Heli-FX™ EndoAnchor™ System SA-85 (UDI 00763000006617)Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00763000006617), received between Oct 13, 2017 and Aug 26, 2021 — classified as 6 deaths, 37 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (38 reports).

1 other recall cover devices cleared under the same FDA submission (K171427, K182957); 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 70 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2021Leak/Splash; Leak/Splash

  ENDOANCHORS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 71MM ABDOMINAL AORTIC ANEURYSM. AN ENDURANT CUFF AND LEFT RENAL STENT WERE ALSO IMPLANTED DURING THE PROCEDURE. A NON-MDT (GORE EXCLUDER) STENT GRAFT SYSTEM WAS PREVIOUSLY IMPLANTED IN THE PATIENT 2 YEARS PRIOR AND THE ENDOANCHORS WERE IMPLANTED FOR THE TREATMENT OF A TYPE IA ENDOLEAK AND MIGRATION. APPROX.. 3.5 YEARS POST INDEX PROCEDURE, A POSSIBLE TYPE IA ENDOLEAK AT THE PROXIMAL STENT GRAFT WITH LACK OF APPOSITION TO THE POSTERIOR ASPECT WAS REPORTED. IT WAS ADDITIONALLY REPORTED THE PATIENT HAD BEEN CONTINUOUSLY LOSING WEIGHT WITH INTERMITTENT ABDOMINAL PAIN INTERVENTION WAS PERFORMED 2 MONTHS LATER WHERE AN ADDITIONAL 3 ENDOANCHORS WERE PLACED AT THE PROXIMAL EDGE OF THE STENT GRAFT. IT WAS REPORTED THE PROCEDURE WAS SUCCESSFUL THE SITE ASSESSED THE EVENT AS PROBABLY RELATED TO THE IMPLANTED ENDOGRAFT NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 12369814 ↗
• DeathFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 59MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2018. A NON-MDT BALLOON EXPANDABLE STENT WAS ALSO USED DURING THE PROCEDURE. AN ENDURANT CUFF AND 3 ENDOANCHORS WERE ALSO IMPLANTED DURING THIS PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPIRED ON THE (B)(6) 2020 DUE TO AN UNKNOWN REASON. THE PATIENT HAD A ASYMPTOMATIC TYPE II ENDOLEAK DIAGNOSED A YEAR PREVIOUSLY WHICH WAS UNRESOLVED. THE SITE HAS SAID THE CAUSE OF DEATH WAS UNKNOWN AND THE PATIENT DID NOT EXPIRE AT THE HOSPITAL. THE SPONSOR ASSESSED THE DEATH AS NOT RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE STUDY DEVICE (ENDOANCHOR). IT WAS SAID THE SPONSOR ASSESSMENT WAS BELIEVED TO BE CONSERVATIVE ESPECIALLY WHEN THE CAUSE OF DEATH IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 11271340 ↗
• MalfunctionNov 27, 2020Device Difficult to Setup or Prepare; Malposition of Device; Device Difficult to Setup or Prepare; Malposition of Device

  A HELI-FX ENDOANCHORING SYSTEM WAS USED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE THIRD ENDOANCHOR DEPLOYED TANGENTIAL TO THE INTENDED LOCATION . WHEN AN ATTEMPT WAS MADE TO LOAD ANOTHER ENDOANCHOR, IT ONLY LOADED HALFWAY INTO APPLIER. THE USE OF THIS DEVICE WAS THEN ABANDONED. A SECOND APPLIER WAS OPENED AND REMAINING ANCHORS WERE INSERTED WITHOUT INCIDENT. AS 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 10913455 ↗
• MalfunctionSep 17, 2020Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 68MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE FINAL ANGIOGRAM CONFIRMED A TYPE IA ENDOLEAK. INTERVENTION WAS PERFORMED AND 10 ENDOANCHORS WERE IMPLANTED. A FINAL ANGIOGRAM SHOWED THE IA ENDOLEAK REMAINED AND A TYPE II ENDOLEAK ALSO PRESENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY AND NOTED A CONICAL INFRARENAL AORTIC NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10545831 ↗
• MalfunctionMar 23, 2020Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE AND AN ENDURANT LIMB WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 80MM ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW-UP, A CT PERFORMED SEVEN YEARS AND SEVEN MONTHS LATER, IT SHOWED A TYPE IA ENDOLEAK WAS PRESENT IN THE BIFURCATE. A ENDOLEAK TYPE IB WAS PRESENT IN THE RIGHT COMMON ILIAC ARTERY IN THE ENDURANT LIMB ALSO. SIXTEEN DAYS POST THE CT, THIS PATIENT WAS BROUGHT TO OR. A 25X25X49 ENDURANT CUFF WAS DEPLOYED TO THE LEVEL OF THE LOWEST (RIGHT) RENAL ARTERY AND SUBSEQUENTLY 6 ENDOANCHORS WERE DEPLOYED IN THE LATERAL AND POSTERIOR RIGHT AND LEFT OBLIQUE REGIONS OF THE PROXIMAL CUFF IN AN UNSUCCESSFUL ATTEMPT TO SEAL THE TYPE 1A ENDOLEAK. AS PER THE PHYSICIAN IT WAS DETERMINED THAT A POSTERIOR CHUNK OF CALCIUM AT THE LEVEL OF THE PROXIMAL SEAL ZONE IN THE AORTA WAS CREATING A GUTTER THAT PREVENTED THE CUFF FROM ACHIEVING A COMPLETE PROXIMAL SEAL. TO ADDRESS THE TYPE IB ENDOLEAK A 16X13X156 TAPERED ENDURANT LIMB WAS USED TO EXTEND SEAL INTO THE RIGHT EXTERNAL ILIAC ARTERY. AFTER THIS WAS IMPLANTED, THE PHYSICIAN IMPLANTED AN ADDITIONAL 16X13X124 LIMB TO EXTEND THE DISTAL SEAL AN ADDITIONAL 1.5-2CM. THE COMPLETION ANGIO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9864497 ↗
• InjuryMar 5, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 59MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE 10 ENDOANCHORS WERE IMPLANTED FOR A 4-10MM PROXIMAL NECK. AN ENDURANT AORTIC CUFF WAS ALSO IMPLANTED TO ADDRESS INADEQUATE PROXIMAL SEAL OF THE STENT GRAFT. AT THE END OF THIS PROCEDURE A TYPE IA ENDOLEAK WAS PRESENT. THIS IA ENDOLEAK WAS EVALUATED AGAIN SIX WEEKS LATER WITH A CT AND ULTRASOUND. THIS IA ENDOLEAK WAS ASSESSED BY THE SITE AS PROBABLY RELATED TO THE INDEX PROCEDURE AND PROBABLY RELATED TO THE STENT GRAFT DEVICE AND RELATED TO THE ANEURYSM THAT WAS TREATED WITH THE ENDOANCHORS. A SECONDARY PROCEDURE WAS CARRIED OUT WHERE THE AAA SAC WAS SUCCESSFULLY COIL EMBOLIZED AND AN ADDITIONAL 10 ENDOANCHORS WERE IMPLANTED ALONG WITH BALLOONING 5 MONTHS AND 2 WEEKS POST INDEX PROCEDURE. THE FOLLOWING DAY AFTER THE SECONDARY PROCEDURE THE PATIENT SUFFERED AN ANEURYSM RUPTURE AND THE PERSISTENT ENDOLEAK WAS NOTED. THIS EVENT WAS ASSESSED BY THE SITE AS POSSIBLY RELATED TO THE INDEX/REINTERVENTION PROCEDURE, PROBABLY RELATED TO THE STENT GRAFT AND HELI-FX DEVICES. AS A RESULT OF THIS THE PATIENT SUFFERED FROM ACUT

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Renal Failure

  MAUDE report 9792874 ↗
• InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HELI-FX APPLIER WAS USED AS AN ACCESSORY DEVICE FOR THE ENDOVASCULAR TREATMENT.   IT WAS REPORTED THAT IMMEDIATELY AFTER WAKING FROM THE PROCEDURE, THE PATIENT HAD PERSISTENT BACK PAIN. THE PATIENT WAS TREATED WITH PAIN MANAGEMENT. PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 9731510 ↗
• MalfunctionJan 2, 2020Component Missing; Device Dislodged or Dislocated; Component Missing; Device Dislodged or Dislocated

  A HELI-FX ENDOANCHOR SYSTEM WAS USED FOR THE ENDOVASCULAR TREATMENT OF A PATIENT. IT WAS REPORTED DURING THE INDEX PROCEDURE THAT THE CASSETTE WAS MISSING THREE ENDOANCHORS. IT WAS ALSO REPORTED THAT ONE ENDOANCHOR DISLODGED DURING THE PROCEDURE AND TRACKED INTO THE PATIENT'S LEFT RENAL ARTERY. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS RELATED TO PATIENT ANATOMY. THE PHYSICIAN REPORTED THAT THE PATIENT HAD A VERY SHORT AORTIC NECK WITH A LARGE ANGLE. NO ADDITIONAL CLINICAL SEQUALAE WAS REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9537587 ↗
• MalfunctionDec 13, 2019Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD A SHORT INFRARENAL NECK OF 6MM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PATIENT HAD A TYPE IA ENDOLEAK. 9 ENDOANCHORS WERE USED TO TREAT THE ENDOLEAK BUT THE ENDOLEAK PERSISTED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS ANATOMY RELATED DUE TO THE PATIENT NECK ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9466177 ↗
• MalfunctionDec 3, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 54 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK LENGTH WAS 10 MM, AND THE NECK DIAMETER RANGED FROM 23-25 MM. MILD PROXIMAL NECK CALCIFICATION AND THROMBUS WAS PRESENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS OBSERVED ON THE COMPLETION ANGIOGRAM. THE PHYSICIAN CARRIED OUT ANOTHER PROXIMAL BALLOON INFLATION, HOWEVER THE TYPE IA ENDOLEAK PERSISTED. THE PHYSICIAN WAS SATISFIED WITH THE PROXIMAL POSITION OF THE STENT GRAFT, AND SO THEY ELECTED TO IMPLANT HELI-FX ENDOANCHORS IN THE PROXIMAL NECK TO TREAT THE ENDOLEAK. 6 ENDOANCHORS WERE IMPLANTED, HOWEVER THE TYPE IA ENDOLEAK WAS OBSERVED AGAIN ON ANOTHER ANGIOGRAM. THE PHYSICIAN THEN ELECTED TO COMPLETE THE PROCEDURE AND FOLLOW UP ON A LATER DATE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9402834 ↗
• InjuryDec 3, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 10 ENDOANCHORS WERE IMPLANTED FOR THE TREATMENT OF A TYPE 1A ENDOLEAK WHICH OCCURRED APPROXIMATELY ONE MONTH EARLIER. HOWEVER, THE ENDOLEAK DID NOT RESOLVE. A CHEVAR PROCEDURE WAS THEN CARRIED OUT ON BOTH RENAL ARTERIES AND AN ENDURANT AORTIC CUFF WAS USED TO EXTEND PROXIMALLY TO THE SMA TO TREAT THE ENDOLEAK. IT WAS REPORTED THAT THE ENDOLEAK WAS MUCH IMPROVED BUT NOT COMPLETELY RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS ANATOMY RELATED DUE TO AN ANGULATED INFRARENAL NECK. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Injury

  MAUDE report 9400778 ↗
• MalfunctionNov 13, 2019Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE ACCESS VESSELS WERE TIGHT AND CALCIFIED. THE PHYSICIAN ATTEMPTED TO IMPLANT A ESBF3214C103E BIFURCATE INITIALLY, HOWEVER IT COULD NOT BE TRACKED TO THE TARGET LANDING ZONE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A SECOND BIFURCATE (ESBF2814C103E), WHICH WAS ABLE TO REACH THE INTENDED LANDING ZONE AND WAS SUCCESSFULLY DEPLOYED. HOWEVER, AFTER DEPLOYMENT THE FINAL ANGIOGRAM SHOWED A TYPE IA ENDOLEAK. THE PHYSICIAN IMPLANTED 9 ENDOANCHORS IN THE PROXIMAL NECK AS TREATMENT. AS PER THE PHYSICIAN, THE ENDOLEAK THEN HAD IMPROVED GREATLY. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED, DUE TO THE SMALL CALCIFIED VESSELS AND CALCIFIED REVERSE FUNNEL NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9314446 ↗
• MalfunctionOct 14, 2019Fracture; Premature Activation; Fracture; Premature Activation

  A HELI-FX ENDOANCHORING SYSTEM WAS IMPLANTED PROPHYLACTICALLY IN AN ENDURANT IIS STENT GRAFT SYSTEM IN DURING THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS NOTED AS WIDE WITH A DIAMETER OF 32 MM. IT WAS REPORTED DURING THE INDEX PROCEDURE, AFTER THE ENDURANT IIS AND LIMBS WERE IMPLANTED AND BALLOONED, FOUR ENDOANCHORS WERE IMPLANTED AT THE PROXIMAL NECK. WHILE IMPLANTING THE FIFTH ENDOANCHOR THE ENDOANHCOR WAS ADVANCED DURING THE FIRST STAGE DEPLOYMENT. DURING THE SECOND STAGE OF DEPLOYMENT THE APPLIER RELEASED WITHOUT WARNING. THE APPLIER WAS REMOVED AND A PORTION OF THE ENDOANCHOR VISIBLY REMAINED IN THE APPLIER TIP. THE REMAINING PORTION OF THE ENDOANCHOR WOULD NOT ADVANCE OUT OF APPLIER. THE PHYSICIAN CHOSE NOT TO IMPLANT A SIXTH ENDOANCHOR WITH A DIFFERENT APPLIER. THE TIP OF THE BROKEN ENDOANCHOR HAD IMPLANTED AND REMAINED IN PLACE. FINAL ANGIOGRAM SHOWED NO ISSUES. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9186070 ↗
• MalfunctionSep 11, 2019Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK LENGTH WAS 15 MM AND THE DIAMETER RANGED FROM 26-30 MM. MILD PROXIMAL NECK CALCIFICATION WAS PRESENT. THERE WAS A HIGHLY ANGULATED AORTIC NECK. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS NOTED ON THE COMPLETION ANGIOGRAM. IT WAS REPORTED THAT THE STENT GRAFT WAS IN A GOOD PROXIMAL POSITION, SO THE PHYSICIAN DECIDED TO IMPLANT ENDOANCHORS. DURING THE FIRST ATTEMPT TO DEFLECT AND ORIENT THE HELI-FX GUIDE, THE DEVICE LOST ITS ABILITY TO DEFLECT. THE PHYSICIAN THEN REMOVED THE GUIDE AND REPLACED IT WITH ANOTHER HELI-FX DEVICE OF SAME SIZE. THE PHYSICIAN WAS THEN ABLE TO PLACE 6 ENDOANCHORS. ANOTHER ANGIOGRAM DEMONSTRATED A REDUCED TYPE IA ENDOLEAK. THE PHYSICIAN THEN DECIDED TO END THE PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE TYPE IA ENDOLEAK COULD NOT BE DETERMINED. THE CAUSE OF THE HELI-FX GUIDE ISSUE WAS STATED TO BE RELATED TO THE PATIENT'S ANATOMY. IT WAS NOTED THAT THERE WAS A HIGHLY ANGULATED AORTIC NECK CREATED SIGNIFICANT TORQUE, CAUSING THE FAILURE OF THE HELI-FX GUIDE. NO ADDITIONAL C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8991572 ↗
• MalfunctionSep 11, 2019Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 70 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE BIFURCATE WAS IMPLANTED AND BALLOONING COMPLETED A TYPE IA ENDOLEAK WAS OBSERVED. THE PHYSICIAN REPEATED BALLOONING OF THE PROXIMAL NECK AND RAN A REPEAT ANGIOGRAM WHICH SHOWED THE AAA SAC WAS CONTINUING TO FILL WITH CONTRAST. THE PHYSICIAN THEN ELECTED TO IMPLANT 10 HELI-FX ENDOANCHORS CIRCUMFERENTIALLY HOWEVER WHILE THE ENDOLEAK DECREASED IT STILL PERSISTED. THE PHYSICIAN OPTED TO END THE PROCEDURE AT THIS TIME. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDERMINED BUT IT WAS NOTED THAT THE ENDOANCHORS WERE INTENDED TO BE USED PROPHYLACTICALLY HOWEVER DUE TO THE ENDOLEAK THEY WERE SUBSEQUENTLY USED AS INTERVENTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8988056 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HELI-FX ENDOANCHORS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. A NON-MEDTRONIC (ZENITH) STENT GRAFT SYSTEM WAS IMPLANTED DON THE SAME DAY.   IT WAS REPORTED THAT 5 DAYS LATER, DURING THE HOSPITALIZATION OF THE PATIENT FOR THE INDEX PROCEDURE AND REINTERVENTION OF THE ANEURYSM, THE PATIENT HAD ACUTE BLOOD LOSS WITH ANEMIA AND DYSPNEA. THE PATIENT WAS TREATED WITH BLOOD TRANSFUSIONS AND RECOVERED WITH TREATMENT. THE INVESTIGATOR ASSESSED THE EVENT AS RELATED TO THE INDEX PROCEDURE, NOT RELATED TO THE ENDOANCHORS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Anemia; Dyspnea; Respiratory Failure

  MAUDE report 8874115 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HELI-FX ENDOANCHORS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. A NON-MEDTRONIC (ZENITH) STENT GRAFT SYSTEM WAS IMPLANTED ON THE SAME DAY. IT WAS REPORTED THAT 5 DAYS LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ACUTE EXACERBATION OF COPD WITH RESPIRATORY FAILURE. FOLLOWING A SUBSEQUENT REINTERVENTION PROCEDURE ON (B)(6) 2019, THE PATIENT HAD ACUTE RESPIRATORY FAILURE WITH HYPERCAPNIA. THE PATIENT WAS TREATED WITH MEDICATION AND RECOVERED WITH TREATMENT. THE INVESTIGATOR ASSESSED THE EVENT AS RELATED TO THE INDEX / REINTERVENTION PROCEDURE, NOT RELATED TO THE DEVICE. IT WAS NOTED THAT THE ACUTE RESPIRATORY FAILURE EVENT WAS LIKELY LINKED TO SEDATION FOR THE REINTERVENTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Dyspnea; Respiratory Failure

  MAUDE report 8873877 ↗
• InjuryJul 30, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THERE WAS NO SIGNIFICANT CALCIFICATION OR TORTUOSITY PRESENT IN THE PATIENT¿S ANATOMY. THE ENDOANCHORS WERE IM PLANTED IN A VALIANT NAVION STENT GRAFT (B)(4). TWO ENDOANCHORS WERE SUCCESSFULLY IMPLANTED BEFORE THE REPORTED EVENT OCCURRED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8840454 ↗
• InjuryJun 28, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATED STENT GRAFT AND ENDOANCHORS WERE IMPLANTED IN PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55 MM ABDOMINAL AORTIC ANEURYSM. THE ENDOANCHORS WERE IMPLANTED FOR THE PREVENTION OF NECK DILATION. NO TYPE IA ENDOLEAK WAS NOTED AFTER IMPLANTATION OF THE LAST ENDOANCHOR. APPROXIMATELY THREE WEEKS LATER THE ENDOLEAK WAS CONFIRMED AS A TYPE IA ENDOLEAK ON CT AFTER THE PATIENT PRESENTED EMERGENTLY WITH INCREASING BACK AND CHEST PAIN. THE ANEURYSM WAS SHOWN TO BE 60 MM AND THE PATIENT UNDERWENT AN INTERVENTION PROCEDURE USING COILS AND ONXY TO RESOLVE THE ENDOLEAK. THE EVENT WAS ASSESSED BY THE INVESTIGATOR TO BE RELATED TO THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 8743594 ↗
• InjuryJun 25, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II AORTIC CUFF AND 4 ENDURANT LIMBS WERE IMPLANTED IN AN UNKNOWN STENT GRAFT SYSTEM FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED 100MM ABDOMINAL AORTIC ANEURYSM WITH A TYPE IA ENDOLEAK. IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL EMERGENTLY. A PREVIOUS UNKNOWN STENT GRAFT WAS IMPLANTED IN THE PATIENT. CT REVEALED A RUPTURED AAA AND TYPE IA ENDOLEAK WITH EXTRAVASATION. THE PHYSICIAN REALIGNED THE UNKNOWN STENT GRAFT WITH THE ENDURANT II AORTIC CUFF AND 4 ENDURANT LIMBS HOWEVER THE TYPE IA ENDOLEAK REMAINED. ENDOANCHORS WERE THEN IMPLANTED TO GAIN SEAL HOWEVER THE TYPE IA ENDOLEAK PERSISTED. A REPEAT CT SHOWED EXTRAVASATION WITHIN THE AAA SAC, SO THE PHYSICIAN ELECTED TO CONVERT TO OPEN REPAIR AND SUTURED THE PROXIMAL PORTION OF GRAFT WITH SUCCESS. THE ENDOLEAK WAS CONFIRMED AS RESOLVED. THE PATIENT WAS REPORTED AS DOING WELL ONE DAY POST PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE RUPTURE AND TYPE IA ENDOLEAK WAS ANATOMY RELATED DUE TO INFRARENAL NECK DILATION. IT WAS REPORTED THAT THE EXTRAVASATION NOTED ON REPEAT CT WAS RELATED TO THE PRE-OP RUPTURE AND NOT RELATED TO THE MEDTRONIC DEVICES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS F

  Patient problems: Injury

  MAUDE report 8730071 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATED STENT GRAFT SYSTEM WAS IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 72MM ABDOMINAL AORTIC ANEURYSM. SEVEN HELI-FX ENDOANCHORS WERE ALSO DEPLOYED DURING THE PROCEDURE. IT WAS REPORTED THAT TWO DAYS LATER THE PATIENT HAD URINARY RETENTION WITH SYMPTOMS OF SUPRAPUBIC PRESSURE AND BILATERAL INGUINAL PAIN. A FOLEY CATHETER WAS PLACED TO TREAT THE PATIENT AND THE EVENT IS RESOLVED. THE INVESTIGATOR ASSESSED THE EVENT AS PROBABLY RELATED TO THE INDEX PROCEDURE AND UNLIKELY RELATED TO A DEVICE. THE SPONSOR ASSESSED THE EVENT TO HAVE A CASUAL RELATIONSHIP TO THE PROCEDURE AND WAS NOT RELATED TO THE ENDOANCHORS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Pain; Urinary Retention

  MAUDE report 8721465 ↗
• MalfunctionJun 17, 2019Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 46 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD A CONICAL NECK OF LENGTH 40 MM AND DIAMETER 20-23 MM. MILD CALCIFICATION AND THROMBUS WAS PRESENT IN THE NECK. THE DIAMETERS OF THE LEFT AND RIGHT ILIAC ARTERIES WERE 11-16 MM AND 11-12 MM, RESPECTIVELY. MILD CALCIFICATION WAS PRESENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE EVAR WAS PERFORMED IN TYPICAL FASHION. UPON THE COMPLETION ANGIOGRAM, AN ENDOLEAK WAS OBSERVED. AFTER PERFORMING ADDITIONAL ANGIOGRAPHY, THE PHYSICIAN FELT THAT THE LEAK WAS A TYPE III. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED AN ADDITIONAL LIMB ((B)(4)) INTO THE EXISTING LEFT LIMB ((B)(4)), HOWEVER THE ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN THEN IMPLANTED AN ADDITIONAL LIMB ((B)(4)) WITHIN THE EXISTING RIGHT LIMB ((B)(4)), HOWEVER THE ANGIOGRAPHY SHOWED THAT THE ENDOLEAK PERSISTED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED 6 HELI-FX ENDOANCHORS. ANGIOGRAPHY THEN SHOWED A REDUCED ENDOLEAK COMPARED TO THE PREVIOUS ANGIOGRAMS. THE PHYSICIAN THEN DECIDED TO END THE PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703044 ↗
• DeathJun 11, 2019Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. THE PATIENT HAD A 75 DEGREE ANGLED AORTIC NECK. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE FINAL ANGIOGRAM SHOWED A TYPE IA ENDOLEAK WHERE THE STENT GRAFT DID NOT OPPOSE THE ANGLED PORTION OF THE NECK. IT WAS NOTED THAT BELOW THE ANGULATION THERE WAS NECK AND THE ANEURYSM SAC DID NOT SHOW ANY CONTRAST. THE PHYSICIAN PLACED 6 ENDOANCHORS AND AS THE ENDOLEAK WAS NOW MINIMAL THE PROCEDURE WAS COMPLETED. THE PHYSICIAN NOTED THAT THE ENDOLEAK WAS POTENTIALLY A TYPE II ENDOLEAK AT THIS POINT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT ANATOMY RELATED DUE TO THE ANGULATED NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aspiration/Inhalation; Death; No Consequences Or Impact To Patient

  MAUDE report 8686225 ↗
• DeathJun 6, 2019Leak/Splash; Leak/Splash

  A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 11 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH A RUPTURED ABDOMINAL ANEURYSM. CT REVEALED THE TALENT GRAFT HAD MIGRATED DOWN FROM THE RENALS WITH THE RUPTURE NOTED AT THE PROXIMAL END OF THE GRAFT. INTERVENTION WAS COMPLETED WHERE THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT AUI GRAFT. THE PROCEDURE WAS PERFORMED UNDER SHORT NECK INDICATION. A TYPE IA ENDOLEAK WAS THEN OBSERVED. HELI-FX ENDOANCHORS WERE IMPLANTED HOWEVER THE ENDOLEAK REMAINED. A OCCLUDER WAS IMPLANTED ON THE LEFT AND AN ENDURANT LIMB (ETLW1624C124E) ON THE RIGHT. IT WAS REPORTED THE PHYSICIAN COULD NOT ACHIEVE A SEAL PROXIMALLY AND DECIDED TO IMPLANT A NON MDT NON AORTIC CUFF PROXIMALLY TO THE ENDURANT AUI. THE CUFF DID NOT LAND WHERE EXPECTED. THE PHYSICIAN SUSPECTED A JUNCTIONAL LEAK AND IMPLANTED AN ADDITIONAL CUFF COVERING THE LEFT RENAL. ON THE FINAL RUN, THE TYPE IA ENDOLEAK WAS STILL OBSERVED. A FEM-FEM WAS THEN PERFORMED. IT WAS THEN REPORTED THE PATIENT EXPIRED. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK AND MIGRATION ARE UNDETE

  Patient problems: Death; Rupture

  MAUDE report 8673834 ↗
• MalfunctionMay 28, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 59 MM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK DIAMETER MEASURES 26-32 MM AND 10 MM IN LENGTH. THE PROXIMAL NECK WAS NOTED AS SHORT WIDE AND CONICAL WITH MODERATE CALCIFICATION AND THROMBUS PRESENT. IT WAS REPORTED DURING THE INDEX PROCEDURE, AFTER THE AUI STENT WAS IMPLANTED A COMPLETION ANGIOGRAM IDENTIFIED A TYPE IA ENDOLEAK. THERE APPEARED TO BE APPROXIMATELY 5-8 MM OF PROXIMAL NECK THAT COULD BE GAINED WITH A PROXIMAL EXTENSION SO THE PHYSICIAN ELECTED TO DEPLOY A PROXIMAL AORTIC EXTENSION JUST BELOW RENAL ARTERIES. A SECOND ANGIOGRAM DEMONSTRATED THE TYPE IA ENDOLEAK REMAINED. 4 HELIX-FX ENDOANCHORS WERE THEN PLACED IN THE PROXIMAL SEAL ZONE. A FINAL COMPLETION ANGIOGRAM WAS PERFORMED DEMONSTRATING A REDUCED AND DELAYED TYPE IA ENDOLEAK. THE PHYSICIAN DECIDED TO END THE PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8646027 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171427, K182957. 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