Endurant® II ETCF2828C49ERecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00613994991447), received between Dec 22, 2016 and Sep 3, 2026 — classified as 7 deaths, 27 injuries, 10 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. 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 ↗

2. Oct 15, 2021Open, Classified

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

   Z-0291-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during treatment of a 61 mm abdominal aortic aneurysm, a type 1a endoleak from a previously implanted non-Medtronic product was treated with an Endurant II aortic cuff extension. There was 10 mm of proximal seal length between the right renal artery and the proximal edge of the previously implanted bifurcated graft. A 28 x 28 x 49 mm Endurant II aortic cuff extension was implanted. Guidewire was biased toward the left lateral aortic wall made exact visualization of the right lateral proximal graft position challenging. Completion  angiography identified partial coverage of the right renal artery, estimated at approximately 40%. The aortic extension landed in the intended position, and patient anatomy reportedly required partial right renal artery coverage to optimize the proximal seal zone. Intervention was required and a 7 mm renal stent was placed in the right renal artery to maintain patency. Completion angiography demonstrated patency of both renal arteries and no residual type 1a endoleak. Per the physician the cause of the occlusion was anatomy related and noted the patient¿s anatomy required partial coverage of right renal artery to optimize proximal sea

  Patient problems: Obstruction/Occlusion

  MAUDE report 50588321 ↗
• InjuryMar 26, 2026Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR OF A 77 MILLIMETER ABDOMINAL AORTIC ANEURYSM, AFTER STANDARD EVAR WAS COMPLETED ON FINAL ANGIOGRAM THE PHYSICIAN WAS CONCERNED THAT THE GRAFT LANDED 5 MILLIMETERS BELOW THE RENAL ARTERIES (20MM NECK LENGTH). NO ENDOLEAK WAS OBSERVED. THE PHYSICIAN ELECTED TO IMPLANT A 28X49 ENDURANT II CUFF. AFTER DEPLOYING THE ENTIRE CUFF BUT BEFORE RELEASE OF THE BARE SPRINGS THE PHYSICIAN WAS CONCERNED ABOUT BEING TOO HIGH ON THE RENALS. NEGATIVE PRESSURE ON THE DELIVERY SYSTEM WAS APPLIED WHILE ROTATING THE SMALL BLUE KNOB TO RELEASE THE BARE SPRINGS. THE BLUE KNOB WAS TURNED UNTIL IT COULD NOT TURN ANY FURTHER BUT DID NOT RELEASE AS INTENDED, LEAVING 3 MILLIMETERS OF BARE SPRINGS IN THE NOSE CONE. SLIGHT FORWARD PRESSURE ON THE DEVICE AND A WRIGGLING MOVEMENT WAS ATTEMPTED BUT THE BARE SPRINGS DID NOT RELEASE. BAIL OUT TECHNIQUES WERE EMPLOYED AND THE BACK END WH EEL REMOVED TO TRY AND SLIDE CLEAR THE TABS FORWARD TO MANUALLY PUSH UP THE NOSE CONE TO RELEASE THE SPRINGS BUT THIS DID NOT WORK. A RELIANT BALLOON WAS INSERTED VIA THE CONTRA SIDE UP AGAINST THE NOSE CONE AND INFLATED. IT EFFECTIVELY RELEASED THE SPRINGS/HOOKS FROM THE NOSE

  Patient problems: Insufficient Information

  MAUDE report 24696172 ↗
• InjuryFeb 9, 2026Leak/Splash; Difficult to Remove; Device Damaged by Another Device

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 65MM AAA.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PROXIMAL ASPECT OF THE ENDURANT BIFURCATE WAS DEPLOYED AS NORMAL WITHOUT INCIDENT. DURING CANNULATION OF THE CONTRALATERAL GATE, THE IPSILATERAL LIMB'S DELIVERY SYSTEM WAS INADVERTENTLY PULLED DOWN, POTENTIALLY ENGAGING ONE OF THE BARE METAL STENTS AND CAUSING IT TO INVERT. THIS MAY HAVE OCCURRED OFF SCREEN SO IT WAS NOT SEEN.  AFTER DEPLOYMENT OF THE CONTRALATERAL LIMB, SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING REMOVAL OF THE IPSILATERAL DELIVERY SYSTEM, AND THE STENT WAS OBSERVED TO ENGAGE IN THE TOP CAP AND SPINDLE OF THE DELIVERY SYSTEM. THE PHYSICIAN PASSED THE SYSTEM BACK UPWARD AND SEVERAL MORE ATTEMPTS WERE MADE ONLY RESULTING IN INVERSION OF THE BARE STENTS WHEN THE FORCE REQUIRED TO REMOVE THE DELIVERY SYSTEM REQUIRED WAS APPLIED.  THE INVERSION CAUSED THE ENDURANT STENT GRAFT TO BE DRAGGED OUT OF THE NECK SEAL ZONE AND INTO THE ANEURYSM. INTRAVASCULAR ULTRASOUND WAS USED TO DETERMINE THAT THE LUMEN WAS MOSTLY CLEAR AND SUITABLE FOR AORTIC CUFF PLACEMENT. A 282849 CUFF WAS PLACED, BUT A TYPE 1A ENDOLEAK WAS OBSER

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

  MAUDE report 24289165 ↗
• InjuryAug 7, 2024Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT CUFF (ETCF2828C49E) WAS IMPLANTED, DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED, DURING THE INDEX PROCEDURE. A TYPE IA ENDOLEAK WAS IDENTIFIED. INTERVENTION WAS PREFORMED TO TREAT THE ENDOLEAK, WHERE TWO HELI-FX ENDOANCHORS WERE SUCCESSFULLY DEPLOYED. HOWEVER, THE APPLIER STOPPED WORKING AND A REPLACEMENT HELI-FX APPLIER WAS USED TO COMPLETE THE DEPLOYMENT OF THE ENDOANCHORS. PER THE PHYSICIAN, THE CAUSE TYPE IA ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927049 ↗
• InjuryApr 15, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE ENDURANT CUFF (B)(6) DEPLOYED UNEVENLY. IT WAS OBSERVED THAT THE LEFT SIDE OF THE GRAFT LANDING HIGHER THAN THE RIGHT. PER THE PHYSICIAN THE CAUSE WAS DUE TO ABNORMAL DEVICE DEPLOYMENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

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

  MAUDE report 19103811 ↗
• InjuryDec 21, 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 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 SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18375335 ↗
• InjuryDec 14, 2023Leak/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 (ESBF2814C103E) AND ENDURANT LIMBS (ETLW1616C93E & ETLW1616C124E) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 62MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2023. THE PROXIMAL AORTIC NECK WAS 23MM AND 26MM IN LENGTH WITH MILD NECK CALCIFICATION. MILD LEFT AND RIGHT ILIAC CALCIFICATION WAS NOTED. IT WAS REPORTED 4 DAYS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A COLD LEG. FOLLOW-UP IMAGING REVEALED A LIMB THROMBOSIS OF THE LEFT LIMB (ETLW1616C124E). ON 05-DEC-2023, OPEN AORTO BIFEM INTERVENTION TO TREAT THE LIMB THROMBOSIS WAS PERFORMED. DURING THE PROCEDURE, BOTH ENDURANT LIMBS (ETLW1616C124E & ETLW1616C93E) WERE EXPLANTED, AND THE ENDURANT IIS (ESBF2814C103E) WAS PARTIALLY EXPLANTED, LEAVING THE SUPRARENAL FIXATIONS IN PLACE AND 2/3S OF THE MAIN BODY BIFURCATE. TWO ENDURANT II AORTIC CUFFS (ETCF2828C49E & ETCF3232C49E) WERE IMPLANTED TO SEAL THE PROXIMAL NECK ATTHE RENAL ARTERIES. HOWEVER, ON (B)(6) 2023 THE PATIENT CONTINUED TO EXPERIENCE PROXIMAL LEAKAGE DESPITE THE AORTO BIFEM PROCEDURE AND CUFF IMPLANTS. THE PHYSICIAN OPTED TO EXPLANT BOTH OF THE CUFFS AND NON MDT GRAFTS WERE IMPLANTED. PER THE PHYSICIAN THE CAUSE OF

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 18332024 ↗
• MalfunctionJul 20, 2023Leak/Splash; Leak/Splash

  AN ENDURANT AUI STENT GRAFT AND ENDURANT LIMB WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. AN ENDURANT II CUFF WAS IMPLANTED 2 YEARS LATER FOR AN UNKNOWN REASON. THE MAX AORTIC DIAMETER AT 2 YEARS WAS NOTED AS 75MM X 81MM. IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE, FOLLOW-UP CT SHOWED AN UNKNOWN ENDOLEAK. IT WAS ALSO NOTED THAT THE DISTAL RIGHT LIMB APPEARS TO HAVE LOST APPOSITION TO THE WALL OF THE RIGHT COMMON ILIAC ARTERY. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17359639 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT CUFF WAS IMPLANTED DURING AN UNKNOWN PROCEDURE. VALIANT NAVION STENT GRAFTS WERE IMPLANTED 5 MONTHS LATER FOR THE ENDOVASCULAR TREATMENT OF A TAA AND DISSECTION   A CT WAS PERFORMED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE. PER THE PHYSICIAN, THE CT INDICATES EXTENSION OF THE SAC INTO THE PSOAS MUSCLE CONCERNING FOR A ABSCESS.  THE PATIENT APPEARS TO HAVE A NON-MEDTRONIC BIFURCATED STENT IMPLANTED AND SEVERAL LIMBS IN THE ABDOMINAL AREA WHERE THE ABSCESS WAS OBSERVED. IT WAS NOTED THAT THE VALIANT NAVION STENT GRAFTS WERE NOT ASSOCIATED WITH THE ABSCESS. NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Abscess; Aneurysm

  MAUDE report 17298596 ↗
• MalfunctionSep 21, 2022Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A  AAA.  IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP APPROXIMATELY 11 YEARS POST-INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS NOTED ON CTA.  INTERVENTION WAS PERFORMED 5 DAYS LATER WHERE AN ENDURANT CUFF ETCF2828C49E WAS IMPLANTED . IT WAS REPORTED THE ENDOLEAK IMPROVED BUT THE TYPE IA ENDOLEAK IS STILL OBSERVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY AND AORTIC NECK DILATION OVER TIME.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS DOING WELL REPORTEDLY. THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461597 ↗
• DeathSep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 68 MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT EXPERIENCED A LEFT RENAL/ABDOMINAL AORTIC RUPTURE AFTER A EBTF2816C146E AND A ETLW1616C124E WERE IMPLANTED DUE TO PROXIMAL BALLOONING WITH A RELIANT BALLOON. THERE WAS A NOTICEABLE GIVE TO THE AORTA WHILE LOOKING AT THE GRAFT DURING THE BALLOONING. AS THE BALLOON PRESSURE WAS RELEASED THE PATIENTS BP DROPPED SIGNIFICANTLY. THE RELIANT BALLOON WAS THEN ADVANCED ABOVE THE SMA AND RE-INFLATED. SEVERAL ANGIOGRAMS WERE TAKEN AND AN EXTRAVASATION WAS SEEN JUST BELOW THE LEFT RENAL ARTERY. A 28X28X49 CUFF WAS PLACE APPROXIMATELY 3MM ABOVE THE MAIN BODY GRAFT IN AN ATTEMPT TO COVER THE TEAR. THE PATIENT STABILIZED BUT THE APPEARANCE OF THE LEAK WAS STILL VISIBLE. THE PHYSICIAN'S THEN DECIDED TO TRANSFER THE PATIENT , SO THE PATIENT COULD HAVE FURTHER MORE COMPLEX INTERVENTION FOR THE RUPTURE, BUT THE PATIENT'S BLOOD PRESSURE DROPPED AGAIN WHILE THE PATIENT'S GROINS WERE BEING CLOSED. SEVERAL ATTEMPTS WERE MADE TO FIX THE TEAR ENDOVASCULARLY WITH NO SUCCESS AND THE DECISION TO CONVERT TO OPEN REP

  Patient problems: Insufficient Information; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 15445112 ↗
• InjuryJul 5, 2022Leak/Splash; Leak/Splash

  THREE ENDURANT AORTIC CUFFS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT A TYPE IA ENDOLEAK WAS OBSERVED ON AN UNKNOWN DATE AND RE-INTERVENTION WAS CARRIED OUT. AN ENDURANT LLS STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE APPROXIMATELY 2.5 YEARS POST IMPLANT OF THE ENDURANT CUFFS. A VALIANT NAVION WAS THEN IMPLANTED AT A DIFFERENT FACILITY DURING AN UNKNOWN ENDOVASCULAR PROCEDURE APPROXIMATELY 11 DAYS LATER. NO CAUSE FOR THE TYPE IA AS PER THE PHYSICIAN WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 14914463 ↗
• InjuryMar 23, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT AND THREE ENDURANT II LIMBS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED THAT DURING A FOLLOW-UP CT SCAN OVER 4 YEARS LATER, A TYPE IA ENDOLEAK AND A SUSPECTED TYPE IB ENDOLEAK WERE FOUND BY THE RADIOLOGY. 4 DAYS LATER THE PATIENT RETURNED TO THE OR FOR SECONDARY INTERVENTION TO TREAT THE TYPE IA LEAK AND EXTEND THE DISTAL SEAL IN THE RCIA. A 28MM PROXIMAL CUFF WAS DEPLOYED AT THE FLOOR OF THE RIGHT RENAL, THUS EXTENDING THE PROXIMAL SEAL BY 5 TO 7 MM. NEXT, A 16 ¿ 20¿82 FLARED ILIAC LIMB WAS DEPLOYED ON THE RIGHT SIDE TO EXTEND THE DISTAL SEAL BY 1.5 TO 2 CM, ALL THE WAY TO THE RIGHT COMMON ILIAC BIFURCATION. AFTER BALLOONING THE PROXIMAL AND DISTAL SEAL ZONES AS WELL AS OVERLAPPED SEGMENTS, THE INITIAL COMPLETION ANGIOGRAM SHOWED A BRISK TYPE IA LEAK ON THE LEFT LATERAL ASPECT OF THE GRAFT. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED 10 ENDOANCHORS CIRCUMFERENTIALLY AT THE TOP OF THE AORTIC CUFF, SPECIFICALLY PLACING 7 ANCHORS IN THE LEFT ANTERIOR AND LEFT POSTERIOR QUADRANTS. A SECOND COMPLETION ANGIOGRAM WAS PERFORMED WHICH CONFIRMED COMPLETE RESOLUTION OF THE TYPE IA LEAK. THE CAUSE OF THE

  Patient problems: Insufficient Information

  MAUDE report 13869007 ↗
• DeathJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON AN UNKNOWN DATE APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED AND A TYPE IA ENDOLEAK WAS IDENTIFIED. THE ANEURYSM SIZE WAS REPORTED TO BE 130MM. A TAVR PROCEDURE WAS SCHEDULED FOR (B)(6) 2021 WHERE THE AORTIC ENDOGRAFTS WERE PLANNED TO BE EXPLANTED HOWEVER ON THE (B)(6) 2021 THE PATIENTS ANEURYSM RUPTURED. INTERVENTION WAS COMPLETED WHERE 2 28MM ENDURANT CUFFS WERE IMPLANTED. THE FIRST CUFF WAS DEPLOYED AT THE LEVEL OF THE SMA COVERING BOTH RENALS. THE SECOND CUFF WAS DEPLOYED DISTAL TO THE FIRST CUFF. THE TYPE IA ENDOLEAK WAS NO LONGER PRESENT AND THE ANEURYSM WAS NOT FILLING ON THE FINAL RUN. IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENT EXPIRED. NO CAUSE OF THE DEATH WAS PROVIDED HOWEVER THE PHYSICIAN COMMENTED THAT THE PATIENT HAD OTHER COMORBIDITIES. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Insufficient Information; Rupture

  MAUDE report 13174550 ↗
• InjuryDec 16, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II AORTIC EXTENSION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 75MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW-UP , AN UNKNOWN ENDOLEAK WAS DISCOVERED. THE PHYSICIAN TREATED THE ENDOLEAK WITH BY PERFORMING A TAAA REPAIR THE FOLLOWING DAY. AS PER THE PHYSICIAN THE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13017848 ↗
• 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 ACCESSORYRENAL 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 SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

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

  MAUDE report 13008343 ↗
• MalfunctionSep 14, 2021Difficult to Remove; Malposition of Device; Device Dislodged or Dislocated; Difficult to Remove; Malposition of Device; Device Dislodged or Dislocated

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN APPROX. 60MM MM ABDOMINAL AORTIC ANEURYSM. ENDOLEAK TYPE 1A WAS OBSERVED ON A FOLLOW-UP VISIT ON AN UNKNOWN DATE (APPROX. 10 YEARS LATER). A CUFF WAS PLACED TO RESOLVE THE ISSUE. IT WAS REPORTED DURING THE INTERVENTION THE DEVICE CAUGHT ON THE SUPRA RENAL STENTS MAKING THE STENT GRAFT PUSH UP WHILE THE PHYSICIAN WAS TRYING TO RETRIEVE THE DEVICE. IT WAS REPORTED THE DELIVERY SYSTEM WAS VERY DIFFICULT TO RETRIEVE OR ADVANCE AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465880 ↗
• DeathJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 80MM PRE RUPTURED AAA DURING THE INDEX PROCEDURE IT WAS REPORTED THE PATIENT HAD AN ANGLED NECK AND THE PHYSICIAN DIDN¿T WANT TO COVER THE RIGHT RENAL SO THE DEVICE WAS LANDED SLIGHTLY LOW. A TYPE IA ENDOLEAK WAS OBSERVED AFTER IMPLANT, ENDOANCHORS WERE PLACED BUT THE ENDOLEAK PERSISTED. AN ADDITIONAL CUFF WAS THEN IMPLANTED TO RESOLVE THE LEAK. IT WAS REPORTED AFTER THE SURGERY, THE PATIENT SUFFERED FROM ABDOMINAL COMPARTMENT SYNDROME, CONTINUOUS BLEEDING FROM LUMBAR ARTERIES EVEN AFTER ANEURYSM WAS SEALED AND EXPIRED PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS PATIENT ANATOMY AND THAT THE PATIENT PASSED AWAY A FEW HOURS AFTER THE PROCEDURE WAS COMPLETED DUE TO COMPLICATIONS NOT RELATED TO DEVICE ISSUES. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT HAS EXPIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12121789 ↗
• MalfunctionMay 21, 2021Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 75MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, IT WAS THE PHYSICIANS INTENTION TO PLACE THE STENT GRAFT SLIGHTLY BELOW THE LEFT RENAL ARTERY DUE TO THE PATIENT HAVING A SMALL LEFT RENAL ARTERY. FOLLOWING THIS, 6 ENDOANCHORS WERE THEN IMPLANTED. A FINAL ANGIOGRAM WAS PERFORMED WHICH SHOWED WHAT APPEARED TO BE A TYPE IA ENDOLEAK. AN ENDURANT AORTIC CUFF WAS THEN IMPLANTED AS TREATMENT AND AFTER THIS IT WAS SAID THE ENDOLEAK APPEARED TO BE MUCH LESS. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862735 ↗
• InjuryOct 30, 2020Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED WHEN THE PATIENT RETURNED APPROXIMATELY 4 YEARS AND 2 MONTHS LATER, INTERVENTION WAS PERFORMED AND AN ENDURANT AORTIC CUFF WAS IMPLANTED FOR A POSSIBLE IA ENDOLEAK THAT WAS SEEN ON CT. A REPAIR WAS SUCCESSFULLY ACHIEVED BY PLACING A CUFF OVER THE RIGHT RENAL AND STENT WAS PLACED THROUGH THE CUFF WITH THE USE OF A LASER. AFTER THE PLACEMENT OF THE CUFF, THERE APPEARED TO BE EITHER A TYPE IV OR A TYPE 3B ENDOLEAK NOTED. THE EXISTING BIFURCATED ENDURANT GRAFT WAS RELINED USING NON-MEDTRONIC PRODUCTS. THIS RESOLVED THE ENDOLEAK AND THE CASE WAS COMPLETED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUEL WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10762277 ↗
• InjuryOct 28, 2020Leak/Splash; Leak/Splash

  AN ANEURX BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. AN ENDURANT CUFF WAS THEN IMPLANTED SEVEN YEARS LATER. IT WAS REPORTED ON THE DATE OF A CT, A TYPE IIIA ENDOLEAK WAS OBSERVED, THE BIFURCATE MAIN BODY AND CUFF SEPARATED CAUSING SAC ENLARGEMENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10748503 ↗
• InjuryOct 22, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 57MM ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD 2 ADDITIONAL LIMBS IMPLANTED IN A SECONDARY UNKNOWN PROCEDURE 3 YEARS POST THE INDEX PROCEDURE AND AN ENDURANT AORTIC CUFF FOR A TYPE IIIB ENDOLEAK 5 YEARS POST THE INDEX PROCEDURE. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT DEMONSTRATED ANEURYSM ENLARGEMENT AND EVIDENCE OF THE PREVIOUS TYPE III ENDOLEAK. THE PHYSICIAN DECIDED TO IMPLANT AN ENDURANT AUI AND WITH A FEM-FEM BY PASS. IN DOING THIS, THE TYPE III ENDOLEAK WAS NO LONGER PRESENT HOWEVER DURING THE LAST ANGIO RUN, WHILE THE AUI LOOKED GOOD, THE ORIGINAL BIFURCATED RIGHT LIMB WAS FILLING WITH CONTRAST. THE PHYSICIAN DECIDED TO WAIT AND SEE ONCE HEPARIN WEARS OFF TO SEE IF THE FLOW SUBSIDES IN THE ORIGINAL GRAFT ON THE RIGHT SIDE. PER THE PHYSICIAN THE CAUSE OF THE ANEURYSM ENLARGEMENT AND ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 10717885 ↗
• DeathAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 66 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE INDEX PROCEDURE WAS PERFORMED WITHOUT COMPLICATION. FINAL ANGIOGRAM WAS PERFORMED AND AN TYPE IA ENDOLEAK WAS OBSERVED WITH NO ISSUES FOUND IN RELATION TO THE POSITION OF THE STENT GRAFT COMPONENTS. THE PHYSICIAN THEN TRIED BALLOONING THE PROXIMAL GRAFT EDGE WITH A RELIANT BALLOON. IT WAS REPORTED THAT AN ANGIOGRAM WAS PERFORMED AFTER BALLOONING, AORTIC RUPTURE WAS OBSERVED. AORTIC OCCLUSION WAS THEN OBTAINED WITH A RELIANT BALLOON. IT WAS STATED THAT AN ENDURANT II AORTIC EXTENSION ((B)(4)) WAS THEN PLACED AT THE LEVEL OF THE RIGHT RENAL ARTERY COVERING THE LEFT RENAL ARTERY AND BALLOONED THE EXTENSION WITH A RELIANT BALLOON. PHYSICIAN WAS ABLE TO ACHIEVE SEAL WITH ENDOLEAK. IT WAS REPORTED THAT THE PATIENT'S AORTA RUPTURED AGAIN AFTER THE INDEX PROCEDURE. AS PER THE PHYSICIAN, CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. THE PATIENT HAS EXPIRED.

  Patient problems: Death; Rupture

  MAUDE report 10390219 ↗
• MalfunctionMay 28, 2020Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED THAT A CT PERFORMED TWO YEARS AND EIGHT MONTHS LATER SHOWED A TYPE IA ENDOLEAK WAS PRESENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. INTERVENTION WAS PERFORMED FIVE DAYS LATER WHERE A 28X49 CUFF WAS IMPLANTED WITH ENDOANCHORS. IT WAS REPORTED THAT THE ENDOLEAK WAS STILL VISIBLE AT THE END OF THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10095171 ↗
• InjuryFeb 12, 2020Malposition of Device; Malposition of Device

  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: Occlusion

  MAUDE report 9699112 ↗

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-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