Endurant® II ETLW1613C156E (UDI 00643169467583)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00643169467583), received between Dec 12, 2016 and Dec 1, 2025 — classified as 4 deaths, 18 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2025Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN EVAR PROCEDURE AFTER THE AUI AND LIMB EXTENSION WERE DEPLOYED AND ANGIOPLASTY WAS PERFORMED WITH A COMPLIANT NON-MDT BALLOON, A HELI-FX ENDOANCHORING SYSTEM WAS THEN PREPARED AS NORMAL. THE FLUOROSCOPY IMAGING WAS ADJUSTED TO REMOVE PARALLAX AND ROTATED TO THE 45 DEGREE OBLIQUE VIEW AS PLANNED. THE FIRST ENDOANCHOR WAS DELIVERED WITHOUT INCIDENT. THE SURGEON THEN REDIRECTED THE SG-64 TO THE OPPOSITE SIDE OF THE AORTA TO PLACE AN ENDOANCHOR ON THE OPPOSING WALL OF THE GRAFT. THE SA-85 WAS LOADED WITH THE SECOND ENDOANCHOR AND ADVANCED TO THE TARGET SITE. WHEN POSITIONED, THE SURGEON INITIATED THE 1ST STAGE DEPLOYMENT AND IT WAS VISUALIZED THAT THE ENDOANCHOR HAD MADE GOOD PENETRATION THROUGH THE GRAFT MATERIAL AND INTO THE AORTIC WALL. THE SURGEON THEN PRESSED THE ADVANCE BUTTON TO COMPLETE THE ANCHOR DEPLOYMENT, AND IT APPEARED THE ANCHOR WAS FULLY DEPLOYED SUCCESSFULLY. THE SA-85 WAS THEN REMOVED, AND THE SURGICAL TECHNICIAN ATTEMPTED TO LOAD A 3RD ENDOANCHOR. HOWEVER, THE APPLIER WOULD NOT GO INTO THE "REVER SE" MODE TO ENGAGE A NEW ANCHOR. UPON CLOSE INSPECTION, THE TEAM REALIZED THAT PART OF THE 2ND ANCHOR REMAINED IN THE APPLIER AND HAD BROKEN DU

  Patient problems: Obstruction/Occlusion

  MAUDE report 23678070 ↗
• InjuryDec 5, 2022Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 75MM AAA . IT WAS CONFIRMED IT WAS A ROUTINE EVAR AND PERFORMED ACCORDING TO THE IFU.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN DEPLOYED AN ENDURANT IIS BIFURCATED SYSTEM ((B)(4))VIA THE LEFT FEMORAL ACCESS, FOLLOWED BY THE CONTRALATERAL LIMB ((B)(4)) VIA THE RIGHT FEMORAL ACCESS, AND THEN THE IPSILATERAL LIMB ((B)(4)) THROUGH THE 16 FR SHEATH PLACED IN THE LEFT FEMORAL ARTERY, AFTER THE MAIN BODY DELIVERY SYSTEM WAS REMOVED. A RELIANT BALLOON WAS THEN USED TO MOLD THE SEAL ZONES AND STENT GRAFT OVERLAP. ALL THIS WAS PERFORMED WITHOUT ANY ISSUES.  ON POST IMPLANT AND BALLOON ANGIOGRAM, AN ENDOLEAK WAS NOTED. DIFFUSE CONTRAST WAS VISUALIZED OUTSIDE THE STENT GRAFT AND WITHIN THE SAC. THE SALES REPRESENTATIVE THOUGHT THIS TO BE A TYPE IV ENDOLEAK DUE TO GRAFT POROSITY AND ANTICOAGULATION. IT WAS REPORTED THAT THE ANESTHETIST  HAD JUST ADMINISTERED 1000 UNITS OF HEPARIN A FEW MINUTES BEFORE THE ANGIOGRAM WAS PERFORMED. THAT WAS ONE HOUR FROM THE INITIAL HEPARIN DOSE OF 6500 UNITS WHEN THE CASE STARTED. THE PHYSICIAN DID NOT AGREE THAT IT WAS A TYPE IV ENDOLEAK. AFTER TAK

  Patient problems: Insufficient Information

  MAUDE report 15914910 ↗
• DeathOct 26, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF AN UNKNOWN SIZE. IT WAS REPORTED APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF ANEURYSM RUPTURE AND IT WAS DISCOVERED THE PATIENT HAD A LATE TYPE IB ENDOLEAK. THE PHYSICIAN IMPLANTED A LIMB EXTENSION ON THE PATIENT'S RIGHT ILIAC ARTERY. FOUR DAYS LATER, THE PATIENT PRESENTED EMERGENTLY AGAIN WITH RUPTURE SYMPTOMS AND AN LATE TYPE IB WAS DISCOVERED ON THE PATIENT'S LEFT ILIAC ARTERY. A 36 AUI STENT GRAFT WAS PLACED AND EXTENDED WITH A 16 X13X156 LIMB. AFTER AUI WAS DEPLOYED WHILE REMOVING THE DELIVERY SYSTEM, NOSE CONE WAS CAUGHT ON SUPER RENAL STENTS. DELIVERY SYSTEM WAS REPOSITIONED AND REMOVED. GRAFTS WERE BALLOONED AND A DIAGNOSTIC ANGIOGRAPHY WAS PERFORMED AND SHOWED SATISFACTORY RESULTS. THE PHYSICIANS BEGAN TO PERFORM FEMORAL TO FEMORAL BYPASS SURGERY. THE PATIENT BEGAN CODING AND CPR WAS PERFORMED FOR 6 MINUTES WHEN TIME OF DEATH WAS CALLED. PER THE PHYSICIAN, THE CAUSE OF THE TYPE IB ENDOLEAK WAS DUE TO ILIAC DILATATION. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Cardiac Arrest; Rupture

  MAUDE report 15672105 ↗
• DeathOct 26, 2022Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF AN UNKNOWN SIZE. IT WAS REPORTED APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF ANEURYSM RUPTURE AND ITWAS DISCOVERED THE PATIENT HAD A LATE TYPE IB ENDOLEAK. THE PHYSICIAN IMPLANTED A LIMB EXTENSION ON THE PATIENT'S RIGHT ILIAC ARTERY. FOUR DAYS LATER, THE PATIENT PRESENTED EMERGENTLY AGAIN WITH RUPTURE SYMPTOMS AND AN LATE TYPE IB WAS DISCOVERED ON THE PATIENT'S LEFT ILIAC ARTERY. A 36 AUI STENT GRAFT WAS PLACED AND EXTENDED WITH A 16 X13X156 LIMB. AFTER AUI WAS DEPLOYED WHILE REMOVING THE DELIVERY SYSTEM, NOSE CONE WAS CAUGHT ON SUPER RENAL STENTS. DELIVERY SYSTEM WAS REPOSITIONED AND REMOVED. GRAFTS WERE BALLOONED AND A DIAGNOSTIC ANGIOGRAPHY WAS PERFORMED AND SHOWED SATISFACTORY RESULTS. THE PHYSICIANS BEGAN TO PERFORM FEMORAL TO FEMORAL BYPASS SURGERY. THE PATIENT BEGAN CODING AND CPR WAS PERFORMED FOR 6 MINUTES WHEN TIME OF DEATH WAS CALLED. PER THE PHYSICIAN, THE CAUSE OF THE TYPE IB ENDOLEAK WAS DUE TO ILIAC DILATATION. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Cardiac Arrest; Rupture

  MAUDE report 15672099 ↗
• InjurySep 23, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT LIMB WAS IMPLANTED ON THE (B)(6) 2022 TO TREAT A TYPE IIIB ENDOLEAK IN A NON MDT STENT WHICH HAD BEEN IMPLANTED 6 YEARS PREVIOUSLY.  IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST INDEX PROCEDURE THE PATIENT EXPERIENCED AN UNWITNESSED FALL CAUSED BY SPINAL CANAL STENOSIS RIGHT FLANK PAIN. THE PATIENT WAS IN PAIN SO PRESENTED TO THE HOSPITAL. IT WAS REPORTED THE PATIENT REQUIRED MEDICATION AS TREATMENT. DUE TO CONCERNS OF A POSSIBLE ENDOVASCULAR LEAK OF THE RIGHT ILIAC STENT THE PATIENT HAD CT SCANS PERFORMED AND A CT OF THE CHEST/ABDOMEN/PELVIS RULED OUT AN ACUTE FRACTURE AND WAS UNREMARKABLE BESIDES A TYPE IIB ENDOLEAK. THERE WERE NO OTHER ISSUED INVOLVED AND SUBJECT WAS DISCHARGED 2 DAYS LATER. THE PATIENT WAS SEEN ON FOLLOW UP CONSULTATION AND WAS EVALUATED BY THE PHYSICIAN. ULTRASONOGRAPHY AND X-RAY DETERMINED THE STENT WAS FINE. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE PROCEDURE, POSSIBLY RELATED TO THE STENT. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE PROCEDURE AND NOT RELATED TO THE DEVICE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470182 ↗
• DeathFeb 24, 2022Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATED STENT GRAFT WAS IMPLANTED DURING 90 MM ABDOMINAL AORTIC ANEURYSM .  IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM UNDER A YEAR LATER, A CT WAS CARRIED OUT AND EVIDENCE OF A TYPE I ENDOLEAK AND RUPTURED ABDOMINAL AORTIC ANEURYSM WAS OBSERVED.  THE PHYSICIAN CARRIED OUT EMERGENCY SURGERY AND THE PATIENT EXPIRED DURING THE PROCEDURE.  IT WAS REPORTED THAT BOTH TYPE IA AND TYPE IB ENDOLEAK WERE OBSERVED. IT IS BELIEVED THAT THE TYPE LB ENDOLEAK IS COMING AROUND THE ETLW1613C156E SN (B)(4) AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS AS A RESULT OF A PULMONARY EMBOLISM.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAD EXPIRED.

  Patient problems: Pulmonary Embolism; Rupture

  MAUDE report 13589996 ↗
• InjuryNov 10, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT DURING THE ENDOVASCULAR TREATMENT OF AN 50+MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER IVUS WAS COMPLETED AN ABNORMALITY WAS SEEN. A CATHETER WAS PLACED AND AN ANGIOGRAM WAS TAKEN WHERE AN ENDOLEAK WAS OBSERVED. IT WAS SUSPECTED TO BE A HOLE IN THE GRAFT. ANOTHER LIMB WAS PLACED INSIDE AND THE ENDOLEAK SEEMED TO SLOW AND DIMINISH. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12785896 ↗
• InjuryJan 25, 2021Adverse 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 UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED FOR FOLLOW-UP UNDER 3 MONTHS LATER WITH COMPLAINTS OF RIGHT LEG CLAUDICATION. AN ULTRASOUND PERFORMED REVEALED AN OCCLUDED RIGHT EXTERNAL ILIAC ARTERY AND RIGHT FEMORAL ARTERY. INTERVENTION WAS PERFORMED AND A LEFT TO RIGHT FEMORAL TO FEMORAL BYPASS WAS PERFORMED WITH GOOD RESULTS. THE PATIENT WAS NOTED TO HAVE GOOD PULSES BILATERALLY. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 11222182 ↗
• InjuryJan 20, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 65MM ABDOMINAL AORTIC ANEURYSM. DURING THE INDEX PROCEDURE, THE DEVICE WAS SUCCESSFULLY DEPLOYED AND THE LIMB WAS POST DILATED WITH BALLOON. IT WAS REPORTED THAT AN ENDOLEAK AT THE GATE OVERLAP WAS NOTED. THE LIMB WAS RE-BALLOONED, BUT THE POSSIBLE ENDOLEAK TYPE 3 OR 4 WAS NOT RESOLVED. THE PHYSICIAN THEN DECIDED TO REALIGN WITH A NEW LIMB 16-16-124 AND BALLOONED THE LIMB. FINAL ANGIOGRAM WAS PERFORMED AND NO ENDOLEAK WAS NOTED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Insufficient Information

  MAUDE report 11201893 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT BIFURCATE STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT PATIENT WAS COMPLAINING OF LEG PAIN, WHERE IT WAS DETERMINED AS LEFT LIMB OCCLUSION. THE EVENT WAS TREATED WITH A RIGHT TO LEFT FEMORAL TO FEMORAL BYPASS. AS PER THE PHYSICIAN, THE CAUSE OF THIS EVENT WAS THAT THE PATIENT HAD RECENTLY DEVELOPED RAPID ATRIAL FIBRILLATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 10850565 ↗
• MalfunctionJun 25, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 53MM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS REPORTED BETWEEN 4MM AND 10MM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE MAIN BODY STENT GRAFT WAS IMPLANTED AT THE LEVEL OF THE RENAL ARTERIES AS PLANNED. A MARKER PIGTAIL WAS PLACED AT THE LEVEL OF THE FLOW DIVIDER CONTRAST INJECTING WAS PERFORMED. THE ENDURANT LIMB ETLW1613C156E, WAS INSERTED AND PUT INTO POSITION. THE DEVICE WAS THEN PUSHED FORWARD INADVERTENTLY AND DEPLOYED INACCURATELY. IT WAS REPORTEDLY TOO LATE TO PUSH THE LIMB DOWN TO THE CORRECT POSITION. THE IPSILATERAL LIMB THEN IMPLANTED CORRECTLY AS PLANNED. THE ENTIRE STENT GRAFT SYSTEM WAS THEN BALLOONED WITH A RELIANT BALLOON. THE FINAL ANGIOGRAM THEN SHOWED A SLIGHT IA ENDOLEAK. IT WAS REPORTED THAT AN AORTIC CUFF COULD NOT BE IMPLANTED AS TREATMENT DUE TO THE INACCURATELY PLACED CONTRALATERAL LIMB. SIX ENDOANCHORS WERE THEN IMPLANTED PROXIMALLY ON THE ENDUANT BIFURCATE DEVICE. THIS RESOLVED THE ENDOLEAK. THE FINAL ANGIOGRAM DEMONSTRATED BOTH PATENT RENALS ARTERIES NO TYPE IA OR IB ENDOLEAKS AND EQUAL-PATENT LIMBS BILATERALLY. AS PER THE PHYSICIAN THE CAUSE OF THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10194124 ↗
• MalfunctionMay 18, 2020Difficult or Delayed Positioning; Deformation Due to Compressive Stress; Difficult or Delayed Positioning; Deformation Due to Compressive Stress

  AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED THAT A TYPE IB ENDOLEAK WAS OBSERVED ON AN UNKNOWN DATE. AN ENDURANT II LIMB WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR REVISION TREATMENT FOR THE TYPE IB ENDOLEAK JUST OVER ELEVEN YEARS POST THE INDEX PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE RIGHT COMMON ILIAC WAS VERY TORTUOUS AND THE DEVICE COULD NOT ADVANCE. THE TIP OF THE DEVICE (DELIVERY SYSTEM) ENDED UP GETTING BENT DUE TO THE DIFFICULTY POSITIONING THE DEVICE. A REPLACEMENT DEVICE WAS THEN IMPLANTED WITH NO REPORTED ISSUES. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY AND NOTED IT TO BE TORTUOUS. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10064854 ↗
• InjuryJan 8, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY THREE YEARS LATER WITH A RUPTURE. CT SHOWED A TYPE III ENDOLEAK AND ANOTHER ENDURANT II STENT GRAFT LIMB ETLW1616C124E WAS IMPLANTED TO SEAL THE SEPARATION OF THE ORIGINAL STENT GRAFT. ANGIOGRAPHY SHOWED THE ENDOLEAK WAS RESOLVED. IT WAS REPORTED THAT THE STENT GRAFT LIMB HAD SEPARATED FROM THE MAIN STENT GRAFT BODY AND THIS LED TO THE RUPTURE. 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: Rupture

  MAUDE report 9562354 ↗
• InjurySep 2, 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 52MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 1 YEAR 3 MONTHS POST IMPLANT WITH CLAUDICATION AND LEFT LIMB PAIN. CT WAS PERFORMED AND SHOWED LEFT STENT GRAFT LIMB OCCLUSION. IT WAS NOTED THAT ANATOMY SHOWED NARROWING OF THE DISTAL END OF THE STENT GRAFT AND LIMITED OUTFLOW IN THE LEFT EIA. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Occlusion

  MAUDE report 8953531 ↗
• InjuryFeb 18, 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 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ONE DAY POST THE INDEX PROCEDURE FOLLOW UP CT DEMONSTRATED LEFT LIMB THROMBOSIS. INTERVENTION WAS COMPLETED WHERE THE LIMB WAS RELINED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS SUSPECTED TO POSSIBLE UNSEEN VESSEL ETIOLOGY IN THE LEIA COVERED BY SHEATH ON FINAL ANGIO THAT LED TO LIMB SHUT DOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion; Thrombus

  MAUDE report 8347152 ↗
• InjuryJan 14, 2019Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 57MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THERE WAS MILD PROXIMAL NECK, AND LEFT AND RIGHT ILIAC, CALCIFICATION PRESENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE MAIN BODY STENT GRAFT AND TWO ENDURANT LIMBS WERE SUCCESSFULLY IMPLANTED. HOWEVER AN ENDOLEAK WAS NOTED ON FOLLOW UP ANGIOGRAM. AFTER ADDITIONAL IMAGING, THE PHYSICIAN STATED THAT THE LEAK APPEARED TO BE A TYPE IIIB FABRIC LEAK ORIGINATING FROM A HOLE IN THE 16X13X156 LIMB. AN ADDITIONAL 16X13X124 ENDURANT LIMB WAS THEN SUCCESSFULLY IMPLANTED, ON THE SAME DAY, TO RELINE THE 16X13X156 LIMB AND RESOLVE THE ENDOLEAK. THE PHYSICIAN DECIDED TO END THE PROCEDURE AND DO A FOLLOW UP IN 30 DAYS. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP ON (B)(6) 2019, A CT SCAN SHOWED NO SIGNS OF ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS A HOLE IN THE FABRIC OF THE STENT GRAFT LIMB. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8243515 ↗
• InjuryOct 22, 2018Adverse 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 60MM DIAMETER ABDOMINAL AORTIC ANEURYSM ON. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE STENT GRAFT WAS IMPLANTED AND THE VESSELS WERE CLOSED LIMITED PULSES WAS NOTED. AN ANGIO WAS COMPLETED WHICH IDENTIFIED AN OCCLUSION OF THE RIGHT LIMB STENT GRAFT WITH POOR DISTAL OUTFLOW. THE PHYSICIAN ELECTED TO PERFORM A LEFT TO RIGHT FEM-FEM BYPASS WHICH RESOLVED THE EVENT. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO POOR DISTAL OUTFLOW DUE TO CALCIFIED FEMORAL ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Injury; Occlusion

  MAUDE report 7991272 ↗
• MalfunctionSep 18, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 65.7MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE STENT GRAFT WAS DIFFICULT TO TRACK UP THE RIGHT FEMORAL. UPON INSPECTION THE PHYSICIAN NOTICED THE BLUE AND GREY HANDLE WERE SEPARATED BY ROUGHLY 2MM. IT WAS REPORTED THAT THE PHYSICIAN REMOVED THE DEVICE TO INSPECT THE STENT GRAFT COVER AND IT WAS FOUND THAT THE STENT COVER HAD BECOME BENT. THE PHYSICIAN DISCONTINUED WITH THAT DELIVERY DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH A NEWLY OPENED DEVICE. IT WAS NOTED THAT NO DAMAGE WAS NOTED TO THE OUTER PACKAGING OF THE DEVICE. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7884524 ↗
• MalfunctionFeb 21, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.7CM ABDOMINAL AORTIC ANEURYSM AND A 3.2CM LEFT COMMON ILIAC ARTERY ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAS HAD ANOTHER MANUFACTURERS BIFURCATE STENT GRAFT IMPLANTED SEVERAL YEARS EARLIER. IT WAS NOTED THAT DURING THE INITIAL IMPLANT OF THIS BIFURCATE, IT DID NOT EXTEND ALL THE WAY TO THE LEFT INTERNAL ILIAC ARTERY. THIS UNCOVERED PORTION OF THE LEFT ILIAC BECAME ANEURYSMAL OVER TIME AND IT WAS NECESSARY TO COIL THE LEFT INTERNAL ILIAC ARTERY AND EXTEND DOWN INTO THE LEFT EXTERNAL ILIAC ARTERY WITH THE ENDURANT LIMB. IT WAS REPORTED THAT DURING DEPLOYMENT OF THE LIMB, THE TIP WAS ADVANCING BUT THE RO MARKER WAS NOT MOVING DOWN IN ORDER TO RELEASE THE STENT GRAFT. UPON THIS DISCOVERY, THE DEVICE WAS REMOVED WITHOUT BEING DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIMB STENT GRAFT WITHOUT ISSUE. 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: No Consequences Or Impact To Patient

  MAUDE report 7285227 ↗
• InjuryDec 20, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 41MM ANEURYSM IN THE RIGHT COMMON ILIAC ARTERY. IT WAS REPORTED THAT THE PATIENT'S CT REVEALED AN OCCLUSION IN THE RIGHT IPSILATERAL LIMB. THE PATIENT RECEIVED TREATMENT WITH A FEMORAL-FEMORAL BYPASS BEING PERFORMED. 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: Injury; Occlusion

  MAUDE report 7132887 ↗
• MalfunctionSep 28, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT RETURNED FOR ROUTINE FOLLOW UP. THE CT REVEALED A DISTAL TYPE I ENDOLEAK. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6899936 ↗
• InjuryAug 28, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW-UP COMPLAINING OF LEFT LEG PAIN. A CTA WAS PERFORMED AND THE LEFT SIDE OF THE STENT GRAFT WAS FOUND OCCLUDED. A TPA DRIP WAS INSERTED AND THE PATIENT WAS SUBSEQUENTLY TREATED WITH INDIGO ASPIRATION SYSTEM TO EVACUATE THE CLOT AND 12MM STENTS FROM ANOTHER MANUFACTURER WERE PLACED IN ILIAC ARTERY. ANGIO REVEALED AREA OF MECHANICAL OCCLUSION WAS CLEAR WITH GOOD FLOW. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS ANATOMY RELATED, (THERE APPEARED TO BE AN AREA IN THE LEFT ILIAC THAT WAS SLIGHTLY STENOSED AND AT A 90 DEGREE TURN). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE AND WAS DISCHARGED.

  Patient problems: Occlusion; Pain

  MAUDE report 6823754 ↗
• MalfunctionAug 11, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.2 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A LIMB OCCLUSION WAS DISCOVERED ON CT IMAGING DONE. NO INTERVENTION HAS BEEN DONE AND THE EVENT IS ONGOING. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

  Patient problems: Occlusion

  MAUDE report 6788340 ↗
• InjuryApr 25, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT A 5.2 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT DURING THE INITIAL PROCEDURE THE PHYSICIAN MODELED ILIAC LIMB WITH A BALLOON. THE FINAL ANGIOGRAM DURING THE INITIAL PROCEDURE LOOKED GOOD. IT WAS REPORTED THE THAT THE PATIENT PRESENTED WITH PAIN NINE DAYS LATER. THE CT REVEALED THAT THE RIGHT ENDURANT 16 X 13 ILIAC LIMB WAS OCCLUDED. THE PHYSICIAN ATTEMPTED A THROMBECTOMY AND THEN ELECTED TO PERFORM A FEMORAL-FEMORAL BYPASS. AFTER THE FEM-FEM BYPASS, THE EVENT WAS RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS RELATED TO THE PATIENT¿S ANATOMY OF CALCIFICATION AND HIGHLY TORTUOUS ARTERIES THAT HAD A SMALL DISTAL DIAMETER. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion; Pain

  MAUDE report 6520307 ↗
• InjuryMar 7, 2017Malposition of Device; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT A 5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE ENDURANT BIFURCATED STENT GRAFT WAS DEPLOYED BELOW THE RENAL ARTERIES WITHOUT ISSUE. THE CONTRALATERAL GATE WAS CANNULATED WITHOUT ISSUE. A SIZING MARKER PIG TAIL WAS PLACED WITH IN THE BIFURCATED STENT GRAFT EXTENDING TO THE LEFT COMMON ILIAC. AN ANGIOGRAM FROM THE LEFT SHEATH WAS PERFORMED. THE PHYSICIAN COUNTED 13 MARKS FROM FLOW DIVIDER TO HYPOGASTRIC ARTERY. OVER THE WIRE AN ENDURANT 16X13X124 LIMB WAS ADVANCED TO THE LEVEL OF THE FLOW DIVIDER. AT THIS POINT THE 124 LENGTH LIMB WAS APPROXIMATELY 3CM PROXIMAL TO HYPOGASTRIC ARTERY THEREFORE THE PHYSICIAN REMOVED THE ENDURANT 16X13X124 LIMB AND AN ENDURANT 16X13X156 LIMB WAS ADVANCED AND DEPLOYED EXTENDING FROM FLOW DIVIDER TO HYPOGASTRIC ARTERY. THE DELIVERY SYSTEM WAS REMOVED. THE REMAINDER OF THE ENDURANT BIFURCATED STENT GRAFT WAS DEPLOYED AND THE DELIVERY SYSTEM WAS REMOVED. THE STENT GRAFTS WERE BALLOONED USING A RELIANT BALLOON AT THE PROXIMAL, DISTAL, AND OVERLAP SECTIONS. ON THE FINAL ANGIOGRAM IT WAS NOTICED THAT THE LEFT HYPOGASTRIC WAS NOT FILLING DUE TO THE 13MM OF THE ENDURAN

  Patient problems: Occlusion

  MAUDE report 6385556 ↗

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-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-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-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-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