Endurant® II ETBF3216C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00613994990983), received between Apr 13, 2017 and Feb 13, 2025 — classified as 2 deaths, 26 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (21 reports).

2 FDA recall records 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 ↗

2. Apr 28, 2021Terminated

   Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.

   Z-1976-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• 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 21372619 ↗
• InjuryNov 15, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT AND A VALIANT CAPTIVIA STENT GRAFT WERE IMPLANTED DURING AN ENDOVASCULAR TREATMENT. 2 ENDURANT II STENT GRAFTS (ETBF3216C145E AND ETLW1616C93E) WERE IMPLANTED APPROXIMATELY 5 YEARS PREVIOUS. 2 TALENT THORACIC STENT GRAFTS (TW4238C111CP & TF4242C198CP) WERE IMPLANTED APPROXIMATELY 8 YEARS PREVIOUS. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING FROM (B)(6) 2021 FOR THE NAVION GRAFT IDENTIFIED A NEW TYPE IB ENDOLEAK. NO STENT RING ENLARGEMENT WAS OBSERVED. THE IMAGING WAS NOTED AS NE FOR FRACTURE AND STENT RING MIGRATION DUE SCAN QUALITY AND OVERLAPS. A TYPE IA ENDOLEAK ON A PROXIMAL NON-NAVION GRAFT WAS IDENTIFIED. AN UNKNOWN INTERVENTION WAS COMPLETED. THE CAUSE OF THE ENDOLEAKS ARE UNDETERMINED. IT WAS NOTED TYPE IB ENDOLEAK DUE TO COMPLETE LOSS OF SEAL ON DISTAL END OF DEVICE (NO CONTRAST GOING INTO THE ANEURYSM SAC, BUT IF THERE¿S NO SEAL AT ALL, IT¿S THE SAME AS A TYPE I (A OR B DEPENDING ON THE END). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15796103 ↗
• DeathMay 19, 2022Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED URGENTLY. CT SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK AND EVIDENCE THAT THE GRAFT WAS IMPLANTED 1CM LOW. THE PHYSICIAN CARRIED OUT A SUCCESSFUL LEFT RENAL CHIMNEY AND AN ENDURANT AORTIC CUFF PLACEMENT AT LEVEL OF THE SMA. IT WAS REPORTED THE PATIENT EXPIRED AFTER THE INTERVENTION. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK IS UNDETERMINED. THE CAUSE OF DEATH WAS AS A RESULT OF THE RUPTURED ABDOMINAL AORTIC ANEURYSM.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Ruptured Aneurysm

  MAUDE report 14434540 ↗
• MalfunctionMay 16, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2.5 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED TO HOSPITAL POST A FALL AND INCIDENTALLY ON CT A TYPE IA ENDOLEAK WAS IDENTIFIED. NO CAUSE AS PER THE PHYSICIAN WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407116 ↗
• InjuryMar 31, 2021Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 56MM AAA. IT WAS REPORTED THE PATIENT WAS PREVIOUSLY TREATED FOR A TYPE II ENDOLEAK 6 YEARS POST THE INDEX PROCEDURE. A FURTHER 3 YEARS LATER DURING FOLLOW UP CT A TYPE IA ENDOLEAK WAS OBSERVED ALONG WITH AN ENLARGED AAA. INTERVENTION WAS PERFORMED WHERE AN ENDURANT AORTIC CUFF WAS IMPLANTED AND EXTENDED UP TO THE RENAL ARTERIES. ENDOANCHORS WERE ALSO IMPLANTED AND THE PHYSICIAN IMPLANTED A ENDURANT LIMB TO EXTEND THE RIGHT ILIAC. AS PER THE PHYSICIAN THE ISSUE HAD BEEN RESOLVED AND THE ENDOLEAK THAT WAS VISUALLY APPARENT AT THE BEGINNING OF THE PROCEDURE WAS NOT VISIBLE AFTERWARDS AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY, THE PREVIOUSLY TREATED TYPE II ENDOLEAK CONTRIBUTED TO FURTHER NECK DILATION CAUSING THE TYPE IA ENDOLEAK. IT WAS REPORTED THE INITIAL ENDOGRAFT WAS PLACED 11MM BELOW THE RENALS DUE TO THE CONICAL NATURE OF THE NECK AT IMPLANT. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11594085 ↗
• InjuryMar 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 71.4 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER DEPLOYING THE GATE ON THE BIFURCATED STENT GRAFT PHYSICIAN NOTICED BLOOD DRIPPING FROM THE BLUE DEPLOYMENT HANDLE ON THE CATHETER. IT WAS STATED THAT THE PHYSICIAN CONTINUED UNTIL DEPLOYMENT WAS COMPLETED AND THE DELIVERY SYSTEM WAS REMOVED FROM THE BODY. IT WAS REPORTED THAT THE PHYSICIAN ESTIMATED THE BLOOD LOSS TO BE 300CC FROM THE DRIPPING. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11485022 ↗
• InjuryJan 21, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 85 MONTHS POST INDEX PROCEDURE, A CT WAS PERFORMED WHERE AN ENDOLEAK TYPE 1A WAS NOTED FROM THE TOP OF EXISTING ENDURANT STENT GRAFT. AN INTERVENTION WAS PERFORMED 2 DAYS LATER WHERE A CUFF WAS IMPLANTED TO RESOLVE THE ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 11207154 ↗
• InjurySep 24, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 65 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 5 YEARS AND 8 MONTHS POST IMPLANT THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURE TO THE HOSPITAL WITH A TYPE III ENDOLEAK. EVENT WAS TREATED WITH AN IMPLANTATION OF A LIMB. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS A SEPARATION OF THE LIMB FROM THE MAIN BODY, THE REASON FOR THE SEPARATION IS UNKNOWN BUT MOST LIKELY DUE TO POOR OVERLAP . NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 10578821 ↗
• InjuryJan 22, 2020Material Deformation; Material Deformation

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY ALMOST SIX WEEKS LATER WITH A DIMINISHED PULSE IN THE RIGHT GROIN AND LEG. A CT WAS PREFORMED AND FOUND THERE WAS LIMB COMPRESSION IN THE GATE OF THE RIGHT LIMB OF THE BIFURCATE DEVICE. IT WAS CONFIRMED BY IVUS THERE WAS NO COMPRESSION PRESENT IN THE STENT GRAFT LIMBS ETLW1620C124E OR ETLW1616C124E. THE LEFT LIMB OF THE DEVICE WAS FOUND TO BE PLACED AT THE FLOW DIVIDER WHILE THE RIGHT LIMB WAS PLACED APPROXIMATELY 2.5-3CM BELOW THE FLOW DIVIDER. THE COMPRESSED PORTION OF THE RIGHT LIMB MEASURED 4MM BY INTRAVASCULAR ULTRASOUND. THE PATIENT WAS BROUGHT TO OR WHERE A 16-16-93 ENDURANT LIMB WAS PLACED FROM THE RIGHT SIDE AND WAS ALIGNED EQUAL TO THE LIMB THAT WAS ON THE LEFT SIDE. TWO 14MM KISSING BALLOONS WERE INFLATED AT THE FLOW DIVIDER. POST PROCEDURE INTRAVASCULAR ULTRASOUND SHOWED EQUAL LIMBS MEASURING 9MM BY 13MM. IT WAS REPORTED THAT THE PATIENTS BLOOD FLOW IMMEDIATELY RESTORED TO THE RIGHT LEG. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROV

  Patient problems: Injury

  MAUDE report 9615867 ↗
• InjuryNov 29, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 85MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS NOTED TO HAVE GOOD EVAR ANATOMY WITH A LONG NECK AND MINOR CALCIFICATION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE UPON COMPLETION ANGIOGRAM, A LARGE BLUSH OF CONTRAST WAS NOTED BELOW THE NECK. ON REPEAT ANGIOGRAM WITH THE CATHETER PULLED FURTHER INTO THE STENT GRAFT TO ELIMINATE THE POTENTIAL OF A TYPE IA ENDOLEAK, THE ENDOLEAK WAS NOTED AGAIN. THE NECK WAS RE-BALLOONED AND ON FURTHER IMAGING WITH CO2 AS CONTRAST TO PRESERVE KIDNEY FUNCTION, THE ENDOLEAK WAS STILL PRESENT AND PERI-GRAFT. AFTER IMPLANTATION OF A CUFF THE ENDOLEAK WAS STILL PRESENT AND AFTER FURTHER IMPLANTATION OF ADDITIONAL STENT GRAFTS TO RELINE THE LIMBS THE ENDOLEAK WAS MOSTLY RESOLVED BUT STILL PRESENT MINIMALLY. THE PROCEDURE WAS COMPLETED. THE PATIENT HAD A FOLLOW-UP ULTRASOUND TWO DAYS LATER WHICH SHOWED THAT THE ENDOLEAK WAS STILL PRESENT. THE CAUSE OF THE ENDOLEAK NOTED WAS NOT PROVIDED AS PER THE PHYSICIAN. THE TYPE OF ENDOLEAK COULD NOT BE CONCLUSIVELY DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 9391441 ↗
• InjuryAug 12, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 4 YEARS POST IMPLANT, THE PATIENT DEVELOPED BACK PAIN AND A CT SHOWED A TYPE IA ENDOLEAK. A SECONDARY PROCEDURE WAS CARRIED OUT THE FOLLOWING DAY. A NON-MEDTRONIC STENT WAS PLACED IN THE SMA AND THEN AN ENDURANT CUFF (ETTF3636C70E) WAS PLACED UP TO THE LEVEL OF THE CELIAC ARTERY. AS THE CUFF WAS NOT LONG ENOUGH TO GET ADEQUATE OVERLAP IN THE ORIGINAL GRAFT A VALIANT NAVION STENT GRAFT (VNMC3737C90TU) WAS ALSO IMPLANTED. FINAL ANGIO SHOWED NO TYPE I ENDOLEAK. 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: Injury

  MAUDE report 8882845 ↗
• InjuryAug 1, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 92 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY 5 YEARS LATER WITH A RAPIDLY GROWING ANEURYSM (INCREASE OF 10MM OVER 6 MONTHS) AND BELLY PAIN. ANEURYSM EXPANSION WAS ALSO PREVIOUSLY NOTED 2 YEARS AND 6 MONTHS PREVIOUS, HOWEVER NO CAUSE WAS NOTED ON EITHER OCCASION. IT WAS ASSUMED THAT A TYPE II LEAK WAS PRESENT, AND THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFT . UPON EVACUATION OF THE AORTA, A LARGE AMOUNT OF PUS WAS NOTED, AND GRAM NEGATIVE COCCI CULTURE WAS VERIFIED. UPON VISUALIZATION, A STITCH POP/HOLE IN THE BIFURCATE STENT GRAFT WAS NOTED, WHICH WAS INVISIBLE ON THE CT SCAN WITH BLOOD SHOOTING OUT OF THE HOLE/HOLES THAT THE STITCH HAD MADE IN THE FABRIC. AFTER EXPLANT OF ALL ENDURANT STENT GRAFTS, AN ANTIBIOTIC WASH OUT OF THE INFECTED AREA WAS CARRIED OUT AND AN AXIBIFEM BYPASS WAS COMPLETED. THE PHYSICIAN DID NOT BELIEVE THE ANEURYSM GROWTH TO BE RELATED TO THE STENT GRAFT LEAK, BUT RATHER TO THE INFECTION. THE CAUSE OF THE STITCH/POP HOLE IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain; Aneurysm; Unspecified Infection

  MAUDE report 8849777 ↗
• InjuryMar 5, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED 37.5 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD SMALL EXTERNAL ILIACS AND A TORTUOUS AORTA. THERE WAS A CONSIDERABLE AMOUNT OF HEMATOMA PRESENT IN THE PATIENT'S ABDOMEN AFTER THE PRE-OPERATIVE RUPTURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE DELIVERY SYSTEM WAS TORQUED INSIDE THE PATIENT ANATOMY TO PROPERLY ALIGN THE GATE. THE DEVICE WAS DEPLOYED. DURING REMOVAL OF THE DELIVERY SYSTEM, THE SYSTEM CAUGHT IN THE DISTAL ASPECT OF THE IPSI-LATERAL LIMB, AT THE JUNCTION OF THE COMMON ILIAC AND THE EXTERNAL ILIAC. WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT'S COMMON FEMORAL ARTERY, IT WAS NOTED THAT THE PART OF THE DELIVERY SYSTEM THAT HAD CAUGHT DURING REMOVAL WAS TWISTED AND CRIMPED. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED PARAPLEGIA AND THE HYPOGASTRICS WERE BILATERALLY OCCLUDED AFTER THE PROCEDURE. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS DUE TO SEVERAL POSSIBLE CONTRIBUTING FACTORS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Occlusion; Paralysis

  MAUDE report 8390310 ↗
• InjuryFeb 25, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR OF A 52 MM ABDOMINAL AORTIC ANEURYSM. AFTER THE BIFURCATED STENT GRAFT, TWO LIMBS AND AN AORTIC CUFF WERE IMPLANTED A SMALL ENDOLEAK WAS NOTED ON THE PATIENT¿S RIGHT SIDE, DIRECTLY ABOVE THE FLOW DIVIDER. THE PHYSICIAN DECIDED TO RE-BALLOON WITH A RELIANT, HOWEVER, ANOTHER ARTERIOGRAM STILL SHOWED THE ENDOLEAK IN THE SAME PLACE. A PIGTAIL CATHETER WAS THEN PLACED INSIDE THE GRAFT AND ANOTHER INTRA-OPERATIVE ARTERIOGRAM WAS PERFORMED. THE ENDOLEAK AGAIN APPEARED IN THE SAME PLACE. AS PER THE PHYSICIAN, THE ENDOLEAK WAS EITHER A TYPE IV OR A TYPE IIIB. THE PHYSICIAN, THEN DECIDED TO PLACE TWO ADDITIONAL LIMBS ETLW1616C93E ON THE RIGHT AND ETLW1616C124E ON THE LEFT APPROXIMATELY 2CM ABOVE THE FLOW DIVIDER, TRY AND UTILIZE MORE FABRIC INSIDE THE BIFURCATED STENT GRAFT. TWO RELIANT BALLOONS WERE PLACED INSIDE THE LIMBS AND THE KISSING TECHNIQUE WAS CARRIED OUT TO FULLY EXPAND THE LIMBS. HOWEVER DURING INFLATION, THE PATIENT¿S BLOOD PRESSURE DROPPED. AN INTRA-OPERATIVE ARTERIOGRAM WAS PERFORMED, AND EXTRAVASATION WAS NOTICED NEAR THE RENAL ARTERIES WHICH DEMONSTRATED A RUPTURE OF THE AORTA. THE PHYSICIAN TH

  Patient problems: Rupture

  MAUDE report 8366572 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TWO DAYS LATER AND IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE CELIAC BRANCHES WERE MIS-IDENTIFIED AS THE RENAL ARTERIES AND AS A RESULT THE STENT GRAFT WAS PLACED ACROSS BOTH RENAL ARTERIES AND SMA. IT WAS REPORTED THAT WHILE THE STENT GRAFT WAS HIGHER THAN ANTICIPATED THE STENT GRAFT DID EXCLUDE THE ANEURYSM. THE PATIENT WAS PLACED ON DIALYSIS. AS THE MESENTERIC ARTERY WAS BEING PERFUSED BY A PATENT CELIAC ARTERY IT WAS DECIDED THAT ADDITIONAL TREATMENT WAS NOT REQUIRED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Occlusion

  MAUDE report 7974008 ↗
• InjuryOct 17, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 57MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING PATIENT FOLLOW UP, A TYPE IA ENDOLEAK WAS OBSERVED ON CT. ON AN UNKNOWN DATE INTERVENTION WAS CARRIED OUT WITH THE ADDITION OF AN AORTIC CUFF AND HELI-FX ENDOANCHORS WERE IMPLANTED. THE EVENT DID NOT RESOLVE. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AN THE PATIENT WILL BE MONITORED.

  Patient problems: Injury; Thrombus

  MAUDE report 7973064 ↗
• MalfunctionOct 9, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 65MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PRE-OP IMAGES DEMONSTRATED A POSSIBLE FOCAL DISSECTION OR PSEUDOANEURYSM AT THE LEVEL OF THE RENAL ARTERIES. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE ON FOLLOW UP CT, A TYPE IA ENDOLEAK WAS IDENTIFIED. CONTRAST WAS IDENTIFIED OUTSIDE THE MOST PROXIMAL PORTION OF THE STENT GRAFT HOWEVER THERE WAS NO CONTRAST IN THE SAC OF THE ANEURYSM. WHILE THE PHYSICIAN HAD CONCERNS THE CURRENT FILLING DEFECT OBSERVED WAS RELATED TO THE PRE-OP SUSPECTED DISSECTION IT HAS BEEN NOTED THAT THERE IS NO RISK CURRENTLY POSED TO THE PATIENT WITH NO INTERVENTION PLANNED. THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7946335 ↗
• MalfunctionAug 30, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY THREE AND A HALF YEARS LATER, DURING PATIENT FOLLOW UP A TYPE IA ENDOLEAK WAS IDENTIFIED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832031 ↗
• InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT THE PATIENTS¿ DAUGHTER CONTACTED TECHNICAL SERVICES APPROX. 6 YEARS POST INDEX PROCEDURE AND STATED THAT THE PATIENTS ¿LEG STENTS¿ INITIALLY FAILED AND AN ADDITIONAL PROCEDURE WAS PERFORMED TO CORRECT THE ISSUE. THE PATIENTS¿ DAUGHTER ALSO STATED THAT SHE BELIEVES THE STENT GRAFTS CAUSED DEMENTIA IN HER FATHER. PER THE PHYSICIAN THE INDEX PROCEDURE WAS SUCCESSFUL WITH AN EXCEPTIONAL FINAL RESULT. POST THE INDEX PROCEDURE THE INCORRECT HYPERTENSIVE MEDICATIONS WERE ADMINISTERED WHICH LED TO SEVERE HYPOTENSION AND A HYPERCOAGULABLE STATE. IT WAS ALSO REPORTED THE PATIENT HAD A CARDIOPULMONARY ARREST. THE PATIENT DEVELOPED BI-LATERAL LIMB THROMBOSIS FROM LOW BLOOD PRESSURE. THE PHYSICIAN PERFORMED A BI-LATERAL THROMBECTOMIES TO CLEAR THE CLOTS. AN ANGIOPLASTY WAS ALSO COMPLETED WITH THE EXTERNAL AND COMMON ILIACS INCLUDING THE RIGHT EXTERNAL ILIAC STENTED. THE PATIENTS THROMBOSED LIMBS WERE OPENED AND FLOW WAS RESTORED. THE PATIENT WAS DISCHARGED AND 2 POST UP CTS SHOWED FAVORABLE CLINICAL STATUS. THIS PATIENT WAS LOST TO FOL

  Patient problems: Cardiac Arrest; Dementia; Low Blood Pressure/ Hypotension; Occlusion

  MAUDE report 7825860 ↗
• InjuryAug 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 A 53MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY ONE WEEK LATER THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A CT SCAN WAS PERFORMED AND A POSSIBLE TYPE II OR IV ENDOLEAK WAS IDENTIFIED. A TYPE III JUNCTIONAL ENDOLEAK AT THE FLOW DIVIDER WAS ALSO OBSERVED. INTERVENTION WAS PERFORMED THE FOLLOWING DAY TO RELINE AND EXTEND THE LEFT LIMB AND RESOLVE THE TYPE III ENDOLEAK HOWEVER THE POSSIBLE TYPE II OR TYPE IV ENDOLEAK PERSISTED. THE PATIENT AGAIN PRESENTED EMERGENTLY APPROXIMATELY FOUR WEEKS LATER WITH THE SAME VAGUE ABDOMINAL SYMPTOMS AND WAS RE-IMAGED. IT WAS DETERMINED THAT THE AAA WAS EFFECTIVELY EXCLUDED, HOWEVER THE POSSIBLE TYPE II/IV ENDOLEAKS REMAIN. THE PATIENT WAS DISCHARGED HOME. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO POOR GATE OVERLAP AND NOTED THAT WHEN CHOOSING THE CONTRA LIMB LENGTH IT WAS FELT A 124 LENGTH MIGHT BE TOO LONG (AND COVER THE HYPOGASTRIC) SO A 93MM LENGTH LIMB WAS CHOSEN WITH A PLAN TO STRETCH AND LENGTHEN. IT APPEARS IN DOING SO ADEQUATE JUNCTIONAL OVERLAP IN THE GATE WAS NOT ACHIEVED. NO ADDITIONAL CLINICAL

  Patient problems: Abdominal Pain; Aneurysm; Injury

  MAUDE report 7756790 ↗
• InjuryJul 24, 2018Material Rupture; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROX. 4 YEARS POST INDEX PROCEDURE WITH A RUPTURE AT THE PROXIMAL ASPECT OF THE ENDURANT II BIFURCATED STENT GRAFT AND THE RIGHT RENAL ARTERY. THE PATIENT RECEIVED INTERVENTION WITH THE ADDITION OF AN ENDURANT CUFF AND 5 ENDOANCHORS. THE EVENT WAS REPORTED TO HAVE BEEN RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Code Available; Rupture

  MAUDE report 7713316 ↗
• InjuryMay 8, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON CT EXAM REVEALED A TYPE IA AND TYPE IB ENDOLEAK ON THE RIGHT SIDE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS RELATED TO LOSS OF SEAL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7493730 ↗
• InjuryJan 9, 2018Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 56.5MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PATIENTS PROXIMAL AORTIC NECK DIAMETER RANGED FROM 21-31MM AND WAS 7-8MM IN LENGTH. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE ENDURANT BIFURCANT WAS DEPLOYED 5MM LOWER THAN THE RENAL ARTERY, LEADING TO A TYPE IA ENDOLEAK. AN ENDURANT CUFF WAS IMPLANTED BUT THE TYPE IA ENDOLEAK WAS STILL OBSERVED. THE PHYSICIAN DEPLOYED 8 ENDOANCHORS AT THE PROXIMAL PART OF THE GRAFT AND STILL OBSERVED A POSSIBLE LATE TYPE IA ENDOLEAK. THE EVENT HAS NOT RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO A VERY SHORT CONICAL NECK WITH ONLY 7MM OF POSSIBLE SEAL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN.

  Patient problems: Injury

  MAUDE report 7174351 ↗
• MalfunctionNov 28, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 52 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT SCAN PERFORMED APPROXIMATELY 3 YEARS POST INDEX PROCEDURE SHOWED WHAT WAS THOUGHT TO BE A TYPE II ENDOLEAK. DURING THE SCAN IT WAS ALSO NOTED THAT THE AAA HAS GROWN FROM 5.2 CM AT IMPLANT TO 5.5 CM. AFTER FURTHER REVIEW OF THE CT SCAN AND THE ANGIOGRAM IT WAS DETERMINED THAT THE PATIENT HAS A PROXIMAL TYPE 1 ENDOLEAK. PER THE PHYSICIAN THE EVENT WAS ANATOMY RELATED (DISEASE PROGRESSION). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7062632 ↗
• InjuryNov 16, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK DIAMETERS WERE 25.9 MM AT 15 MM ABOVE THE RIGHT RENAL, 26.1 MM AT THE RIGHT RENAL, 28.3 MM AT 15 MM BELOW THE RIGHT RENAL, AND 30.1 MM AT 30 MM BELOW THE RIGHT RENAL. THE RCIA AND LCIA HAD 40 DEGREES LAO AND 35 DEGREES RAO RESPECTIVELY. IT WAS REPORTED THAT A CT EXAM PERFORMED APPROXIMATELY 2 MONTHS POST INDEX PROCEDURE, REVEALED STENT GRAFT OCCLUSION. AN ANGIOGRAM COMPLETED 2 DAYS LATER REVEALED THAT THERE WERE NO KINKS IN THE STENT GRAFT; HOWEVER, THE STENT GRAFT WAS OCCLUDED UP TO THE BIFURCATION OF THE ENDURANT STENT GRAFTS. THE PHYSICIAN ELECTED TO DO THROMBOLYSIS AND IMPLANTED A SELF-EXPANDING BARE METAL STENT. THE BLOOD FLOW WAS RESTORED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT¿S ANATOMY; TORTUOUS ANATOMY AND DISRUPTION OF VESSEL DISTAL TO STENT GRAFT CAUSING THE OCCLUSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 7036308 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100021. One submission often covers many models, so check the product and lot details in each record.

• Z-0292-2022 · Oct 15, 2021 · Open, Classified
  Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STEN
• Z-0291-2022 · Oct 15, 2021 · Open, Classified
  Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT G
• Z-0290-2022 · Oct 15, 2021 · Open, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• Z-2135-2021 · Jun 7, 2021 · Open, Classified
  Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat 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