Endurant® II ETCF3636C49ERecalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00613994991461), received between Dec 12, 2016 and Jul 27, 2026 — classified as 15 deaths, 47 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (53 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  An Endurant IIs stent graft system and Endurant cuff ETCF3636C49E were implanted during the endovascular treatment of a 37mm X 42mm abdominal aortic aneurysm with PAU. Left Hypogastric embolization due to Lt Common Iliac aneurysm was also performed. It was reported during the index procedure, the main body was landed low due to conical neck and ETCF3636C49E, was used to cuff up to the renal with no difficulty and the procedure completed. It was reported on the one month follow up it was identified that the left renal had been covered but still with flow into it. Review of CTA showed that it appeared the ostium of the left renal was occluded but had flow distal to the occlusion. Intervention was completed (b)(6) 2026) with the implant of a renal stent. Post the intervention the physician reported that the during the intervention procedure technically everything went fine putting stent in the left renal, but later the patient had some hypotension and some other renal issues. The patient is currently being monitored in ICU. Per the physician the cause was anatomy related due to conical Infrarenal neck. No additional clinical sequelae were reported and the patient is fine.

  Patient problems: Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Unspecified Kidney or Urinary Problem

  MAUDE report 50032301 ↗
• MalfunctionMay 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 EARLIER 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25054510 ↗
• MalfunctionNov 7, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR FOR A 67 MM ABDOMINAL AORTIC ANEURYSM, USING THE STENT GRAFT ETCF3636C49E ENDUR II AOEXT, AFTER DEPLOYMENT,  A NON MEDTRONIC GUIDE WIRE WAS PULLED BACK UNINTENTIONALLY AND UNNOTICED BY THE PHYSICIAN AND BUCKLED AT THE TIP OF THE DELIVERY SYSTEM. THE PHYSICIAN DIDNT FEEL COMFORTABLE TRYING TO ADVANCE SUCH A STIFF WIRE BACK INTO THE AORTA IN THAT POSITION AND DECIDED TO REMOVE THIS WIRE AND REPLACE IT WITH A LESS STILL WIRE.  THE WIRE WOULDN'T ADVANCE THROUGH THE DISTAL TIP OF THE DELIVERY SYSTEM. IT WAS FELT LIKE IT WAS HITTING UP AGAINST SOMETHING BENDING THE WIRE UP. THE PHYSICIAN TRIED MULTIPLE DIFFERENT STIFFNESS OF WIRES AND THE SAME ISSUE OCCURRED. THE PHYSICIAN TRIED TO USE A WIRE CHEATER BUT NOTHING WOULD HELP THE WIRE PASS THROUGH THE PORT. THE TIP OF ANY WIRES WOULDN¿T PASS AT ABOUT 1 INCH INTO THE BACK END OF THE DELIVERY SYSTEM AND EVERY WIRE WOULD COME OUT CURLED UP AND DAMAGED. EVENTUALLY THE PHYSICIAN TRIED THE BACK END OF A NON MEDTRONIC WIRE AND IT WENT THROUGH BUT THE PHYSICIAN DIDN'T WANT THAT TO BE IN THE AORTA DUE TO ITS LENGTH AND IT BEING THE BACK END. EVENTUALLY AFTER SPINNING THE BACK END SUPER RENAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494421 ↗
• MalfunctionSep 15, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  A ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 58MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A FINAL CONTRAST ANGIOGRAM REVEALED A TYPE IA ENDOLEAK INVOLVING THE ESBF3614C103E BIFURCATE STENT GRAFT . AN ENDURANT CUFF (ETCF3636C49E) WAS PLACED TO TREAT THE ENDOLEAK AND WAS DEPLOYED WITHOUT ISSUE. HOWEVER, DURING REMOVAL OF THE ENDURANT CUFF DELIVERY SYSTEM, THE SPINDLE CAUGHT THE STENT STRUTS , PULLING ONE OF THE STRUTS DOWNWARD AND CAUSING IT TO REMAIN IN THIS POSITION. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO REPOSITION THE STENT STRUT USING A 12MM BALLOON AND A RELIANT BALLOON. SINCE THE TYPE IA ENDOLEAK WAS RESOLVED, THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT FURTHER ISSUES. PER THE PHYSICIAN, THE CAUSE OF THE EVENTS WAS ANATOMY RELATED DUE TO AN ANGLED AND CONICAL INFRARENAL AORTIC NECK. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050526 ↗
• MalfunctionAug 26, 2024Leak/Splash; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  AN ANEURX STENT GRAFT SYSTEM AND EXTENSION CUFF WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. IT WAS REPORTED APPROXIMATELY 16 YEARS POST THE INDEX PROCEDURE, FOLLOW-UP CT SHOWED BOTH EXISTING PROXIMAL STENT GRAFTS HAD MIGRATED DUE TO NECK EXPANSION LEADING TO A TYPE IA ENDOLEAK. INTERVENTION WAS PERFORMED. A ENDURANT CUFF ETCF3636C49E (V31180196) WAS DEPLOYED WITHOUT INCIDENT, LANDING JUST DISTAL TO THE ORIGIN OF THE RENAL ARTERIES. HELI-FX ENDOANCHORS WERE THEN DEPLOYED SA-85 (LOT #0011791286) 2 ENDOANCHORS WERE DEPLOYED WITHOUT INCIDENT. DURING THE DEPLOYMENT OF THE 3RD ENDOANCHOR THE INITIAL STEP OF DEPLOYMENT WAS PERFORMED WITHOUT INCIDENT AS THE ENDOANCHOR SUCCESSFULLY ENGAGED AND PENETRATED THE STENT GRAFT FABRIC IN THE CORRECT ORIENTATION, HOWEVER, DURING THE SECOND STEP, THE ENDOANCHOR APPEARED TO CHANGE ORIENTATION. THE 3RD ENDOANCHOR HAD TO BE REPOSITIONED SEVERAL TIMES. IT HAS APPEARED THAT THE ENDOANCHOR INTERACTED WITH CALCIUM DURING THE FINAL STAGE DEPLOYMENT. THE SA-85 WOULD NOT LOAD THE 4TH ENDOANCHOR AND DAMAGE TO THE TIP OF THE SA-85 WAS SUSPECTED. A SECOND SA-85 (LOT # 0011823330) WAS OPENED AND 3 MORE ENDOANCHORS WERE DEPLOYED WITHOUT INCIDENT. THE PHY

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

  MAUDE report 20064496 ↗
• InjuryAug 13, 2024Leak/Splash; Leak/Splash

  AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROX. 18 YEARS POST INDEX PROCEDURE THAT THE PATIENT PRESENTED EMERGENTLY EXPERIENCING BACK PAIN. A CT SCAN REVEALED A TYPE IA ENDOLEAK, CAUSED BY THE MIGRATION OF THE ANEURX STENT GRAFT, WHICH HAD MIGRATED 50MM FROM THE RENAL ARTERY. INTERVENTION WAS PERFORMED THE SAME DAY. THE ANEURX STENT GRAFT WAS INITIALLY REINFORCED WITH TWO ENDURANT II STENT GRAFT CUFFS BUT THE ENDOLEAK PERSISTED. THE PHYSICIAN THEN OPTED TO RELINE THE ENTIRE STENT GRAFT WITH A NEW ENDURANT IIS BIFURCATED STENT GRAFT SYSTEM AND EXTENDED THE ENDURANT II LIMBS TO THE RENAL ARTERIES SUCCESSFULLY RESOLVING THE ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS ANATOMY RELATED DUE TO THE PATIENTS DILATED AORTIC NECK. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 19970587 ↗
• InjuryDec 12, 2023Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device; Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device

  A NON MDT STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA . APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE, AN ENDURANT II AORTIC EXTENSION , LIMB AND ENDOANCHORS WERE IMPLANTED AS PART OF THE PRE-PLANNED TREATMENT OF THE 80MM AAA.  IT WAS REPORTED THAT DURING THIS PROCEDURE, THE PHYSICIAN ADVANCED THE 36 ENDURANT EXTENSION FROM A PERCUTANEOUS LEFT COMMON FEMORAL ARTERY  APPROACH. UPON ADVANCING THE CUFF THROUGH THE EXISTING NON MDT AAA GRAFT ,  THE LEFT LIMB OF THE NON MDT STENT GRABBED THE ENDURANT II CUFFS DELIVERY SYSTEM AND FOLDED UPON ITSELF. THE PHYSICIAN  DEPLOYED THE CUFF WITHOUT PROBLEM. WHILE TRYING TO REMOVE THE ENDURANT II AORTIC EXTENSIONS DELIVERY SYSTEM , RESISTANCE WAS MET . THE TAPERED TIP  WAS RECAPTURED  ABOVE THE STENT GRAFT  AS USUAL BUT THE PHYSICIAN COULD NOT BRING THE FRONT GRIP BACK TO THE SLIDER (GREY TO BLUE MANEUVER). THE TAPERED TIP APPEARED STUCK IN THE GATE AREA OF THE EXISTING NON MDT STENT GRAFT.  AT THIS STAGE, A MORE SENIOR PHYSICIAN WAS CALLED FOR ASSISTANCE. THIS PHYSICIAN  DISCOVERED THAT THE NON MDT ZENITH MAIN BODY AND LIMB HAD SEPARATED. THE DECISION WAS MADE TO DO A CUT DOWN ON THE LEFT COMMON FEMORAL ARTERY. ONCE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18308989 ↗
• InjuryDec 8, 2023Device Damaged by Another Device; Positioning Problem; Device Damaged by Another Device; Positioning Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE EMERGENT ENDOVASCULAR TREATMENT OF A 71MM INFRA-RENAL IMPENDING RUPTURE. THE PROXIMAL AORTIC NECK DIAMETER WAS NOTED AS 30MM AND WAS 20MM IN LENGTH. SEVERE NECK ANGULATION AND VESSEL TORTUOSITY, ACCOMPANIED BY MODERATE TO SEVERE VESSEL CALCIFICATION WAS NOTED.. IT WAS REPORTED DURING THE INDEX PROCEDURE, POST-IMPLANTATION OF THE BIFURCATED STENT GRAFT AND LIMB STENT GRAFTS, AN ANGIOGRAM IDENTIFIED A TYPE IA ENDOLEAK. AN ATTEMPT WAS MADE TO IMPLANT AN AORTIC CUFF (B)(6), BUT DUE TO THE COMPLEXITY OF THE ANATOMY AND THE EXISTING ENDOGRAFT, THE CUFF WAS WITHDRAWN BEFORE DEPLOYMENT FROM THE RIGHT FEMORAL ARTERY. RESISTANCE DURING REMOVAL WAS ENCOUNTERED AND THE PATIENT'S BLOOD PRESSURE DROPPED. IT WAS DETERMINED THAT THE RIGHT EXTERNAL ILIAC HAD RUPTURED. A RIGHT ILIAC BYPASS WAS PERFORMED TO REPAIR AND STABILIZE THE INJURY. THE PATIENT THEN BECAME STABLE AFTER THE REPAIR. A REPLACEMENT AORTIC CUFF (B)(6) WAS SUCCESSFULLY IMPLANTED, RESOLVING THE TYPE IA ENDOLEAK PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK IS UNDETERMINED. THE CAUSE OF THE RUPTURE WAS DUE TO THE COMPLEXITY OF THE ANATOMY AND THE EXISTING ENDOGRAFT. NO

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 18290564 ↗
• MalfunctionNov 6, 2023Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2006. ON (B)(6) 2016, AN ENDURANT CUFF (B)(6) WAS IMPLANTED. PER THE PATIENT , THIS STENT GRAFT WAS IMPLANTED DUE TO MIGRATION OF THE ANEURX STENT GRAFT. IT WAS CONFIRMED FROM THE SITE THAT THE PATIENT ALSO HAD ENDOANCHORS IMPLANTED IN 2016. IT WAS REPORTED ON (B)(6) 2023 VIA THE PATIENT, THAT AN ENDOLEAK WAS PRESENT. IT WAS CONFIRMED FROM THE SITE THAT A FOLLOW UP CT TAKEN ON (B)(6) 2023 CONFIRMED THE PRESENCE OF A TYPE IA ENDOLEAK AND ANEURYSM ENLARGEMENT. NO CAUSE OF THE MIGRATION OR ENDOLEAK WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 18071649 ↗
• MalfunctionMay 9, 2023Leak/Splash; Leak/Splash

  AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED BY A PATIENT REPRESENTATIVE VIA TECHNICAL SERVICES THAT THE PATIENT WAS DIAGNOSED WITH AN ENDOLEAK IN THE PREVIOUSLY TREATED AORTIC ANEURYSM APPROXIMATELY 14 YEARS POST INDEX PROCEDURE. THE PHYSICIAN CONFIRMED THE ENDOLEAK WAS A TYPE IA BUT WAS UNSURE OF THE CAUSE OF THE EVENT. IT WAS CONFIRMED THAT A TYPE IA ENDOLEAK HAD BEEN PREVIOUSLY IDENTIFIED ON AN UNKNOWN DATE IN THE ANEURX STENT GRAFT. AN ENDURANT CUFF WAS IMPLANTED TO TREAT THIS ENDOLEAK APPROXIMATELY 12 YEARS AND 3 MONTHS POST INDEX PROCEDURE NO ADDITIONAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895517 ↗
• InjuryMar 30, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II AORTIC CUFF WAS IMPLANTED DURING THE ENDOVASCULAR REPAIR OF A TYPE IA ENDOLEAK IN AN EXISTING ENDURANT ENDOGRAFT. THE DIAMETER OF THE ABDOMINAL AORTIC ANEURYSM WAS NOTED AS 52MM. IT WAS NOTED THE PATIENT PRESENTED WITH PAIN. IT WAS NOTED THE PATIENT HAD A SHORT NECK. IT WAS REPORTED DURING THE INDEX PROCEDURE. A CT SHOWED A TYPE I ENDOLEAK FROM THE PREVIOUS ENDOGRAFT PLACEMENT. CONTRAST WAS SEEN L EAKING FROM THE POSTERIOR/ RIGHT WALL OF AORTA BELOW THE RENAL ARTERIES. ACCORDING TO THE CT, THERE WAS APPROX 10MM OF SPACE FROM THE RENAL ARTERY TO THE TOP OF FABRIC FROM THE PREVIOUS DEVICE (32 MAIN BODY PREVIOUSLY IMPLANTED). THE NECK BELOW THE RENALS WAS ANGLED AND MEASURED APPROX 29-30 MM IN DIAMETER. IT WAS DECIDED TO ATTEMPT TO IMPLANT THE ENDURANT CUFF ( 36X36X49) TO FIX THE ENDOLEAK. AFTER PARALLAX CORRECTION ( 20 LAO AND 20 CRANIAL) ANGIOGRAM SHOWED CLEAR VISITATION OF THE RENALS, NECK, GRAFT AND ENDOLEAK. A RIGHT IPSI APPROACH WAS USED TO CUFF PLACEMENT. THE GRAFT WAS DEPLOYED APPROX 10MM ABOVE THE PREVIOUS GRAFT. A RELIANT BALLOON WAS THEN USED TO MOLD THE GRAFT INTO POSITION. REPEAT ANGIO SHOWED BOTH RENALS, HOWEVER A TYPE I ENDOLEAK WAS EVIDENT. 7 ENDOANCHORS

  Patient problems: Renal Failure

  MAUDE report 16642147 ↗
• DeathJul 19, 2022Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A CT SHOWED A RUPTURED ANEURYSM AND A TYPE IA ENDOLEAK WITH A CONTAINED RUPTURE. THE PATIENT WAS TREATED BY PLACING A BALLOON EXPANDABLE 6MM NON-MDT STENT INTO THE LEFT RENAL ARTERY AS A CHIMNEY AND A ETCF3636C49E WAS EXTENDED TO THE SMA. THE TYPE IA APPEARED TO BE DOWN TO A SMALL AMOUNT. THE PHYSICIAN OPTED TO STOP WITH THE RESULT. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK AND RUPTURE COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Myocardial Infarction; No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 15052311 ↗
• InjuryMay 20, 2022Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 61MM ABDOMINAL AORTIC ANEURYSM. HELI-FX ENDOANCHORS WERE ALSO IMPLANTED PROPHYLACTICALLY. A NON MDT STENT WAS USED TO SNORKEL THE LEFT RENAL ARTERY. AN ANGULATED NECK WAS NOTED. IT WAS REPORTED DURING THE INDEX PROCEDURE THE BIFURCATE WAS DEPLOYED FROM THE RIGHT TO THE LEVEL OF THE LEFT RENAL ARTERY WITH SOME POTENTIAL FABRIC COVER. AFTER THE ENDOANCHORS WERE PLACED AN ANGIOGRAM IDENTIFIED LOSS OF SEAL WITH A BRISK ENDOLEAK AT THE LEVEL OF THE LEFT RENAL ARTERY. A 36X36X49 ENDURANT CUFF WAS IMPLANTED AND A NON MDT STENT PLACED. WHILE IMPLANTING THE CUFF COVERAGE OF THE LOWER POLE OF THE RENAL ARTERY WAS CONFIRMED. FURTHER CONTRAST INJECTION SHOWED A SIGNIFICANT ENDOLEAK POST IMPLANT OF THE CUFF. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL 36X36X49 ENDURANT CUFF TO THE LEFT RENAL ARTERY. DURING THE IMPLANT OF THE SECOND CUFF A BALLOON (6X100MM) WAS PLACED IN THE NON MDT STENT. A RELIANT BALLOON WAS THEN USED TO BALLOON THE PROXIMAL CUFFS AND NON MDT STENT. FOLLOWING DEFLATION OF THE RELIANT BALLOON IT APPEARED THAT THE DUAL BALLOON TECHNIQUE HAD RESULTED IN THE RUPTURE OF THE LEFT RENAL ARTERY

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

  MAUDE report 14454179 ↗
• DeathMar 28, 2022Adverse 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 90MM RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE STENT GRAFT SYSTEM WAS IMPLANTED A TYPE IA ENDOLEAK WAS OBSERVED. THE PATIENT'S BLOOD PRESSURE WAS DROPPING AND THE PHYSICIAN ELECTED TO IMPLANT AN AORTIC CUFF AND COVER THE RENAL ARTERIES TO RESOLVE THE ENDOLEAK. POST OP THE PATIENT WAS ADMITTED TO ICU WHERE THEY SUFFERED A CARDIAC ARREST AND EXPIRED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED AND DETERMINED THE DEATH WAS DUE TO THE RUPTURED AAA AND HEART FAILURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT EXPIRED.

  Patient problems: Low Blood Pressure/ Hypotension; Myocardial Infarction; Rupture

  MAUDE report 13926371 ↗
• InjuryFeb 14, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II AORTIC EXTENSION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 58MM ABDOMINAL AORTIC ANEURYSM .  IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT OVER 2 YEARS LATER WHERE A TYPE IA ENDOLEAK WAS OBSERVED ON CT. THE TYPE IA ENDOLEAK WAS TREATED THE NEXT DAY WHERE 8 ENDOANCHORS WERE IMPLANTED AND THE TYPE IA ENDOLEAK RESOLVED.  AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE PATIENTS OWN ANATOMY AS A RESULT OF AN ANGLED NECK.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENTS IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13522682 ↗
• InjuryOct 18, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A ABDOMINAL AORTIC ANEURYSM. THE PATIENTS LAST FOLLOW-UP VISIT WAS 4 YEARS POST THE INDEX PROCEDURE. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 9 YEAS POST THE INDEX PROCEDURE WITH A POSSIBLE RUPTURED ANEURYSM. A CT WAS PERFORMED WHICH SHOWED A TYPE IA ENDOLEAK AND A TYPE IB ENDOLEAK COMING FROM THE RIGHT ILIAC ATTACHMENT SITE. INTERVENTION WAS PERFORMED WHERE AN ENDURANT CUFF WAS PLACED UP TO THE LEVEL ON THE SMA ARTERY. THE PHYSICIAN THEN SNORKELED BOTH RENAL ARTERIES SUING NON MDT STENTS. A RELIANT BALLOON WAS THEN USED TO AID THE FIXATION OF THE GRAFT. THE PHYSICIAN THEN PLACED 15 ENDOANCHORS ON THE CUFF. AN ANGIOGRAM WAS PERFORMED WHICH STILL SHOWED A BLUSH OF ENDOLEAK PRESENT. THE  PHYSICIAN  THEN DECIDED TO EXTEND THE NON MDT RENAL STENTS AND ALSO SNORKEL THE SMA AND PLACE A VALIANT THORACIC  STENT GRAFT. THE VALIANT WAS THEN BALLOONED USING A RELIANT BALLOON. AN ANGIOGRAM WAS PERFORMED WHICH SHOWED THE TYPE IA ENDOLEAK WAS NOW RESOLVED. THE PHYSICIAN THEN TREATED THE TYPE IB ENDOLEAK COMING FROM THE RIGHT IPSILATERAL LIMB OF THE BIFURCATED GRAFT. AN 16X16X82 ILIAC

  Patient problems: Insufficient Information

  MAUDE report 12645472 ↗
• DeathMay 27, 2021Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Material Deformation; 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 55 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE DEVICE WAS IMPLANTED, WHERE AN ENDOLEAK TYPE 1A WAS NOTED AFTER BALLOONING. THE PHYSICIAN THEN DECIDED TO IMPLANT AN AORTIC CUFF. IT WAS STATED THAT WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE DELIVERY SYSTEM TO RECAPTURE TIP, THE DISTAL PORTION OF CUFF APPEARED TO FOLD IN ON ITSELF, WHICH WAS UNABLE TO BE OPENED ENDOVASCULARLY, SO DECISION WAS MADE TO CONVERT TO OPEN SURGERY. IT WAS REPORTED THAT THE SURGEON CLAMPED AORTA BELOW THE RIGHT RENAL ARTERY AND CUT OUT PART OF THE STENT GRAFT, AND PROCEEDED WITH AORTO-AORTO TUBE GRAFT. THE DEVICE WAS EXPLANTED PARTIALLY. AFTER SURGERY, THE PATIENT WAS TRANSFERRED TO ICU AND DIED ON THE NEXT DAY. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS THAT THE DISTAL GRAFT DID NOT FULLY OPEN AFTER UNSHEATHING. THE PHYSICIAN STATED THAT PART OF THE GRAFT WAS NOT OPEN OR GOT CAUGHT ON THE DELIVERY SYSTEM AS IT WAS ADVANCED PROXIMALLY TO RECAPTURE TIP. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 11894755 ↗
• MalfunctionMar 25, 2021Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 81 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 33 MONTHS POST INDEX PROCEDURE, AN ENDOLEAK TYPE IA WAS NOTED. AN ETCF3636C49E AND ETCF3636C49E WERE IMPLANTED ALONG WITH BILATERAL RENAL SNORKELS ON THE FOLLOWING DAY. A VERY SLIGHT ENDOLEAK PERSISTED AND WAS NOT RESOLVED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO DILATED AORTA. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11569160 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT AUI STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 52 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE ACCESS WAS SMALL AND IT WAS DIFFICULTY TO REMOVE THE DEVICE FROM THE INTENDED LANDING ZONE. FINAL ANGIOGRAPHY WAS PERFORMED WHERE IT SHOWED AN ENDOLEAK TYPE 1A. AN ETCF3636C49E CUFF WAS THEN IMPLANTED, HOWEVER WHEN THE PHYSICIAN WAS REMOVING THE DEVICE, A RUPTURE OF THE EXTERNAL ILIAC ARTERY OCCUR. IT WAS STATED THAT A ETLW1610C156E WAS IMPLANTED TO REPAIR THE RUPTURED EXTERNAL ILIAC ARTERY. FINAL ANGIOGRAM SHOWED THAT THE TYPE 1A ENDOLEAK WAS RESOLVED. THE CAUSE OF THE EVENT AS PER THE PHYSICIAN, WAS ANATOMY DUE TO A SMALL CALCIFIED ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Perforation of Vessels; Rupture

  MAUDE report 11555097 ↗
• DeathJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS AND AN ENDURANT AORTIC EXTENSION CUFF WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 305MM THORACIC AORTIC ANEURYSM. A DAY LATER, THE PATIENT HAD A RETROGRADE TYPE A AORTIC DISSECTION AND EXPIRED BEFORE REACHING THEATRE. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Vascular Dissection

  MAUDE report 11116178 ↗
• InjuryNov 17, 2020Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 01 MONTH POST INDEX PROCEDURE, DURING A FOLLOW-UP, A CT WAS PERFORMED WHERE AN ENDOLEAK TYPE 1 WAS NOTED. THE EVENT WAS TREATED WITH CHIMNEY, ETCF3636C49E CUFF AND A NON-MEDTRONIC STENT WERE IMPLANTED THE RIGHT RENAL ARTERY IT WAS STATED THAT 10 APTUS ENDOANCHORS WERE ALSO PLACED AND THE ENDOLEAK WAS SIGNIFICANTLY LESS. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Insufficient Information

  MAUDE report 10851289 ↗
• MalfunctionOct 8, 2020Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 70 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE BIFURCATED STENT GRAFT WAS LANDED APPROXIMATELY 0.5CM BELOW THE RIGHT LOWEST RENAL. IT WAS STATED THAT AN ANGIOGRAM WAS AFTER ALL THE STENTS GRAFTS WERE IMPLANTED, WERE A TYPE 1A ENDOLEAK WAS NOTED. THE PHYSICIAN THEN DECIDED TO IMPLANT AN ENDURANT CUFF, HOWEVER A SMALL TYPE 1A ENDOLEAK WAS STILL REMAINED, BUT THE PHYSICIAN WAS SATISFIED WITH THE PROCEDURE. AS PER THE PHYSICIAN, CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10649055 ↗
• InjuryAug 19, 2020Leak/Splash; Leak/Splash

  A TALENT BIFURCATE STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 85 MM PRE-RUPTURE ABDOMINAL AORTIC ANEURYSM IT WAS REPORTED APPROXIMATELY 137 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY, WITH COMPLAINTS OF ABDOMINAL PAIN. CT WAS PERFORMED AND SHOWED WHAT APPEARED TO BE A TYPE 1A ENDOLEAK. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO TREAT THE ENDOLEAK BY PLACING A ETCF3636C49E CUFF AND A HELI-FX ENDOANCHOR SYSTEM. IT WAS STATED THAT THE TYPE 1 ENDOLEAK WAS STILL NOTED AFTER THE DEVICES WERE IMPLANTED. THE PHYSICIAN THEN DECIDED TO PLACE A BILATERAL CHIMNEYS USING A NON-MEDTRONIC STENTS IN THE RIGHT AND LEFT RENAL ARTERY. ETTF3636C70E WAS ALSO IMPLANTED TO TREAT THE EVENT. FINAL ANGIOGRAPHY WAS PERFORMED WITH NO ENDOLEAK FOUND. AS PER THE PHYSICIAN, CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10424296 ↗
• InjuryJun 4, 2020Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, FINAL ANGIOGRAM SHOWED THERE WAS A PROXIMAL TYPE I ENDOLEAK PRESENT FOLLOWING THE PLACEMENT OF ENDOANCHORS. AS PER THE PHYSICIAN IT APPEARED THE STENT GRAFT WAS IMPLANTED LOWER THAN PLANNED SO A ETCF3636C49E AORTIC CUFF WAS IMPLANTED CLOSER TO THE RIGHT RENAL ARTERY. AFTER IMPLANTED THE CUFF, THE PHYSICIAN IMPLANTED TWO MORE ENDOANCHORS. IT WAS CONFIRMED THAT THE ADDITIONAL TWO ENDOANCHORS WERE IMPLANTED AFTER THE AORTIC CUFF AS THE CUFF DIDN'T FULLY RESOLVE THE TYPE IA ENDOLEAK. THE IA ENDOLEAK WAS NO LONGER PRESENT AT THE END OF THE PROCEDURE. THE FINAL ANGIOGRAM SHOWED A TYPE II ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY. IT WAS NOTED THE PATIENT HAD A REVERSE FUNNEL NECK 23MM -30MM OVER 15MM'S. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10117730 ↗
• DeathApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 89MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT POST-OPERATIVELY A CT PERFORMED 2 YEARS AND 11 MONTHS LATER IDENTIFIED A TYPE IA ENDOLEAK WAS PRESENT. IT WAS REPORTED THAT THE ANEURYSM MEASURED 7.5 CM X 8.9 CM. INTERVENTION WAS PERFORMED JUST UNDER A MONTH LATER, A ENDURANT AORTIC CUFF ETCF3636C49E WAS IMPLANTED ALONG WITH THE IMPLANTATION OF ENDOANCHORS. A 6X22 NON-MDT( ICAST) WAS ALSO PLACED IN THE LEFT RENAL. DESPITE THIS THE TYPE IA ENDOLEAK WAS STILL PRESENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND NOTED THE AORTIC NECK DIAMETER HAD ENLARGED. IT WAS REPORTED THE PATIENT PRESENTED TO THE ER WITH A RUPTURED ANEURYSM APPROXIMATELY FOUR WEEKS POST THE RE-INTERVENTION. A CHIMNEY WAS PLACED IN THE LEFT RENAL ARTERY AND A ENDURANT AORTIC CUFF ETCF3636C49E WAS IMPLANTED UP TO THE RIGHT RENAL AND SMA. A CHIMNEY WAS THEN PLACED INTO THE SMA AND COVERED THE RIGHT RENAL ARTERY, SMA, AND CELIAC ARTERY WITH A VALIANT NAVION VNMF4343C103E STENT GRAFT AND THEN PLACED ANOTHER VALIANT NAVION VNMF4040C103E MORE PROXIMALLY. A FINAL ANGIOGRAM SHOWED THE IA ENDOLEAK HAD RESOLVED AN

  Patient problems: Cardiac Arrest; Death

  MAUDE report 9942367 ↗

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