AFTER BEING TREATED WITH AN ENDURANT STENT GRAFT SYSTEM. THE PATIENT, WHO WAS INITIALLY TREATED FOR AN 85MM ANEURYSM, PRESENTED TO THE ER WITH A RUPTURED AAA APPROX. 8 YEARS, 3 MONTHS POST INDEX PROCEDURE. A COMPUTED TOMOGRAPHY SCAN REVEALED A TYPE IA ENDOLEAK, AND IT WAS NOTED THAT DISEASE PROGRESSION OF THE AORTA LED TO NECK DILATION BEYOND THE DIAMETER OF THE PROXIMAL STENT GRAFT, RESULTING IN A LOSS OF SEAL. THE PATIENT UNDERWENT AN EMERGENCY OPEN SURGICAL GRAFT REPAIR, WHICH INCLUDED THE EXPLANT OF THE ENDURANT STENT GRAFT SYSTEM, LEAVING THE PROXIMAL PORTION OF THE MAIN BODY AND SUPRARENAL FIXATION STENT IN PLACE. IT WAS STATED THE PHYSICIAN DID NOT SEE AN ENDOLEAK FROM THE ENDURANT LIMBS. A BIFURCATED SURGICAL GRAFT WAS OVERSEWN TO THE STENT GRAFT REMNANT AND THE AORTA. THE SURGERY WAS REPORTED TO HAVE GONE WELL, AND THE PATIENT WAS RECOVERING. THE EVENT WAS RESOLVED WITH THE SURGICAL INTERVENTION.

  Patient problems: Insufficient Information; Rupture

  MAUDE report 21372620 ↗
• MalfunctionSep 3, 2024Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  AN ENDURANT II STENT GRAFT ETLW1620C124E LIMB WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 40MM AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER DEPLOYMENT OF THE STENT GRAFT THE TRIGGER ON THE DELIVERY SYSTEM WOULD NOT MOVE AND WAS JAMMED. THE PHYSICIAN WAS UNABLE TO JOIN THE GREY SLIDER TO THE BLUE TRIGGER HANDLE. THE PHYSICIAN WAS ABLE TO REMOVE THE DELIVERY SYSTEM WITHOUT PATIENT INJURY DESPITE THIS. IT WAS CONFIRMED THE DEPLOYMENT ITSELF WENT FINE. PER THE PHYSICIAN THE CAUSE OF THE REMOVAL DIFFICULTY COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125061 ↗
• InjuryMay 2, 2024Leak/Splash; Leak/Splash

  TWO ENDURANT II/ IIS STENT GRAFT SYSTEM WERE IMPLANTED DURING THE TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM. AN ADDITIONAL ENDURANT LIMB (ETLW1616C156E) WAS IMPLANTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE. IT WAS REPORTED DURING A FOLLOW-UP CT IMAGING APPROXIMATELY 5YEARS POST THE INDEX PROCEDURE., A LOSS OF SEAL OF THE ENDURANT ETLW1620C124E LIMB EXTENDING PAST THE INTERNAL ILIAC WAS OBSERVED. INTERVENTION WAS PERFORMED THE NEXT DAY AND AN ENDURANT II/IIS LIMB ETLW1613C156E WAS EXTENDED PAST THE INTERNAL ILIAC ARTERY. PER THE PHYSICIAN THE CAUSE OF THE STENT GRAFTS LACK OF APPOSITION WAS DUE TO DISEASE PROGRESSION OF THE AORTA. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE

  Patient problems: Insufficient Information

  MAUDE report 19227966 ↗
• InjuryApr 12, 2024Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT (ETBF3220C166E) AND ENDURANT LIMB (ETLW1620C124E) WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 7 8MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY EXPERIENCING ABDOMINAL PAIN. A CT SCAN REVEALED THAT BOTH THE LIMBS HAD PULLED INTO THE ANEURYSM SAC CAUSING BILATERAL TYPE IB ENDOLEAKS IN ETBF3220C166E & E TLW1620C124E. INTERVENTION WAS PERFORMED AND TWO ADDITIONAL ENDURANT II STENT GRAFT LIMBS (ETLW1620C156) IMPLANTED ON THE RIGHT AND (ETLW1624C156E) PLACED ON THE LEFT WERE SUCCESSFULLY EXTENDED TO THE HYPOGASTRIC RESOLVING THE TYPE IB ENDOLEAK.  PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAKS WAS ANATOMY RELATED DUE TO THE PATIENTS SHORT COMMON ILIAC. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain

  MAUDE report 19094956 ↗
• DeathMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON THE (B)(6) 2020.   IT WAS REPORTED ON 13-FEB-2024, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. IMAGING SHOWED A SUSPECTED TYPE IIIB ENDOLEAK ORIGINATING FROM THE PREVIOUSLY PLACED BIFURCATE GRAFT. INTERVENTION WAS PERFORMED WHERE AN ENDURANT AUI AND ENDURANT EXTENSION CUFF WERE IMPLANTED WHICH RESOLVED THE ENDOLEAK. NO ENDOLEAK WAS VISUALIZED ON ANGIOGRAM AFTER PLACEMENT OF THE AUI GRAFT. IT WAS REPORTED THE PATIENT EXPIRED ON AN UNKNOWN DATE FOLLOWING THE AORTIC RUPTURE. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE III ENDOLEAK COULD NOT BE DETERMINED. IT IS BELIEVED THE ENDOLEAK CAUSED THE ANEURYSM RUPTURE. *ADDITIONAL INFORMATION RECEIVED 15TH OF APRIL 2024 AND 25TH OF APRIL 2024: NO OTHER INVASIVE PROCEDURE WAS PERFORMED FOLLOWING THE INDEX PROCEDURE. THE PATIENT EXPIRED ON THE (B)(6) 2024 (3 DAYS AFTER PRESENTING EMERGENTLY). THE CAUSE OF DEATH WAS THE ANEURYSM RUPTURE. IT WAS CONFIRMED A NON MDT (GORE) CUFF AND A NON-MEDTRONIC ( GORE) LIMB WERE IMPLANTED DURING THE INTERVENTION WITH THE ETUF3614C102E GRAFT.

  Patient problems: Insufficient Information; Rupture

  MAUDE report 18995480 ↗
• InjuryJul 17, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM AAA.  IT WAS REPORTED OVER FIVE YEARS LATER, THE PATIENT PRESENTED EMERGENTLY TO ER WITH A RUPTURED AAA. A CTA PERFORMED REVEALED A TYPE IB ENDOLEAK WAS PRESENT. THE PATIENT WENT TO OR WHERE AN ENDURANT LIMB ETLW1610C124E  WAS INSERTED PAST THE RT HYPOGASTRIC ARTERY INTO THE PROXIMAL RT EXTERNAL ILIAC ARTERY. 10 NON MDT COILS WERE ALSO IMPLANTED. THE IB ENDOLEAK RESOLVED.  PER THE PHYSICIAN THE CAUSE OF THE IB ENDOLEAK WAS ANATOMY AND DISEASE PROGRESSION.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 17331519 ↗
• InjuryJun 9, 2023Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  TWO ENDURANT II STENT GRAFT LIMBS WERE IMPLANTED AS PART OF THE ENDOVASCULAR TREATMENT OF A 86MM AAA. IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN SHOWED THAT THE BILATERAL LIMBS WERE NO LONGER OPPOSED WERE ARE IN THE DISTAL AORTA. IB ENDOLEAKS WERE IDENTIFIED. INTERVENTION WAS PERFORMED AND BOTH LIMBS WERE EXTENDED PROXIMALLY TO THE INTERNAL ILIAC ARTERIES. PER THE PHYSICIAN THE CAUSE OF THE IB ENDOLEAKS AND MIGRATION ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17097951 ↗
• InjuryApr 14, 2023Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. NEARLY FOUR AND A HALF YEARS LATER ON A CTA, A TYPE IB ENDOLEAK WAS SEEN COMING FROM ONE OF THE ILIAC LIMBS V07454577 OR V07481055. IT IS UNKNOWN WHICH STENT GRAFT HAS THE IB AS BOTH STENT GRAFTS ARE THE SAME SIZE. 15 DAYS LATER AN ENDURANT II LIMB ETLW1613C146E WAS INTENDED TO BE IMPLANTED AS PART OF THE ENDOVASCULAR TREATMENT OF THE IB ENDOLEAK. THE AAA MEASURED 55MM. IT WAS REPORTED THAT DURING THE PROCEDURE, THE RIGHT INTERNAL ILIAC ARTERY WAS COILED FIRST BEFORE ATTEMPTING TO DELIVER THE LIMB  . AFTER THREE ATTEMPTS TO DELIVER THE STENT GRAFT IT WAS DISCOVERED THAT THE TAPERED TIP WAS NOT FLUSH WITH THE REST OF THE DELIVERY SYSTEM AND WAS GETTING HUNG UP ON THE TIGHT ACCESS SITE. IT WAS CONFIRMED THERE WAS A GAP BETWEEN THE TAPERED TIP AND RADIOPAQUE RING THUS CAUSING THE DELIVERY SYSTEM TO NOT BE SMOOTH AND THE GAP WAS CATCHING ON THE ANATOMY NOT ALLOWING IT TO ADVANCE THROUGH THE VASCULATURE. THE DEVICE WAS NOT INSPECTED UNTIL AFTER THE THIRD ATTEMPT TO DELIVER THE LIMB AND THAT IS WHEN IT WAS DISCOVERED IT WAS NOT A SMOOTH TRANSITION BETWEEN THE TAPERED TIP AND RADIOPAQUE RING. THE USE O

  Patient problems: Insufficient Information

  MAUDE report 16742783 ↗
• DeathJul 26, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II BIFURCATE STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT  OF A AAA. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE WITH A ANEURYSM RUPTURE. THE CT SCAN SHOWED BOTH ILIAC LIMBS WERE IN THE ANEURYSM SAC, BOTH LIMBS LACKED SEAL AND APPOSITION TO THE COMMON ILIAC ARTERIES.  DURING TRANSFER TO THE HOSPITAL , THE PATIENT CODED AND CONTINUED TO WHILE IN THE EMERGENCY DEPARTMENT. DESPITE RESUSCITATION  ATTEMPTS THE PATIENT EXPIRED.  PER THE PHYSICIAN THE CAUSE OF THE IB ENDOLEAK WAS DISEASE PROGRESSION OF THE COMMON ILIAC ARTERIES. THE CAUSE OF DEATH WAS THE RUPTURED ANEURYSM.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Rupture

  MAUDE report 15103290 ↗
• MalfunctionJul 14, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT AND AN ENDURANT STENT GRAFT SYSTEM(BIFURCATE AND TWO ENDURANT LIMBS) WERE IMPLANTED FOR THE TREATMENT OF A FUSIFORM ANEURYSM OF AN UNKNOWN SIZE ON THE (B)(6) 2019.  IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT ON THE (B)(6) 2020 AND A TYPE IA ENDOLEAK AND AORTIC ENLARGEMENT WERE IDENTI FIED. THE PATIENT EXPIRED ON THE (B)(6) 2020.  COREL AB IMAGING REVIEW OF CT'S FROM (B)(6) 2020 REVEALED A NON-NAVION GRAFT TYPE IB ENDOLEAK FROM ILIAC SEAL. THE VALIANT NAVION WAS NOT EVALUATED FOR FRACTURE AND STENT RING DISPLACEMENT DUE TO SCAN QUALITY. NO CAUSE OF THE TYPE IA AND TYPE IB ENDOLEAK AS PER THE PHYSICIAN WAS PROVIDED.  AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS NOT AORTIC-RELATED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15013147 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 52MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY 8 DAYS POST-INDEX PROCEDURE AND A CTA PERFORMED SHOWED THE RIGHT LIMB WAS OCCLUDED. THE PATIENT UNDERWENT OPEN THROMBECTOMY WITH REALIGNMENT OF THE LIMB EXTENDED INTO THE EXTERNAL ILIAC AND THE NEW LIMB WAS REINFORCED AT THE TAKEOFF OFF THE EXTERNAL ILIAC WITH A 7MM BALLOON EXPANDABLE STENT. THE FINAL ANGIO SHOWED THAT THE OCCLUSION HAD BEEN RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION WAS DUE TO THE PATIENTS ANATOMY AS A RESULT OF A TORTUOUS ILIAC. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14987156 ↗
• MalfunctionApr 11, 2022Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem

  AN UNKNOWN CV-SR DEVICE WAS INTENDED TO BE USED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE ON AN UNKNOWN DATE.  IT WAS REPORTED DURING THE INDEX PROCEDURE WHEN THE DELIVERY SYSTEM WAS REMOVED SOME DEBRIS WAS NOTED ON THE DELIVERY SYSTEM.  NO CAUSE OF THE EVENT WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENTS STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14070870 ↗
• InjuryMar 23, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE ETLW1624C124E WAS IMPLANTED ON THE LEFT SIDE WHILE THE ETLW1620C124E WAS IMPLANTED ON THE RIGHT SIDE. A RELIANT BALLOON AND SENTRANT SHEATHS WERE ALSO USED DURING THE PROCEDURE. IT WAS REPORTED POST IMPLANTATION , AN OCCLUSION OF THE LEFT LIMB WAS NOTED. IT WAS REPORTED THE PATIENT WAS SUFFERING FROM CHEST PAINS ONE WEEK AFTER THE AAA REPAIR AND A TYPE I ENDOLEAK WAS OBSERVED. THE SITE ASSESSED THE ENDOLEAK AS POSSIBLY RELATED TO THE STENT GRAFT AND PROBABLY RELATED TO THE STUDY PROCEDURE. THE SPONSOR ASSESSED IT AS PROBABLY RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE STENT GRAFTS. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 13858155 ↗
• MalfunctionMar 2, 2022Defective Component; Defective Component

  AN ENDURANT II LIMB WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WHICH WAS 42MM .  IT WAS REPORTED DURING THE INDEX PROCEDURE THE PHYSICIAN NOTED A GAP BETWEEN THE GRAFT COVER AND TAPER TIP. THE STENT GRAFT WAS IMPLANTED AND THERE WAS NO INJURY TO THE PATIENT. AS PER THE PHYSICIAN THE CAUSE OF THE DIMENSIONAL DEVIATION WAS DUE TO PRODUCT MAKE UP.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13651265 ↗
• InjuryFeb 17, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 13 MONTHS POST THE INDEX PROCEDURE THE PATIENT WAS EXPERIENCING LEG SYMPTOMS. NO ENDOLEAK WAS IDENTIFIED ON CT SCAN, BUT THERE WAS A SUSPECTED INTERMITTENT TYPE IB ENDOLEAK WITH AN INCREASE IN ANEURYSM SIZE ALSO NOTED.  INTERVENTION WAS PERFORMED WHERE THE PHYSICIAN EXTENDED BILATERALLY. BOTH THE HYPOGASTRIC ARTERIES WERE PATENT AND NO ENDOLEAK SEEN AT END OF PROCEDURE. THE CAUSE OF THE EVENT WAS NOT SPECIFIED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 13548914 ↗
• MalfunctionDec 8, 2021Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED FOR THE TREATMENT OF A SUSPECTED TYPE III ENDOLEAK IN A PREVIOULSY 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 BALLONNING THE RELAINT 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 SUSPTECTED 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12959359 ↗
• InjuryNov 16, 2021Leak/Splash; Migration or Expulsion of Device; Leak/Splash; 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 . IT WAS REPORTED DURING APPROXIMATELY 5 YEARS LATER THAT THE RIGHT LIMB HAD PULLED OUT OF THE COMMON ILIAC ARTERY AND THE LEFT LIMB HAD ROUGHLY 1CM OF SEAL. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

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

  MAUDE report 12819136 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM AAA. IT WAS REPORTED APPROXIMATELY ONE MONTH POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH RIGHT LEG PAIN. CT SHOWED THE RIGHT LIMB WAS OCCLUDED. INTERVENTION WAS PERFORMED WHERE THE PHYSICIAN WAS ABLE TO CROSS THE LIMB AND USE A NON MDT DEVICE TO SUCK THE CLOT OUT AND CLEAN THE LIMB OUT. THE STENT GRAFT WAS THEN BALLOONED AND ANOTHER STENT WAS IMPLANTED IN THE EIA TO FIX THE BLOOD FLOW. THE PATIENT IS CURRENTLY RECOVERING IN THE HOSPITAL WITH A RESIDUAL DISTAL CLOT AND IS EXPECTED TO MAKE A FULL RECOVERY. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY AND DUE TO THE PATIENT STOPPING THEIR MEDICATION AND STILL SMOKING WHICH LEAD TO THE LIMB THROMBOSIS. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion; Pain; Thrombosis/Thrombus

  MAUDE report 12370074 ↗
• InjuryJul 21, 2021Malposition of Device; Malposition of Device

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 64MM X 54MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE RIGHT ETLW1620C124E LIMB WAS PLACED SHORT OF ANTICIPATED LANDING ZONE AND REQUIRED A LIMB EXTENSION BEING PLACED. THE LEFT EXTERNAL ILIAC ARTERY WAS DISSECTED DURING ACCESS AND A ETEW2020C82E STENT WAS IMPLANTED TO TREAT THE DISSECTION. TWO DAYS LATER, THE PATIENT PRESENTED EMERGENTLY WITH COLD PULSELESS LEGS. A CTA WAS PERFORMED WHICH SHOWED THE RIGHT ILIAC ETLW1620C146E DEVICE WAS KINKED AND THROMBOSED, THE LEFT EXTERNAL ILIAC WAS THROMBOSED ALSO. INTERVENTION WAS PERFORMED, THE PHYSICIAN PERFORMED BILATERAL FEMORAL CUTDOWNS AND BILATERAL EMBOLECTOMIES. A NON MDT STENT WAS PLACED IN THE KINKED RIGHT LIMB AND THEN BOTH LIMBS WERE BALLOONED AT THE SAME TIME TO 16MMS. IT WAS REPORTED, THE CAUSE OF THE DISSECTION TO THE LEFT EXTERNAL ILIAC WAS CAUSED DURING ACCESS WHICH THE PHYSICIAN FELT WAS A CAUSE OF INADEQUATE VISUALIZATION WITH FLUORO UNIT AND PT SIZE. IT WAS ALSO REPORTED, THE 20 PORTION OF THE LEFT LIMB WAS NEXT TO THE 16 PORTION OF THE RIGHT LIMB AND ONCE THE DISSECTED LEFT EXTERNAL ILIAC SHUT

  Patient problems: Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 12201687 ↗
• InjuryMay 27, 2021Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN MAY HAVE PARTIALLY COVERED THE LEFT HYPOGASTRIC ARTERY WITH THE ETLW1620C124E ENDURANT LIMB. A FINAL ANGIOGRAM SHOWED NO FLOW IN THE LEFT HYPOGASTRIC ARTERY, HOWEVER THE PHYSICIAN STATED THERE WAS GOOD CROSS FLOW NOTED FROM THE RIGHT HYPOGASTRIC ARTERY. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY. THE ILIAC ARTERY WAS NOTED TO BE SEVERELY TORTUOUS AND CONTAINED THROMBUS. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11892562 ↗
• InjuryMay 24, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 47MM DIAMETER AAA. DURING THE INDEX PROCEDURE, AFTER THE STENT GRAFT WAS PLACED, ANGIO SHOWED TYPE IIIB ENDOLEAK -CONTRAST WAS EXTRAVASATING OUTSIDE THE GRAFT IN THE PROXIMAL PORTION OF THE RIGHT COMMON ARTERY. A 1620124 LIMB WAS ADDITIONAL IMPLANTED TO RE ALIGN THE ORIGINAL LIMB THAT WAS IMPLANTED TO RESOLVE THE ENDOLEAK. IT WAS REPORTED THE EVENT WAS CAUSED BY EXCESSIVE BALLOONING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11869489 ↗
• InjuryMay 18, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS ATTEMPTED IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TYPE 1B ENDOLEAK FROM PRIOR EVAR DONE 5 YEARS BEFORE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER INSERTING THE ENDURANT LIMB THROUGH TORTUOUS ILIACS ARTERIES, THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE THE GRAFT BUT THE GRAFT COVER WASN'T COMING DOWN WHILE DEPLOYING. THE DEVICE WAS THEN REMOVED FROM THE PATIENT, WHERE IT WAS NOTED THAT THE STENT RING WAS PROTRUDING THROUGH OF THE GRAFT COVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER STENT GRAFT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11840434 ↗
• InjuryFeb 24, 2021Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PRE-RUPTURED 65MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 38 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH A TYPE 3 ENDOLEAK ON THE ETLW1624C156E LIMB AND A TYPE 1B ENDOLEAK ON THE ETLW1620C124E. ETLW1624C124E WAS IMPLANTED TO TREAT THE EVENT AND EMBOLIZED THE INTERNAL ILIAC ARTERY AND BUILT DOWN TO THE EXTERNAL WITH A ETLW1610C156E LIMB. ENDOLEAKS WERE RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS A TYPE 3 HOLE IN THE LIMB. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11372691 ↗

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-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