Heli-FX™ EndoAnchor™ System SA-85 (UDI 00763000225933)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00763000225933), received between Jan 30, 2020 and Mar 3, 2026 — classified as 6 deaths, 18 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (24 reports).

1 other recall cover devices cleared under the same FDA submission (K171427); 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.

• DeathMar 3, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED FOR NSTMI AND FLANK PAIN AND WAS BEING TREATED BY CARDIO DUE TO HIS HEART FAILURE HISTORY. DURING ADMISSION A CT SHOWED CHRONIC AORTIC DISSECTION WITH ASCENDING ENDOLEAK. VASCULAR SURGERY WAS CONSULTED AND NO ACUTE INTERVENTION WAS RECOMMENDED WITH PLANS FOR ELECTIVE SURGERY IN 1 MONTH. DURING HOSPITALIZATION THE PATIENT DEVELOPED ACUTE UNRESPONSIVENESS REQUIRING EMERGENT INTUBATION. THE PATIENT SUFFERED AN ACUTE INFARCT IN THE RIGHT OCCIPITAL LOBE AND A CHRONIC INFARCT IN THE LEFT PARIETAL LOBE AND WAS TREATED WITH THROMBOLYTIC THERAPY FOLLOWED BY SUCCESSFUL MECHANICAL THROMBECTOMY. THE POST-PROCEDURE COURSE WAS COMPLICATED BY EPISTAXIS AND OROPHARYNGEAL AND GROIN ACCESS BLEEDING, SUSPECTED TO BE THROMBOLYTIC-INDUCED DISSEMINATED INTRAVASCULAR COAGULATION. SIX HOUR POST THROMBECTOMY HEAD CT SHOWED R P-O EVOLVING INFARCT WITH HAEMORRHAGIC CONVERSION IN THE STROKE BED AND CONTRAST STAINING. DUE TO DIC, PATIENT DEVELOPED A DISTRIBUTIVE SHOCK. THIS RESULTED IN ACUTE KIDNEY INJURY. THE PATIENT SUFFERED WITH PERSISTENT FEVERS AND LEUKOCYTOSIS, LIKELY RELATED TO WORSENING ASCENDING DISSECTION WITH EN

  Patient problems: Aortic dissection; Disseminated Intravascular Coagulation (DIC); Fever; Hemorrhage/Blood Loss/Bleeding; Hemothorax; Myocardial Infarction; Pain; Pneumonia; Renal Failure; Shock; Stroke/CVA; Unspecified Infection; Vascular Dissection

  MAUDE report 24497319 ↗
• InjuryAug 21, 2023Fracture; Fracture

  AN ENDURANT IIS STENT GRAFT SYSTEM AND HELI-FX ENDOANCHORS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE ENDOANCHORS WERE USED DUE TO SHORT NECK, 4-5MM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE ENDURANT BIFURCATE AND 2 ENDURANT LIMBS WERE SUCCESSFULLY IMPLANTED. 2 TO 3 ENDOANCHORS WERE THEN SUCCESSFULLY DEPLOYED WITHOUT ANYISSUES. DURING THE FIRST STAGE OF DEPLOYING THE NEXT ENDOANCHOR, THE ENDOANCHOR ATTACHED TO THE AORTIC WALL, HOWEVER DURING FINAL DEPLOYMENT, SOME ISSUES WERE NOTED. WHILE ATTEMPTING TO REMOVE THE APPLIER, HALF OF THE ENDOANCHOR BROKE OFF, LEAVING HALF IMPLANTED BETWEEN THE GRAFT AND AORTIC WALL. THE OTHER HALF WAS SEEN UNDER FLUOROSCOPY IN THE HELI-FX GUIDE. IT WAS REPORTED POST THE PROCEDURE NO PULSES WERE FELT AT THE RIGHT DP/PT AND POPLITEAL ARTERIES. A DOPPLER WAS COMPLETED SHOWING THE SAME RESULT. CUTDOWNS WERE THEN COMPLETED. IT WAS NOTED THAT THERE WAS HEAVY CALCIFICATION AT THE AREA OF THE NON-MEDTRONIC CLOSURE DEVICE ( PRO-GLIDE) WHICH CAUSED INFLOW OCCLUSION. PER THE PHYSICIAN THE CAUSE OF THE FRACTURED ENDOANCHOR WAS DUE TO THE ENDOANCHOR DEVICE. THE CAUSE OF THE OCCLUSION WAS DUE TO THE NON-MEDTRONIC

  Patient problems: Insufficient Information

  MAUDE report 17583141 ↗
• InjuryJan 10, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED 100MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2023. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE STENTS WERE DEPLOYED, ON THE FINAL ANGIOGRAM A TYPE IA ENDOLEAK WAS OBSERVED. THE PHYSICIAN ELECTED TO IMPLANT 8 ENDOANCHORS HOWEVER A SLIGHT ENDOLEAK WAS STILL SEEN AND THE PROCEDURE WAS COMPLETED. THE NEXT DAY A CT SCAN SHOWED THE TYPE IA ENDOLEAK. THE PHYSICIAN DECIDED TO COMPLETE FURTHER INTERVENTION THAT DAY. A 5 VESSEL LASER FENESTRATION TO EXTEND THE ENDOGRAFT UP TO GET TO HEALTHY TISSUE WAS PERFORMED. THE CELIAC, SMA, RIGHT RENAL AND BOTH LEFT RENAL ARTERIES WERE PRE-STENTED WITH NON MDT STENTS . A VALIANT VAMF3030C100TU (30818855) WAS PLACED OVER THE VISCERAL VESSELS. ALL THE VISCERAL VESSELS WERE LASERED AND A COVERED STENT PLACED IN EACH VESSEL. A NON MDT STENT WAS USED IN THE SMA AND NON MDT STENTS WERE USED IN THE CELIAC, RIGHT RENAL, AND BOTH LEFT RENAL ARTERIES. THE RIGHT LIMB OF THE ENDURANT WAS ALSO EXTENDED DOWN TO THE RIGHT HYPOGASTRIC WITH A ETEW1313C82E LOT V30472973. THE FINAL ANGIOGRAM SHOWED THE PROXIMAL TYPE I ENDOLEAK HAD RESOLVED. PER THE PHYSICIAN THE CAUSE OF

  Patient problems: Insufficient Information

  MAUDE report 16129113 ↗
• MalfunctionDec 19, 2022Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A RUPTURED 74MM AAA. IT WAS REPORTED DURING THE PROCEDURE , THE EVAR WENT WELL WITHOUT ANY ISSUES. POST OP ANGIOGRAM SHOWED A TYPE IA ENDOLEAK. 6 ENDOANCHORS WERE THEN PLACED AT THE PROXIMAL PORTION OF THE GRAFT.  ANOTHER ANGIOGRAM SHOWED A SLIGHT TYPE IA ENDOLEAK STILL. THE PROCEDURE WAS THEN COMPLETED.  PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS ANATOMY AND AN ANGLED  INFRA RENAL AORTIC NECK .  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004813 ↗
• MalfunctionOct 24, 2022Leak/Splash; Leak/Splash

  HELI-FX ENDOANCHORS WERE IMPLANTED WITH A VALIANT NAVION GRAFT FOR THE TREATMENT OF A TYPE IB ENDOLEAK IN AN EXISTING VALIANT NAVION STENT GRAFT. 3 NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM APPROXIMATELY I YEAR PREVIOUSLY. IT WAS REPORTED APPROXIMATELY 18 MONTHS POST THE ENDOANCHOR PROCEDURE FOLLOW UP CT IDENTIFIED A SUSPECTED TYPE IIIB ENDOLEAK OR PSEU DOANEURYSM. IT IS UNKNOWN WHICH STENT GRAFT HAS THE ENDOLEAK. THE PHYSICIAN SUSPECTS ONE OF THE FIRST STENT GRAFTS IMPLANTED DURING THE ORIGINAL INDEX PROCEDURE (V29978123, V30012199, V30055106) PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 15657490 ↗
• MalfunctionSep 26, 2022Malposition of Device; Malposition of Device

  A HELI-FX ENDOANCHORING SYSTEM WAS USED WITH A NON MDT STENT GRAFT IN AN UNKNOWN ENDOVASCULAR PROCEDURE.  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED 3 ENDOANCHORS. WHEN ATTEMPTING TO IMPLANT THE 4TH ENDOANCHOR, IT APPEARED TO DEPLOY AND THEN DISLODGE OUTSIDE THE STENT GRAFT BUT NOT IN THE ADVENTITIA WALL. IT WAS SAID THAT THE ENDOANCHOR WAS NOT PREPPED CORRECTLY AS INSTEAD OF ONE PRESS FORWARD TO VERIFY ANCHOR TWO FORWARD BUTTON PRESS' WERE PERFORMED THEN THE BACK BUTTON RETRACTION. THE PHYSICIAN WAS CONCERNED ABOUT GRAFT/AORTA WALL APPOSITION IN THAT AREA OF THE MISDEPLOYED ENDOANCHOR. PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15483624 ↗
• InjuryAug 10, 2022Malposition of Device; Malposition of Device

  A HELI-FX ENDOANCHORING SYSTEM WAS USED AS PART OF A TAA REPAIR PROCEDURE. IT WAS REPORTED DURING THE PROCEDURE, ONE ENDOANCHOR DID NOT SUCCESSFULLY PENETRATE THE AORTIC WALL AND FELL INTO THE THORACIC GRAF T. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY SNARE AND REMOVE THIS ENDOANCHOR.  PER THE PHYSICIAN THE CAUSE OF THE EVENT IS  LARGE ANATOMY  AND IT WAS DIFFICULT TO APPLY ADEQUATE FORCE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15200920 ↗
• MalfunctionJun 27, 2022Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 51MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED DURING THE PROCEDURE, THAT THE EVAR WAS COMPLETED WITHOUT ISSUE. IT WAS NOTED THAT THE POST IMPLANT ANGIOGRAM SHOWED A TYPE IA ENDOLEAK. THE PHYSICIAN THEN RE-BALLOONED WITH A RELIANT BALLOON BUT THE ENDOLEAK REMAINED.  THE PHYSICIAN THEN ELECTED TO IMPLANT ENDOANCHORS AND 9 ENDOANCHORS WERE IMPLANTED. ANOTHER ANGIOGRAM WAS PERFORMED WHICH STILL SHOWED THE PRESENCE OF THE TYPE IA ENDOLEAK. IT WAS THEN DECIDED TO STOP THE PROCEDURE AND FOLLOW-UP THE PATIENT WITH FURTHER IMAGING AT A LATER DATE.  PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND A CONICAL INFRA RENAL AORTIC NECK (19-24MM ).   NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828580 ↗
• MalfunctionJun 27, 2022Misfire; Activation, Positioning or Separation Problem; Device Damaged by Another Device; Misfire; Activation, Positioning or Separation Problem; Device Damaged by Another Device

  A HELI-FX ENDOANCHORING SYSTEM WAS USED PROPHYLACTICALLY WITH AN ENDURANT CUFF IN THE ENDOVASCULAR TREATMENT OF A A PAU IN THE DISTAL AORTA. A  SHORT DISTAL LANDING ZONE DISTAL OF THE PAU TO THE AORTIC BIFURCATION WAS PRESENT AND IT WAS DECIDED TO USE AN AORTIC CUFF DUE TO THE RENAL TO BIFURCATION LENGTH.  IT WAS REPORTED DURING THE PROCEDURE, AFTER PLACEMENT OF THE AORTIC CUFF THE PHYSICIAN USED THE ENDOANCHORS TO AID FIXATION ON THE GRAFT AT  THE PROXIMAL AND DISTAL LANDING ZONES. WHEN THEAPPLIER WAS TURNED ON  THE MOTOR SOUNDED VERY SLOW AND DIFFERENT THAN NORMAL. THE ENDOANCHOR DID LOAD AND IT WAS CHECKED TO MAKE SURE THE ENDOANCHOR  WAS LOADED. 4 ENDOANCHORS WERE THEN PLACED AT THE TOP OF THE AORTIC CUFF.  THE MOTOR SOUNDED VERY SLOW THE ENTIRE TIME. NEXT THE PHYSICIAN WENT TO THE DISTAL AORTA AND PLACED THE FIRST ENDOANCHOR ON THE PATIENTS RIGHT SIDE. WHEN THE PHYSICIAN WENT TO PLACE THE SECOND ENDOANCHOR, THE PHYSICIAN  WENT TO STAGE ONE AND THE ANCHOR WENT STRAIGHT TO DEPLOYMENT, IT DID NOT STOP. THE ANCHOR WAS NOT ALIGNED PROPERLY AND WENT IN AT A STEEP ANGLE. THIS CAUSED THE BOTTOM OF THE STENT GRAFT TO BE PUSHED UP. IT WAS NOTED THAT THE PHYSICIAN HAD NOT SEEN AN APPLIER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828321 ↗
• MalfunctionJun 14, 2022Leak/Splash; Activation, Positioning or Separation Problem; Device Damaged by Another Device; Leak/Splash; Activation, Positioning or Separation Problem; Device Damaged by Another Device

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED FOR THE TREATMENT OF A 56MM ABDOMINAL AORTIC ANEURYSM WITH A SHORT NECK. IT WAS REPORTED DURING THE INDEX PROCEDURE THAT THE LEFT RENAL ARTERY WAS STENTED PRE GRAFT PLACEMENT AND THE ANGLE OF THE RENAL ARTERY CHANGED DRAMATICALLY. THE PHYSICIAN THEN ELECTED TO LAND THE GRAFT INFRA RENAL. THE MAIN BODY AND CONTRALATERALLIMB WERE IMPLANTED SUCCESSFULLY. THE FINAL ANGIOGRAM SHOWED A PROXIMAL TYPE IA ENDOLEAK. BALLOONING WAS PERFORMED BUT THE TYPE IA ENDOLEAK PERSISTED. THE PHYSICIAN ATTEMPTED TO IMPLANT HELI-FX ENDOANCHORS TO TREAT THE ENDOLEAK AND NOTED THAT THE APPLIER SOUNDED REALLY SLOW AND DIFFERENT THAN NORMAL. DURING THE SECOND STAGE OF DEPLOYMENT, THE APPLIER DID NOT FULLY RELEASE ALL THE WAY AND CLICKED AT THE END OF DEPLOYMENT. THE PHYSICIAN TRIED TO PULL THE APPLIER BACK BUT IT WAS STUCK ON THE ENDOANCHOR. ONCE IT WAS RELEASED, SIX ADDITIONAL ENDOANCHORS WERE THEN PLACED, BUT THE APPLIER STILL CONTINUED TO SOUND SLOW. A FINAL ANGIOGRAM WAS PERFORMED AND THE TYPE IA ENDOLEAK REMAINED. BALLOONING WAS CARRIED OUT BUT THE PHYSICIAN DECIDED TO FINISH THE PROCEDURE AND WILL MONITOR THE PATIENT. AS PER THE PHYSICIAN, THE CAUSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14684884 ↗
• MalfunctionMay 18, 2022Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT WHERE A TYPE I ENDOLEAK WAS OBSERVED. THE PHYSICIAN IMPLANTED HELI-FX ENDOANCHORS TO TREAT THE ENDOLEAK 3 DAYS LATER . 14 ENDOANCHORS WERE PLACES IN THE PROXIMAL PORTION OF THE GRAFT TO SEAL THE ENDOLEAK. THE ENDOLEAK PERSISTED AFTER ENDOANCHORS WERE IMPLANTED. AS PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427606 ↗
• InjuryApr 19, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 68.5MM X 64 ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED FROM A CT SCAN PERFORMED 3 MONTHS BEFORE THE RUPTURED ANEURYSM, THE AAA HAD EXPANDED. A CTA WAS COMPLETED 3 DAYS LATER, NO TYPE IA ENDOLEAK WAS VISUALIZED, HOWEVER DILATION OF THE NECK WAS SEEN AND THERE WAS CONCERN THAT THE NECK WOULD CONTINUE TO DILATE AND EVENTUALLY CAUSE A IA ENDOLEAK. THE RIGHT ILIAC HAD ALSO DILATED BEYOND THE LIMB DIAMETER AND A IB ENDOLEAK WAS VISUALIZED. IT WAS CONFIRMED THAT THE LIMB THAT HAD THE TYPE IB ENDOLEAK WAS THE ETLW1628C93E (V05987682). INTERVENTION WAS PERFORMED WHERE THE ENDURANT CUFF, LIMB AND ENDOANCHORS WERE PLACED TO PREVENT FURTHER NECK DILATATION, AND THE RIGHT INTERNAL ILIAC WAS EMBOLIZED AND A LIMB WAS EXTENDED INTO THE EXTERNAL ILIAC ARTERY. IT WAS NOTED THE PATIENT DID NOT HAVE A TYPE IA ENDOLEAK VISUALIZED ON CTA OR ANGIOGRAM, HOWEVER THE PATIENT DID HAVE A TYPE II ENDOLEAK FROM PATENT LUMBAR ARTERIES AND A PATENT IMA THAT ORIGINATED AT THE LEVEL OF L-2. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY TO HOSPITAL 3 MONTHS LATER AFTER BEING FOUND UNCONSCIOUS ON THE F

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Ischemia; Rupture

  MAUDE report 14139963 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TO ER WITH A RUPTURED AAA. THE CT DID NOT SHOW AN ENDOLEAK BUT A INTERMITTENT TYPE IA ENDOLEAK WAS CONSIDERED. AAA MEASURES WERE 54X49MM WITH A SIGNIFICANT AMOUNT OF BLOOD IN THE RETROPERITONEUM. THE DEVICE WAS PLACED AT THE LOWEST LEFT RENAL ARTERY THEREFORE A CUFF WAS NOT ADDED. NO TYPE IA ENDOLEAK COULD BE SEEN ON ANGIOGRAM HOWEVER THE PHYSICIAN DECIDED TO IMPLANT 10 ENDOANCHORS. THERE WAS NO TYPE IB EITHER HOWEVER THE RIGHT LIMB HAD SEAL FOR 3CM BUT THERE WAS STILL 3CM TO THE HYPO AND IT DECIDED TO EXTENDED THE LIMB. IT WAS REPORTED THERE WAS ADEQUATE SEAL BUT THE PHYSICIAN WANTED TO MAXIMIZE COVERAGE. AFTER THE GROIN WAS CLOSED, THE PATIENT LOST THE PULSE IN HIS RIGHT GROIN AND LEG. THROMBECTOMY WAS ATTEMPTED SEVERAL TIMES WITHOUT ANY CLOT BEING REMOVED. PATIENT HAD DOPPLER SIGNALS IN BOTH FEET AT THE END OF THE CASE AND AS OF THIS MORNING. PER PHYSICIAN, THE PATIENT IS DOING WELL AND CONTINUES TO HAVE PULSES IN BOTH FEET. IT WAS REPORTED THE PATIENT RETURNED TO OR AROUND A WEEK LATER FOR ANGIOGRAM AND CT SCAN SHOWED NEW THROMBUS FORMATI

  Patient problems: Obstruction/Occlusion

  MAUDE report 14081811 ↗
• MalfunctionApr 4, 2022Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATED STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN 85MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON AN UNKNOWN DATE THE PATIENT RETURNED FOR A FOLLOW-UP WHERE A TYPE IA ENDOLEAK WAS IDENTIFIED. APPROXIMATELY 6 WEEKS POST THE INDEX PROCEDURE INTERVENTION WAS COMPLETED. A BALLOON ANGIOPLASTY WITH IMPLANT OF ENDOANCHORS WAS PERFORMED HOWEVER THE ENDOLEAK REMAINED. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO CAUSE AS PER THE PHYSICIAN WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13993712 ↗
• DeathFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HELI-FX ENDOANCHORING SYSTEM WAS USED IN THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED DURING THE PROCEDURE,  FINAL ANGIOGRAM WAS TAKEN IN WHICH THE PHYSICIAN SAID THE IMAGES WERE GREAT. WHILE THE PHYSICIAN  WAS CLOSING THE PATIENTS PERCUTANEOUS  GROIN INCISIONS, THE PATIENT WENT INTO CARDIAC ARREST. THE PATIENT SUBSEQUENTLY EXPIRED.  AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT WAS SAID THE PATIENT WAS TREATED  WITH SUCCESSFUL STENT GRAFT AND HELI-FX PLACEMENT. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Cardiac Arrest

  MAUDE report 13439772 ↗
• MalfunctionFeb 1, 2022Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  AN ENDURANT IIS BIFURCATED STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 60MM ABDOMINAL AORTIC A NEURYSM .  IT WAS REPORTED DURING THE INDEX PROCEDURE THAT THE GRAFT WAS PLACED WITHIN 2MM OF THE LOWEST RENAL ARTERY. WHEN BALLOONING POST STENT GRAFT PLACEMENT WITHIN THE PROXIMAL PORTION OF THE GRAFT, TWO RELIANT BALLOONS RUPTURED UPON INFLATION. A NON-MDT BALLOON WAS THEN USED AND THIS BALLOON ALSO RUPTURED. AN ANGIOGRAPHY SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK WITH INCOMPLETE EXPANSION OF THE GRAFT TO THE WALL ON THE RIGHT LATERAL ASPECT OF THE AORTA. 10 ENDOANCHORS WERE USED TO TREAT THE TYPE IA ENDOLEAK BUT THE ENDOLEAK PERSISTED.  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS DUE TO THE PATIENTS OWN ANATOMY. THE PHYSICIAN QUESTIONED IF THE BALLOON RUPTURING COULD BE ATTRIBUTED TO THE GRAFT NOT EXPANDING TO THE WALL TO SEAL OR WAS THERE POSSIBLY UNSEEN CALCIUM.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13413806 ↗
• MalfunctionJan 17, 2022Fracture; Device Damaged by Another Device; Fracture; Device Damaged by Another Device

  A HELI-FX ENDOANCHOR SYSTEM WAS USED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED DURING THE INDEX PROCEDURE AN ENDOANCHOR BROKE IN HALF AFTER DEPLOYMENT. HALF REMAINED IN THE APPLIER AND THE OTHER HALF REMAINED IN THE AORTA. THE APPLIER WAS REMOVED FROM THE PATIENT. NO CAUSE OF THE EVENT HAS BEEN PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13264683 ↗
• InjuryDec 3, 2021Fracture; Fracture

  A HELI-FX ENDOANCHORING SYSTEM WAS USED DURING AN ENDOVASCULAR PROCEDURE WHERE A ENDURANT STENT GRAFT WAS IMPLANTED. DURING THE INDEX PROCEDURE WHEN THE PHYSICIAN WAS DEPLOYING THE 4TH ENDOANCHOR, STAGE 1 DEPLOYED AS NORMAL AND ENGAGED INTO THE GRAFT. WHEN PERFORMING THE SECOND STAGE DEPLOYMENT OF THE ENDOANCHOR, IT APPEARED THE ENDOANCHOR CAME IN CONTACT WITH A STENT STRUT - THE DEVICE MADE A WINDING NOISE AND THE VERY MOST PROXIMAL CROSS BAR AND FIRST CIRCLE OF THE HELI-FX ENDOANCHOR BROKE OFF AND EMBOLIZED INTO THE MAIN BODY OF THE GRAFT. THE PHYSICIAN USED A NON-MDT DEVICE TO SNARE THE BROKEN SCREW AND REMOVE IT FROM THE PATIENT WITH NO PATIENT ISSUES. 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: Insufficient Information

  MAUDE report 12922668 ↗
• InjuryNov 1, 2021Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  A HELI FX ENDOANCHOR WAS IMPLANTED IN THE PATIENT DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT  DURING THE INDEX PROCEDURE, WHEN THE SURGEON WAS IMPLANTING A HELI-FX ANCHOR, AS THE SCREW WAS BEING INSERTED, THE BACK END OF THE SCREW SNAPPED OFF AND FLOATED UP ABOVE THE GRAFT. THE SURGEON TRIED TO RETRIEVE THE LITTLE PIECE OF ANCHOR SCREW BUT WAS UNABLE TO REMOVE. THE SURGEON OPTED TO LEAVE THE FRAGMENT IN THE PATIENT, AS DID NOT WANT TO RISK DAMAGING THE AORTA RETRIEVING IT. NO FURTHER ACTION WAS DONE. AS PER THE PHYSICIAN, IT IS LIKELY THAT THE SCREW MAY HAVE HIT SOME CALCIFIED PLAQUE. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12727751 ↗
• DeathJul 1, 2021Leak/Splash; Misfire; Leak/Splash; Misfire

  AN ENDURANT STENT GRAFT SYSTEM AND HELI-FX ENDOANCHOR WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 84 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE HELI-FX APPLIER STOPPED WORKING AFTER 7 ENDOANCHORS WERE PLACED. ENDOLEAK TYPE 1A WAS NOTED AS A RESULT OF THIS EVENT. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Respiratory Problem

  MAUDE report 12098716 ↗
• DeathJun 16, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 79 MM ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS HAVING AN URGENT EVAR FOR A SYMPTOMATIC AAA. THE PATIENT HAD A HEAVILY CALCIFIED DISTAL AORTA AND ILIAC AS WELL AS CALCIUM IN A HIGHLY ANGULATED NECK. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AUI AND LIMB WERE DEPLOYED BUT A LARGE TYPE 1A ENDOLEAK WAS NOTED. 15 ENDOANCHORS WERE IMPLANTED, BUT THE ENDOLEAK TYPE 1A PERSISTED. AN AORTIC CUFF WAS THEN PLACED MORE PROXIMALLY AND BALLOONED AGGRESSIVELY WITH A RELIANT BALLOON. NO ENDOLEAK WAS OBSERVED AFTER PLACEMENT OF THE CUFF. IT WAS STATED THAT ONCE THE RELIANT BALLOON WAS DEFLATED, PATIENTS' BLOOD PRESSURE IMMEDIATELY DROPPED. ANGIOGRAM WAS PERFORMED, WHERE NO ENDOLEAK WAS OBSERVED. HOWEVER EXTRAVASATION AROUND THE UPPER PART OF THE STENT GRAFT AND ABOVE THE STENT GRAFT WITH NO FLOW GOING INTO THE ANEURYSM WAS NOTED. THE BALLOON WAS PLACED SUPRA CELIAC WHICH STABILIZED THE PATIENT'S BLOOD PRESSURE. URGENT EXPLANT OF ENDURANT GRAFTS AND OPEN AORTO-BI FEM BYPASS WAS PERFORMED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. IT WAS REPORTED, THE PATIENT HAD MUL

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Rupture

  MAUDE report 12006964 ↗
• MalfunctionJun 8, 2021Difficult to Insert; Difficult to Insert

  A HELI-FX ENDOANCHORING SYSTEM WAS ATTEMPTED TO BE IMPLANTED WITH A NON-MEDTRONIC STENT GRAFT DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE APPLIER COULD NOT ADVANCE OUTSIDE OF GUIDE FOLLOWING DEPLOYMENT OF FIRST TWO ENDO ANCHORS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958124 ↗
• InjuryMay 21, 2021Leak/Splash; Leak/Splash

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

  Patient problems: Insufficient Information

  MAUDE report 11862751 ↗
• InjuryMay 10, 2021Fracture; Fracture

  AN ENDURANT IIS BIFURCATED STENT GRAFT AND HELIFX ENDOANCHORS WERE IMPLANTED IN THE PATIENT, IN AN UNKNOWN ENDOVASCULAR PROCEDURE. DURING THE INDEX PROCEDURE, AFTER THE ENDURANT BIFURCATE DEVICE WAS IMPLANTED; SIGNIFICANT INFOLDING OF THE STENT GRAFT ALONG WITH A TYPE IA ENDOLEAK WAS OBSERVED. A NON-MDT STENT WAS ADDITIONALLY IMPLANTED TO RESOLVE THE EVENT. IT WAS REPORTED THAT WHEN ATTEMPTING TO IMPLANT ENDOANCHORS, THE ENDO-ANCHOR BROKE DURING DEPLOYMENT. IT WAS STATED THAT THE ENDOACHOR TRAPPED BEHIND THE NON-MEDTRONIC DEVICE. 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 11796327 ↗
• MalfunctionMar 25, 2021Fracture; Fracture

  AN HELI-FX WAS ATTEMPTED TO BE USED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE FIRST ENDO-SUTURE WAS LOADED AND DELIVERED SUCCESSFULLY. ON PICKING UP SECOND SUTURE FROM THE HOLDING DEVICE IT FAILED TO LOAD THE ENDO-SUTURE ON MULTIPLE ATTEMPTS. IT WAS STATED THAT THE ENDO-SUTURE WAS ONLY LOADED HALF WAY. MULTIPLE ATTEMPTS TO RESET THE DEVICE WAS ALSO FAILED. A SECOND DEVICE WAS OPENED AND THE PROCEDURE COMPLETED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567596 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171427. One submission often covers many models, so check the product and lot details in each record.

• Z-3227-2017 · Sep 13, 2017 · Terminated
  Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sea