Endurant® II ETBF2813C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00613994991300), received between Jan 24, 2017 and Jan 13, 2026 — classified as 1 death, 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (14 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT, PRESENTING WITH NAUSEA AND VOMITING 3 DAYS AFTER THE IMPLANTATION OF AN ENDURANT II STENT GRAFT SYSTEM. THE PATIENT STATED THAT THEY HAD NOT HAD A BOWEL MOVEMENT IS 2 DAYS. THE PATIENT WAS DIAGNOSED WITH CONSTIPATION, OBSTRUCTION, ELECTROLYTE IMBALANCE, POST-SURGICAL PAIN AND GASTRITIS. TREATMENT INCLUDED THE ADMINISTRATION OF ANALGESICS, ANTIEMETICS, AND ANTIHISTAMINES. THE EVENT WAS REPORTED TO HAVE RESOLVED THE FOLLOWING DAY. THE SITE ASSESSED THE NAUSEA AND VOMITING AS NOT RELATED TO THE DEVICE, INDEX PROCEDURE OR AN UNDERLYING CONDITION AND/OR DISEASE. THE SPONSOR ASSESSED THE EVENT AS HAVING A CAUSAL RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Constipation; Electrolyte Imbalance; Gastritis; Nausea; Pain; Vomiting

  MAUDE report 24051102 ↗
• InjuryNov 10, 2025Fracture; Leak/Splash; Migration or Expulsion of Device; Detachment of Device or Device Component; Fracture; Leak/Splash; Migration or Expulsion of Device; Detachment of Device or Device Component

  AN ETBF2813C166E STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS REPORTED THAT 3 WEEKS LATER THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ABDOMINAL PAIN AND THE AAA MEASURING 90MM. A CT REVEALED THAT THE SUPRA-RENAL STENT HAD DETACHED FROM THE MAIN BODY OF THE ENDURANT STENT GRAFT AND THE ENDURANT STENT GRAFT HAD MIGRATED INTO THE ABDOMINAL AORTIC ANEURYSM SAC. AN ATTEMPTED REPAIR OF THE STENT MIGRATION WAS PERFORMED USING THREE NON-MDT (GORE 31X100 CTAG) DEVICES. A IA ENDOLEAK REMAINED. DUE TO THE PERSISTENT TYPE 1A ENDOLEAK, A 32X32X49 ENDURANT CUFF WAS SUBSEQUENTLY PLACED TO ADDRESS AND SUCCESSFULLY RESOLVE THE ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain

  MAUDE report 23508740 ↗
• InjuryMay 26, 2025Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM (ETBF2813C166E, ETLW1616C93E, ETEW1313C82E AND ETLW1613C124E) WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA . A ETLW1610C124E LIMB WAS IMPLANTED APPROXIMATELY 9 YEARS LATER. THE REASON FOR THIS PROCEDURE IS UNKNOWN. WHEN THE PATIENT RETURNED FOR FOLLOW-UP, A TYPE IA AND A TYPE IB ENDOLEAK WERE NOTED. THE ANEURYSM MEASURED 55MM. INTERVENTION WAS PERFORMED ONE DAY LATER WHERE A ETLW1624C124E AND ETCF3232C49E WERE IMPLANTED AS TREATMENT. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS WAS ANATOMY, SPECIALLY AORTIC NECK DILATION AND ILIAC DISEASE PROGRESSION.

  Patient problems: Insufficient Information

  MAUDE report 22083620 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 65MM AAA. IT WAS NOTED THAT FOLLOW-UP APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE SHOWED NO ENDOLEAKS. IT WAS REPORTED APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURE ON THE POSTERIOR WALL OF THE ANEURYSM NECK APPROXIMATELY 30MM DOWN FROM THE RENAL ARTERIES. THE PHYSICIAN EXPLANTED THE ENDURANT STENT GRAFT AND PLACED A NON-MDT TUBE GRAFT. PER THE PHYSICIAN THE CAUSE OF THE RUPTURE IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 20492185 ↗
• InjuryJan 16, 2024Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. IT WAS REPORTED THAT A CT PERFORMED ON AN UNKNOWN DATE, IDENTIFIED A POSSIBLE TYPE IA ENDOLEAK. UPON FURTHER REVIEW OF THE CT, THERE WAS SOME CONTRAST NOTED AROUND THE PROXIMAL END OF THE GRAFT AND THE RIGHT RENAL ARTERY WAS NO LONGER FUNCTIONING. IT WAS REPORTED THAT THE RIGHT RENAL KIDNEY FAILURE WAS AN ACCIDENTAL FINDING ON THE CT. THE REDUCED RENAL FUNCTION WAS NOT A RESULT OF THE ENDOLEAK AND WAS NOT CAUSED BY THE STENT GRAFT. THERE WAS ABOUT 15MM OF SPACE ABOVE THE BIFURCATE GRAFT. APPROXIMATELY 8 YEARS AND 5 MONTHS AFTER THE INDEX PROCEDURE, , THE PHYSICIAN PLACED AND ENDURANT 26 X 36 X 49 AORTIC CUFF INSIDE THE BIFURCATE UP TO THE LEVEL OF THE RENAL ARTERY. THE CUFF WAS THEN BALLOONED. AN ANGIOGRAM WAS PERFORMED AND THE APPARENT LEAK WAS RESOLVED. DURING THE FINAL ANGIOGRAM, IT WAS NOTED THAT BOTH COMMON ILIAC ARTERIES HAD EXPANDED DISTAL TO THE GRAFT LIMBS. THERE WAS NO APPARENT ENDOLEAK OR LOSS OF DISTAL SEAL, BUT THE PHYSICIAN DECIDED TO THEN EXTEND BOTH LIMBS TO PREVENT ANY FURTHER DILATION. THE PHYSICIAN PLACED A 16X16X93 IN BOTH ILIAC ARTERIES EXTENDING DOWN TO THE INTE

  Patient problems: Insufficient Information

  MAUDE report 18515949 ↗
• MalfunctionJul 18, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED A FOLLOW UP CTA IDENTIFIED A SMALL TYPE IA ENDOLEAK. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SOB ON THE FOLLOWING MONTH AND THE PHYSICIAN WAS ASKED TO REVIEW. CARDIOLOGY WERE ALSO CONSULTED. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED.  NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL MONITORED.

  Patient problems: Dyspnea

  MAUDE report 17341376 ↗
• InjuryOct 24, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE THE PATIENT HAD AN OPEN AORTIC REPAIR COMPLETED WITH EXPLANT OF THE GRAFTS DUE TO ANEURYSMAL GROWTH FROM 6.9CM TO 7.5CM IN SIX MONTHS. IT WAS ALSO NOTED THAT THE PATIENT HAS HAD MULTIPLE INTERVENTIONS IN THE PAST TO CORRECT TYPE II ENDOLEAKS. PER THE PHYSICIAN THE REASON FOR THE EXPLANT WAS DUE TO AAA GROWTH. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15657208 ↗
• InjuryMay 20, 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 FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT IS REPORTED THE PATIENT PRESENTED FOR ISSUES UNRELATED TO THEIR ABDOMINAL AORTIC ANEURYSM. A CT WAS PERFORMED AND AN INCIDENTAL FINDING OF TYPE IA ENDOLEAK WAS OBSERVED. AN ABDOMINAL ANGIOGRAM WAS PERFORMED A FEW DAYS LATER AND IT WAS ALSO NOTED THE GRAFT APPEARS TO HAVE PARTIALLY SEPARATED FROM THE SUPRARENAL STENT.  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK AND SEPARATION CANNOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 14460884 ↗
• InjuryMay 13, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 52MM ABDOMINAL AORTIC AN EURYSM. IT WAS REPORTED THAT PATIENT HAD A CT, IT WAS NOTED THAT THERE IS A TYPE IA ENDOLEAK FROM THE TOP OF THE GRAFT 2CM DISTAL TO THE LOWEST RENAL ARTERY AND A POSSIBLE QUESTIONABLE TYPE III ENDOLEAK AT THE FLOW DIVIDER. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 14390809 ↗
• MalfunctionFeb 23, 2022Device Damaged Prior to Receipt by User; Detachment of Device or Device Component; Device Damaged Prior to Receipt by User; Detachment of Device or Device Component

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT DURING THE ENDOVASCULAR TREATMENT OF A 62MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, ONCE THE GRAFT WAS IN PLACE AND BEING DEPLOYED THE DISTAL END OF THE DEPLOYMENT SYSTEM WAS DISCOVERED TO BE BROKEN. AFTER FURTHER INVESTIGATION THE GRAFT BOX WAS DISCOVERED TO BE BENT AS WELL AS THE BOX USED TO SHIP THE DEVICE. PER THE PHYSICIAN THE CAUSE OF THE DEPLOYMENT SYSTEM TO BE BROKEN WAS SUGGESTED TO BE RELATED TO THE DAMAGE ON THE SHIPPING BOX RECEIVED.  NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT IS ALIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583636 ↗
• 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 YEARS 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: Rupture

  MAUDE report 12645466 ↗
• InjuryAug 31, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 70MM AAA . IT WAS REPORTED THE PATIENT HAD AN ELEVATED HAEMATOCRIT POST OP OF INDEX PROCEDURE AND A CTA WAS PERFORMED 2 DAYS POST PROCEDURE TO DETERMINE IF THERE WAS A BLEED. THE IMAGES SHOWED NO EVIDENCE OF BLEED, HOWEVER A TYPE IA ENDOLEAK AND A SUSPECTED TYPE IB (FROM THE LEFT SIDE) WERE OBSERVED ON CT. AN ANGIOGRAM WAS PERFORMED 4 DAYS LATER WHERE A TYPE IB WAS RULED OUT BUT THE TYPE IA WAS CONFIRMED, IT WAS REPORTED THERE WAS APPROXIMATELY 1CM BELOW THE LOWEST RENAL ARTERY ON THE LEFT AND THE TOP OF THE FABRIC OF THE ENDURANT BIFURCATED GRAFT. AN ENDURANT CUFF WAS ADDITIONALLY IMPLANTED TO RESOLVE THE ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO AN INADEQUATE PROXIMAL SEAL IN THE NECK OF THE INFRA-RENAL AORTA NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12390801 ↗
• InjuryJan 21, 2020Leak/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 7 YEARS AND 2 MONTHS POST INDEX PROCEDURE THE PATIENT¿S FOLLOW UP CT SHOWED THAT THE PATIENT¿S RIGHT COMMON ILIAC ARTERY HAD ENLARGED TO APPROXIMATELY 90MM AND IT APPEARED TO BE LEAKING THOUGH THE LIMB OF THE BIFURCATED STENT GRAFT. THE PATIENT WAS BROUGHT TO THE OR AND ANGIOGRAMS SHOWED THE RIGHT LIMB WAS LEAKING CONTRAST. THE ENDOLEAK WAS CONFIRMED TO BE A TYPE III FABRIC. THE PHYSICIAN DECIDED TO PLACE AN ADDITIONAL STENT GRAFT LIMB WHERE THE LEAK WAS OCCURRING AND FINAL ANGIO SHOWED THAT THE ENDOLEAK HAS RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9611398 ↗
• InjuryDec 13, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 42MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 6 YEARS AND 4 MONTHS POST IMPLANT WITH INCREASING BACK AND FLANK PAIN. CTA SHOWED A TYPE IA AND TYPE IB ENDOLEAK WITH SIGNIFICANT DILATION OF BOTH COMMON ILIAC ARTERY'S (LEFT CIA>70MM) AND EXPANSION OF THE PROXIMAL AORTIC NECK. IT WAS CONFIRMED THAT THE BIFURCATE STENT GRAFT WAS NOT INVOLVED IN THE TYPE IB ENDOLEAK. THE LEFT COMMON ILIAC LIMB APPEARED TO BE ¿FLOATING¿ IN THE COMMON ILIAC SPACE. TREATMENT WAS PERFORMED THE FOLLOWING DAY AND IT WAS DECIDED TO EXTEND BILATERALLY IN THE EIA'S ALONG WITH COIL EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY. BILATERAL CHIMNEY GRAPHS WERE ALSO PLACED IN BOTH RENALS TO FACILITATE EXTENSION OF THE COVERAGE TO THE LEVEL OF THE SMA. THE ENDOLEAKS WERE RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO LOSS OF THE PATIENT TO FOLLOW UP - LOSS OF APPOSITION OF THE STENT GRAFT, DUE TO THE DILATION OF THE PATIENT'S VESSELS, THAT LEAD TO THE ENDOLEAKS WAS NOT SEEN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9464963 ↗
• InjuryJul 23, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT REVEALED A TYPE IA ENDOLEAK AS WELL AS PROBABLE BILATERAL TYPE IB ENDOLEAKS WITH AAA EXPANSION. INTERVENTION WAS COMPLETED ON BY IMPLANTING A CUFF AND 9 ENDOANCHORS PROXIMALLY AND EXTENDING BOTH LIMBS. AN ANGIOGRAM WAS COMPLETED DEMONSTRATING COMPLETE RESOLUTION OF ALL ENDOLEAKS. PER THE PHYSICIAN THE CAUSE OF THE IA ENDOLEAK WAS LIKELY DUE TO AORTIC DILATATION WHICH CAUSED THE AAA TO DILATE AS WELL AS THE ILIACS UNTIL THE LIMBS LOST SEAL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8816697 ↗
• DeathNov 29, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 54MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS DESCRIBED AS REVERSE CONICAL AND ANTERIORLY ANGLED. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, DURING THE INITIAL IMPLANTATION OF THE STENT GRAFT THERE WAS A TYPE IA ENDOLEAK NOTED. AFTER A SERIES OF BALLOONING OF THE PROXIMAL NECK WITH THE RELIANT BALLOON, ANOTHER ANGIOGRAM WAS PERFORMED. AT THIS STAGE, THE TYPE IA ENDOLEAK BECAME MORE PRONOUNCED. THE PHYSICIAN IMPLANTED AN AORTIC CUFF TO REPAIR THE TYPE IA ENDOLEAK. AFTER THE CUFF WAS IMPLANTED IT WAS NOTED ON THE ANGIOGRAM THAT THE DEVICE WAS PLACED OVER BOTH RENAL ARTERIES. THE PHYSICIAN PERFORMED A SERIES OF TECHNIQUES TO REPOSITION THE STENT GRAFT, BUT IT WAS UNSUCCESSFUL. THE STENT GRAFT WAS THEN PUSHED FURTHER SUPERIORLY THROUGH MANIPULATION OF TRYING TO BRING THE CUFF MORE DISTAL. THE PATIENT WAS MOVED TO THEATRE FOR EXPLANTATION OF THE AORTIC CUFF. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE REVERSE CONICAL AND ANTERIORLY ANGLED PROXIMAL NECK ANATOMY OF THE PATIENT. IT WAS REPORTED THAT THE PATIENT EXPIRED THE NEXT DAY FROM A MYOCARDIAL INFA

  Patient problems: Death; Myocardial Infarction

  MAUDE report 7066184 ↗
• InjuryJul 26, 2017Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS INSERTED IN A IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 63 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 23 MM IN DIAMETER AND 15 MM IN LENGTH WITH 10 DEGREE ANGULATION. IT WAS REPORTED THAT POST IMPLANT THE BALLOON PULLED THE BIFUR DISTAL ENOUGH TO CREATE TYPE 1 ENDOLEAK. THIS WAS IMMEDIATELY RESOLVED WITH AN AORTIC CUFF. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED (CONICAL NECK). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6744870 ↗
• InjuryJan 24, 2017Adverse 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 4.8 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED AT A ROUTINE FOLLOW UP APPOINTMENT. THE PATIENT INFORMED THE PHYSICIAN THAT THE ENDURANT STENT GRAFTS HAD BEEN EXPLANTED AND AN OPEN SURGICAL REPAIR WAS PERFORMED DUE TO A SYSTEMIC INFECTION THAT HAD CAUSED THE STENT GRAFT TO BECOME INFECTED AT ANOTHER FACILITY. PER THE EXPLANTING PHYSICIAN, THE INFECTION WAS NOT A STENT GRAFT PROBLEM OR RELATED TO THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6274096 ↗

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