Endurant® II ETBF2813C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00613994991294), received between Mar 9, 2017 and May 25, 2026 — classified as 2 deaths, 14 injuries.

The most frequently reported specific device problem is “Leak/Splash” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• DeathMay 25, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 50 MM ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY 9.5 YEARS LATER WITH A RUPTURED ANEURYSM. IT WAS NOTED THAT THE PATIENT HAD A FALL AT THEIR HOME 3 DAYS BEFORE. TOTAL OCCLUSION OF THE RIGHT ILIAC LIMB, NOTED AS THE IPSILATERAL LIMB OF THE BIFURCATE WAS ALSO IDENTIFIED ON THE CT SCAN. AN ENDOLEAK WAS IDENTIFIED AND WAS SUSPECTED TO BE A TYPE III FABRIC ENDOLEAK. A 28 AUI STENT GRAFT WAS THEN IMPLANTED VIA THE LEFT SIDE BUT THE ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN ATTEMPTED TO ACCESS THE RIGHT LIMB BY CUTTING DOWN ON THE COMMON FEMORAL BUT WERE UNABLE TO PASS A WIRE UP THE LIMB SO NO THEY COULD NOT PERFORM ANY TREATMENT TO RESTORE FLOW. THE PRE-OPERATIVE CTA PERFORMED SHOWED THE RIGHT LIMB TOTALLY OCCLUDED , HOWEVER, THERE WAS SOME FLOW INTO THE RIGHT LIMB OBSERVED DURING THE PROCEDURAL ANGIOGRAM. IT WAS REPORTED THAT THE PATIENT EXPIRED ON THE SAME DAY. ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS ATTRIBUTED TO THE TYPE III ENDOLEAK FOLLOWING TRAUMA.

  Patient problems: Obstruction/Occlusion; Rupture

  MAUDE report 25268466 ↗
• InjuryDec 21, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 66MM AAA. IT WAS NOTED THAT THE DIAMETER AT IMPLANT OF THE RENAL ARTERY WAS 22-25MM, THE LENGTH OF PROXIMAL NECK AT IMPLANT WAS 37MM AND THE DEGREE OF ANGULATION WAS 120 DEGREES. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE FOLLOWING IMPLANTATION OF THE BIFURCATE STENT GRAFT AND 2 LIMBS, AN ANGIOGRAM SHOWED A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO ADD AN AORTIC EXTENSION CUFF PROXIMALLY TO CORRECT THE ENDOLEAK. AFTER THE CUFF WAS PLACED, AN ANGIOGRAM NO LONGER DEMONSTRATED BLOOD FLOW INTO THE RIGHT RENAL ARTERY. NUMEROUS ATTEMPTS WERE MADE TO CANNULATE THE RIGHT RENAL ARTERY WITH CATHETERS AND WIRE BUT NONE WERE SUCCESSFUL. THE PATIENT RECEIVED A TEMPORARY DIALYSIS CATHETER PRIOR TO LEAVING THE PROCEDURE ROOM. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO THE ANGULATION OF THE INFRARENAL AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 18371166 ↗
• InjuryApr 8, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED IN THE EMERGENCY WITH BACK PAIN. IT WAS NOTED THAT PATIENT HAD A AAA RUPTURE AND THE STENT GRAFT WAS EXPLANTED. THE GRAFT WAS INTACT WHEN IT WAS EXPLANTED. A SURGICAL GRAFT WAS IMPLANTED DURING THE INTERVENTION. PER PHYSICIAN, THE CAUSE OF ENDOLEAK/RUPTURE COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain; Rupture

  MAUDE report 14051174 ↗
• InjuryMay 17, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 7 YEAR POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH COMPLAINTS OF BACK PAIN. A CT WAS PERFORMED, WHERE A TYPE 1A POSTERIOR ENDOLEAK WAS NOTED. AN ENDURANT 3232C49E AORTIC EXTENSION CUFF WAS PLACED. THE EVENT WAS RESOLVED. 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 11832500 ↗
• InjuryMar 1, 2021Leak/Splash; Leak/Splash

  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 A FINAL ANGIOGRAM WAS PERFORMED, WHERE A TYPE 1A ENDOLEAK WAS NOTED. 7 ENDOANCHORS WERE IMPLANTED BUT THE ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN THEN DECIDED TO PLACE ETCF2828C49E CUFF. THE EVENT WAS RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO A SLIGHTLY ANGULATED AORTIC NECK, WHICH CAUSED THE GRAFT TO LAND APPROXIMATELY 3MM BELOW LEFT RENAL. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11392945 ↗
• InjuryDec 18, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 47MM RUPTURED ABDOMINAL AORTIC ANEURYSM ON THE (B)(6) 2015. IT WAS REPORTED THE PATIENT PRESENTED TO EMERGENCY ROOM WITH BACK PAIN AND A CT WAS PERFORMED APPROXIMATELY 5 YEARS AND 8 MONTHS POST IMPLANT. THE PHYSICIAN STATED IT LOOKED LIKE THE STENT GRAFT HAD BEEN PLACED LOW AND ENDOANCHORS WERE THEN IMPLANTED. A IA ENDOLEAK WAS DIAGNOSED ON THIS CT. INTERVENTION WAS PERFORMED ON THE SAME DATE, AN ENDURANT CUFF AND 4 ENDOANCHORS WERE IMPLANTED. 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: Pain

  MAUDE report 11035741 ↗
• InjurySep 23, 2019Fracture; Leak/Splash; Fracture; 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 PATIENT HAD ANEURYSM GROWTH WITHOUT EVIDENCE OF ANY ENDOLEAK. AN INTERVENTION PROCEDURE WAS CARRIED OUT APPROXIMATELY FOUR YEARS AND NICE MONTHS POST THE INDEX PROCEDURE AND AN ENDURANT STENT GRAFT CUFF ETCF3232C49E, ENDURANT STENT GRAFT LIMB ETLW1620C93E AND ENDURANT STENT GRAFT LIMB ETLW1613C93E WERE IMPLANTED IN THE PATIENT AS TREATMENT. IT WAS REPORTED THAT NO ENDOLEAK WAS SEEN DURING THE PROCEDURE. THE PATIENT THEN PRESENTED WITH ABDOMINAL PAIN APPROXIMATELY ONE MONTH LATER AND CT SHOWED AN ENDOLEAK THAT APPEARED TO ORIGINATE ABOVE THE FLOW DIVIDER OF THE ORIGINAL BIFURCATED STENT GRAFT. THE GENERAL AREA OF THE ENDOLEAK WAS CONFIRMED BY ANGIO DURING AN INTERVENTION PROCEDURE CARRIED OUT THE FOLLOWING DAY. IT WAS REPORTED THAT AN ENDURANT AUI DEVICE WAS IMPLANTED AS TREATMENT. IT WAS ALSO REPORTED THAT BALLOONING WAS THEN CARRIED OUT WITH A RELIANT BALLOON, HOWEVER THE RELIANT BALLOON BURST WHEN IN THE AREA ABOVE THE FLOW DIVIDER. FURTHER ANGIO SHOWED THAT CONTRAST APPEARED TO BE LEAKING INTO THE ORIGINAL BIFURCATED STENT GRAFT AND IN

  Patient problems: Aneurysm; Pain

  MAUDE report 9104163 ↗
• InjuryAug 21, 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 DURING PATIENT FOLLOW UP, A CT SCAN IDENTIFIED AN OCCLUSION. IT WAS REPORTED THAT THE LEFT SIDE OF THE GRAFT BECAME OCCLUDED, WITH THE OCCLUSION BEGINNING AT THE FLOW DIVIDER AND EXTENDING THROUGH THE EXTERNAL ILIAC ARTERY. BLOOD FLOW IS THEN RESUMING IN THE FEMORAL ARTERY. THE PHYSICIAN ATTEMPTED TO PERFORM A THROMBECTOMY, BUT WAS UNSUCCESSFUL AND A FEM-FEM BYPASS WAS PERFORMED INSTEAD. THE ISSUE WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNCERTAIN BUT THE PHYSICIAN NOTED THAT THE OCCLUSION MAY HAVE ORIGINATED AT THE NARROWING AT THE PROXIMAL LEFT COMMON ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Occlusion

  MAUDE report 7800490 ↗
• InjuryApr 9, 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 WHEN THE PATIENT RETURNED FOR A FOLLOW CT WHERE THE PHYSICIAN OBSERVED A TYPE IA ENDOLEAK. THE PHYSICIAN ATTRIBUTED THE CAUSE OF THE ENDOLEAK TO DISEASE PROGRESSION DUE TO ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7406134 ↗
• InjuryJan 3, 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 IN DIAMETER ABDOMINAL AORTIC ANEURYSM. FIVE HELI-FX ENDOANCHORS WERE ALSO IMPLANTED FROM THE MAIN BODY OF THE STENT GRAFT TO THE PROXIMAL NECK DURING THE INDEX PROCEDURE FOR CONCERN FOR LATE FAILURE. IT WAS REPORTED THAT TWO DAYS POST PROCEDURE, THE PATIENT DEVELOPED URINARY RETENTION DETERMINED TO BE RELATED TO THE PROCEDURE. THE PATIENT RECEIVED TREATMENT WITH MEDICATION AND CATHETERIZATION AND THE EVENT RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Urinary Retention

  MAUDE report 7159539 ↗
• InjuryDec 20, 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 OF UNKNOWN SIZE. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER WITH A COLD LEG. CT PERFORMED REVEALED AN OCCLUSION OF THE PATIENTS RIGHT IPSILATERAL STENT GRAFT LIMB AND REDUCED FLOW DIAMETER IN THE CONTRALATERAL LEFT GRAFT LIMB. ADDITIONALLY, CONSIDERABLE THROMBUS BUILD-UP WAS NOTED IN THE AORTIC SECTION OF THE BIFURCATED PIECE. ON THE SAME DATE, A THROMBECTOMY WAS PERFORMED ON THE PATIENT¿S CONTRALATERAL LIMB TO REMOVE THE CLOT AND A STENT WAS ALSO PLACED IN THAT AREA TO IMPROVE FLOW ON THAT SIDE. A FEM-FEM BYPASS WAS PERFORMED TO RESTORE FLOW TO THE PATIENTS RIGHT LOWER EXTREMITY. IT WAS NOTED THAT THE PATIENT HAS ALSO BEEN PRESCRIBED ANTI-COAGULANTS TO DISSOLVE AND RETARD CLOTTING. THE TREATMENT PERFORMED RESOLVED THE ISSUE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO HYPER-COAGULOPATHY AND POLYCYTHEMIA OF THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 7132846 ↗
• InjuryAug 30, 2017Leak/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 THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN IN THE EMERGENCY ROOM AND IT WAS DETERMINED THE ANEURYSM HAD RUPTURED. THE PHYSICIAN THOUGHT THE EVENT WAS DUE TO A TYPE II ENDOLEAK. THE DECISION WAS MADE TO EXPLANT AND UPON EXPLANT IT WAS NOTED THERE WAS AN ENDOLEAK THAT APPEARED TO COME FROM A HOLE IN THE FABRIC OF THE STENT GRAFT. PER THE PHYSICIAN THE CAUSE OF THE RUPTURE WAS DUE TO THE ENDOLEAK. THE CAUSE OF THE TYPE III ENDOLEAK WAS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain; Rupture

  MAUDE report 6829565 ↗
• InjuryJul 6, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 50MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE DURING FOLLOW-UP A LIMB OCCLUSION WAS DISCOVERED IN THE CONTRALATERAL LIMB. AN ANGIOGRAM WAS PERFORMED. IT WAS NOTED THAT THERE WAS AN UNDERSIZED SELF-EXPANDING STENT PRESENT IN THE LEFT COMMON ILIAC ARTERY. THE CLOT WAS REMOVED FROM THE OCCLUDED LIMB AND A BALLOON EXPANDABLE STENT WAS PLACED IN THE LEFT COMMON ILIAC ARTERY AND THE EVENT WAS RESOLVED. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS DUE TO USER ERROR; AN UNDERSIZED SELF-EXPANDING STENT THAT WAS PRESENT IN THE LEFT COMMON ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 6691454 ↗
• DeathApr 13, 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 A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.1 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM AND A 2.5 CM IN DIAMETER RIGHT ILIAC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS SEVERE CALCIFICATION IN THE VESSELS. IT WAS REPORTED THAT THE RIGHT AND LEFT COMMON FEMORAL ARTERIES WERE EXPOSED AND CONTROLLED SECURED WITH A VESSEL LOOPS. USING AN 18GAUGE NEEDLE TO GAIN ACCESS INTO THE RIGHT COMMON FEMORAL VASCULAR ANATOMY. ANOTHER MANUFACTURER¿S 7FR SHEATH WAS PLACED AND A GLIDE WIRE WITH ANOTHER MANUFACTURER¿S CATHETER WERE ADVANCED TO THE SUPRARENAL AORTA. THE GLIDE WIRE WAS EXCHANGED FOR ANOTHER GUIDE WIRE. THE CATHETER AND SHEATH WERE REMOVED AND A SENTRANT 12FR SHEATH WAS ADVANCED TO THE EXTERNAL ARTERY. THE SENTRANT 12FR SHEATH WAS UNABLE TO BE ADVANCED INTO THE RIGHT COMMON ILIAC DUE TO THE CALCIUM. ANOTHER MANUFACTURER¿S DILATOR WAS USED TO DILATE THE COMMON AND EXTERNAL ILIAC ARTERIES. POST DILATATION THE PHYSICIAN ATTEMPTED TO ADVANCE THE SENTRANT 12FR SHEATH AGAIN WITHOUT SUCCESS. THE PHYSICIAN ELECTED TO ACCESS THE LEFT COMMON FEMORAL ARTERY. A 18GA NEEDLE WAS USED ALONG WITH SENTRANT 16FR SHEATH WAS USED TO GAIN ACCESS INTO THE

  Patient problems: Death; Myocardial Infarction

  MAUDE report 6491947 ↗
• InjuryMar 9, 2017Malposition of Device; Activation, Positioning or Separation Problem; Device Damaged by Another Device; Malposition of Device; Activation, Positioning or Separation Problem; Device Damaged by Another Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN INTENTIONALLY INSERTED ANOTHER MANUFACTURER¿S 7 FR. 90 CM SHEATH THROUGH THE LEFT BRACHIAL ARTERY DOWN TO THE LEFT RENAL ARTERY, TO IMPLANT ANOTHER MANUFACTURER¿S COVERED STENT INTO THE LEFT RENAL ARTERY AND LAND PROXIMAL TO IT AT THE RIGHT ONE. HE THEN CANNULATED THE LEFT RENAL ARTERY WITH A GLIDEWIRE AND PLACED A 7 MM X 38 MM COVERED STENT INTO IT. THE PHYSICIAN THEN DEPLOYED THE ENDURANT BIFURCATED STENT GRAFT AND THE ENDURANT CONTRA LIMB. THE PHYSICIAN THEN DEPLOYED THE SUPRA RENAL STENT WHILE INFLATING THE BALLOON TO EXPAND THE COVERED STENT TO THE NOMINAL DIAMETER. THE ENDURANT BIFURCATED STENT GRAFT WAS BALLOONED AT THE PROXIMAL END WHILE KEEPING THE COVERED STENT BALLOON INFLATED. BOTH THE BALLOONS WERE DEFLATED. THE PHYSICIAN ATTEMPTED TO RETRACT THE 7FR SHEATH BUT IT WOULD NOT MOVE, DUE TO THE SUPRARENAL STENT ANCHOR PINS THAT WERE EMBEDDED IN IT. AS THE 7FR SHEATH WAS PULLED BACK THE ENDURANT STENT GRAFT MOVED PROXIMAL. THE PHYSICIAN WAS UNABLE TO WITHDRAWAL THE COVERED STENT BALL OON THROUGH THE 7

  Patient problems: Occlusion; Renal Failure

  MAUDE report 6393179 ↗
• InjuryMar 9, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT A 5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT RETURNED FOR FOLLOW UP. THE CT REVEALED THAT THE LEFT ENDURANT ILIAC LIMB WAS OCCLUDED UP TO THE FLOW DIVIDER. THE PHYSICIAN ELECTED TO PERFORM THROMBOLYSIS WITHIN THE STENT GRAFTS. THE OCCLUSION WAS CORRECTED AND BLOOD FLOW WAS RESTORED. THE PHYSICIAN CANNOT DETERMINE THE CAUSE OF THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 6392623 ↗

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 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