Endurant® II ETLW1620C93E (UDI 00643169467514)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00643169467514), received between Feb 27, 2017 and Aug 14, 2025 — classified as 3 deaths, 15 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Device Damaged Prior to Receipt by User; Deformation Due to Compressive Stress; Device Damaged Prior to Receipt by User; Deformation Due to Compressive Stress

  AN ENDURANT II STENT GRAFT WAS INTENDED TO BE USED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS REPORTED THAT PRIOR TO THE INDEX PROCEDURE WHEN OPENING THE BOX AND THE STERILE PACKAGING WE IDENTIFIED A KINK IN THE DELIVERY SYSTEM. THE PHYSICIAN WAS UNHAPPY WITH THE APPEARANCE AND CHOSE TO OPEN ANOTHER GRAFT OF EXACT SIZE AND IMPLANT THAT ONE. IT WAS CONFIRMED THAT BOTH DELIVERY BOX AND ORANGE PRODUCT BOX WAS DAMAGED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS RELATED TO DELIVERY SYSTEM DAMAGE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802903 ↗
• InjuryNov 17, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED AAA. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE, FOLLOW-UP CT SHOWED A ENDOLEAK BETWEEN LIMB PIECES. THE PHYSICIAN NOTED THAT IT WAS A TYPE IIIA OR A  HOLE IN THE LIMB. ON THE SAME DATE INTERVENTION WAS PERFORMED AND THE STENT GRAFTS WERE RE-LINED WITH NON-MDT STENT GRAFTS. NO CAUSE WAS PROVIDED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 18157983 ↗
• InjuryAug 21, 2023Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  AN ENDURANT II LIMB WAS IMPLANTED AS PART OF THE ENDOVASCULAR TREATMENT OF A 64MM AAA .  IT WAS REPORTED DURING THE INDEX PROCEDURE, A DAMAGED NON MDT STIFF GUIDE WIRE PULLED THE TAPERED TIP OF THE ENDURANT DELIVERY SYSTEM OFF.  THE PATIENT REQUIRED A CUT DOWN AND A SNARE WAS USED TO REMOVE THE DETACHED TIP.  PER THE PHYSICIAN THE CAUSE OF THE DETACHMENT WAS THE DAMAGED GUIDEWIRE.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17582629 ↗
• InjuryAug 8, 2023Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 53MM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK DIAMETER WAS NOTED AS 18MM AND 20MM IN LENGTH. SEVERE NECK ANGULATION AND MILD NECK CALCIFICATION WERE OBSERVED.  IT WAS REPORTED DURING THE INDEX PROCEDURE, THE MAIN BODY AND CONTRA LIMB WERE SUCCESSFULLY DEPLOYED. AFTER DEPLOYMENT OF IPSI LIMB (IN RIGHT ILIAC), THE PHYSICIAN HAD DIFFICULTY PERFORMING THE ¿GRAY TO BLUE¿ MANEUVER. MORE FORCE THAN NECESSARY WAS REPORTED TO BE REQUIRED, HOWEVER, THE PHYSICIAN ULTIMATELY DECIDED TO CEASE THAT EFFORT AND SIMPLY PULL THE DELIVERY SYSTEM THROUGH THE LIMB AND INTO THE SENTRANT SHEATH. AFTER THE DELIVERY SYSTEM WAS REMOVED, THE PHYSICIAN WAS EASILY ABLE TO PERFORM THE GRAY TO BLUE MANEUVER. UPON RETURNING TO THE SCREEN AND VIEWING THE PROXIMAL MAIN BODY, IT WAS OBSERVED THAT THE GRAFT AND PROXIMAL CROWN WERE NOW POSITIONED DISTAL TO THE ORIGINAL LANDING ZONE WHERE IT HAD BEEN PLACED. DUE TO THE NECK ANGULATION, THE CROWN AND FABRIC IN THE FIRST 20MM OF THE GRAFT DID NOT APPOSE THE WALL OF AORTIC NECK CAUSING A LARGE TYPE IA ENDOLEAK. IN AN ATTEMPT TO FIX THIS THE PHYSICIAN IMPLANTED A 25 ENDURANT CUFF ((

  Patient problems: Insufficient Information

  MAUDE report 17478899 ↗
• DeathJul 25, 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 TREATMENT OF A UNKNOWN SIZED RUPTURED AAA. THE LENGTH OF THE PROXIMAL NECK WAS 14MM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE MAIN BODY AND LIMBS WERE IMPLANTED. THE PATIENTS BLOOD PRESSURE KEPT DROPPING TO A CONCERNING LEVEL. THE PHYSICIAN IMPLANTED A NON MDT CUFF IN ORDER TO PREVENT A TYPE IA ENDOLEAK, HOWEVER IT DID NOT PREVENT THE LEAK FROM HAPPENING AND THE PATIENTS PRESSURE CONTINUED TO DROP. THE PHYSICIAN THEN IMPLANTED AN ENDURANT AUI STENT GRAFT. ONCE THIS WAS IMPLANTED, THE PHYSICIAN DECOMPRESSED THE ABDOMEN IN ORDER TO PREVENT COMPARTMENT SYNDROME DEVELOPING FROM THE RUPTURED ANEURYSM BLEEDING IN TO THE ABDOMEN AND RETRO PERONEAL SPACE.  THE PATIENT EXPIRED DURING THE DECOMPRESSION. PER THE PHYSICIAN THE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information; Low Blood Pressure/ Hypotension

  MAUDE report 17388392 ↗
• InjuryJan 25, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED APPROXIMATELY 44 MONTHS POST THE INDEX PROCEDURE, DURING A LAPAROTOMY THE PHYSICIAN DISCOVERED HOLES IN THE LIMBS. THE PHYSICIAN RELINED BOTH LIMBS AND IMPLANTED AN ENDURANT AORTIC CUFF AS A PRECAUTION. IT WAS CONFIRMED THE PROCEDURE WENT WELL WITH NO ENDOLEAK AT THE END OBSERVED.  PER THE PHYSICIAN THE CAUSE OF THE TYPE IIIB ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16240943 ↗
• DeathDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM. IT WAS REPORTED ON AN UNKNOWN DATE, FOLLOW UP IMAGING IDENTIFIED AN EXPANDING ABDOMINAL AORTIC ANEURYSM WITH SUSPECTED OCCULT TYPE III ENDOLEAK AND IMPENDING LOSS OF SEAL IN THE RIGHT ILIAC LIMB. APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE ULTRASOUND GUIDED NEEDLE PLACEMENT RIGHT FEMORAL ARTERY, CIRCUMFERENTIAL PLACEMENT OF ENDOANCHORS IN THE ABDOMINAL AORTIC ENDOGRAFT AND PLACEMENT OF A RIGHT ILIAC LIMB EXTENSION WAS COMPLETED. IT WAS REPORTED APPROXIMATELY 12 MONTHS LATER THE PATIENT PRESENTED AND WAS DIAGNOSED WITH A R MCA INFARCT AND HOSPITALIZED. TREATMENT WAS GIVEN AND THE PATIENT HAD A HAEMORRHAGIC CONVERSION WITH ICH, IV EXTENSION AND SAH. THE PATIENT WAS INTUBATED BUT EXTUBATED FOR COMFORT CARE AND THE PATIENT EXPIRED 2 DAYS POST HOSPITALISATION. PER THE PHYSICIAN THE CAUSE OF THE ANEURYSM EXPANSION AND TYPE III ENDOLEAK ARE UNDETERMINED. THE CAUSE OF THE STROKE LEADING TO DEATH WAS NOT PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 15922332 ↗
• MalfunctionJul 22, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AN ENDURANT II STENT GRAFT WAS INTENDED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 54MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE WHEN THE BOX FOR THE IPSILATERAL 124MM ENDURANT LIMB INTENDED TO BE IMPLANTED WAS OPENED IT WAS DISCOVERED THE INCORRECT GRAFT (146) WAS INSIDE. WHEN BOXES FOR TWO 93MM LIMBS WERE OPENED THEY CONTAINED PACKAGING FOR A 146MM LIMB. WHEN THE CONTRALATERAL LIMB WAS IMPLANTED IT WAS NOTED WHEN THE PACKAGING WAS OPENED TO BE A 124 LIMB, HOWEVER WHEN THE STENT WAS PUT IN THE BODY IT WAS DISCOVERED IT WAS ACTUALLY A 93 LIMB BASED ON THE STICKER ON THE DELIVERY SYSTEM. THE ENDURANT LIMB ETLW1620C93E ((B)(4)) WAS NOTED WHEN OPENED TO CONTAIN A 124 LIMB. THE PATIENT RECEIVED TREATMENT USING ADDITIONAL AVAILABLE GRAFTS (2 X 124 LIMBS) AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. IT WAS NOTED THAT THE BOXES WERE OPENED WHEN LOOKING FOR THE APPROPRIATE SIZE FOR THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15082201 ↗
• InjuryNov 15, 2021Adverse 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.. IT WAS REPORTED ONE MONTH POST THE INDEX PROCEDURE FOLLOW UP IMAGING IDENTIFIED RIGHT LIMB STENOSIS PROXIMAL TO THE RIGHT ILIAC ARTERY. THE SPONSOR HAS ASSESSED THE CAUSE OF THE STENOSIS AS RELATED TO THE ENDURANT DEVICE. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12813240 ↗
• MalfunctionAug 16, 2021Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 52 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A ROUTINE CT PERFORMED UNDER 10 YEARS LATER SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK AND A IB ENDOLEAK ON THE ENDURANT LIMB (V00885373). INTERVENTION WAS PERFORMED ABOUT A MONTH LATER. AN ENDURANT CUFF AND ENDOANCHORS WERE IMPLANTED, WHICH RESOLVED THE IA ENDOLEAK. FOLLOWING THIS, AN ATTEMPT WAS MADE TO REPAIR THE IB ENDOLEAK. THE PHYSICIAN DID NOT HAVE CONSENT TO COIL AND COVER THE LEFT HYPOGASTRIC ARTERY SO THE PHYSICIAN EXTENDED WITH AN ETLW1620C93E ENDURANT LIMB BUT THIS PROVED UNSUCCESSFUL AND THE IB ENDOLEAK REMAINED. AS PER THE PHYSICIAN THE CAUSE OF THE IA ENDOLEAK COULD NOT BE DETERMINED. THE CAUSE OF THE IB ENDOLEAK WAS STATED TO BE AS A RESULT OF CONTINUED ANEURYSMAL DISEASE OF THE ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12323818 ↗
• InjuryJul 15, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 67 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT WAS PERFORMED APPROXIMATELY 6 YEARS POST PROCEDURE, WHERE A POTENTIAL TYPE 1B ENDOLEAK WAS OBSERVED. AFTER REVIEW OF THE CT, THE 16X20X93 ON THE IPSILATERAL (RIGHT SIDE) WAS NOTED TO HAVE CONTRAST OUTSIDE OF LIMB AND FLOW NOTED IN THE ANEURYSM SAC. PHYSICIAN THEN DECIDED TO TAKE PATIENT TO SURGERY FOR FURTHER EVALUATION AND INTERVENTION. UPON FIRST ANGIOGRAM, DISTAL PORTION OF 16X20X93 NOTED IN PROXIMAL COMMON ILIAC AND CONTRAST FLOWING BACK INTO SAC. ADDITIONALLY, A SMALL TYPE 1A ENDOLEAK WAS NOTED AT THE NECK BELOW THE RENALS ARTERY, CONTRAST BLUSHING OUTSIDE OF GRAFT INTO SAC. PATIENT DID NOT PRESENT WITH ANY SIGNS OR SYMPTOMS OF A RUPTURE. IT WAS STATED THAT THE A 32X32X49 ABDOMINAL CUFF WAS PLACED DIRECTLY BELOW THE RENALS ARTERY. THE 16 X 20 X 93 LIMB ON THE IPSILATERAL SIDE WAS EXTENDED WITH A 16 X 10 X 124 INTO THE EXTERNAL ILIAC. DUE TO THE TORTUOSITY, A 13 X 10 NON-MEDTRONIC DEVICE WAS EXTENDED OUT OF THE 16 X 10 X 124. PER ANGIOGRAM, THE TYPE 1A AND TYPE 1B ENDOLEAK WERE RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF T

  Patient problems: Insufficient Information

  MAUDE report 12174428 ↗
• DeathMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS ATTEMPTED TO BE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 58 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE ILIAC ARTERY RUPTURED WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE LIMB DEVICE INTO ILIAC ARTERY. A RELIANT BALLOON WAS THEN ADVANCED AND INFLATED IN ORDER TO CONTROL BLEEDING. IT WAS STATED THAT A FLANK INCISION WAS PERFORMED TO REPAIR THE ILIAC ARTERY WHEN PATIENT WENT INTO CARDIAC ARREST REQUIRING CPR. AFTER 20 MINUTES OF CPR, THE PATIENT WAS PRONOUNCED DEAD. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY, DUE TO TORTUOUS CALCIFIED LEFT ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT EXPIRED.

  Patient problems: Perforation of Vessels

  MAUDE report 11848408 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP FOUR YEARS LATER , A DISTAL TYPE IB ENDOLEAK WAS IDENTIFIED. INTERVENTION WAS PERFORMED THE NEXT DAY AND TWO VALIANT NAVION DEVICES PLUS AN ENDURANT LIMB (ETLW1620C93E) WAS IMPLANTED AS TREATMENT. IT WAS STATED IMMEDIATELY AFTER THE PROCEDURE, THE PATIENT WAS FOUND TO BE PARALYZED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Paralysis

  MAUDE report 10911040 ↗
• MalfunctionOct 21, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ENDURANT LIMB WAS INTENDED TO BE IMPLANTED AS PART OF THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE LIMB WOULD NOT FULLY DEPLOY. IT WAS SAID ONLY ONE STENT WAS RELEASED, SO THE DEVICE WAS ABLE TO BE RETRIEVED THROUGH THE SHEATH AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE CASE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS A DEVICE MALFUNCTION. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10710458 ↗
• InjuryMay 7, 2020Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 56MM RUPTURED ABDOMINAL AORTIC ANEURYSM. THE STENT GRAFT LIMB ETLW1620C93E WAS IMPLANTED ON THE RIGHT SIDE. POST-OPERATIVE CT HAD SHOWN WHAT APPEARED TO BE A TYPE II ENDOLEAK FROM BILATERAL LUMBAR ARTERIES. IT WAS REPORTED THAT WHILE THE PATIENTS INITIALLY STABILISED AND BACK PAIN WAS IMPROVING, THE PATIENT¿S PAIN BEGAN TO WORSEN THE DAY AFTER THE INDEX PROCEDURE. THE PATIENT WAS BROUGHT TO THE OR WHERE THE RETROPERITONEUM WAS EXPOSED. THE RIGHT INTERNAL ILIAC ARTERY WAS LIGATED, AND THE STENT GRAFT LIMB ETLW1610C156E WAS IMPLANTED TO EXTEND TO THE RIGHT EXTERNAL ILIAC ARTERY THROUGH A RIGHT FEMORAL CUTDOWN. IT WAS REPORTED THAT THE PATIENT HAD A DILATED DISTAL RIGHT COMMON ILIAC, BUT SEAL WAS ACHIEVED DURING THE PROCEDURE. THROMBIN WAS ALSO INJECTED IN THE ANEURYSM SAC BILATERALLY TO PROMOTE THROMBOSIS OF THE LUMBAR ARTERIES AND THE PROCEDURE WAS THEN COMPLETED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS THE DILATED DISTAL RIGHT COMMON ILIAC AND BILATERAL LUMBAR ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 10032115 ↗
• InjuryFeb 11, 2020Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 61MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW-UP, A CT PERFORMED TEN MONTHS LATER FOUND THERE WAS A TYPE IIIA ENDOLEAK PRESENT BETWEEN LIMBS ETLW1616C124E AND ETLW1620C93E. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT MAY BE DUE TO COMPRESSION OF RIGHT ILIAC LIMB AND THIS MAY BE CONTRIBUTING TO THE TYPE IIIA ENDOLEAK. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 9693095 ↗
• MalfunctionSep 28, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 64 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE DISTAL AORTA DIAMETER WAS NOTED AS 25.7MM. THE RIGHT COMMON PROXIMAL ILIAC DIAMETER MEASURED 14.7MM AND THE LEFT COMMON PROXIMAL ILIAC DIAMETER 14.8MM. IT WAS REPORTED APPROXIMATELY TWO AND A HALF YEARS LATER A ROUTINE FOLLOW UP CT SCAN IDENTIFIED A TYPE IB ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918170 ↗
• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 49MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH THIGH PAIN 3 DAYS LATER. IT WAS REPORTED THAT A THROMBECTOMY OF THE LEFT STENT GRAFT WAS PERFORMED FOR THE OCCLUSION AND THEN BILATERAL SELF-EXPANDING STENT WERE PLACED IN THE LIMBS AT THE LEVEL OF THE NATIVE AORTIC BIFURCATION. SUBSEQUENTLY, A COMPARTMENT FASCIOTOMY WAS PERFORMED. THIS RESOLVED THE EVENT. 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: Injury; No Code Available; Occlusion; Pain

  MAUDE report 7673157 ↗
• MalfunctionJun 11, 2018Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A >50MM ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY ONE YEAR LATER IT WAS REPORTED THAT ON CT A LIMB OCCLUSION WAS OBSERVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS BOTH ANATOMY RELATED DUE TO THE TORTUOSITY OF THE ILIAC ARTERIES AND DEVICE RELATED DUE TO A KINK IN THE STENT GRAFT LIMB. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient; Occlusion

  MAUDE report 7587094 ↗
• InjuryMay 8, 2018Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 47MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A COLD LEG AND THROMBOSIS OF THE RIGHT LIMB. THE PATIENT RECEIVED TREATMENT WITH THROMBOLYSIS AND BALLOON ANGIOPLASTY OF THE RIGHT LIMB. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO AN OVERSIZED STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Occlusion

  MAUDE report 7493701 ↗
• InjuryMar 27, 2018Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF BILATERAL ILIAC ANEURYSM MEASURING 24MM (RIGHT AND 17MM (LEFT). IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED THE BIFURCATED DEVICE, WITH AN ANTERIOR GATE PLACEMENT, CANNULATED THE GATE AND VERIFIED GATE CANULATION BY SPINNING A PIGTAIL CATHETER JUST DISTAL TO THE RENAL ARTERIES. THE CONTRALATERAL ENDURANT LIMB WAS SELECTED BY THE PHYSICIAN AFTER A RETROGRADE SHOT OF CONTRAST WAS INJECTED AND MEASURED WITH A MARKING PIGTAIL CATHETER. UPON PLACING THE LIMB INTO THE PATIENT, THE PHYSICIAN DETERMINED THAT THE LIMB WAS TOO LONG AND REMOVED IT (V07563224). THE PHYSICIAN CHOSE THE SHORTER FLARED ENDURANT LIMB (V06697031) AND THE LIMB WAS PLACED JUST SHORT OF THE FLOW DIVIDER MAINTAINING 3CM OVERLAP, WHICH WAS VERIFIED BY THE MINIMUM OVERLAP MARKER ON THE LIMB. AFTER THE CONTRALATERAL LIMB WAS PLACED, THE BIFURCATED DEVICE WAS FULLY DEPLOYED AND REMOVED FROM THE PATIENT AND A 16 FRENCH SHEATH WAS PLACED INTO THE RIGHT COMMON FEMORAL ARTERY. A RETROGRADE SHOT OF CONTRAST COMBINED WITH A PIGTAIL(FOR MEASURING LENGTH) WAS GIVEN AND THE DOCTOR SELECTED THE RIGHT EXTENSION ENDURANT LIMB AND PLACED IT

  Patient problems: Ischemia; Occlusion

  MAUDE report 7372718 ↗
• MalfunctionNov 1, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A ROUTINE 6 MONTH FOLLOW UP DOPPLER ULTRASOUND SCAN WAS PERFORMED. DURING THE SCAN, THE PHYSICIAN IDENTIFIED RIGHT LIMB OCCLUSION. AT THIS TIME THE PATIENT COMPLAINED OF TIREDNESS AND NUMBNESS OF THE RIGHT LEG, BUT THESE SYMPTOMS HAVE SINCE RESOLVED. THE CAUSE OF THE EVENT CANNOT BE DETERMINED, AS PER THE PHYSICIAN. THE PHYSICIAN STATED THAT THE PATIENT WILL RECEIVE NO FURTHER TREATMENT OR INTERVENTION AT PRESENT.

  Patient problems: Occlusion; Pain

  MAUDE report 6992612 ↗
• InjuryApr 18, 2017Adverse 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 5.5 CM ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, ANOTHER MANUFACTURER'S BARE STENT WAS IMPLANTED IN THE LEFT EXTERNAL ILIAC BECAUSE THE PHYSICIAN DID NOT LIKE THE WAY THAT IT LOOKED. IT WAS REPORTED THAT THERE WAS A SHORT SEGMENT LEFT ILIAC OCCLUSION ON THE DAY FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE OCCLUSION SEGMENT WAS A DISSECTION IN THE LEFT EXTERNAL ILIAC DISTAL TO A SEGMENT TREATED WITH A SELF-EXPANDING BARE STENT, AND WAS NOT AN ISSUE WITH THE STENT GRAFT. THE POST IMPLANT PULSE IN THE LEFT FOOT WAS DIMINISHED, BUT WAS NOT A CONCERN INITIALLY. HOWEVER, IT WAS LATER NOTED THAT THE THERE WAS NO PULSE IN THE FOOT. A CT WAS PERFORMED AND THE DISSECTION WAS DISCOVERED. AN ADDITIONAL STENT WAS PLACED ACROSS THE DISSECTED SEGMENT TO SUCCESSFULLY RE-ESTABLISH DISTAL FLOW. THE PHYSICIAN COMMENTED THAT IT WAS A MISTAKE TO HAVE NOT LOOKED MORE DISTAL ON THE RUN POST BARE STENT PLACEMENT BECAUSE THE DISSECTED SEGMENT WOULD HAVE BEEN IDENTIFIED DURING THE INDEX PROCEDURE. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPO

  Patient problems: Occlusion; Vascular Dissection

  MAUDE report 6500795 ↗
• InjuryApr 12, 2017Occlusion Within Device; Occlusion Within Device

  ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT HAS EXPERIENCED PAIN AND OTHER BLOOD CLOTS.

  Patient problems: Embolus; Occlusion; Pain

  MAUDE report 6486939 ↗
• InjuryFeb 27, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE FINAL ANGIOGRAM REVEALED A POSSIBLE PROXIMAL TYPE I ENDOLEAK AND DISTAL TYPE I ENDOLEAK. THE PHYSICIAN MODELLED THE STENT GRAFTS WITH A RELIANT BALLOON AND AGGRESSIVELY BALLOONED THE PROXIMAL LANDING ZONE AGAIN. HOWEVER DUE TO THE AMOUNT OF CONTRAST ANOTHER ANGIOGRAM TO DETERMINE IF THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED WAS NOT PERFORMED. THE C-ARM WAS PLACED IN A CAUDAL POSITION AND THE LEFT SHEATH WAS INJECTED SHOWING AT DISTAL TYPE I ENDOLEAK, THE ENDURANT 16X20X93 DID NOT HAVE ENOUGH PURCHASE INTO THE VESSEL. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT 20X20X82 LIMB EXTENDING DOWN JUST PROXIMAL TO THE LEFT HYPOGASTRIC. THE ENDURANT STENT GRAFTS WERE MODELLED AGAIN WITH THE RELIANT BALLOON, AND THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. THE PHYSICIAN STATED THAT THE CAUSES OF THE ENDOLEAKS WERE RELATED TO THE PATIENT¿S ANATOMY, PROXIMAL AORTIC NECK ANGULATION AND THE DISTAL TYPE I ENDOLEAK WAS DUE TO NOT ENOUGH PURCHASE INTO THE VESSEL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6363211 ↗

Recalls under the same FDA submission

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

• Z-0290-2022 · Oct 15, 2021 · Open, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• Z-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-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