Heli-FX™ EndoAnchor™ System SA-85 (UDI 00763000645113)Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00763000645113), received between Nov 21, 2022 and Aug 12, 2026 — classified as 4 deaths, 14 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (27 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionAug 12, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218471 ↗
• MalfunctionMay 1, 2026Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT A PATIENT REPRESENTATIVE CONTACTED TECHNICAL SERVICES APPROXIMATELY 14 YEARS LATER AND STATED THAT THE PATIENT EXPERIENCED AN ENDOLEAK THAT WAS REPAIRED 4 MONTHS PREVIOUSLY WITH AN ENDURANT CUFF. SUBSEQUENT INFORMATION RECEIVED CONFIRMED THAT THE ENDOLEAK WAS A TYPE IA INVOLVING THE ENDURANT BIFURCATED GRAFT. THE ENDOLEAK DID NOT RESOLVE FOLLOWING CUFF IMPLANTATION; THEREFORE, SIX ENDOANCHORS WERE PLACED, RESULTING IN A REDUCTION OF THE ENDOLEAK. THE PHYSICIAN LATER CONFIRMED THAT THE ENDOLEAK WAS FULLY RESOLVED ON FOLLOW-UP IMAGING. LACK OF WALL APPOSITION WAS NOTED IN THE LEFT LIMB; HOWEVER, NO TYPE IB ENDOLEAK WAS IDENTIFIED. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE TYPE IA ENDOLEAK WAS PROGRESSIVE DILATION OF THE AORTA SINCE THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25054516 ↗
• MalfunctionApr 24, 2026Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. 5 WEEKS LATER, STENT GRAFT INFOLDING WAS OBSERVED ON IMAGING. THE SPONSOR ASSESSED THE INFOLDING AS POSSIBLY RELATED TO PROCEDURE AND RELATED TO DEVICE. THE CAUSE WAS UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24978172 ↗
• InjuryApr 15, 2026Malposition of Device; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDEX ENDOVASCULAR PROCEDURE TO TREAT A 45 MM ABDOMINAL AORTIC ANEURYSM, AN ENDURANT II/IIS STENT GRAFT SYSTEM (ESBF3214C103E WITH ETLW1616C93E AND ETLW1620C93E) WAS IMPLANTED SUCCESSFULLY AND ENDO-ANCHORS WERE THEN DEPLOYED. FIVE ENDO-ANCHORS WERE IMPLANTED SUCCESSFULLY; HOWEVER, DURING DEPLOYMENT OF THE SIXTH ENDO-ANCHOR, THE ANCHOR WAS REPORTED TO NOT BE ENGAGED WITH THE GRAFT FABRIC OR ARTERIAL WALL WHEN DEPLOYED. THE ENDO-ANCHOR MIGRATED ABOVE THE SUPRARENAL STENTS OF ESBF3214C103E. THE PHYSICIAN REMOVED THE ENDO-ANCHOR DELIVERY SYSTEM, INSERTED THE DILATOR OF A 16 FR SHEATH, AND ADVANCED THE 16 FR SHEATH PROXIMAL TO THE SUPRARENAL STENTS OF ESBF3214C103E OVER A STIFF 0.035-INCH GUIDEWIRE, THEN REMOVED THE DILATOR. A GOOSE-NECK STYLE SNARE WAS INSERTED TO ATTEMPT TO SNARE THE UNFIXED ENDO-ANCHOR. DURING THIS MANEUVER THE 16 FR SHEATH AND SNARE WERE PULLED DOWN INTO THE GRAFT, AFTER WHICH THE SNARE BECAME TANGLED WITH THE SUPRARENAL STENTS OF ESBF3214C103E. THE PHYSICIAN ATTEMPTED UNSUCCESSFULLY TO FREE THE SNARE AND THEN CONVERTED TO AN OPEN SURGICAL REPAIR OF THE ABDOMINAL ANEURYSM. THE ESBF3214C103E, ETLW1616C93E, ETLW1620C93E, AND SA-85 ENDO-A

  Patient problems: Insufficient Information

  MAUDE report 24881348 ↗
• InjuryMar 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR CASE USING THE HELI-FX ENDOSYSTEM PROPHYLACTICALLY WITH A NON MDT ENDO-GRAFT. THE AORTA DIAMETER AT THE RENAL ARTERY WAS 29-30MM AND THE PROXIMAL AORTIC NECK LENGTH WAS 15MM AT IMPLANT. THE VESSEL WAS NOT TORTUOUS AND HAD NO CALCIFICATION AT IMPLANT. IT WAS REPORTED DURING THE INDEX PROCEDURE ONE ENDOANCHOR BECAME DISLODGED FROM THE ENDOGRAFT AND EMBOLIZED INTO THE RIGHT RENAL ARTERY. AN ATTEMPT WAS MADE TO RECOVER THE ENDOANCHOR WITH AN EN-SNARE, BUT THIS WAS UNSUCCESSFUL. THE ENDOANCHOR REMAINS IN THE RENAL ARTERY, AND THE PATIENT HAS NOT RECEIVED ANY FURTHER TREATMENT. A 30-DAY COMPUTED TOMOGRAPHY IS PLANNED TO DETERMINE ANY ADVERSE EVENTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE CAUSE OF THE DISLODGEMENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24589108 ↗
• InjuryMar 9, 2026Misfire; Malposition of Device; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE PLACEMENT OF AN ENDOANCHOR USING THE HELI-FX APPLIER, THE APPLIER WOULD NOT DISENGAGE. THE APPLIER WAS ROTATED COUNTERCLOCKWISE IN AN ATTEMPT TO RELEASE THE ANCHOR, WHICH THEN BECAME DISLODGED AND FLOATED TOWARDS THE HEAD. AN ATTEMPT TO SNARE THE DISLODGED ANCHOR WAS UNSUCCESSFUL, AND THE ANCHOR WAS SUBSEQUENTLY LODGED INTO AN INTERCOSTAL ARTERY USING A GASTROINTESTINAL GRASPER. PLACEMENT OF ADDITIONAL ENDOANCHORS WAS RESUMED, BUT THERE WAS DIFFICULTY RELEASING THE ENDOANCHOR DURING THE NEXT ATTEMPT. A NEW APPLIER WAS OPENED AND USED TO SUCCESSFULLY PLACE THE REMAINING ENDOANCHORS WITHOUT FURTHER ISSUES. THE EVENT WAS RESOLVED BY REPLACING THE APPLIER AND COMPLETING THE PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24543688 ↗
• MalfunctionDec 19, 2025Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING USE OF A HELI-FX ENDOANCHOR SYSTEM, THE END OF THE ENDOANCHOR BROKE OFF INSIDE THE APPLIER AND WAS SUBSEQUENTLY REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847677 ↗
• MalfunctionOct 24, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE FOR TREATMENT OF A 57MM ANEURYSM, THE STENT GRAFT ESBF3614C103E ENDUR IIS BIF WAS IMPLANTED IN THE ABDOMINAL AORTA. A COMPLETION ANGIOGRAM IDENTIFIED A TYPE 1A ENDOLEAK, ALTHOUGH THE POSITION OF THE PROXIMAL GRAFT EDGE WAS OPTIMAL AND ENDOANCHORS WERE PLACED IN THE DESIRED LOCATIONS. NO ADDITIONAL STEPS WERE TAKEN AT THE TIME, AND FOLLOW-UP IMAGING WAS PLANNED IN 30 DAYS TO FURTHER EVALUATE THE SITUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377251 ↗
• DeathOct 1, 2025Adverse 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 AAA .ENDOANCHORS WERE ALSO IMPLANTED DUE TO A AORTIC CONICAL NECK. IT WAS REPORTED THE PATIENT PRESENTED UNDER THREE MONTHS LATER AND THE STENT GRAFTS WERE EXPLANTED THE FOLLOWING DAY DUE TO AN INFECTED GRAFT. THE PHYSICIAN NOTED THERE WAS PUS SURROUNDING THE GRAFT UPON EXPLANT. THE PATIENT PASSED AWAY ON THE SAME DATE. NO CAUSE OF THE INFECTION OR THE PATIENT DEATH WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 23190503 ↗
• MalfunctionJun 9, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE INVOLVING THE STENT GRAFT ETBF2816C124E ENDUR II BIF, A LARGE ENDOLEAK WAS OBSERVED AFTER FULL DEPLOYMENT OF THE DEVICE. THE PATIENT WAS TREATED FOR A 42MM SACCULAR ANEURYSM WITH ENDOVASCULAR AORTIC REPAIR AND ESAR.IT WAS STATED THAT ENDOANCHORS WERE PLACED AFTER THE ENDOLEAK WAS OBSERVED TO RULE OUT A TYPE IA ENDOLEAK. DURING THE INVESTIGATION OF THE ENDOLEAK, THERE WAS A POSSIBILITY OF A TEAR OR HOLE IN THE ENDOGRAFT. PATIENT LEFT THE OPERATING ROOM WITH WHAT WAS THOUGHT TO BE A TYPE IIIB ENDOLEAK. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE PATIENT WILL BE MONITORED. A 30 DAY FOLLOW UP IS PLANNED TO CONFIRM THE ENDOLEAK TYPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165860 ↗
• MalfunctionJun 9, 2025Fracture; Misfire; Device Damaged by Another Device; Fracture; Misfire; Device Damaged by Another Device

  A HELI-FX ENDOANCHORING SYSTEM WAS USED TO AID THE DISTAL FIXATION OF A NON MDT FENESTRATED STENT GRAFT. THE FIRST ENDOANCHOR WAS LOADED AND THEN THE APPLIER INSERTED INTO PATIENT. THE DESIRED POSITION WAS ACHIEVED AND THE FIRST STAGE OF DEPLOYMENT COMPLETED. THE PHYSICIAN WAS HAPPY WITH THE POSITION SO THE SECOND STAGE OF DEPLOYMENT WAS COMMENCED. DURING THE DEPLOYMENT, THE CATHETER TORQUED DOWN AND JUMPED FORWARD. IT WAS THOUGHT IT CAUGHT ON THE STENT GRAFT AND PART OF THE ENDOANCHOR DEPLOYED. WHEN REMOVING THE APPLIER, A SMALL PIECE OF METAL WHICH WAS BELIEVED TO BE THE FOOTPLATE OF THE ENDOANCHOR WAS NOTICED. ANOTHER APPLIER WAS USED TO CONTINUE THE CASE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165312 ↗
• DeathApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDEX PROCEDURE INVOLVING THE HELI-FX ENDOSYSTEM AND A N ENDURANT IIS, A RUPTURE WAS SUSPECTED WHEN THE NON-MEDTRONIC WIRE APPEARED TO DEFLECT OUTSIDE THE AORTIC LUMEN UPON REMOVAL OF THE HELI-FX GUIDE. PRE-OPERATIVELY THE DIAMETER OF THE AORTA AT THE RENAL ARTERY MEASURED 26MM WHILE THE LENGTH OF THE PROXIMAL AORTIC NECK WAS 9MM. MODERATE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. THE PROCEDURE INITIALLY INVOLVED THE SUCCESSFUL PLACEMENT OF A 32MM BIFURCATED DEVICE AND 16X16MM DIAMETER LIMBS, ALONG WITH SIX ENDOANCHORS DUE TO THE PATIENT'S SHORT AND CONICAL NECK ANATOMY. A SELECTIVE ANGIOGRAM WAS PERFORMED, AND NO RUPTURE LEAKS WERE IDENTIFIED AT THAT TIME. HOWEVER, APPROXIMATELY ONE HOUR LATER, THE PATIENT WAS REPORTED TO BE UNSTABLE, PROMPTING ANOTHER ANGIOGRAM WHICH REVEALED A TEAR ABOVE THE LEFT RENAL ARTERY. THE LEFT RENAL ARTERY WAS EMBOLIZED VIA BRACHIAL APPROACH AND COVERED WITH A 32X32X49MM AORTIC CUFF, WHILE THE RIGHT RENAL ARTERY WAS STENTED AND "SNORKELED" BEHIND A 36X36X49MM AORTIC CUFF, MAINTAINING BLOOD FLOW THROUGH THE STENT. THE PATIENT RECEIVED THREE UNITS OF BLOOD AND WAS TRANSFERRED TO CRITICAL CARE. MULTIPLE

  Patient problems: Stroke/CVA

  MAUDE report 21760743 ↗
• MalfunctionMar 31, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING A PROPHYLACTIC PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM, A MALFUNCTION OCCURRED WITH A HELI-FX AP PLIER. AFTER SUCCESSFULLY IMPLANTING THREE ENDOANCHORS, THE FOURTH ENDOANCHOR FAILED TO LOAD FULLY INTO THE APPLIER WAS STICKING OUT. THE PHYSICIAN FOLLOWED THE INSTRUCTIONS FOR USE USING THE HELI-FX APPLIER. WHEN AN ATTEMPT WAS MADE TO LOAD ANOTHER ENDOANCHOR, THE SAME ISSUE OCCURRED. TO RESOLVE THE ISSUE, ANOTHER APPLIER WAS OPENED AND USED TO COMPLETE THE SURGERY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH THE USE OF THE NEW APPLIER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729094 ↗
• MalfunctionMar 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT TREATED FOR AN ANEURYSM WITH A STENT GRAFT ESBF2514C103E ENDUR IIS BIF EXPERIENCED AN APPARENT TYPE IA ENDOLEAK. THE EVENT WAS DISCOVERED ON THE DATE OF A CT SCAN. NO PRE-OPERATIVE ANEURYSM RUPTURE WAS NOTED. THE PHYSICIAN CONFIRMED THAT THE TYPE IA ENDOLEAK WAS CAUSED BY VESSEL TORTUOSITY. INTERVENTION WAS PERFORMED, DURING WHICH THE PHYSICIAN BALLOONED THE VESSEL, PLACED ENDOANCHORS, AND DEPLOYED A NON-MDT STENT, RESULTING IN NEAR-COMPLETE RESOLUTION OF THE ENDOLEAK. THERE WAS A VERY FAINT ENDOLEAK VISIBLE AT THE END OF THE INTERVENTION. THE PHYSICIAN SUSPECTS THIS MAY BE RESOLVED WITH HEPARIN REVERSAL. A FOLLOW-UP EVALUATION IS PLANNED IN 30 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661681 ↗
• MalfunctionNov 21, 2024Fracture; Device Difficult to Setup or Prepare; Device Displays Incorrect Message; Activation, Positioning or Separation Problem; Material Deformation; Fracture; Device Difficult to Setup or Prepare; Device Displays Incorrect Message; Activation, Positioning or Separation Problem; Material Deformation

  A HELI-FX APPLIER AND ENDOANCHORS WERE USED PROPHYLACTICALLY AS AN ACCESSORY DEVICE DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE WHEN DEPLOYING AN ENDOANCHOR, ON THE SECOND STAGE OF DEPLOYMENT, THE ENDOANCHOR APPEARED TO BREAK. THE ENDOANCHOR LOOKED DEFORMED, IT APPEARED TO FRACTURE BUT REMAINED IN PLACE IN THE GRAFT. NO REMNANTS OF THE ENDOANCHOR REMAINED IN THE APPLIER. THE ENDOANCHORS DID NOT INTERACT WITH ANY CALCIUM OR METAL OF THE STENT GRAFT WHEN TRYING TO DEPLOY. THE PHYSICIAN REMOVED THE APPLIER FROM THE GUIDE AND THE APPLIER STOPPED WORKING AND WOULD NOT LOAD ANY ENDOANCHOR AND THE LIGHTS WERE FLASHING. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746520 ↗
• DeathNov 11, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED 45MM AAA. IT WAS REPORTED THAT THE PATIENT HAD A TYPE I ENDOLEAK AT THE END OF THE PROCEDURE. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PATIENT WAS TREATED FOR A RUPTURE DUE TO THE TYPE IA. 10 ENDOANCHORS WERE PLACED, HOWEVER ON THE POST-ANGIO THE TYPE IA ENDOLEAK REMAINED. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS DUE TO UNDER-SIZING. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650619 ↗
• InjuryNov 6, 2024Leak/Splash; Leak/Splash

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

  Patient problems: Insufficient Information

  MAUDE report 20620822 ↗
• MalfunctionOct 30, 2024Leak/Splash; Device Displays Incorrect Message; Activation, Positioning or Separation Problem; Leak/Splash; Device Displays Incorrect Message; Activation, Positioning or Separation Problem

  AN ENDURANT STENT GRAFT CUFF WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS ALSO REPORTED THAT THE PATIENT HAD A PREVIOUSLY IMPLANTED STENT GRAFT PRIOR TO THE IMPLANTATION OF THE ENDURANT CUFF. IT WAS REPORTED DURING THE INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS IDENTIFIED. INTERVENTION WAS PERFORMED 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. THE ENDO ANCHORS DID NOT IMMEDIATELY FIX THE TYPE 1A. HOWEVER, THE PHYSICIAN EXPECTED THAT THAT ONCE HEPARIN WORE OFF THAT IT WOULD SEAL. 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 20568865 ↗
• MalfunctionAug 26, 2024Leak/Splash; Migration or Expulsion of Device; Device Difficult to Setup or Prepare; Activation, Positioning or Separation Problem; Material Deformation; Leak/Splash; Migration or Expulsion of Device; Device Difficult to Setup or Prepare; Activation, Positioning or Separation Problem; Material Deformation

  AN ANEURX STENT GRAFT SYSTEM AND EXTENSION CUFF WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. IT WAS REPORTED APPROXIMATELY 16 YEARS POST THE INDEX PROCEDURE, FOLLOW-UP CT SHOWED BOTH EXISTING PROXIMAL STENT GRAFTS HAD MIGRATED DUE TO NECK EXPANSION LEADING TO A TYPE IA ENDOLEAK. A ENDURANT CUFF ETCF3636C49E ((B)(6)) WAS DEPLOYED WITHOUT INCIDENT, LANDING JUST DISTAL TO THE ORIGIN OF THE RENAL ARTERIES. HELI-FX ENDOANCHORS WERE THEN DEPLOYED SA-85 (LOT #0011791286) 2 ENDOANCHORS WERE DEPLOYED WITHOUT INCIDENT. DURING THE DEPLOYMENT OF THE 3RD ENDOANCHOR THE INITIAL STEP OF DEPLOYMENT WAS PERFORMED WITHOUT INCIDENT AS THE ENDOANCHOR SUCCESSFULLY ENGAGED AND PENETRATED THE STENT GRAFT FABRIC IN THE CORRECT ORIENTATION, HOWEVER, DURING THE SECOND STEP, THE ENDOANCHOR APPEARED TO CHANGE ORIENTATION. THE 3RD ENDOANCHOR HAD TO BE REPOSITIONED SEVERAL TIMES. IT IS APPEARED THAT THE ENDOANCHOR INTERACTED WITH CALCIUM DURING THE FINAL STAGE DEPLOYMENT. THE SA-85 WOULD NOT LOAD THE 4TH ENDOANCHOR AND DAMAGE TO THE TIP OF THE SA-85 WAS SUSPECTED. A SECOND SA-85 (LOT # 0011823330) WAS OPENED AND 3 MORE ENDOANCHORS WERE DEPLOYED WITHOUT INCIDENT. THE PHYSICIAN DECIDED TO IMPLANT A SECO

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

  MAUDE report 20064324 ↗
• MalfunctionAug 20, 2024Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  HELI-FX ENDOANCHORS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED DURING THE INDEX PROCEDURE, STAGE 1 OF THE ENDOANCHOR DEPLOYMENT WAS SUCCESSFULLY INITIATED. HOWEVER, WHEN STAGE 2 DEPLOYMENT WAS INITIATED, THE APPLIER MADE AN UNUSUALLY LOUD SOUND, AND IT WAS UNCLEAR IF THE ENDOANCHOR HAD CONTINUED TO PENETRATE FURTHER INTO THE AORTIC WALL ON IMAGING. UPON REMOVING THE APPLIER AND ATTEMPTING TO LOAD AN ADDITIONAL ENDOANCHOR BY PRESSING THE BACK BUTTON, IT WAS DISCOVERED THAT A PARTIAL ENDOANCHOR REMAINED ON THE APPLIER DELIVERY SYSTEM. A NEW HELI-FX APPLIER ((B)(6)) ALONG WITH A NEW CASSETTE WAS THEN OPENED AND THE ENDOANCHORS WERE SUCCESSFULLY DEPLOYED AS PLANNED WITHOUT FURTHER ISSUES OR PATIENT IMPACT. PER THE PHYSICIAN THE CAUSE OF THE ENDOANCHOR FRACTURE WAS NOT DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PA TIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20004181 ↗
• InjuryMay 16, 2024Leak/Splash; Leak/Splash

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

  Patient problems: Insufficient Information

  MAUDE report 19329396 ↗
• InjuryMay 8, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM ALONG WITH ENDOANCHORS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK DIAMETER WAS NOTED TO MEASURE 29-28MM, FROM PROXIMAL TO DISTAL. THE PROXIMAL AORTIC NECK WAS NOTED AS WIDE, EXHIBITING MILD CALCIFICATION AND NO THROMBUS. IT WAS REPORTED ON THE ONE-MONTH FOLLOW-UP, CT IDENTIFIED INFOLDING WITH A TYPE IA ENDOLEAK. PER THE PHYSICIAN THE CAUSE THE ENDOLEAK AND INFOLDING WAS DUE TO THE OVERSIZING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 19266528 ↗
• MalfunctionMar 29, 2024Fracture; Device Difficult to Setup or Prepare; Fracture; Device Difficult to Setup or Prepare

  A HELI-FX ENDOANCHORING SYSTEM (0011580490) WAS USED PROPHYLACTICALLY WITH AN ENDURANT STENT GRAFT FOR A HOSTILE AORTIC NECK. IT WAS REPORTED DURING THE PROCEDURE, THE HELI-FX APPLIER WAS UNABLE TO FULLY LOAD THE ENDOANCHOR. A NEW HELI-FX APPLIER WAS USED AS A REPLACEMENT AND TREATMENT WAS SUCCESSFULLY COMPLETED. 5-6 ENDOANCHORS HAD BEEN IMPLANTED BEFORE THE APPLIER STOPPED WORKING. IT WAS REPORTED THAT LAST ENDOANCHOR WAS SUCCESSFULLY DEPLOYED AND SECURELY IMPLANTED IN THE VESSEL WALL. THERE WAS NO DAMAGE TO THE APPLIER OR PACKAGING BEFORE USE. THE APPLIER DID NOT DISPLAY ANY ERROR LIGHTS. PER THE PHYSICIAN THE DIFFICULTY LOADING THE ENDOANCHOR WAS DEVICE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE. DEVICE ANALYSIS SHOWED A FRACTURED ENDOANCHOR INSIDE THE APPLIER HOUSING. THE SITE WERE UNABLE TO CONFIRM IF THE ENDOANCHOR FRACTURE OCCURRED OUTSIDE THE PATIENT BUT DID CONFIRM THAT THE LAST ENDOANCHOR WAS SUCCESSFULLY DEPLOYED AND SECURELY IMPLANTED IN THE VESSEL WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002693 ↗
• MalfunctionMar 21, 2024Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, EVAR WAS COMPLETED WITH THE PROXIMAL FABRIC EDGE OF THE MAIN BODY POSITIONED AT THE LEVEL OF THE RENAL ARTERIES. AN ENDOLEAK WAS IDENTIFIED ON THE FINAL ANGIOGRAM. THE PHYSICIAN IMPLANTED 10 ENDOANCHORS WITHIN THE PROXIMAL SEAL ZONE. THE POST GRAFT AND ENDOANCHOR ANGIOGARM CONTINUED TO SHOW A TYPE IA ENDOLEAK. THE PROCEDURE WAS COMPLETED. PER THE PHYSICIAN THE CAUSE OF THE SUSPECTED TYPE IA ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949298 ↗
• MalfunctionMar 20, 2024Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 77MM ABDOMINAL AORTIC ANEURYSM.THE PATIENT HAD A SHORT, ANGLED NECK. IT WAS NOTED THAT THE LENGTH OF THE PROXIMAL AORTIC NECK AT IMPLANT WAS APPROX. 6-16MM AND PROXIMAL AORTIC NECK DIAMETER WAS NOTED AS 29MM, BOTH THE LEFT AND RIGHT COMMON ILIAC ARTERIES HAD MODERATE VESSEL CALCIFICATION. IT WAS REPORTED DURING THE INDEX PROCEDURE, ESBF3614C103E WAS PLACED IN THE SHORT ANGLED NECK. CT IMAGING REVEALED A TYPE IA ENDOLEAK. ENDOANCHORS WERE IMPLANTED BUT FAILED TO RESOLVE THE ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK IS ANATOMY RELATED DUE TO SHORT ANGLED NECK. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941899 ↗