Endurant® II ETBF3616C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00613994991041), received between Jan 3, 2017 and May 1, 2026 — classified as 1 death, 26 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (30 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 16, 2026.

Recalls naming this device

1. Dec 21, 2021Open, 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Fracture; Leak/Splash; Migration or Expulsion of Device; Detachment of Device or Device Component

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 65MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 11 YEARS POST THE INDEX PROCEDURE DURING A CT FOR A DIFFERENT TREATMENT AN INCIDENTAL FINDING WAS IDENTIFIED. THE PROXIMAL SUPRARENAL FIXATION STENT WAS IDENTIFIED TO BE DISCONNECTED FROM THE GRAFT BODY. FUTURE TREATMENT IS PLANNED. NO PATIENT SYMPTOMS WERE REPORTED DUE TO THE EVENT. PER THE PHYSICIAN THE CAUSE IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25054871 ↗
• 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 AN UNKNOWN ENDOVASCULAR PROCEDURE IT WAS REPORTED VIA PATIENT SERVICES THAT THE PATIENT'S WIFE CALLED TO INFORM THAT APPROXIMATELY 2 YEARS AND 2 MONTHS AFTER THE INDEX PROCEDURE, THE ENDURANT II STENT GRAFTS WERE EXPLANTED DUE TO AN INFECTION. THE INFECTION WAS REPORTEDLY IDENTIFIED AFTER THE PATIENT DEVELOPED A HIGH FEVER. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL "SEQUELAE" WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 22468350 ↗
• InjuryJun 25, 2025Fracture; Leak/Splash; Migration or Expulsion of Device; Fracture; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 11 YEARS AND 3 MONTHS POST-INDEX PROCEDURE THE PATIENT PRESENTED WITH A 110MM ABDOMINAL ANEURYSM RUPTURE, AND IMAGING REVEALED THAT THE PREVIOUSLY IMPLANTED ENDOGRAFT HAD MIGRATED DOWNWARD NEAR THE RENAL ARTERIES, WITH AT LEAST TWO PEAKS OF THE SUPRARENAL FIXATION STILL IN PLACE. THERE WAS A SUSPECTED FRACTURING OF THE SUPRARENAL FIXATION. PARTS OF THE SUPRA RENAL STENT WERE FOUND AT NEAR RENAL ARTERIES, WHILE OTHER PARTS OF THE SUPRA RENAL STENT WERE OBSERVED AT THE FABRIC PORTION THAT MIGRATED DOWN. A TYPE IA ENDOLEAK WAS ALSO CONFIRMED BY THE PHYSICIAN. THE PATIENT WAS IN STABLE CONDITION BUT REMAINED HOSPITALIZED AND WAS RECOVERING FROM THE RUPTURE. INTERVENTION TREATMENT INCLUDED THE IMPLANTATION OF A THORACIC GRAFT FROM THE SUPERIOR MESENTERIC ARTERY TO THE PREVIOUS GRAFT. THE PREVIOUSLY IMPLANTED ENDURANT LIMBS DID NOT HAVE ANY ISSUES. PER THE PHYSICIAN, THE MIGRATION/SEPARATION OF THE ENDOGRAFT CONTRIBUTED TO THE TYPE IA ENDOLEAK LEADING TO THE ANEURYSM RUPTURE. NO ADDITIONAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm expansion; Rupture

  MAUDE report 22326010 ↗
• MalfunctionNov 14, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS REPORTED APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE THAT DURING A FOLLOW-UP APPOINTMENT IDENTIFIED A TYPE IB ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE EVENT 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 18130195 ↗
• DeathOct 6, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ADDITIONALLY, 7 ENDURANT STENT GRAFTS WERE ALSO IMPLANTED DURING THE PROCEDURE. THE VALIANT NAVION STENTS (B)(6) WERE IMPLANTED IN THE THORACIC AORTA, WITH THE SECOND DEVICE OVERLAPPING AT PROXIMAL END OF THE FIRST TO ENSURE A MORE SECURE SEAL. ENDO-DEBRANCHING USING AN ENDURANT STENT GRAFT IN THE PROXIMAL ABDOMINAL AORTA WAS A MODIFIED ENDURANT UNITARY GRAFT; IT WAS EXTENDED INTO EACH OF THE CELIAC, SMA, L & R RENAL ARTERIES AND LINED WITH NON MDT SELF-EXPANDING STENTS; IT WAS EXTENDED INTO DISTAL ABDOMINAL AORTA WITH 16X20X124 ENDURANT IIS STENT GRAFTS X2 (WITH THE SECOND OVERLAPPING AT THE PROXIMAL END OF THE FIRST FOR BETTER SEAL/COVERAGE) IT WAS REPORTED DURING THE INDEX PROCEDURE A TYPE IV ENDOLEAK (UNKNOW WHICH DEVICE) WAS DETECTED. FOLLOWING THE INDEX PROCEDURE, A FOLLOW UP CT SCAN REVEALED AN UNKNOWN ENDOLEAK IN THE THORACIC AORTA, ALONG THE RIGHT POSTEROLATERAL MARGIN OF THE VALIANT NAVION GRAFT. THE ENDOLEAK WAS OBSERVED AT THE SITE WHERE THE COMPONENTS OVERLAPPED AT THE DIAPHRAGMATIC HIATUS. POST THE PROCEDURE, CTA FOR CONCERN FOR MESENTERIC ISCHEMIA ¿DEMONSTRATED

  Patient problems: Insufficient Information; Ischemia; Stroke/CVA

  MAUDE report 17884903 ↗
• MalfunctionApr 26, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 67MM AAA. IT WAS REPORTED APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE, FOLLOW-UP CT IDENTIFIED A TYPE IA ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS DISEASE PROGRESSION. NO ADDITIONAL  CLINICAL SEQUALAE WERE PROVIDED WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815309 ↗
• MalfunctionJan 6, 2023Fracture; Fracture

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED 100MM ABDOMINAL AORTIC ANEURYSM. A VALIANT NAVION STENT GRAFT WAS ALSO IMPLANTED ON THE SAME DATE. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING FROM APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE IDENTIFIED MULTIPLE FRACTURES ON THE PROXIMAL STENT OF THE NON NAVION ABDOMINAL STENT GRAFT. THE CAUSE OF THE FRACTURES ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16111156 ↗
• MalfunctionDec 14, 2022Material Twisted/Bent; Material Twisted/Bent

  AN ENDURANT II BIFURCATE STENT GRAFT WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 135MM AAA . PREVIOUSLY THE PATIENT HAD A NON MDT STENT GRAFT, A ENDURANT CUFF, A TALENT LIMB AND A ANEURX LIMB GRAFT IMPLANTED. THE PLAN WAS TO COMPLETELY RELINE THE PREVIOUSLY IMPLANTED STENT GRAFTS.  IT WAS REPORTED THAT WHEN ATTEMPTING TO IMPLANT THE ENDURANT II BIFURCATE, THE PHYSICIAN AND THE SALES REPRESENTATIVE ATTENDING THE CASE WERE UNABLE TO LOCATE THE "E" MARKER TO DETERMINE WHERE THE GATE WOULD ULTIMATELY OPEN.  IT WAS SAID THE PATIENT HAD ONLY 83MM FROM THE PROXIMAL LANDING ZONE TO THE FLOW DIVIDER. GATE PLACEMENT WAS ESSENTIAL AND IT WAS A MUST THAT THE STENT GRAFT BE DEPLOYED ABOVE THE FLOW DIVIDER ON THE CONTRA-LATERAL SIDE AND NOT CROSSED LIMBS. THE DELIVERY SYSTEM WAS THEN REMOVED OUT OF THE PATIENT AND UPON INSPECTION OF HOW THE STENT GRAFT WAS CONTAINED IN THE DELIVERY SYSTEM , IT WAS SAID THE GRAFT APPEARED TWISTED.  THIS STENT GRAFT WAS THEN DISCARDED AND A ENDURANT IIS BIFURCATE WAS IMPLANTED WITHOUT ISSUES ALONG WITH 4 ENDURANT LIMBS.  PER THE PHYSICIAN THE CAUSE 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 15975549 ↗
• MalfunctionSep 7, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE TREATMENT OF A 70MM ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED THAT CT IMAGES REVEALED A TYPE 1A AND 1B (LEFT) ENDOLEAK. THE PHYSICIAN STATED THAT IT APPEARS THAT THE NECK AND THE LEFT COMMON ILIAC HAVE DILATED TO A LARGER DIAMETER THAN THE DEVICE. IT WAS MENTIONED THAT THE PREVIOUS SCAN SHOWED THAT THE AAA WAS SHRINKING AND THERE WAS NO LEAK, HOWEVER THIS SCAN SHOWED AAA EXPANSION (NOW 62MM) AND 2 ENDOLEAKS. PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK IS ANATOMY RELATED DUE TO NECK AND LEFT COMMON ILIAC ARTERY DILATATION. NO ADDITIONAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15368687 ↗
• MalfunctionJun 9, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 76MM ABDOMINAL AORTIC AN EURYSM .  IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT. THE RADIOLOGY REPORT INDICATED A TYPE 3 ENDOLEAK. IT WAS REPORTED PER THE SALES REP WHO REVIEWED THE CT FILMS, THAT HALF OF THE SUPRARENAL FIXATION IS IN PLACE AT THE INITIAL LANDING ZONE AND THE OTHER HALF IS ATTACHED TO THE GRAFT, SEVERAL CENTIMETERS LOWER. THERE APPEARS TO BE BROKEN AND PARTIAL DETACHMENT OF THE SUPRARENAL FIXATION NO CAUSE OF THE EVENT WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14641500 ↗
• InjuryMay 5, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 100MM ABDOMINAL AORTIC A NEURYSM.  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY OVER 7 YEARS LATER, WHERE A TYPE IA ENDOLEAK WAS DISCOVERED. THE PHYSICIAN TREATED THE TYPE IA ENDOLEAK WITH A PROXIMAL EXTENSION WITH ENDOANCHORS AND THE TYPE IA ENDOLEAK RESOLVED.  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS DUE TO THE PATIENTS OWN ANATOMY AS A RESULT OF DISEASE PROGRESSION.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 14285935 ↗
• InjuryJan 26, 2022Fracture; Leak/Splash; Detachment of Device or Device Component; Fracture; Leak/Splash; Detachment of Device or Device Component

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55-65MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON AN UNKNOWN DATE AAA EXPANSION WAS IDENTIFIED. THE PATIENT WAS SCHEDULED AND BROUGHT BACK TO THE OR FOR A TRANSCAVAL EMBOLIZATION OF THE AAA SAC DUE TO THE EXPANSION. A STENT GRAFT FRACTURE WAS IDENTIFIED ON THE FLUOROSCOPY/ XRAY IMAGE DURING THE PROCEDURE. 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; Insufficient Information

  MAUDE report 13357838 ↗
• InjuryJun 25, 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 A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 1 MONTH LATER, THE PATIENT PRESENTED EMERGENTLY, WHERE THROMBUS WAS NOTED ON THE LEFT LIMB OF THE EXISTING STENT GRAFT. THROMBECTOMY WAS PERFORMED. THROMBUS WAS PRESENT IN THE MAIN BODY SO THE PHYSICIAN OPTED TO PUT IN A CUFF AND EXTENDED BOTH SIDES PROXIMAL INTO THE CUFF WHICH RELINED THE EXISTING LIMBS. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12065220 ↗
• MalfunctionApr 19, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 51MM DIAMETER AAA. APPROXIMATELY 7 YEARS LATER, IT WAS REPORTED THE PATIENT RETURNED FOR FOLLOW UP WHERE A SUSPECTED TYPE IA ENDOLEAK WAS OBSERVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685331 ↗
• InjuryFeb 22, 2021Fracture; Leak/Splash; Fracture; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 96 MONTHS POST INDEX PROCEDURE, A CT WAS PERFORMED WERE IT WAS NOTED THAT THE ETBF3616C166E BIFURCATED STENT GRAFT "CRACKED" TEARING A HOLE IN GRAFT AND CAUSING AAA TO GROW. IT WAS STATED THAT THE PATIENT HAD PRESENTED WITH NO SYMPTOMS DURING ROUTINE FOLLOW UP. ADDITIONAL STENT GRAFTS WERE IMPLANTED TO EXTEND CHEVAR AND RE-LINE THE ORIGINAL IMPLANT. THE EVENT WAS RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11358153 ↗
• MalfunctionDec 1, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM, AND HELI-FX ENDO-ANCHORS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT ANGIOGRAM IDENTIFIED A TYPE IA ENDOLEAK. A RELIANT BALLOON WAS USED TO BALLOON, HOWEVER, THE ENDOLEAK PERSISTED. PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK IS ANATOMY RELATED LIKELY DUE TO NECK DILATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10926587 ↗
• InjuryOct 16, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP, OVER EIGHT YEARS LATER. A TYPE I ENDOLEAK WAS REPORTED DUE TO NECK DILATION. INTERVENTION WAS PERFORMED ON THE SAME DATE, A ENDURANT 36X70 AORTIC CUFF WAS IMPLANTED ALONG WITH NON MDT BALLOON EXPANDABLE STENT BILATERALLY AS A SNORKEL, AND THE CUFF WAS PLACED DISTALLY TOWARDS THE SMA TO TRY AND RESOLVE THE ENDOLEAK. ON FINAL ANGIOGRAM, A GUTTER ENDOLEAK STILL REMAINED. 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: Injury

  MAUDE report 10689120 ↗
• InjuryJul 29, 2020Difficult or Delayed Positioning; Difficult to Insert; Activation, Positioning or Separation Problem; Difficult or Delayed Positioning; Difficult to Insert; Activation, Positioning or Separation Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 75 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE STENT GRAFT OVER A NON-MEDTRONIC GUIDE WIRE. THE GUIDEWIRE WAS EXCHANGED BY ANOTHER NON-MEDTRONIC DEVICE. IT WAS STATED THAT DIFFICULTIES WERE ENCOUNTERED, BUT THE PHYSICIAN WAS ABLE TO ADVANCE THE DEVICE TO THE LEVEL OF THE RENAL ARTERY. IT WAS REPORTED THAT ONCE THE DEVICE WAS DEPLOYED TO THE LEVEL OF THE CONTRALATERAL GATE, AN ATTEMPT WAS PERFORMED TO DEPLOY THE TIP CAPTURE, BUT IT WOULD NOT MOVE. IT WAS STATED THAT THE WHEEL WOULD MAKE FEW TURNS AND THEN STOP TURNING. SEVERAL ATTEMPTS WERE PERFORMED TO READJUST THE WIRE AND DEPLOY THE ENTIRE IPSILATERAL SIDE AND TO DEPLOY THE TIP CAPTURE WITH OUT SUCCESS. THE PHYSICIAN DECIDED TO DISASSEMBLED THE DELIVERY SYSTEM TO ATTEMPT TO MANUALLY DEPLOY THE TIP CAPTURE WITHOUT SUCCESS. IT WAS REPORTED THAT THE PHYSICIAN MOVED THE DEVICE PROXIMAL TO ATTEMPT TO DEPLOY THE DEVICE AND WERE COVERING THE RENAL ARTERY AND POSSIBLY SMA . THE PHYSICIAN TOOK A WIRE OVER THE FLOW DIVIDER TO PULL

  Patient problems: Injury; Occlusion

  MAUDE report 10338341 ↗
• MalfunctionJan 22, 2020Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55M ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE INDEX PROCEDURE WAS COMPLETED WITHOUT ANY OBVIOUS CLINICAL ISSUES. HOWEVER, FOLLOW UP CT THREE MONTHS LATER SHOWED A TYPE IA ENDOLEAK FROM A LARGE INFOLD IN THE STRAIGHT TUBE PORTION OF THE MAIN STENT GRAFT BODY. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO AN OVERSIZED STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 9615559 ↗
• InjurySep 18, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II AORTIC CUFF WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. THE CURRENT PROXIMAL AORTIC NECK DIAMETER MEASURES 32 MM. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. CT IDENTIFIED AN ENLARGING AAA AND A SUSPECTED TYPE IA/IB ENDOLEAK. INTERVENTION WAS COMPLETED AND THE PHYSICIAN ELECTED TO IMPLANT A 36 MM AORTIC CUFF, 5 ENDOANCHORS AND A 20 MM LIMB EXTENSION TO THE RCI WITH RESOLUTION OF THE ENDOLEAK CONFIRMED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Pain

  MAUDE report 9081470 ↗
• InjuryJun 10, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2014. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH PAIN. A TYPE IA ENDOLEAK WAS ID ENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT HELI-FX ENDOANCHORS AS TREATMENT AND THE ENDOLEAK WAS CONFIRMED AS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 8682668 ↗
• InjuryOct 1, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN APPROXIMATELY SIX YEARS LATER AND A CT SCAN WAS CARRIED OUT. IT WAS REPORTED THE PATIENT HAD A TYPE IA ENDOLEAK AND STRANDING, ALONG THE RIGHT SIDE OF THE STENT GRAFT. AN INTERVENTION PROCEDURE WAS CARRIED OUT AND A NON-MDT STENT WAS IMPLANTED IN THE LEFT RENAL ARTERY AS A CHIMNEY DEVICE AND AN ENDURANT II CUFF WAS IMPLANTED UP TO THE RIGHT RENAL ARTERY. IT WAS REPORTED A TYPE IA ENDOLEAK WAS STILL OBSERVED SO THE PHYSICIAN ALSO IMPLANTED SOME HELI-FX ENDOANCHORS. IT WAS REPORTED THE LEAK WAS THEN MUCH LESS. THE PHYSICIAN REPORTED THAT THE PATIENT¿S STATUS WAS MUCH IMPROVED POST OP. THE EVENT WAS REPORTED TO BE RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain; Rupture

  MAUDE report 7922381 ↗
• MalfunctionAug 7, 2018Leak/Splash; Insufficient Device Problem Information; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT, APPROXIMATELY 3.5 YEARS POST INDEX PROCEDURE, THE DURING A FOLLOW UP A CT SCAN REVEALED AN ENDOLEAK OF UNKNOWN ORIGIN. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Consequences Or Impact To Patient

  MAUDE report 7755729 ↗
• InjuryJul 24, 2018Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE ON AN UNKNOWN FOLLOW UP DATE A TYPE IA ENDOLEAK WAS IDENTIFIED. THE PATIENT RECEIVED TREATMENT WITH A NON-MEDTRONIC DEVICE WAS IMPLANTED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 7713353 ↗
• InjuryMay 23, 2018Use of Device Problem; Use of Device Problem

  A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON A CT EXAM PERFORMED APPROXIMATELY 8 YEARS POST INDEX PROCEDURE A TYPE IA ENDOLEAK WITH MIGRATION OF THE STENT GRAFT WAS OBSERVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT MAY BE RELATED TO DISEASE PROGRESSION IN THE ANEURYSMAL NECK. IT WAS REPORTED THAT AN INTERVENTION WAS CARRIED OUT TO TREAT THE TYPE IA ENDOLEAK. IT WAS PLANNED TO RELINE THE TALENT STENT GRAFT WITH A ENDURANT II BIFURCATION STENT GRAFT DURING THE PROCEDURE AND PLACE ENDOANCHORS IS THE PROXIMAL MAIN BODY DUE TO THE WIDE ANGULATED NECK. IT WAS REPORTED THAT FOLLOWING DEPLOYMENT OF THE ENDURANT II BIFURCATION STENT GRAFT IT WAS DETERMINED BY MULTIPLE ANGLED FLUOROSCOPY THAT THE GRAFT WAS LOADED BACKWARDS IN THE DELIVERY SYSTEM. THE GATE WAS 180 DEGREES FROM THE BLUE DOT ON THE DELIVERY SYSTEM. IT WAS REPORTED THAT DUE TO THIS UNPLANNED POSTERIOR POSITION, GATE CANNULATION PROVED DIFFICULT. IT WAS ALSO REPORTED THE GATE WAS SEVERELY COMPRESSED DUE TO THE EXTREME ANGULATION OF THE AORTA. THE GATE COULD NOT BE SUCCESSFULLY CANNULATED. AN AUI AND ENDURANT II LIMB

  Patient problems: Injury

  MAUDE report 7537017 ↗

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-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-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 i
• 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 aort
• 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