Endurant® II ETBF2516C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00613994991263), received between May 19, 2017 and Mar 21, 2025 — classified as 3 deaths, 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (11 reports).

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

5 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 ↗

2. Feb 27, 2017Class IITerminated

   Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.

   Z-1543-2017 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• DeathMar 21, 2025Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ADDITIONALLY, AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED THE SAME DAY. APPROX. 1 YEAR AND 2 MONTHS POST INDEX PROCEDURE, A VALIANT NAVION STENT GRAFT WAS IMPLANTED ALONG WITH AN ADDITIONAL ENDURANT LIMB . IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT PRESENTED EMERGENTLY EXPERIENCING CHEST AND BACK PAIN. CT IMAGING REVEALED A TYPE IA ENDOLEAK, A TYPE IB ENDOLEAK, AND A TYPE III ENDOLEAK, THOUGH NO RUPTURE WAS OBSERVED. THE PATIENT UNDERWENT RELINING WITH A NON-MDT THORACIC GRAFT. THE RELINING OF THE GRAFTS WAS SUCCESSFUL, BUT MULTIPLE COMPLICATIONS AROSE DURING THE PROCEDURE, INCLUDING A LACERATED BOWEL DUE TO ANESTHESIA-RELATED ISSUES, AND PNEUMONIA. THESE COMPLICATIONS ULTIMATELY LED TO THE PATIENT¿S DEATH 10 DAYS LATER. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS AND GRAFT ISSUES WAS UNKNOWN. AN AUTOPSY REVEALED SIX HOLES IN THE IN THE OUTERMOST VALIANT CAPTIVIA STENT GRAFT WHICH APPEARED TO BE CAUSED BY THE INNER FREE FLOW GRAFT¿S BARE METAL RUBBING THROUGH THE OUTER GRAFT. THE CAUSE OF DEATH WAS DUE TO MULTIPLE COMPLICATIONS FROM THE PROCEDURE INCLUDING THE LAC

  Patient problems: Back pain; Bowel Perforation; Chest Pain; Pneumonia

  MAUDE report 21661780 ↗
• InjuryJun 9, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED 80MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED APPROXIMATELY 5 YEARS POST INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A CT TAKEN SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK. THE PHYSICIAN NOTED THE STENT GRAFT HAD NOT MIGRATED, BUT THE NECK HAD DILATED FURTHER RESULTING IN THE ENDOLEAK. THE PHYSICIAN CHOSE TO COVER THE PATIENTS LEFT RENAL ARTERY AND PLACE AN ENDURANT CUFF  AND HELI-FX ENDOANCHORS AT THE LEVEL OF THE RIGHT RENAL ARTERY.  A FINAL ANGIOGRAM WAS PERFORMED AND THE ENDOLEAK HAD RESOLVED.  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS DUE TO THE PATIENTS ANATOMY AS A RESULT OF NECK DILATION.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 14643379 ↗
• DeathSep 28, 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 ABDOMINAL AORTIC ANEURYSM  IT WAS REPORTED ON THE DAY OF THE INDEX PROCEDURE THE PATIENT HAD A RUPTURED AORTIC ANEURYSM. AN ATTEMPT TO COMPLETE EMERGENCY INTERVENTION WAS ATTEMPTED HOWEVER THE PATIENT COULD NOT BE RESITUATED AND PASSED AWAY. THE CAUSE OF THE DEATH IS UNDETERMINED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pain; Rupture

  MAUDE report 12540542 ↗
• InjuryAug 19, 2020Difficult to Insert; Malposition of Device; Difficult to Insert; Malposition of Device

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 43MM SACCULAR ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY CANNULATING THE CONTRALATERAL SIDE OF THE BIFURCATE, WHICH WAS ON THE PATIENT'S LEFT AND AT THE SIDE OF THE SACCULAR ANEURYSM. IT WAS SAID THE PHYSICIAN DECIDED TO THEN SNARE AND RETRIEVE THE GUIDEWIRE FROM THE GATE, WHEN THE REMAINDER OF THE MAINBODY STENT GRAFT DEPLOYED, IT PUSHED THROUGH THE GATE AND IT TO THE SACCULAR ANEURYSM. AS A RESULT A THE PHYSICIAN IMPLANTED A AUI STENT GRAFT, PERFORMED A FEM-FEM BYPASS AND COIL EMBOLIZED THE LEFT COMMON ILIAC ARTERY. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND NOTED THE SACCULAR ANEURYSM AND SMALL DISTAL AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10425464 ↗
• InjuryFeb 12, 2020Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS PRESENT UPON COMPLETION ANGIOGRAM. THIS LEAK WAS REPORTED TO BE MORE PROMINENT THAN THE TYPE IV ENDOLEAK THAT WAS PRESENT ON THE PATIENTS LEFT. THE PHYSICIAN REBALLOONED THE PROXIMAL NECK BUT THE ENDOLEAK PERSISTED. IT WAS THEN DECIDED TO PLACE AN ENDURANT AORTIC CUFF. THIS DEVICE DEPLOYED BUT IN DOING SO IT PARTIALLY COVERED THE SUPERIOR MESENTERIC ARTERY (SMA). THE SMA WAS THEN CANNULATED AND A NON-MDT BARE METAL STENT WAS IMPLANTED. ON FINAL ANGIOGRAM THE SMA WAS PATENT AND THE PROCEDURE WAS COMPLETED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9699113 ↗
• InjurySep 16, 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 ON AN UNKNOWN DATE A TYPE IIIB ENDOLEAK WAS IDENTIFIED IN THE BIFURCATED STENT GRAFT. THE STENT GRAFT WAS RELINED WITH A TRIVASCULAR DEVICE TO RESOLVE THE EVENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9069494 ↗
• InjuryOct 22, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 51MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ALMOST TWO YEARS LATER THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK WITH A RUPTURE AT THE RENAL ARTERIES. IT WAS REPORTED THAT AN ENDURANT II CUFF WAS IMPLANTED AND THE EVENT WAS 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: Rupture

  MAUDE report 7989319 ↗
• InjuryAug 8, 2018Leak/Splash

  AN ENDURANT II AORTIC CUFF STENT GRAFT AND APTUS ENDOANCHORS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TYPE IA ENDOLEAK IN A PREVIOUSLY IMPLANTED ENDURANT II STENT GRAFT SYSTEM IMPLANTED 10 MONTHS PREVIOUSLY. IT WAS REPORTED APPROXIMATELY 3 MONTHS POST THE IMPLANTATION OF THE ENURANT CUFF AND ENDOANCHORS THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN AND A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO SURGICAL CONVERT THE PATIENT TO A CONVENTIONAL GRAFT AND EXPLANT THE EVAR DEVICES AND ENDOANCHORS. IT WAS REPORTED DURING THE REINTERVENTION PROCEDURE THE PATIENT SUFFERED INTRAOPERATIVE SPLENIC BLEEDING AND HYPOTENSION. THE PATIENT WAS DIAGNOSED WITH THROMBOCYTOPENIA MARKED BY ABNORMAL HAEMATOLOGY VALUES FROM THE ASSOCIATED BLOOD LOSS DURING THE RE-INTERVENTION SURGERY WHICH WAS REPORTED AS 3.5L. A SPLENECTOMY WAS PERFORMED AND THE PATIENT WAS TREATED WITH MEDICATION INCLUDING SEVERAL BLOOD AND PLATELET INFUSIONS. IT WAS FURTHER REPORTED THE PATIENT EXPERIENCED AND ACUTE KIDNEY INJURY MOST LIKELY CONTRAST INDUCED MARKED WITH OLIGURIA AND DIAGNOSED WITH A UTI. THIS WAS TREATED WITH MEDICATION AND PROLONGED HOSPITALISATION. THE PATIENT ALSO REQUIRED MEC

  Patient problems: Abdominal Pain; Blood Loss; Hemorrhage/Blood Loss/Bleeding; Injury; Low Blood Pressure/ Hypotension; Renal Failure; Respiratory Failure; Unspecified Infection

  MAUDE report 7761131 ↗
• InjuryJul 20, 2018Overfill; Device Damaged by Another Device; Device Damaged by Another Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 57 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. DURING THE INDEX PROCEDURE, IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS BALLOON MOULDING THE IPSILATERAL LIMB OF THE MAIN BODY STENT GRAFT, THE BALLOON WAS OVER INFLATED CAUSING DISSECTION OF THE RIGHT LIMB AND EXTRAVASATION. A NON-MEDTRONIC STENT WAS IMPLANTED TO COVER THE RIGHT HYPOGASTRIC ARTERY AT THE DISTAL END OF THE IPSILATERAL LIMB, TO COVER THE DISSECTION AND STOP THE BLEEDING. THE PROXIMAL END OF THE NON-MDT STENT WAS POST DILATED USING A 14 MM BALLOON TO SEAL AND EXTEND INTO THE MAIN BODY OF THE ENDURANT IPSILATERAL LIMB. THE PROCEDURE WAS COMPLETED WITH NO SIGN OF AN ENDOLEAK. LATER THAT DAY, THE PATIENT'S LIMB BECAME OCCLUDED WITH DIMINISHED PULSES DUE TO THE IMPLANTED NON-MDT STENT GRAFT DEAD ENDING INTO THE TORTUOUS EXTERNAL ILIAC . A MECHANICAL THROMBECTOMY WAS PERFORMED WITH A NON-MEDTRONIC CATHETER TO REMOVE THE MAJORITY OF THE CLOT AND ANOTHER MANUFACTURES STENT GRAFT WAS PLACED WITHIN THE PREVIOUSLY IMPLANTED NON MEDTRONIC STENT GRAFT DOWN THE EXTERNAL ILIAC. THE ENDURANT IPSILATERAL LIMB WAS THEN RELINED USING ANOTHER ENDURA

  Patient problems: Blood Loss; Diminished Pulse Pressure; Extravasation; Injury; Intimal Dissection; Occlusion; Thrombus

  MAUDE report 7705775 ↗
• MalfunctionJul 12, 2018Leak/Splash

  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 APPROXIMATELY 3.5 YEARS POST INDEX PROCEDURE A FOLLOW UP CT SCAN INDICATED A TYPE IA ENDOLEAK WITH ANEURYSM EXPANSION. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 7681059 ↗
• InjuryJan 8, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN ELECTED TO IMPLANT THE ENDURANT BIFURCATE LOW TO PRESERVE AN ACCESSORY RENAL ARTERY. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW UP CT PERFORMED APPROXIMATELY 3.5 YEARS POST INDEX PROCEDURE WHERE A TYPE IA ENDOLEAK WAS OBSERVED. IT WAS REPORTED THAT A 25X70 ENDURANT AORTIC CUFF WAS IMPLANTED AND THE ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PHYSICIAN STATED 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 7172296 ↗
• InjuryDec 1, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 51MM DIAMETER RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, ON ANGIOGRAM, A BILLOWING BLUSH OF CONTRAST WAS OBSERVED AROUND THE LEVEL OF THE FLOW DIVIDER. DURING THIS PROCEDURE THERE WAS A 14 AND 16 FR SHEATH IN PLACE (OCCLUSIVE TO EXTERNALS). AFTER REPEAT ANGIOGRAMS, THE PHYSICIAN DETERMINED THAT THERE WAS A TYPE III FABRIC ENDOLEAK. IN ORDER TO RESOLVE THE ENDOLEAK, THE PHYSICIAN ELECTED TO RELINE THE STENT GRAFT WITH AN ENDURANT 25X49 AORTIC CUFF FOLLOWED BY AN ENDURANT 16X16X93 STENT GRAFT LIMB (RIGHT) AND ENDURANT 16X10X82 STENT GRAFT LIMB (LEFT). ON FINAL ANGIOGRAM, THE PHYSICIAN ASPIRATED THE SHEATHS BILATERALLY AND A SMALL BLUSH WAS STILL PRESENT. THE PHYSICIAN WAS CONFIDENT THIS WAS RELATED TO HEPARIN ADMINISTRATION AND WOULD RESOLVE POST-SURGERY. IT WAS REPORTED THAT THE PATIENT WAS DOING GREAT POST-SURGERY. AS PER THE PHYSICIAN, THE CAUSE OF THE REPORTED ENDOLEAK WAS RELATED TO A STENT GRAFT FABRIC ISSUE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7074019 ↗
• InjuryNov 29, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER A FOLLOW UP ABDOMINAL CT PERFORMED APPROXIMATELY 5 YEARS POST INDEX PROCEDURE, A TYPE II AND POSSIBLE TYPE IB ENDOLEAK WERE NOTED. THE PHYSICIAN NOTED THAT THE DISTAL RIGHT COMMON ILIAC MEASURED 17MM DISTAL TO THE BIFURCATED LIMB AND, SO HE PLANNED TO USE A 20MM DISTAL FLARED LIMB. DURING THE RE-INTERVENTION, RETROGRADE ANGIOGRAM WAS PERFORMED, AND THE PHYSICIAN CONFIRMED A TYPE II ENDOLEAK WITH PATENT LUMBAR ARTERIES AND A TYPE 1B ENDOLEAK. THE PHYSICIAN THEN COILED THE LUMBAR ARTERY AND PLACED GLUE INTO THE ANEURYSMAL SAC. THE PHYSICIAN THEN PLACED A 16X20X93MM LIMB TO EXTEND TO THE RIGHT HYPOGASTRIC ARTERY. THE PHYSICIAN WAS SATISFIED WITH THE FINAL ANGIOGRAM AS NO TYPE 1B ENDOLEAK WAS PRESENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT MAY HAVE BEEN DUE TO LACK OF ADEQUATE LENGTH OF SEAL OF THE STENT GRAFT LIMB INSIDE THE NATIVE RIGHT COMMON ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7066185 ↗
• InjuryNov 15, 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 APPROXIMATELY 5 YEARS POST INDEX PROCEDURE, A CT EXAM REVEALED THAT THERE IS A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT 25X25X49 AORTIC CUFF ALONG WITH HELI-FX ENDOANCHORS. THE PROXIMAL TYPE I ENDOLEAK WAS 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: Injury

  MAUDE report 7032465 ↗
• DeathJul 13, 2017Device Damaged by Another Device; Device Damaged by Another Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS ATTEMPTED FOR USE IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE ENDURANT II DEVICE WAS INSERTED THROUGH ANOTHER MANUFACTURES SHEATH. THE PHYSICIAN ATTEMPTED TO ADJUST THE SHEATH BACKWARDS BUT WAS UNABLE TO MOVE IT. IT WAS NOTED THAT ANOTHER MANUFACTURER'S ILIAC STENT WAS IMPLANTED TWO YEARS PRIOR WAS PRESENT IN THE RIGHT ILIAC ARTERY. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE ENDURANT II DEVICE, BUT COULD NOT. A RELIANT BALLOON WAS INSERTED AND INFLATED TO OCCLUDE THE AORTA SO THE SHEATH AND ENDURANT II DEVICE COULD BE REMOVED. HOWEVER, IN THE PROCESS OF REMOVAL THE VESSEL WAS AVULSED JUST DISTAL TO THE AORTIC BIFURCATION. IT WAS FURTHER REPORTED THAT THE PREVIOUSLY PLACED ILIAC STENT HAD LOCKED ON TO THE SHEATH AND FORCED THE PHYSICIAN TO REMOVE THE SHEATH AND THE ENDURANT II DEVICE TOGETHER. IT WAS ALSO NOTED THAT THE ILIAC STENT HAD CLUNG TO THE SHEATH AND WAS REMOVED AS WELL. A SURGICAL CUT DOWN AND FEMORAL-FEMORAL BY PASS WAS PERFORMED TO FIX THE VESSEL AVULSION. IT WAS THEN REPORTED THAT CARE WAS WITHDRAWN AND THE PATIENT DIED THREE DAYS POST-OPERATIVELY. THE PATIENT REPORTEDLY HAD POO

  Patient problems: Death; Perforation of Vessels

  MAUDE report 6710983 ↗
• InjuryJun 6, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 61MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 46MM IN LENGTH, 20MM IN DIAMETER PROXIMALLY AND 17MM IN DIAMETER DISTALLY. IT WAS REPORTED THAT THE PATIENT LOST MOTOR FUNCTIONS IN LEFT LEG AND WENT TO THE ER FOR CLAUDICATION. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY AND A CT WAS DONE AND SHOWED THE IPSILATERAL LIMB WAS OCCLUDED. THE PATIENT WAS BROUGHT TO THE OR. A WIRE WAS PASSED THROUGH THE CLOT AND THE PHYSICIAN USED A FOGERTY CATHETER TO CLEAN IT OUT. AFTER THE LIMB WAS CLEANED OUT THE PHYSICIAN GAINED ACCESS ON THE RIGHT SIDE AND PUT A WIRE UP AS WELL AND PLACED KISSING STENTS FROM ANOTHER MANUFACTURER BILATERALLY. THE COMPLETION ANGIO LOOKED GREAT AND THE PATIENT HAD A STRONG PALPABLE PULSE IN FEMORAL AS WELL AS POSTERIOR TIBIA. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS ANATOMY RELATED; THE DISTAL AORTA MEASURES 19MM OVER 2.0MM AND THAT THE TWO 16MM LIMBS IN THAT ZONE IS WHAT CAUSED THE OCCLUSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Claudication; Occlusion

  MAUDE report 6615500 ↗
• InjuryMay 19, 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. IT WAS REPORTED THAT THE PATIENT RETURNED WITH ONE LIMB OCCLUDED ON AN UNKNOWN DATE FOLLOWING THE INDEX PROCEDURE. A FEM-FEM BYPASS WAS PERFORMED UTILIZING THE PATENT LIMB. THE PATIENT COMPLAINED OF CLAUDICATION. THROMBUS WAS FOUND TO BE PRESENT IN THE PATENT LIMB AND IT WAS FEEDING INTO THE FEM-FEM BYPASS. NO ADDITIONAL INTERVENTION WAS DONE. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNKNOWN. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Claudication; Occlusion

  MAUDE report 6578497 ↗

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-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-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