Endurant® II ETLW1610C156E (UDI 00643169467637)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00643169467637), received between Dec 12, 2016 and Apr 2, 2025 — classified as 5 deaths, 29 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Occlusion Within Device” (7 reports).

6 other recalls cover devices cleared under the same FDA submission (P100021); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

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.

• MalfunctionApr 2, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR FOR A 40MM COMMON ILIAC ARTERY ANEURYSM, THE STENT GRAFT ETLW1610C156E ENDUR II LIMB WAS OPENED, PREPPED AND INSERTED INTO THE PATIENT VIA THE LEFT GROIN THROUGH A 16FR SENTRANT SHEATH. UNDER FLUOROSCOPY, IT WAS ADVANCED SO THAT THE PROXIMAL LIMB MARKERS LINED UP WITH THE FLOW DIVIDER OF THE ALREADY IMPLANTED BIFURCATED DEVICE. AFTER CONFIRMING THE POSITION OF THE LIMB, THE SURGEON BEGAN TO DEPLOY THE LIMB BY ROTATING THE BLUE HANDLE COUNTERCLOCKWISE AND PINNING THE GRAY FRONT GRIP. THE GRAFT COVER WAS SEEN ON FLUOROSCOPY RETRACTING AWAY FROM THE NOSE CONE AS IT SHOULD, HOWEVER, THE STENT GRAFT WITHIN THE DELIVERY SYSTEM WAS ALSO RETRACTING AWAY FROM THE NOSE CONE. AT THIS TIME IT WAS NOTED ON FLUOROSCOPY THAT THE DISTAL END OF THE STENT GRAFT WITHIN THE DELIVERY SYSTEM AGAINST THE STENT STOP WAS BUNCHING UP ON ITSELF. AS THE GRAFT COVER WAS RETRACTING THE STENT GRAFT WITHIN WAS ALSO RETRACTING. THE STENT GRAFT WAS NEVER DEPLOYED AND REMAINED INSIDE THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMADE BY ROTATING THE BLUE HANDLE CLOCKWISE UNTIL THE GRAFT COVER AND NOSE CONE REJOINED. THE DELIVERY SYSTEM WAS REMOVED FROM THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750020 ↗
• MalfunctionNov 13, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ENDURANT II STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE WHEN DEPLOYING THE LIMB, THE NOSECONE OF THE DEVICE MOVED PROXIMALLY WHEN TURNING THE BLUE GRIP HANDLE. THE GRAFT COVER DID NOT RETRACT AND SO THE LIMB WOULD NOT DEPLOY. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT ANY INJURY. THE PROCEDURE WAS COMPLETED WITH EXCLUSION OF THE AAA. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679705 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 50MM AAA ON (B)(6) 2024. THE AORTIC NECK DIAMETER M EASURED 26MM AT THE RIGHT ACCESSORY RENAL, AT 5MM BELOW RIGHT ACCESSORY RENAL ARTERIES ITS DIAMETER WAS 27MM, 10MM BELOW RIGHT ACCESSORY RENAL ARTERIES WAS 29MM, AND IT MEASURED 30MM 15MM BELOW RIGHT ACCESSORY RENAL ARTERY. THE NECK MEASURED 20MM IN LENGTH WITH THROMBUS. IT WAS REPORTED DURING THE INDEX PROCEDURE ALL DEVICES WERE IMPLANTED WITH NO ISSUES AND ALL STENT GRAFTS WERE BALLOONED USING A RELIANT BALLOON. UPON COMPLETION ANGIOGRAM THE PHYSICIAN NOTED A CREASE IN THE MAIN BODY (B)(6). THE PHYSICIAN PLACED THE RELIANT BALLOON BACK UP AND RE BALLOONED THE MAIN BODY AGAIN AND SAW WHAT LOOKED LIKE 2 SEPARATE LUMENS OF THE GRAFT. IVUS WAS USED TO LOOK AT THE GRAFT AND CONFIRMED 2 SEPARATE LUMENS OF THE GRAFT AND WHAT SEEMED LIKE A STENT STRUT HANGING IN THE AORTA AND COULD NOT DETERMINE IF THE STRUT WAS BROKEN. THE PHYSICIAN THEN USED 2 RELIANT BALLOONS TO TRY TO IRON OUT THE GRAFT, WHICH DID NOT WORK. DURING DEPLOYMENT, THE MARKERS ALL LINED UP BEFORE WE RELEASED THE TIP CAPTURE AND AFTER TIP CAPTURE RELEASED, 3 MARKERS WERE ALL ON THE SAME SIDE N

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18967320 ↗
• InjuryFeb 19, 2024Obstruction of Flow; Obstruction of Flow

  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 ON THE SAME DATE 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 18730546 ↗
• InjuryApr 7, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  AN ENDURANT II/IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 36.3MM ILIAC ANEURYSM .  IT WAS REPORTED DURING THE INDEX PROCEDURE THE BIFURCATED STENT GRAFT WAS DEPLOYED INFERIOR TO THE RENAL ARTERIES WHICH WAS CONFIRMED BY ANGIOGRAMS. DURING DEPLOYMENT OF THE CONTRALATERAL LIMB THERE WAS DIFFICULTY ALIGNING THE LIMB MARKER WITH THE MARKER ON THE FLOW DIVIDER. THE LIMB MOVED DOWN MULTIPLE TIMES WHILE ATTEMPTING TO ALIGN PROPERLY. THE PHYSICIAN PUSHED UP ON THE DELIVERY SYSTEM OF THE LIMB TO AVOID THE LIMB MOVING DOWNWARDS. THE LIMB WAS DEPLOYED WITH THE PROXIMAL PORTION APPROXIMATELY 1CM BELOW THE FLOW DIVIDER AND LANDED SHORT OF THE TARGET ZONE. THE PHYSICIAN THEN DEPLOYED A LONGER CONTRALATERAL LIMB TO ACHIEVE BOTH PROXIMAL ALIGNMENT AT THE FLOW DIVIDER AND DISTAL LENGTH FOR THE SEAL. AFTER DEPLOYMENT OF THE IPSILATERAL LIMB AND BALLOONING, IT WAS NOTED ON THE FINAL ANGIOGRAM THAT THERE WAS COVERAGE OF BOTH RENAL ARTERIES. THE PHYSICIAN THEN CATHETERISED THE RENAL ARTERIES AND PLACE STENTS TO PUSH DOWN THE PROXIMAL FABRIC OF THE BIFURCATED STENT GRAFT.  NO CAUSE AS PER THE PHYSICIAN WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUELAE WAS P

  Patient problems: Insufficient Information

  MAUDE report 14042953 ↗
• InjuryDec 9, 2021Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 36MM X 34MM RIGHT COMMON ILIAC ANEURYSM SAC . THE RIGHT INTERNAL ILIAC ARTERY WAS FIRST PLUGGED AND COILED. IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT , A TYPE IB ENDOLEAK WAS DISCOVERED ON THE ENDURANT LIMB ETLW1610C156E. IT WAS OBSERVED THAT THE LIMB HAD RETRACTED BACK UP INTO THE RIGHT COMMON ILIAC ARTERY ANEURYSM . THE PHYSICIAN IMPLANTED A LIMB AT THE LEVEL OF THE FLOW DIVIDER AND DOWN INTO THE REIA WHICH RESOLVED THE ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK WAS DUE TO PATIENTS OWN ANATOMY AS THE PHYSICIAN STATED THAT THE GRAFT LOST SEAL BECAUSE THE RCIA ANEURYSM WAS SO LARGE THAT IT EVENTUALLY PULLED THE LIMB OUT OF THE RIGHT EXTERNAL ILIAC ARTERY BACK INTO THE RCIA CAUSING THE TYPE IB ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12967016 ↗
• MalfunctionNov 29, 2021Defective Component; Defective Component

  ENDURANT II LIMBS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM . DURING THE INDEX PROCEDURE THE IMPLANTING PHYSICIAN NOTED THAT THERE WAS A NOTICEABLE 1.5MM GAP BETWEEN GRAFT COVER AND THE TAPERED TIP IN THE ENDURANT LIMB ETLW1610C156E. THE BLUE HANDLE WAS COMPLETELY FLUSH WITH THE GRAY FRONT HANDLE. THERE WAS NO POSSIBILITY OF CLOSING UP THE GAP. THE PHYSICIAN DETERMINED THAT IT WOULD NOT BE AN ISSUE AS LONG THE DELIVERY SYSTEM WASN'T ADVANCED INTO THE VESSELS BARE. SO THE DEVICE WAS DELIVERED THROUGH A 16FR SHEATH, AND THE LIMB SUCCESSFULLY DEPLOYED WITHOUT ISSUE. THE PHYSICIAN THEN OPENED THE NEXT LIMB ETLW1624C93E FOR THE CASE AND NOTICED THE THERE WAS ALSO A NOTICEABLE GAP BETWEEN THE GRAFT COVER AND TAPERED TIP THIS TIME THE GAP WAS MORE NOTICEABLE AT 2MM. THERE WAS NO POSSIBILITY OF TURNING THE BLUE HANDLE TO CLOSE UP THE GRAFT COVER AS IT WAS FLUSHED. THE PHYSICIAN EXERCISED THE SAME CAUTION BY DELIVERING THE LIMB THROUGH A 16FR SHEATH WITH THE DISTAL END IN THE SAC. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS A MANUFACTURING ISSUE AND THERE WAS NO CAUSE ATTRIBUTABLE TO THE PHYSICIAN¿S ACTIONS OR THE PATIENT ANATO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882269 ↗
• MalfunctionOct 15, 2021Material Deformation; Material Deformation

  AN ENDURANT II WAS INTENDED TO BE IMPLANTED DURING A SECONDARY ENDOVASCULAR PROCEDURE. IT WAS REPORTED DURING THE PROCEDURE THE DELIVERY SYSTEM WAS DIFFICULT TO ADVANCE AND WHEN IT WAS REMOVED FROM THE PATIENT IT NOTED THAT THE GRAFT COVER AT BASE NEAR THE TAPER TIP WAS DAMAGED. ALTERNATIVELY ANOTHER ENDURANT LIMB WAS IMPLANTED.  AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638388 ↗
• MalfunctionAug 4, 2021Device Damaged by Another Device; Positioning Problem; Device Damaged by Another Device; Positioning Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS ATTEMPTED TO BE IMPLANTED IN THE PATIENT. IT WAS STATED THAT THE PATIENT HAD A PREVIOUS NON MEDTRONIC STENT IN HIS EXTERNAL ILIAC AND A ENDURANT ILIAC STENT IN HIS COMMON ILIAC ARTERY AND THE PATIENT'S EXTERNAL ILIAC WAS STARTING TO PULL UP TOWARDS THE PATIENT'S EXTERNAL. THEREFORE, THE PHYSICIAN DECIDED TO BRIDGE THE ENDURANT STENT AND THE STENT IN THE EXTERNAL WITH ANOTHER ENDURANT ILIAC STENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, DIFFICULTIES TO ADVANCE THE DEVICE INTO THE PATIENTS COMMON ILIAC ARTERY WAS ENCOUNTERED, SEVERAL ATTEMPTS WERE PERFORMED WITHOUT SUCCESS. THE PHYSICIAN THEN DECIDED TO PULL THE DEVICE, BUT ONCE THE DEVICE WAS OUTSIDE THE PATIENT DIFFICULTIES TO PULL THE DELIVERY SYSTEM BACK WAS ALSO ENCOUNTERED. THE PHYSICIAN DEPLOYED THE STENT GRAFT OUTSIDE OF THE PATIENT AND WHERE IT WAS NOTED THAT THE GUIDE WIRE WAS CRIMPED. AND THIS WAS THOUGHT TO BE THE REASON FOR THE DEVICE ADVANCING ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ENDURANT STENT GRAFT AND A NEW GUIDE WIRE. AS PER THE PHYSICIAN, CAUSE OF THE DEVICE ADVANCING DIFFICULTY WAS USER ERROR. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273254 ↗
• InjuryJul 20, 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 UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 1 MONTHS POST PROCEDURE, IT WAS REPORTED THAT A CT WAS PERFORMED, AS THE PATIENT WAS COMPLAINING OF LEFT LEG PAIN, WHERE THE CT SHOWED WHAT APPEARED TO BE A LEFT LIMB OCCLUSION. THROMBECTOMY WAS PERFORMED AND A NON-MEDTRONIC STENTS AND A SELF EXPANDING STENTING WERE IMPLANTED IN THE LIMB 2 DAYS LATER. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY. THE PHYSICIAN STATED THAT THE TRANSITION FROM THE LEFT COMMON ILIAC TO THE LEFT EXTERNAL WAS TORTUOUS NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 12196363 ↗
• InjuryMay 6, 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 THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 59 MM ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH LEG PAIN AND CLAUDICATION. ICE WAS APPLIED IN ORDER TO PREPARE THE AREA FOR TREATMENT ON THE FOLLOWING DAY. IT WAS REPORTED THAT THROMBOSIS AND OCCLUSION WERE NOTED. ON THE NEXT DAY, THE PHYSICIAN PLACED BILATERAL BALLOON EXPANDABLE COVERED STENTS WITHIN THE ENDURANCE THAT GRAPHS AT THE LEVEL OF THE AORTIC BIFURCATION. THE BALLOON EXPANDABLE STENTS WERE BALLOONED BILATERALLY WITH 9 MM BALLOONS PROVIDING EQUIVALENT LUMENS . AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY. IT WAS STATED THAT THE RIGHT LIMB WAS COMPRESSED IN THE ALREADY BIFURCATION WHICH LED TO THROMBOSIS AND OCCLUSION. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 11783791 ↗
• InjuryMar 30, 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 THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 57 X 53MM DIAMETER AAA. APPROXIMATELY 2 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH OTHER MEDICAL ISSUES AND A LEFT LIMB OCCLUSION WAS DISCOVERED. INTERVENTION WAS PERFORMED WHERE THE LEFT COMMON FEMORAL ARTERY WAS EXPOSED AND A FOGARTY CATHETER WAS PASSED SEVERAL TIMES TO REMOVE THE THROMBUS FROM THE STENT GRAFT TO THE LEFT EXTERNAL ILIAC. A LIMB EXTENSION WAS IMPLANTED AND BALLOONED WITH A RELIANT BALLOON. ANGIOGRAM SHOWED THE FLOW HAD GREATLY IMPROVED AND THE PROCEDURE WAS COMPLETED. THE CAUSE OF THE OCCLUSION PER THE PHYSICIAN WAS DUE TO THE DISTAL LIMB HAVING BEEN LANDED IN A NARROWING WITHIN THE DISTAL LEFT CIA NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 11589360 ↗
• InjuryOct 22, 2020Adverse 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 ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, ON THE FINAL ANGIOGRAM THERE WAS A TYPE IA ENDOLEAK. THE PHYSICIAN THEN RE-BALLOONED THE PROXIMAL NECK AND PERFORMED ANOTHER ANGIOGRAM. THE TYPE 1A LEAK WAS STILL PRESENT. THE PHYSICIAN DECIDED TO WAIT TO SEE IF THE LEAK WOULD RESOLVE UPON REVERSAL OF HEPARIN. AFTER THE EVAR THE PHYSICIAN PERFORMED BILATERAL ENDARTERECTOMIES ON THE COMMON FEMORAL ARTERIES. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Occlusion

  MAUDE report 10718926 ↗
• DeathOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A LEFT COMMON ILIAC ANEURYSM AND ECTATIC RIGHT COMMON ILIAC. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE STENT GRAFT WAS DEPLOYED, FINAL ANGIO SHOWED A GOOD RESULT AND THE PATIENT WAS TAKEN TO SICU POST-OP. IT WAS REPORTED TWO HOURS POST TRANSFER THE PATIENT BECAME HYPOTENSIVE AND CODED. THE PATIENT WAS TRANSFERRED TO THE CATH LAB WHERE CPR WAS IN PROCESS. AN ANGIO SHOWED A RUPTURED RIGHT EXTERNAL ILIAC, IT WAS UNCLEAR WERE THE RUPTURE WAS SO AN ETLW1610C156E (B)(4) WAS IMPLANTED TO COVER THE RIGHT HYPOGASTRIC AND EXTENDED INTO THE EXTERNAL ILIAC. THE BLEEDING WAS GOTTEN UNDER CONTROL HOWEVER THE PATIENT HAD LOST TOO MUCH BLOOD AND HAD BEEN GETTING CPR AND RESUSCITATED FOR AN HOUR AT THIS TIME. THE PHYSICIAN DECIDED TO STOP AND PRONOUNCED THE PATIENT DECEASED. PER THE PHYSICIAN THE CAUSE OF THE DEATH WAS DUE TO THE RUPTURED EXTERNAL ILIAC THAT WAS NOT VISUALIZED ON THE COMPLETION ANGIOGRAM.

  Patient problems: Cardiac Arrest; Death; Low Blood Pressure/ Hypotension

  MAUDE report 10682748 ↗
• InjurySep 1, 2020Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 84MM X 114MM PRE RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE THE PATIENT PRESENTED WITH A RUPTURED AAA WITH EXISTING DUE TO A TYPE IB ENDOLEAK ON THE RIGHT. A 16X10X124 ENDURANT LIMB WAS PLACED TO EXTEND THE EXISTING LIMB (16X10X156) AND RESOLVE THE TYPE IB ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 10475891 ↗
• InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT AUI AND ENDURANT LIMB STENT GRAFT WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 46MM AAA AND 35MM RIGHT COMMON ILIAC ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY ON THE JUST OVER A MONTH LATER, COMPLAINING OF NUMBNESS IN THE LOWER EXTREMITIES BILATERALLY. THE PHYSICIAN CONFIRMED THE ABSENCE OF A FEMORAL PULSE AND IDENTIFIED AN OCCLUSION. INTERVENTION WAS PERFORMED ON THE SAME DATE AND THE PATIENT UNDERWENT A THROMBECTOMY AND THE PROXIMAL END OF THE STENT GRAFT WAS RELINED WITH AN AUI ETUF2514C102E STENT GRAFT. 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: Numbness; Occlusion

  MAUDE report 10447071 ↗
• DeathAug 21, 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 48 X 52 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER BALLOONING BOTH LIMBS, BOTH INTERNAL ILIAC ARTERY WERE COVERED. 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: Death; Occlusion

  MAUDE report 10436003 ↗
• InjuryAug 21, 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 THE ENDOVASCULAR TREATMENT OF A 57MM ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THIS PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY COMPLICATIONS. IT WAS REPORTED THAT ON THE DATE OF THE CT, UNDER TWO YEARS LATER, IT WAS NOTED THE RIGHT ENDURANT LIMB ETLW1610C156E WAS OCCLUDED. THE CAUSE WAS THE EVENT WAS NOT REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Occlusion

  MAUDE report 10435992 ↗
• InjuryOct 31, 2019Difficult to Remove; Difficult to Remove

  A SENTRANT SHEATH WAS USED AS A CONDUIT FOR AN ENDURANT DEVICE DURING EVAR FOR A RUPTURED 70MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT HAD A SHORT NECK. IT WAS REPORTED DURING THE INDEX PROCEDURE THE ENDURANT LIMB BECAME STUCK IN THE SHEATH DURING WITHDRAWAL. THE FEMORAL ARTERY HAD TO BE SURGICALLY EXPOSED AND THE SHEATH HAD TO BE ¿CUT AWAY¿ FROM THE LIMB TO BE REMOVED. THE SHEATH WAS REPLACED WITH A NEW 16FR SENTRANT SHEATH AND PROCEDURE WAS COMPLETED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9261042 ↗
• InjurySep 12, 2019Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 33 MM ABDOMINAL AORTIC ANEURYSM AND 55 MM RIGHT COMMON ILIAC ANEURYSM. THE PROXIMAL AORTIC NECK DIAMETER MEASURED 23 MM AND 50 MM IN LENGTH WITH MILD VESSEL TORTUOSITY NOTED. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE STENT GRAFTS WERE IMPLANTED, A FINAL AORTOGRAM IDENTIFIED AN ENDOLEAK IN THE RIGHT LIMB. RE-BALLOONING WAS ATTEMPTED HOWEVER THE ENDOLEAK PERSISTED. A BALLOON WAS THEN INFLATED INSIDE THE LIMB WITH CONTRAST INJECTED INSIDE THE LIMB WHILE THE BALLOON WAS INFLATED. A TYPE IIIB ENDOLEAK COMING FROM A HOLE WAS NOTED INSIDE THE LIMB. THE LIMB WAS THEN RELINED WITH AN ADDITIONAL ENDURANT LIMB (1610124) AND THE ENDOLEAK CONFIRMED AS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9008609 ↗
• InjuryMay 29, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 75MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN EXTENDED INTO THE RIGHT ILIAC LIMB WITH AND ENDURANT LIMB AND BALLOONED THE AREA. CONTRAST INJECTION WAS INJECTED AND IT SHOWED A SIGNIFICANT BLUSH FILLING THE RIGHT COMMON AND INTERNAL ILIAC ARTERIES. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS A TYPE IIIB ENDOLEAK DUE TO A HOLE IN THE STENT GRAFT FABRIC FROM CALCIUM IN THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN DID NOT BELIEVE IT WAS A TYPE IB ENDOLEAK. INTERVENTION WAS PERFORMED WITH THE IMPLANTATION OF A 16X10X156 NON MDT STENT INTO THE EXTERNAL ILIAC LIMB TO RESOLVE THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8649129 ↗
• InjuryMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 52MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS LATER THE PATIENT PRESENTED TO ER WITH AN OCCLUDED RIGHT LIMB OF THE ENDOGRAFT. A CT CONFIRMED THE OCCLUSION. THE THROMBUS WAS CONFINED TO THE LIMB ONLY, WITH NO OCCLUSION PRESENT IN THE MAIN BIFURCATE. IT WAS REPORTED THAT THE THROMBUS WAS VERY FRESH AND THERE WERE NO OBVIOUS ISSUES WITH THE STENT GRAFT. THE PATIENT WAS TAKEN TO SURGERY AND AN OPEN THROMBECTOMY WAS PERFORMED. FINAL ANGIOGRAM CONFIRMED THE OCCLUSION WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion; Thrombus

  MAUDE report 8648872 ↗
• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY ONE YEAR POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY. A CT DEMONSTRATED A RUPTURED PSEUDO ANEURYSM IN THE RIGHT EXTERNAL ILIAC AT THE DISTAL END OF THE 16X10X156. DUE TO THE PATIENTS POOR CONDITION THE PHYSICIAN EXCLUDED OPEN REPAIR AND ELECTED TO EXTEND THE GRAFT WITH A 10X10X82 GRAFT. FINAL ANGIO CONFIRMED NO EXTRAVASATION AND THE PATIENT IS REPORTED TO BE RECOVERING WELL. PER THE PHYSICIAN THE CAUSE OF THE PSUEDANEURYSM WAS DUE TO AN INFECTION. THE PATIENT'S FEM-FEM GRAFT BECAME INFECTED ALONG WITH THE AUI DEVICE AND THE LIMB. THIS INFECTION LED THE EXTERNAL ILIAC TO BECOME WEAKENED. THE CAUSE OF THE GRAFT INFECTION WAS DUE TO A WOUND INFECTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pseudoaneurysm; Rupture; Unspecified Infection

  MAUDE report 8612178 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 53MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY TEN DAYS LATER WITH A COLD LEFT LEG. A CTA SHOWED OCCLUSION OF THE LEFT LIMB FROM THE FLOW DIVIDER TO THE LEFT FEMORAL ARTERY. AN EMBOLECTOMY OF THE LEFT LIMB WAS PERFORMED, AND A LARGE AMOUNT OF THROMBUS WAS REMOVED. TWO ADDITIONAL LIMBS ETLW1610C124E AND ET EW1010C82E WERE IMPLANTED INSIDE THE EXISTING LIMB. BALLOON ANGIOPLASTY WAS ALSO PERFORMED INSIDE THE DISTAL GRAFT MATERIAL TO MAINTAIN PATENCY. FINAL ANGIOGRAM SHOWED FULL PATENCY OF THE LEFT LIMB AND ILIAC SYSTEM. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE DISTAL LEFT LIMB TERMINATING JUST PRIOR TO AN ANTERIOR DIRECTIONAL CHANGE OF THE LEFT EXTERNAL ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion; Thrombus

  MAUDE report 8513964 ↗
• InjuryApr 5, 2019Adverse 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 59MM ABDOMINAL AORTIC ANEURYSM. THE REIA MEASURED 7-9MM WITH STENOSIS OBSERVED. THE LEIA MEASURED 8-9MM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 2 MONTHS POST THE INDEX PROCEDURE WITH A COLD LEG AND A LIMB OCCLUSION WAS VISUALIZED ON IMAGINE. THE PATIENT RECEIVED INTERVENTIONAL TREATMENT ON THE SAME DAY WITH STENTING AND THROMBECTOMY TO RESOLVE THE OCCLUSION. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 8486639 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100021. One submission often covers many models, so check the product and lot details in each record.

• Z-0292-2022 · Oct 15, 2021 · Open, Classified
  Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STEN
• Z-0290-2022 · Oct 15, 2021 · Open, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• Z-0291-2022 · Oct 15, 2021 · Open, Classified
  Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT G
• Z-2135-2021 · Jun 7, 2021 · Open, Classified
  Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infra
• Z-2136-2021 · Jun 7, 2021 · Open, Classified
  Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoili
• Z-1543-2017 · Feb 27, 2017 · Terminated
  Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166