Endurant® II ETBF2816C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00613994991324), received between Dec 22, 2016 and May 18, 2026 — classified as 4 deaths, 32 injuries, 5 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 41 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 12 YEARS POST THE INDEX PROCEDURE, DURING A CT SCAN FOR A DIFFERENT REASON AN INCIDENTAL FINDING OF AN ENDOLEAK WAS IDENTIFIED WITH COMMON ILIAC ARTERY ENLARGEMENT. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AT THE TIME OF THE FINDING. INTERVENTION WAS PERFORMED WHERE A LIMB EXTENSION (16-24-93) WAS IMPLANTED WITH AN EXCELLENT RESULT. THE PHYSICIAN ATTRIBUTED THE FINDING TO ANATOMY WITH DISEASE PROGRESSION OVER A 12-YEAR PERIOD. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm expansion

  MAUDE report 25199464 ↗
• MalfunctionMar 1, 2024Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM (ETBF2816C145E, ENLW1616C124E / ENLW1628C93E / ETLW1624C82E) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. SEVERE NECK ANGULATION WAS NOTED. IT WAS REPORTED APPROXIMATELY 11 YEARS POST THE INDEX PROCEDURE, FOLLOW-UP IMAGING IDENTIFIED A TYPE IA ENDOLEAK AND BILATERAL ILIAC ANEURYSMS. THE BILATERAL ANEURYSMS IN THE ILIACS ARE DUE TO DISEASE PROGRESSION WITH NO CORRELATION TO THE TYPE IA ENDOLEAK. IMAGING SHOWS THERE IS NO ROOM TO EXTEND AT THE NECK. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK AND BILATERAL ANEURYSMS IS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815162 ↗
• InjuryMar 28, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 88MM AAA.  IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY AND A TYPE IB ENDOLEAK WAS DIAGNOSED. THE PATIENT HAD A LIMB EXTENSION IMPLANTED ON THE SAME DATE AS TREATMENT AND THE TYPE IB ENDOLEAK RESOLVED.  PER THE PHYSICIAN THE CAUSE OF THE IB ENDOLEAK WAS DISEASE PROGRESSION.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16625998 ↗
• MalfunctionJul 27, 2022Difficult to Insert; Device Damaged Prior to Receipt by User; Material Deformation; Difficult to Insert; Device Damaged Prior to Receipt by User; Material Deformation

  AN ENDURANT II BIFURCATED STENT GRAFT WAS INTENDED TO BE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED THE BOX WAS DAMAGED DURING SHIPPING. ON VISUAL INSPECTION THE GRAFT LOOKED FINE, BUT WHEN THE GRAFT WAS PLACED OVER THE WIRE THE HYPO TUBE WAS KINKED AND THE WIRE WAS UNABLE TO PASS. A BACK-UP STENT GRAFT THAT WAS BROUGHT TO THE PROCEDURE WAS IMPLANTED ALTERNATIVELY. AS PER THE PHYSICIAN THE CAUSE OF THE EVEN WAS DUE TO THE BENT GRAFT.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15110763 ↗
• InjuryMar 23, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 68.5MM X 64 ABDOMINAL AORTIC ANEURYSM. AN ENDURANT CUFF AND LIMB WERE THEN IMPLANTED PRESUMABLY FOR THE TREATMENT OF A TYPE IA ENDOLEAK OVER 6 YEARS LATER. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY TO HOSPITAL NEARLY 3 MONTHS LATER, AFTER BEING FOUND UNCONSCIOUS ON THE FLOOR. A CT SHOWED A LARGE RUPTURED ABDOMINAL AORTIC ANEURYSM AND WHAT APPEARED TO BE A TYPE IA ENDOLEAK. THE PATIENT WAS TAKEN URGENTLY TO OR FOR CONVERSION TO OPEN REPAIR. IT WAS NOTED AT THIS TIME IN THE PATIENT¿S HISTORY THAT THE PATIENTS RIGHT KIDNEY WAS NOT FUNCTIONAL AS IT WAS TOTALLY ATRETIC AND THE LEFT RENAL ARTERY IS STENOTIC AND JAILED WITH 2 SUPRARENAL EXTENSIONS FROM THE ENDOGRAFT AND THE NEW PROXIMAL EXTENSION. ON THE RIGHT SIDE, THE INTERNAL ILIAC ARTERY IS COILED BECAUSE OF A COMMON ILIAC ANEURYSM AND THE STENT GRAFT EXTENDS INTO THE EXTERNAL ILIAC ARTERY. THERE WAS A VERY LARGE HEMATOMA ANTERIORLY AND IN THE RIGHT RETRO PERITONEUM . IT WAS SAID THE PATIENT PROBABLY HAD A STENT INSERTED INTO THE LEFT ANTERIOR DESCENDING ARTERY AROUND THE TIME OF THE EVAR. DURING THE OPEN CONVERSION

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Ischemia; Rupture

  MAUDE report 13856286 ↗
• InjuryFeb 15, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF AN UNKNOWN SIZE . IT WAS REPORTED THE PATIENT PRESENT EMERGENTLY AND A CT SHOWED THE PRESENCE OF A TYPE IIIA ENDOLEAK AS A RESULT OF SEPARATION OF THE RIGHT COMMON ILLIAC EXTENSION FROM THE MAIN BODY STENT GRAFT.  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IIIA ENDOLEAK 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 13533425 ↗
• InjuryJan 7, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A ABDOMINAL AORTIC ANEURYSM .  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY AND A CT WAS PERFORMED WHERE CONTRAST WAS NOTED OUTSIDE OF THE GRAFT. THE ENDOLEAK WAS TREATED BY IMPLANTED AN AUI STENT GRAFT AND PERFORMING A FEM-FEM BYPASS ON THE SAME DATE. AS PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK CANNOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13189479 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM MEASURING 95MM. PRE-OP IT WAS NOTED THE PATIENTS LEFT INTERNAL ILIAC WAS OCCLUDED. THE RIGHT COMMON ILIAC HAD A 35MM ANEURYSM AND THE RIGHT INTERNAL WAS OCCLUDED AT THE TIME OF THE INDEX PROCEDURE. POST THE INDEX PROCEDURE THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER. IT WAS REPORTED 2 WEEKS POST THE PROCEDURE, THE PATIENT PRESENTED EMERGENTLY FROM THE REHAB FACILITY WITH SEVERE LEG PAIN. A CT SCAN SHOWED COMPLETE OCCLUSION OF THE AORTA FROM THE RENAL ARTERIES DOWN TO THE FEET. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM AND AN AX-FEM BYPASS WAS PREFORMED. BI LATERAL LEG THROMBECTOMIES WERE PREFORMED TO REMOVE CLOT FROM THE LEGS. THE PATIENT WAS REPORTED TO BE IN A STABLE CONDITION WITH PULSES IN BOTH LEGS POST THE PROCEDURE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 13173961 ↗
• DeathDec 15, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE IN A POST IMPLANT ANGIOPLASTY THE PATIENTS AORTA RUPTURED. AN ENDURANT 36X16X145 WAS IMMEDIATELY PLACED BELOW MAIN RENAL ARTERIES AND ABOUT 3.5 CM'S ABOVE THE PREVIOUSLY PLACED MAIN BODY GRAFT (28X16X103) WHICH WAS PLACED LOW TO SAVE TWO ACCESSORY RENAL ARTERIES. THE CONTRA LIMB WAS CANNULATED AND AN ADDITIONAL CONTRA LIMB PLACED TO EXCLUDE AN ENDOLEAK. IT APPEARED THAT THE ENDOLEAK WAS RESOLVED HOWEVER, THE BLOOD PRESSURE DID NOT GET BACK TO NORMAL. A 28X49 AORTIC CUFF WAS EXTENDED PROXIMAL AND THE ENDOLEAK WAS RESOLVED. IT APPEARED THE RENAL ARTERIES WERE MOSTLY COVERED. THE PATIENT WAS TRANSFERRED OUT OF THE ANGIO SUITE TO ICU AND EXPIRED 5 DAYS POST THE INDEX PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE RUPTURE AND DEATH IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 13008356 ↗
• InjuryAug 3, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 65 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 98 MONTHS POST INDEX PROCEDURE, A CT WAS PERFORMED, WHERE IT WAS REVEALED THE AAA SIZE TO BE INCREASING TO 6.1 X 6.5CM AND A ENDOLEAK TYPE 1A WAS OBSERVED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 12267003 ↗
• InjuryMar 24, 2021Leak/Splash; Migration or Expulsion of Device; Material Deformation; Leak/Splash; Migration or Expulsion of Device; Material Deformation

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A >50MM AAA. APPROX 6 YEARS 5 MONTHS POST PROCEDURE, DURING A FOLLOW UP VISIT AN ENLARGING AAA WAS OBSERVED ALONG WITH A TYPE IIIA ENDOLEAK WHERE THE LIMBS OVERLAP ON THE LEFT CI. IT WAS REPORTED THE RIGHT LIMB HAD NEARLY PULLED OUT OF THE RIGHT ILIAC AND INTO THE SAC, THE LEFT LIMB HAD ALSO PULLED INTO THE SAC AND BOTH LIMBS WERE COMPRESSED DUE TO TORTUOSITY. THE LIMBS IMPLANTED INTO THE LCI WERE SEPARATED AND THE LIMB IN THE RCI WAS PULLED INTO THE SAC INTERVENTION WAS PERFORMED ON THE SAME DATE WHERE NON MDT STENTS WERE IMPLANTED BILATERALLY TO RESOLVE THE KINKING AND RELINED WITH NEW LIMBS AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11562971 ↗
• InjuryMar 4, 2021Obstruction of Flow; Obstruction of Flow

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50+MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT 2 DAYS LATER, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH LEG PAIN. IT WAS STATED THAT THE LEFT LIMB WAS CLOTTED DUE TO A KINK/COMPRESSION. THE EVENT WAS TREATED WITH THROMBOLYTIC THERAPY FOR 24-48 HOURS AND A NON-MEDTRONIC STENT WAS THEN IMPLANTED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS PATIENTS' ANATOMY. IT WAS STATED THAT THE DISTAL AORTA WAS 18MM AND THAT A BALLOON EXPANDABLE STENTS SHOULD HAVE BEEN PLACED DURING THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 11412503 ↗
• InjuryFeb 16, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A CTA REVEALED A TYPE IIIB ENDOLEAK IN THE MAIN BODY PORTION OF THE BIFURCATED GRAFT PROXIMAL TO THE FLOW DIVIDER. INTERVENTION WAS PERFORMED ON THE SAME DATE, AN 28/28/49 ENDURANT AORTIC CUFF WAS PLACED AT LEVEL OF FLOW DIVIDER TO THE TOP OF EXISTING GRAFT. THIS WAS BALLOONED WITH A NON MDT BALLOON. POST INTERVENTION ANGIOGRAM SHOWED THE ENDOLEAK HAD RESOLVED. 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: Pain

  MAUDE report 11331327 ↗
• InjuryFeb 10, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 6.7X 6.2CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED A TYPE II ENDOLEAK WAS PRESENT FOR THE FIRST YEAR FOLLOWING IMPLANT BUT THEN THE PATIENT WAS LOST TO FOLLOW-UP FOR 3 YEARS. A CTA PERFORMED ON AN UNKNOWN DATE, SHOWED AN INCREASE IN ANEURYSM SIZE TO 7.7 X 7.3CM AND A SUSPECTED TYPE IIIB ENDOLEAK. THE PATIENT RETURNED TO THE CATH LAB FOR ANGIOGRAPHY WHICH CONFIRMED THE CTA FINDINGS OF A JET OF CONTRAST ESCAPING INTO THE AAA SAC VIA A HOLE IN THE GRAFT IN THE POSTERIOR SEGMENT OF THE BIFURCATED MAIN BODY. INTERVENTION WAS THEN PERFORMED AND VIA A WIRE AND CATHETER THE HOLE WAS CANNULATED AND NON MDT COILS WAS DELIVERED AND AFTER IT WAS FELT A SUFFICIENT NUMBER HAD BEEN PLACED. A 10MM NON MDT PLUG WAS DEPLOYED TO THE HOLE IN THE GRAFT AND POST PROCEDURE ANGIOGRAPHY SHOWED THAT NO FURTHER JET OF CONTRAST WAS EXITING THE HOLE. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11306578 ↗
• InjuryFeb 8, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 62MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE, DURING A FOLLOW-UP, THE PATIENT PRESENTED WITH AN ENDOLOEAK TYPE 1A. THE EVENT WAS TREATED ON THE SAME DAY WITH COILS PLACED IN THE SAC, AORTIC CUFF WAS IMPLANTED AND ENDOANCHORS WERE ALSO USED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS ANATOMY DUE TO AORTIC NECK DILATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11293435 ↗
• InjuryDec 10, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE, THE PATIENT AS COMPLAINING OF ABDOMINAL PAIN. A CT PERFORMED SHOWED A TYPE IB ENDOLEAK AT THE RIGHT COMMON ILIAC WITH MINIMAL CONTRAST FILLING ANEURYSM SAC DUE TO POOR DISTAL SEALING ZONE OF THE ENDURANT LIMB ETLW1616C82E. A POTENTIAL TYPE IA ENDOLEAK WAS ALSO SEEN ON THE CT. INTERVENTION WAS PERFORMED THE NEXT DAY, THE RIGHT COMMON ILIAC ARTERY WAS EXTENDED WITH A 16 X 24 X 93 TO ACHIEVE DISTAL SEAL. ADDITIONALLY, A 32 X 32 X 49 CUFF WAS PLACED IN PROXIMAL NECK SECURED WITH 8 ENDOANCHORS PROPHYLACTICALLY. THE POTENTIAL TYPE 1A PRESENT ON THE CTA WAS NOT VISUALIZED ON ANGIOGRAM DURING THE SECONDARY PROCEDURE. THE PROXIMAL CUFF AND HELI-FX ANCHORS WERE PLACED PROPHYLACTICALLY TO PREVENT CONTINUED DISEASE PROGRESSION THAT WAS INITIATED BY THE DISTAL TYPE 1B. AFTER PLACEMENT OF THESE PIECES, FINAL ANGIOGRAM CONFIRMED NO PRESENCE OF ANY ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS UNDER SIZING. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 10982022 ↗
• InjuryOct 21, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 70 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT HAD A CT COMPLETED , 3 DAYS LATER DUE TO HAVING A LARGE HEMATOMA IN HIS GROIN (RIGHT) POST-OP. IT WAS CONFIRMED THAT THE HEMATOMA WAS CAUSED BY A RIGHT HERNIA REPAIR THAT WAS DONE AFTER THE EVAR PROCEDURE. IT WAS NOTICED ON THE CT SCAN, THAT THE IPSILATERAL LIMB WAS KINKED ABOUT 1 CM PAST THE GRAFT BIFURCATION DUE TO AN ANGLE IN THE PROXIMAL AORTA. INTERVENTION WAS PERFORMED AND A NON MDT WAS IMPLANTED TO STRAIGHTEN THE KINK. A FINAL ANGIOGRAM SHOWED NO KINKING. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND NOTED THE AORTIC NECK ANGLE WAS 45 AND ABOUT 6 CM'S FROM THE LOWEST RENAL ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10710357 ↗
• InjuryAug 22, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON AN UNKNOWN DATE AN UNKNOWN TYPE ENDOLEAK WAS IDENTIFIED. INTERVENTION ON AN UNKNOWN DATE WAS COMPLETED WITH COILING AND GLUE. IT IS UNKNOWN IF THE ENDOLEAK RESOLVED POST THE INTERVENTION. THE CAUSE OF THE ENDOLEAK IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 10440464 ↗
• InjuryAug 19, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM AS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON THE DATE THE PATIENT RETURNED FOR FOLLOW UP, FIVE YEARS AND FIVE MONTHS LATER, A TYPE III ENDOLEAK WAS IDENTIFIED. INTERVENTION WAS PERFORMED THE NEXT DAY. THE ENDOLEAK WAS RESOLVED WITH THE IMPLANTATION OF AN AORTIC CUFF ETCF3232C49E, TWO ENDURANT LIMBS AND A NON-MDT STENT GRAFT. 7 ENDOANCHORS WERE ALSO IMPLANTED DURING THE PROCEDURE AND BALLOONING WAS PERFORMED USING RELIANT BALLOONS. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS THAT THERE WAS A HOLE IN THE MAIN BODY STENT GRAFT ABOUT 1CM ABOVE THE FLOW DIVIDER. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10424315 ↗
• InjuryJul 14, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 95MM RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY UNDER SEVEN YEARS LATER WITH ABDOMINAL AND BACK PAIN. A CTA REVEALED A TYPE IA ENDOLEAK. INTERVENTION WAS PERFORMED AND AN ENDURANT AORTIC CUFF WAS IMPLANTED AS TREATMENT FROM THE MOST INFERIOR RENAL ARTERY. THIS WAS BALLOONED AND A FINAL ANGIOGRAM CONFIRMED THE ENDOLEAK HAD RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY. IT WAS REPORTED THAT IT WAS A CONICAL AORTIC NECK THAT LOST SEAL OVER TIME. IT WAS NOTED THE BIFURCATE WAS APPROXIMATELY 12MM BELOW MOST INFERIOR RENAL ARTERY. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 10269999 ↗
• InjuryFeb 27, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 95MM ABDOMINAL AORTIC ANEURYSM. DURING THIS PROCEDURE A HELI -FX ENDOANCHORING SYSTEM WAS USED FOR AN APPARENT TYPE IA ENDOLEAK AND SEVEN ENDOANCHORS WERE IMPLANTED. THIS RESOLVED THE ENDOLEAK. DURING THE INDEX PROCEDURE IT WAS REPORTED THAT THE PATIENT WAS HYPOTENSIVE, BLEEDING AND ANEMIC. IT WAS REPORTED THAT THE PATIENT HAD AN ESTIMATED BLOOD LOSS OF 400MLS. THIS WAS THEN TREATED AND THE PATIENT RECEIVED AN INFUSION OF 2 UNITS OF RED BLOOD CELLS, WAS GIVEN MEDICATION AND HAD DIAGNOSTIC IMAGING PERFORMED. IT WAS CONFIRMED THAT THE ENDOANCHORS WERE USED IN THIS PROCEDURE FOR BOTH A CONCERN FOR LATE FAILURE AND FOR A TYPE IA ENDOLEAK. IT WAS REPORTED THAT FOUR ENDOANCHORS WERE USED TO SECURE THE TRUNK DUE TO A SHORT ANGULATED NECK AND A FURTHER THREE ENDOANCHORS WERE IMPLANTED AS A FINAL ARTERIOGRAM DEMONSTRATED A PERSISTENT FLOW COMING FROM THE RIGHT LATERAL ASPECT OF THE DEVICE WHICH WAS CONFIRMED TO BE THE IA ENDOLEAK. THIS EVENT WAS REPORTED TO HAVE RESOLVED FOUR DAYS LATER AND RECOVERED WITH TREATMENT. FINAL ARTERIOGRAM SHOWED THE ENDOLEAK HAD RESOLVED. THIS EVENT HAS BEEN ASSESSED BY THE SITE A

  Patient problems: Anemia; Blood Loss; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 9762649 ↗
• InjuryMar 8, 2019Leak/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 APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED AND AN ANGIOGRAM IDENTIFIED A SMALL TYPE IA ENDOLEAK FROM THE TOP OF THE GRAFT. THE PHYSICIAN ELECTED TO IMPLANT A CUFF AND ENDOANCHORS TO ENSURE SEAL AND RESOLVE THE ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED AND COMMENTED THAT THERE APPEARED TO BE SOMEWHAT OF A SHORT SEAL ZONE AND THE INITIAL GRAFT APPEARED TO BE PLACED ABOUT 5MM UNDER THE RENAL ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8403231 ↗
• InjuryNov 26, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE EMERGENCY ENDOVASCULAR TREATMENT OF A 70MM RUPTURED ABDOMINAL AORTIC ANEURYSM. DURING THE INDEX PROCEDURE, IT WAS REPORTED THAT AFTER THE ENDURANT MAIN BODY HAD BEEN IMPLANTED, AN ANGIOGRAM SHOWED A TYPE IA ENDOLEAK. AN ADDITIONAL CUFF AND ENDOANCHORS WERE THEN IMPLANTED TO RESOLVE THE EVENT. THE ENDOLEAK WAS RESOLVED AFTER THE IMPLANTATION OF THE CUFF AND ENDOANCHORS WERE ADDED FOR ADDITIONAL ANCHORING DUE TO THE SHORT NECK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED, DUE TO A SHORT ANGLED NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8101178 ↗
• InjurySep 19, 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 APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE THE PATIENT WAS PRESENTED EMERGENTLY WITH BACK PAIN. THE PHYSICIAN NOTED NO VISIBLE ENDOLEAKS BUT THE ANEURYSM HAS INCREASED IN SIZE BY AT LEAST 10MM. IT WAS ALSO NOTED THAT THE STENT GRAFT WAS A FEW MM FROM THE LOWEST RENAL ARTERY AND THE RIGHT ILIAC LIMB WAS ONLY INTO THE CIA A FEW MM. THEREFORE, ON THE SAME DAY, THE PHYSICIAN INSERTED A 32MM ENDURANT CUFF AND EXTENDED THE RIGHT COMMON ILIAC WITH A ENDURANT STENT GRAFT LIMB. THE PROXIMAL CUFF WAS ANCHORED VIA HELI-FX ENDOANCHORS. THE PROCEDURE WAS SUCCESSFUL. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Injury; Pain

  MAUDE report 7888580 ↗
• 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 80 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT 4.5 YEARS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN AND HYPOTENSION. AN ANEURYSM RUPTURE WAS DIAGNOSED WITHOUT ANY ENDOLEAK BEING OBSERVED. INTERVENTION WAS COMPLETED ON THE SAME DAY. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT CUFF AND 3 ADDITIONAL ENDURANT LIMBS WITHIN THE ORIGINAL STENT GRAFT SYSTEM 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: Abdominal Pain; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 7825838 ↗

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-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-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-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-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-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