Endurant® IIs ESBF2314C103E (UDI 00643169439993)Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00643169439993), received between Feb 3, 2017 and May 18, 2026 — classified as 9 deaths, 38 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (26 reports).

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

2. Oct 15, 2021Open, Classified

   Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

   Z-0292-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Leak/Splash

  IT WAS REPORTED THAT AN ENDURANT II/IIS BIFURCATED STENT GRAFT WAS USED DURING AN ENDOVASCULAR AORTIC REPAIR FOR A 40 MM SACCULAR ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE GRAFT WAS DEPLOYED WITHOUT ISSUES. THE GRAFT WAS THEN BALLOONED WITH A RELIANT, AND A POST-DEPLOYMENT ANGIOGRAM SHOWED A TYPE IV ENDOLEAK WITH EXTRAVASATION INTO WHAT APPEARED TO BE A RUPTURE DISTAL TO THE FLOW DIVIDER (ACTIVATED CLOTTING TIME OF 374). ADDITIONAL ENDOVASCULAR TREATMENT WAS PERFORMED WITH TWO NON MDT 9 MM X 39 MM STENTS PLACED HALF ABOVE AND HALF BELOW THE FLOW DIVIDER, FOLLOWED BY ADDITIONAL BALLOONING USING TWO 12 MM X 4 CM BALLOONS IN A KISSING TECHNIQUE. A POST-INTERVENTION ANGIOGRAM CONFIRMED RESOLUTION OF THE TYPE INTRAVENOUS ENDOLEAK AND EXTRAVASATION. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION AND WAS REPORTED TO BE ALIVE WITH NO INJURY. THE PHYSICIAN ATTRIBUTED THE EVENT TO ANATOMY, STATING THE PATIENT HAD A NARROW DISTAL AORTA AND A SHELF INDENTATION BENEATH THE ANEURYSM THAT MAY HAVE RUPTURED DURING GRAFT BALLOONING.

  Patient problems: Rupture

  MAUDE report 25199766 ↗
• MalfunctionNov 26, 2025Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM, THE SUPRARENAL DEPLOYMENT WHEEL HOUSING BROKE DURING DEPLOYMENT OF THE ESBF2314C103E STENT GRAFT. PRIOR TO THE PROCEDURE, THE DEVICE WAS INSPECTED AND THERE WAS NO NOTICEABLE DAMAGE. DESPITE THE BACK-END WHEEL BREAKING THE STENT GRAFT FULLY DEPLOYED WITHOUT INCIDENT AND THERE WAS NO IMPACT TO THE POSITION OF THE STENT GRAFT. THERE WAS NO STRENUOUS PRESSURE PLACED ON THE DELIVERY SYSTEM DURING DEPLOYMENT. THERE WAS NO ISSUE RECAPTURING THE TAPERED TIP, THE PHYSICIAN HELD THE BACK OF THE DELIVERY SYSTEM FORWARD AND SPUN THE BACK-END WHEEL TO RECAPTURE. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656875 ↗
• MalfunctionNov 13, 2025Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 55MM AAA. THE PATIENT HAD PRESENTED WITH FLANK PAIN AND WAS TREATED EMERGENTLY. DURING THE INDEX PROCEDURE, UPON COMPLETION ANGIOGRAPHY, THERE WAS AN ENDOLEAK DISCOVERED OF UNKNOWN ORIGIN. MULTIPLE RUNS WERE COMPLETED TO FIND THE SOURCE OF THE LEAK. THE ENDOLEAK WAS SUSPECTED TO BE EITHER A TYPE II OR TYPE IV AT THE TIME OF THE PROCEDURE. A FOLLOW-UP CT 3 DAYS LATER STILL SHOWED THE ENDOLEAK. THE PATIENT WAS DISCHARGED. AT THE 30 DAY CT, THE ENDOLEAK WAS STILL THERE AND THE PHYSICIAN BELIEVED IT TO BE A TYPE IIIB ENDOLEAK AT THIS STAGE. THE PATIENT DECLINES ANY INTERVENTION. THE CAUSE OF THE TYPE IIIB ENDOLEAK IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541696 ↗
• InjuryOct 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN INTRAOPERATIVE PROCEDURE INVOLVING THE ENDURANT II/IIS, A TYPE IA PROXIMAL ENDOLEAK WAS OBSERVED AT COMPLETION ANGIOGRAPHY. THE ADJUNCTIVE PROCEDURE PERFORMED WAS 7 ENDOANCHORS PLACED AT THE PROXIMAL SEAL ZONE DUE TO THE ENDOLEAK. THE ENDOLEAK STILL REMAINED AFTER THE ENDOANCHORS. THE CAUSE COULD NOT BE CONFIRMED. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX PROCEDURE AND DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 23423913 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN EVAR PROCEDURE INVOLVING THE IMPLANTATION AN ENDURANT IIS STENT GRAFT SYSTEM, THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 800 CC. A BLOOD TRANSFUSION OF 250 CC WAS REQUIRED. IT WAS SAID THAT DURING THE PROCEDURE, THE BILATERAL INGUINAL LIGAMENTS WERE INCISED. ON THE RIGHT SIDE, THE INGUINAL LIGAMENT WAS INCISED, AND THE DISTAL EXTERNAL ILIAC ARTERY WAS ISOLATED AND DISSECTED FREE, WHICH WERE THEN REPAIRED WITH A RUNNING 6-0SUTURE. THE SPONSOR ASSESSED THE EVENT AS RELATED TO THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 22383503 ↗
• MalfunctionMay 20, 2025Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE INVOLVING THE STENT GRAFT ESBF2314C103E ENDUR IIS BIF, THE TRIGGER WOULD NOT DISENGAGE TO ALLOW RECAPTURE OF THE DELIVERY SYSTEM, NECESSITATING THE SYSTEM TO BE REMADE. THE PATIENT WAS BEING TREATED FOR A 60MM ANEURYSM. THE HEALTHCARE PROFESSIONAL INDICATED A DEVICE ISSUE AS THE CAUSE, ALTHOUGH THE SPECIFIC CAUSE COULD NOT BE DETERMINED. THE DELIVERY SYSTEM WAS THEN REMOVED WITHOUT RECAPTURING THE TAPERED TIP WHICH DIDNT RESULT IN ANY INJURY TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050793 ↗
• InjuryFeb 5, 2025Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. LESS THAN ONE MONTH LATER, A STENOSIS IN THE STENT GRAFT LIMBS WAS NOTED DUE TO KINKING AND EXTERNAL COMPRESSION. THERE WAS NO THROMBUS FORMATION. THE SPONSOR ASSESSED THE STENOSIS AS RELATED TO THE DEVICE. THE SITE ASSESSED THE STENOSIS AS POSSIBLY RELATED TO THE STUDY DEVICE. THERE HAS BEEN NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Pain

  MAUDE report 21312196 ↗
• MalfunctionNov 21, 2024Leak/Splash; Leak/Splash

  AN ENDURANT II/IIS STENT GRAFT WAS IMPLANTED AS PART OF THE ADVANCE STUDY FOR THE TREATMENT OF ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED AT THE END OF THE INDEX PROCEDURE, AN UNSPECIFIED ENDOLEAK WAS OBSERVED.  THE SPONSOR ASSESSED THE UNKNOWN ENDOLEAK AS POSSIBLE RELATED TO THE DEVICE AND INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20744498 ↗
• InjuryNov 6, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60MM AAA. IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE OR WITH A SUSPECTED TYPE II ENDOLEAK, HOWEVER THE AORTOGRAM PERFORMED REVEALED THE LEAK TO BE A IA ENDOLEAK. THE PHYSICIAN IMPLANTED 9 ENDOANCHORS TO TRY TO RESOLVE THE ENDOLEAK. THE ENDOLEAK SLOWED DOWN BUT REMAINED. THE PHYSICIAN GAINED ACCESS TO THE LEFT FEMORAL VEIN AND VENA CAVA AND USED A LASER TO CROSS FROM THE VENA CAVA TO THE AORTA IN THE ANEURYSM SAC. MULTIPLE COILS WERE IMPLANTED AND THE FINAL AORTOGRAM REVEALED RESOLUTION OF THE IA ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE IA ENDOLEAK WAS ANATOMY RELATED. THE PHYSICIAN NOTED THAT THE AORTIC NECK HAD DETERIORATED CAUSING THE GRAFT TO LOSE SEAL. THE GRAFT HAD NOT MOVED FORM ITS ORIGINAL POSITION NOR HAD IT CHANGED SHAPE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 20620601 ↗
• DeathOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS REPORTED ON (B)(6) 2024 THAT THE PATIENT PRESENTED EMERGENTLY AND WAS TRANSFERRED TO THE OPERATING ROOM ON (B)(6) TO EXPLANT THE ENDURANT GRAFT BECAUSE IT WAS BELIEVED TO BE INFECTED. AN AORTA BIFEM WAS PERFORMED AND WHEN THE CLAMP WAS RELEASED THERE WAS A LOT OF BLEEDING. THE PHYSICIAN PROCEEDED TO SUTURE THE WHERE THE LEAKS WERE HOWEVER THEU PERSISTED, SO AN AX BY FEM BYPASS WAS PERFORMED. THE NEXT DAY ON CTA IT WAS DETERMINED THAT THE SMA WAS LIGATED. THAT EVENING THE PATIENT WAS BROUGHT BACK TO THE OR AND IT WAS DETERMINED THAT THE PATIENT HADDEAD BOWELS AND STILL BLEEDING FROM THE PRIOR REPAIR. THE GENERAL SURGEON WAS CALLED IN TO REVIEW. IT WAS REPORTED THE PATIENT EXPIRED ON (B)(6) 2024. THE CAUSE OF THE SUSPECTED INFECTION AND DEATH IS UNDETERMINED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 20358609 ↗
• InjurySep 12, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS REPORTED APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN AND A TYPE IA ENDOLEAK WAS IDENTIFIED. THE PATIENT WAS TAKEN TO THE OR AND A NON-MDT STENT WAS IMPLANTED HOWEVER THE ENDOLEAK REMAINED. IT WAS NOTED BY THE PHYSICIAN THAT THE AORTIC NECK WAS MEASURING 12-13MM IN DIAMETER AND 10MM IN LENGTH AND SO THE ENDURANT STENT GRAFT WAS CONSTRAINED AND THE PROXIMAL SEALING STENT COULD NOT FULLY OPEN AS THE GRAFT WAS OVERSIZED IN RELATION TO THE PATIENT¿S ANATOMY . THE PROXIMAL ENDOLEAK REMAINED AFTER THE NON MDT STENT WAS IMPLANTED. THE PHYSICIAN DID NOT FEEL A GOOD ENDOVASCULAR OPTION EXISTED GIVEN HOW SMALL THE AORTA WAS AT THE RENAL LEVEL AND AN OPEN REPAIR WAS PERFORMED WHERE THE ENDOGRAFT WAS EXPLANTED, WITH THE EXCEPTION OF THE SUPRARENAL STENT AND THE MOST PROXIMAL ASPECT OF THE GRAFT WHERE THE ENDOANCHORS WERE IN PLACE. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS DUE TO OVERSIZING. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 20198241 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED AS PART OF THE ADVANCE STUDY FOR THE TREATMENT OF ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED 4 DAYS POST INDEX PROCEDURE, BLOOD TEST RESULTS CONFIRMED DECREASED EGFR LEVELS FROM BASELINE LABS COLLECTED. PER SITE, NO INTERVENTION/TREATMENT HAS BEEN PERFORMED. THE DECREASED EGFR LEVELS ARE RECOVERING/RESOLVING. THE SITE ASSESSED THE DECREASED EGFR LEVELS AS NOT RELATED TO THE INDEX PROCEDURE AND DEVICE AND PROBABLY RELATED TO AN UNDERLYING CONDITION / DISEASE. THE SPONSOR ASSESSED THE DECREASED EGFR LEVELS AS POSSIBLY RELATED TO THE INDEX PROCEDURE AND NOT RELATED TO THE DEVICE, OR TO THE UNDERLYING CONDITION / DISEASE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Renal Failure

  MAUDE report 20064499 ↗
• InjuryMay 16, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM AAA ALONG WITH 4 ENDOANCHORS. A SMALL PAU/DILATION OF THE DESCENDING THORACIC AORTA (APPROX 26/28MM) IS PRESENT. IT WAS NOTED THAT THE PATIENT HAS A SHORT, SEVERELY ANGULATED NECK WITH MILD PROXIMAL NECK CALCIFICATION AND THROMBUS. SMALL COMMON ILIACS WITH MODERATE CALCIFICATION AND TORTUOSITY. IT WAS REPORTED THAT ONE MONTH FOLLOW-UP CT SHOWED A IA ENDOLEAK. INTERVENTION WAS COMPLETED WHERE AN ENDURANT CUFF WAS OPENED TO TRY TO GAIN ADDITIONAL SEAL ZONE LENGTH BELOW THE RIGHT RENAL ARTERY TO TREAT THE IA ENDOLEAK. THE RIGHT RENAL WAS HIGHER THAN THE LEFT. HOWEVER, DUE TO TORTUOSITY ADDITIONAL LENGTH COULD NOT BE ACHIEVED FROM EITHER RIGHT OR LEFT APPROACHES. IT WAS DECIDED NOT TO IMPLANT THE ADDITIONAL CUFF. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS ANATOMY RELATED DUE TO THE PATIENT'S EXTREMELY SHORT ANGULATED NECK. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 19329389 ↗
• MalfunctionApr 24, 2024Material Deformation; Material Deformation

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A PENETRATING AORTIC ULCER (PAU) OF THE INFRA-RENAL AORTA. THE PROXIMAL AORTIC NECK DIAMETER MEASURED 19MM PROXIMALLY <(>&<)> 19MM DISTALLY WITH A NECK LENGTH OF 40MM. INFRARENAL ANGULATION WAS 28 DEGREES. MILD NECK CALCIFICATION WAS PRESENT. MILD BILATERAL ILIAC CALCIFICATION WAS NOTED. THE CELIACWAS ENLARGED AT 16.8MM AND THE DISTAL LCFA ALSO ENLARGED AT 15.7MM DUE TO THE FACT TREATING A PAU MINIMAL OVERSIZING IN CIA'S SEALING WITH 13MM LIMBS WAS RECOMMENDED. IT WAS REPORTED AT THE ONE-MONTH FOLLOW-UP ON 23-APR-2024, CT IMAGING IDENTIFIED MILD INFOLDING JUST ABOVE THE FLOW DIVIDER OF ESBF2314C103E. NO ENDOLEAKS WERE DETECTED, AND THE PAU SHOWED NO SIGNS OF EXPANSION/ FILLING. PER THE PHYSICIAN THE CAUSE THE INFOLDING IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174220 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 52MM AAA. IT WAS REPORTED THAT 12 HOURS POST THE INDEX PROCEDURE IT WAS NOTED THAT THE RIGHT LIMB ETLW1610C156E WAS OCCLUDED DUE TO BEING CRUSHED IN THE DISTAL AORTA BY THE LEFT LIMB ETLW1616C124E. INTERVENTION WAS PERFORMED WHERE A THROMBECTOMY WAS PERFORMED. A NON-MDT STENT WAS PLACED IN THE RIGHT LIMB AT THE PROXIMAL END. A 10X59 BALLOON EXPANDABLE STENT WAS PACED AT THE SAME TIME IN THE LEFT LIMB TO PREVENT THAT SIDE FROM BEING CRUSHED, BUT THE LEFT LIMB WAS NOT BLOCKED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED. IT WAS NOTED THAT THERE WAS CALCIUM PRESENT IN THE DISTAL AORTA. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18854680 ↗
• MalfunctionSep 22, 2023Material Deformation; Material Deformation

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 40MM AAA . THE AORTIC NECK WAS NOTED TO MEASURE 18MM TO 21MM PROXIMAL TO DISTAL ALONG A 5CM LENGTH. MILD PROXIMAL NECK THROMBUS WAS NOTED WITH MODERATE CALCIFICATION IN THE PROXIMAL NECK ALSO REPORTED.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, POST CANNULATION OF THE CONTRA LATERAL LIMB, AN INTRAVASCULAR ULTRASOUND WAS PLACED INTO THE 23MM PORTION OF THE BIFURCATED GRAFT AND AN INFOLDING WAS OBSERVED.  THE CASE THEN CONTINUED THROUGH ITS NORMAL SEQUENCE. A RELIANT BALLOON WAS USED TO MOLD THE NECK OF THE  GRAFT, LIMB OVERLAP AND THROUGHOUT THE LIMBS BILATERALLY. PRIOR TO PERFORMING A FINAL ANGIOGRAM WITH CONTRAST, A INTRAVASCULAR ULTRASOUND WAS USED AGAIN TO OBSERVE THE AORTIC NECK AND IT WAS NOTED THE INFOLDING HAD RESOLVED.  PER THE PHYSICIAN THE CAUSE OF INFOLDING COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17796638 ↗
• InjurySep 14, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 76MM AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE BIFURCATE (B)(6) WAS DELIVERED VIA THE RIGHT GROIN AND DEPLOYED UNTIL THE CONTRA-LATERAL GATE WAS OPENED. THE CONTRA-LATERAL GATE WAS CANNULATED VIA THE LEFT GROIN ACCESS AND A MARKER PIGTAIL WAS USED TO VERIFY. A HAND INJECTION VIA THE LEFT SHEATH WAS PERFORMED TO DETERMINE THE LIMB LENGTH NEEDED. (B)(6) WAS DELIVERED AND DEPLOYED AND THE DELIVERY SYSTEM WAS REMOVED. THE DEPLOYMENT OF (B)(6) WAS COMPLETED AND THE DELIVERY SYSTEM WAS REMOVED. A 16F DRY-SEAL SHEATH WAS USED TO BACK-FILL THE ACCESS SITE. A HAND INJECTION VIA THE RIGHT ACCESS SITE WAS PERFORMED AND A MARKER PIGTAIL WAS USED TO DETERMINE THE LIMB LENGTH NEEDED. (B)(6) WAS DELIVERED AND DEPLOYED VIA THE 16F SHEATH AND THE DELIVERY SYSTEM WAS REMOVED. BALLOONING OF THE ENDOGRAFTS WAS PERFORMED USING 2 RELIANT BALLOONS AND AN IVUS WAS PERFORMED WHICH DETERMINED THE NEED FOR COVERED BALLOON MOUNTED STENTS IN THE PROXIMAL ILIAC ARTERIES. NON-MDT STENT GRAFTS WERE DEPLOYED AND AN ANGIOGRAM WAS PERFORMED WHICH (B)(6) WAS INSERTED VIA THE RIGHT LIMB ACCESS AND WHILE ADVANCING THE

  Patient problems: Insufficient Information

  MAUDE report 17743271 ↗
• InjuryAug 28, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 50MM + AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THERE WAS AN ENDOLEAK WAS OBSERVED AT THE FINAL RUN. THE PHYSICIAN RE-BALLOONED THE BIFURCATE USING A RELIANT BALLOON AND RE-RAN THE FINAL RUN HOWEVER A PERSISTENT EARLY ENDOLEAK WAS SEEN WITH ANEURYSM FILLING. THE PHYSICIAN OCCLUDED THE AORTA BY BALLOONING THE BIFURCATE AND TOOK AN ANGIOGRAM VIA PIGTAIL TO DETERMINE THE LOCATION OF THE ENDOLEAK. NO ENDOLEAK WAS SEEN USING THIS METHOD. 4 ENDOANCHORS WERE IMPLANTED IN THE BIFURCATE AND ANOTHER ANGIOGRAM WAS DONE BUT THE ENDOLEAK REMAINED. ANOTHER 2 ENDOANCHORS FROM THE SAME CASSETTE WERE PLACED BUT THE ENDOLEAK WAS STILL PRESENT. IT WAS NOTED THAT THE LAST ACT WAS OVER 350. THE PHYSICIAN BELIEVES THERE IS A TEAR IN THE ENDURANT IIS BIFURCATE STENT GRAFT. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 17629979 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A AAA . IT WAS SAID DURING THE IMPLANT, THE PHYSICIAN SUSPECTED THE ANEURYSM WAS INFECTED BUT THE PATIENT REQUIRED TREATMENT. IT WAS REPORTED THAT THE STENT GRAFTS WERE EXPLANTED DUE TO AN INFECTION. IT WAS REPORTED IMMEDIATELY POST-OP THE PATIENT DID NOT HAVE ANY SYMPTOMS AND THE INFECTION INITIALLY RESOLVED, BUT PRESENTED AGAIN MONTHS LATER. PER THE PHYSICIAN THE CAUSE OF THE EXPLANT WAS INFECTION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Unspecified Infection

  MAUDE report 17547720 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE EMERGENT  ENDOVASCULAR TREATMENT OF A RUPTURED AAA. IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENTS SHOWED SIGNS OF AN INFECTION IN THE ABDOMEN. FIVE WEEKS LATER, THE STENT GRAFTS WERE EXPLANTED AND REPLACED WITH CADAVER TISSUE.  PER THE PHYSICIAN, THE CAUSE OF THE EXPLANT WAS AN INFECTION.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Unspecified Infection

  MAUDE report 16384620 ↗
• DeathFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN AN ENDOVASCULAR TREATMENT OF A RUPTURED AAA .  IT WAS REPORTED THROUGH TECHNICAL SERVICES, THAT ON THE REGISTRATION THAT WAS SUBMITTED FOR THESE STENT GRAFTS, THAT IT WAS NOTED THE PATIENT WAS DECEASED ON THE SAME DATE AS THE IMPLANT. IT WAS THEN CONFIRMED THAT THE ENDURANT IIS STENT GRAFT SYSTEM HAD BEEN IMPLANTED WITHOUT ISSUES AND WITHOUT ANY MALFUNCTIONS OBSERVED. NO MEDTRONIC REPRESENTATIVE WAS AT THE PROCEDURE. THE PATIENT SUBSEQUENTLY DIED FROM MULTIPLE ORGAN FAILURE ON THE SAME DATE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16310445 ↗
• InjuryJan 13, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 51MM AAA.  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT GRAFTS WERE IMPLANTED UNEVENTFULLY. DUE TO A NARROW DISTAL AORTA, PTA BALLOONS WERE USED TO OPEN LUMENS. AN ANGIOGRAM WAS PERFORMED AND AN ENDOLEAK WAS PRESENT. THE PHYSICIAN WAS UNABLE TO DETERMINE EXACT SOURCE OF THE LEAK. THERE WAS EXTRAVASATION FROM THE LEAK, AND THE PATIENT BECAME ACUTELY HYPOTENSIVE. A CONFORMABLE BALLOON WAS USED TO OCCLUDE AORTA AND STABILIZE THE  PATIENT. FOLLOW ON ANGIOGRAMS WERE INCONCLUSIVE, THE LEAK PERSISTED. A CUFF WAS PLACED DUE TO POSSIBLE IA OR TYPE IV  ENDOLEAK. THE PATIENT CONTINUED TO BE UNSTABLE AND THE PATIENT WAS CONVERTED TO OPEN REPAIR. THE BIFURCATE STENT GRAFT WAS SUSPECTED OF CONTAINING THE UNKNOWN ENDOLEAK BUT IT IS NOT KNOWN. IT WAS CONFIRMED THE IMPLANT OF THE ENDURANT CUFF DID NOT MAKE ANY IMPACT TO THE ENDOLEAK. THE BIFURCATE AND AORTIC CUFF  WERE DISSECTED BELOW THE M STENT AND SEWED INTO A SURGICAL GRAFT. THE OTHER STENT GRAFTS WERE PARTIALLY DISSECTED AND SEWED INTO A SURGICAL GRAFT AND REMOVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.  NO ADDITIONA

  Patient problems: Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 16156179 ↗
• InjuryDec 15, 2022Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 56MM RUPTURED AAA.  IT WAS REPORTED THAT A TYPE III ENDOLEAK WAS DIAGNOSED ON THE UNKNOWN DATE. THE PATIENT UNDERWENT OPEN REPAIR AND THE STENT GRAFT WAS EXPLANTED.  PER THE PHYSICIAN THE CAUSE OF THE TYPE III ENDOLEAK WAS EXCESSIVE BALLOONING AT THE FLOW DIVIDER DURING THE INDEX PROCEDURE.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 15986819 ↗
• InjurySep 29, 2022Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 78MM ABDOMINAL AORTIC ANEURYSM. EVAR USING THE LASER TECHNIQUE TO LASER THE SMA AND BOTH RENAL ARTERIES WAS PERFORMED. TORTUOUS ANATOMY WAS NOTED (VERY TIGHT DISTAL AORTA AND VERY TORTUOUS ANATOMY AROUND THE VISCERAL SEGMENT). IT WAS REPORTED DURING THE INDEX PROCEDURE THE SMA AND BOTH RENAL ARTERIES WERE PRE-STENTED WITH MEDTRONIC VISI-PRO STENTS. THE ENDURANT GRAFT WAS PLACED BELOW THE CELIAC ARTERY, DEPLOYED AND REMOVED FROM THE BODY. AN APTUS TOURGUIDE WAS INSERTED ALONG WITH THE LASER. THE SMA WAS LASERED AND A NON MDT (7X22)STENT PLACED. THE SAME LASER WAS USED TO SUCCESSFULLY LASER THE RIGHT RENAL. TWO APTUS GUIDES KINKED DUE TO SEVERE ANGULATION OF THE ANATOMY DURING THE PROCEDURE. A 5X29 NON MDR STENT WAS PLACED IN THE ARTERY. THE PHYSICIAN THEN PROCEEDED TO THE LEFT RENAL WHICH WAS VERY TORTUOUS AND HAD A DOWNWARD CURVE. AFTER SEVERAL HOURS OF TRYING ATTEMPTS TO GET TO THE RENAL ARTERY WERE UNSUCCESSFUL. THE PHYSICIAN WAS ABLE TO GET IN THE ARTERY BUT UNABLE TO GET ANY STENT TO TRACK AROUND THE TORTUOUS RENAL ARTERY. IT WAS NOTED THEARTERY WAS DISSECTED AND THE DECISION WAS M

  Patient problems: Renal Failure; Vascular Dissection

  MAUDE report 15508794 ↗
• InjuryJun 10, 2022Activation, Positioning or Separation Problem; Device Damaged by Another Device; Activation, Positioning or Separation Problem; Device Damaged by Another Device

  AN ENDURANT IIS STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 56MM ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD BILATERAL ILIAC STENTS IN PLACE THAT WERE IMPLANTED ON AN EARLIER DATE. IT WAS REPORTED DURING THE INDEX PROCEDURE AN 18F SHEATH WAS ADVANCED THROUGH THE PATIENTS RIGHT CFA, EXTERNAL ILIAC AND COMMON ILIAC. AFTER THE NON MDT SHEATH WAS IN PLACE THE 23MM ENDURANT IIS MAIN BODY WAS ADVANCED AND DELIVERED HOWEVER THE ENDURANT GRAFT DID NOT OPEN FULLY. THE GRAFT WAS EXPLANTED AS A RESULT AND AN OPEN REPAIR COMPLETED. AS PER THE PHYSICIAN IT WAS DETERMINED THAT EITHER THE SHEATH OR THE DEVICE DISLODGED THE ILIAC STENT AND WHEN THE STENT WAS ADVANCED INTO THE AORTA IT CAUSING THE ENDURANT GRAFT TO NOT OPEN FULLY.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 14652531 ↗

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-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