APTUS Heli-FX® SA-85Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00643169647695), received between Mar 17, 2017 and Mar 15, 2022 — classified as 8 deaths, 28 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (19 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HELI-FX ENDOANCHORS WERE IMPLANTED FOR THE TREATMENT OF A TYPE IB ENDOLEAK IN A NON MDT STENT GRAFT (HEMASHIELD GRAFT). THE NON MDT GRAFT WAS ORIGINALLY IMPLANTED 21 YEARS PRIOR TO THE HELI-FX PROCEDURE. THE MAX TAA DIAMETER DURING THE HELI-FX PROCEDURE WAS NOTED AS 47MM. A VALIANT STENT GRAFT WAS ALSO IMPLANTED DURING THE INTERVENTION. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE HELI-FX PROCEDURE, FOLLOW UP IMAGING DEMONSTRATED 1 ENDOANCHOR DID NOT MAINTAIN ADEQUATE PENETRATION INTO THE AORTIC WALL AND IT WAS NOTED ''THE 6 O'CLOCK POSITION ENDOANCHOR IS NO LONGER IN THE AORTIC WALL; REMAINS WITHIN THE STENT MATERIAL''. THE CAUSE OF THE DISLODGEMENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770247 ↗
• InjuryMay 11, 2020Adverse 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 82MM MAXIMUM DIAMETER ABDOMINAL AORTIC ANEURYSM. DURING THE INDEX PROCEDURE 5 ENDOANCHORS WERE ALSO IMPLANTED TO THE PROXIMAL NECK DURING THIS PROCEDURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PATIENT HAD AN HYPOTENSIVE EVENT. THIS RESOLVED WITH MEDICATION GIVEN TO THE PATIENT. THIS EVENT WAS ASSESSED BY THE SITE AS POSSIBLY RELATED TO THE INDEX PROCEDURE. THE SPONSOR ASSESSED THIS EVENT AS HAVING A CAUSAL RELATIONSHIP TO THE INDEX PROCEDURE AND NOT RELATED TO THE STUDY DEVICE. NO CAUSE OF THE EVENT WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 10042409 ↗
• DeathMay 6, 2020Leak/Splash; Leak/Splash

  A HELI-FX ENDOANCHORING SYSTEM WAS USED ALONG WITH THE IMPLANTATION OF A NON-MDT STENT GRAFT IN THE ENDOVASCULAR TREATMENT OF A MAXIMUM DIAMETER 62MM ABDOMINAL AORTIC ANEURYSM. SIX ENDOANCHORS WERE IMPLANTED TO THE MAIN BODY OF STENT GRAFT TO PROXIMAL NECK PRIMARILY IN THE PREVENTION OF NECK DILATION. THE PATIENT WAS DISCHARGED THE NEXT DAY. TWO YEARS LATER, A TYPE IA ENDOLEAK WITH ENLARGING AAA SAC AND PENETRATING ULCER IN DESCENDING THORACIC AORTA WAS OBSERVED. THE PATIENT WAS GIVEN MEDICATION. THE PATIENT HAD ABDOMINAL PAIN IN ASSOCIATION WITH THIS. THIS EVENT WAS ASSESSED BY THE SITE AS UNLIKELY RELATED TO THE INDEX PROCEDURE, POSSIBLY RELATED TO DEVICE (UNCERTAIN WHICH DEVICE) AND RELATED TO THE ANEURYSM TREATED BY THE ENDOANCHORS. THERE WAS A PLAN WAS TO INTERVENE WITH ENDOANCHORS HOWEVER THE PATIENT HAS MULTIPLE CO MORBIDITIES OF CHF AND CKD IV, MAKING SURGICAL INTERVENTION HIGH RISK. A FEW DAYS LATER, THE TYPE IA ENDOLEAK WAS INCREASING AND WAS DEEMED BY THE SITE AS RELATED TO THE ANEURYSM TREATED BY THE ENDOANCHORS. TWO YEARS AND EIGHT MONTHS LATER POST THE INDEX PROCEDURE, THE PATIENT EXPIRED UNDER HOSPICE CARE. THE DEATH WAS DEEMED RELATED TO THE EVENT. NO ADDITIONAL CLI

  Patient problems: Death

  MAUDE report 10028971 ↗
• InjuryOct 3, 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 54 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. HELI-FX ENDOANCHORS WERE IMPLANTED ON THE SAME DAY, DUE TO CONCERN FOR LATE FAILURE. IT WAS REPORTED THAT ON THE DAY AFTER THE INDEX PROCEDURE, THE PATIENT HAD FEBRILITY, WITH A FEVER OF GREATER THAN 101 DEGREES FAHRENHEIT. THE PATIENT WAS TREATED WITH MEDICATION AND RECOVERED WITH TREATMENT. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICES OR THE INDEX PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS PROCEDURE RELATED, NOT RELATED TO THE ENDOANCHORS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Fever

  MAUDE report 9150903 ↗
• InjuryAug 9, 2019Leak/Splash; Leak/Splash

  A HELI-FX ENDOANCHORING SYSTEM WAS IMPLANTED FOR THE TREATMENT OF NECK DILATION IN AN ENDURANT STENT GRAFT SYSTEM IN A 79.2 ABDOMINAL AORTIC ANEURYSM. AN ENDURANT II LIMB EXTENSION WAS ALSO IMPLANTED DURING THE PROCEDURE. THE ENDURANT STENT GRAFT SYSTEM WAS ORIGINALLY IMPLANTED 5 YEARS EARLIER. THE PROXIMAL AORTIC NECK MEASURED 27.8MM TO 33.9MM. THE NECK LENGTH WAS NOTED AS 7.5MM. IT WAS REPORTED THAT 2.5 YEARS POST ENDOANCHOR IMPLANTATION A GUTTER ENDOLEAK FROM THE LEFT RENAL ARTERY STENT WAS OBSERVED. INTERVENTION WITH BALLOON ANGIOPLASTY OF PROXIMAL ENDOGRAFT SEAL ZONE AND KISSING BALLOON ANGIOPLASTY OF THE LEFT RENAL ARTERY STENT WAS COMPLETED WITH THE EVENT CONFIRMED AS RESOLVED. PER THE INVESTIGATOR THE CAUSE OF THE GUTTER ENDOLEAK WAS POSSIBLY RELATED TO A PREVIOUS INTERVENTION/INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8877659 ↗
• InjuryAug 8, 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 56 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. 6 HELI-FX ENDOANCHORS WERE ALSO IMPLANTED PROPHYLACTICALLY FOR PREVENTION OF NECK DILATION. IT WAS REPORTED THAT OCCLUSION OF THE LEFT STENT GRAFT LIMB WAS NOTED ON APPROXIMATELY 10 WEEKS POST IMPLANT, WITH SYMPTOMS OF BILATERAL LEG CLAUDICATION. THE PATIENT WAS HOSPITALIZED AND A LEFT TO RIGHT FEM-FEM BYPASS WAS CARRIED OUT, WHICH RESOLVED THE EVENT. THE INVESTIGATOR ASSESSED THE EVENT AS RELATED TO THE INDEX PROCEDURE, NOT RELATED TO THE DEVICES. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE STUDY PROCEDURE OR THE ENDOANCHORS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Claudication; Occlusion

  MAUDE report 8874545 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HELI-FX ENDOANCHORS AND AN ENDURANT AORTIC CUFF WERE IMPLANTED FOR THE TREATMENT OF MIGRATION AND A TYPE IA ENDOLEAK IN A TALENT STENT GRAFT SYSTEM. THE TALENT STENT GRAFT WAS ORIGINALLY IMPLANTED APPROXIMATELY 13 YEARS PREVIOUSLY. THE CURRENT AAA DIAMETER MEASURED 42.8MM. THE DIAMETER AT THE PROXIMAL AORTIC NECK MEASURED 33.5MM-33.3MM WITH A 30 DEGREE ANGULATION. MODERATE THROMBUS AND LOCALISED CALCIFICATION WERE OBSERVED AT THE SEAL ZONE. IT WAS REPORTED DURING THE INDEX PROCEDURE UNINTENTIONAL PARTIAL COVERAGE OF THE RIGHT RENAL ARTERY OCCURRED. A NON MDT RENAL STENT WAS IMPLANTED AND THE EVENT RESOLVED. IT WAS FURTHER REPORTED APPROXIMATELY 2 WEEKS POST THE INDEX PROCEDURE, RIGHT RENAL ARTERY STENT THROMBOSIS OCCURRED WITH A DECREASE IN RENAL FUNCTION. A CT CONFIRMED LOWER POLE ISCHEMIA/INFARCT OF THE RIGHT KIDNEY. THE EVENT IS CURRENTLY UNRESOLVED WITH PERMANENT ADVERSE SEQUELAE. PER THE INVESTIGATOR THE CAUSE OF THE RIGHT RENAL STENT THROMBOSIS WAS RELATED TO THE INDEX PROCEDURE. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Ischemia; Occlusion; Renal Failure; Thrombus

  MAUDE report 8314154 ↗
• DeathOct 9, 2018Adverse 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 THE PATIENT. A NON-MDT STENT GRAFT SYSTEM WAS PREVIOUSLY IMPLANTED IN THE PATIENT APPROXIMATELY THREE YEARS EARLIER AND THE ENDOANCHORS WERE IMPLANTED TO TREAT A TYPE IA ENDOLEAK. A NON-MDT CUFF WAS ALSO IMPLANTED ALONG WITH THE ENDOANCHORS. IT WAS REPORTED THAT THE PATIENT EXPIRED APPROXIMATELY ONE YEAR AND EIGHT MONTHS AFTER IMPLANTATION OF THE ENDOANCHORS. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death

  MAUDE report 7947456 ↗
• DeathOct 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HELI-FX APPLIER AND ENDOANCHORS WERE USED IN CONJUNCTION WITH AN ENDURANT STENT GRAFT SYSTEM IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 76MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT LESS THAN TWO YEARS LATER THE PATIENT EXPIRED OF A CAUSE UNKNOWN AT A REHAB FACILITY. IT IS UNKNOWN IF A MDT DEVICE OR PROCEDURE IS RELATED TO THE PATIENT'S DEATH. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED.

  Patient problems: Death

  MAUDE report 7921632 ↗
• MalfunctionJul 25, 2018Leak/Splash

  A HELI-FX ENDO ANCHORING SYSTEM WAS USED AS AN ACCESSORY DEVICE FOR THE ENDOVASCULAR TREATMENT OF A TYPE IA ENDOLEAK IN A PREVIOUSLY IMPLANTED ENDOLOGIX STENT GRAFT SYSTEM (IMPLANTED 6 YEARS PREVIOUSLY). AAA DIAMETER MEASURED 60MM WITH A PROXIMAL NECK ANGULATION OF 20 DEGREES. 50% THROMBUS AT SEAL ZONE AND 10% CALCIUM AT SEAL ZONE. DURING THE PROCEDURE, IT WAS REPORTED THAT 8 ENDOANCHORS WERE IMPLANTED ALONG WITH A NON-MDT EXCLUDER ILIAC BRANCH EXCLUDER INTERNAL ILIAC DEVICES. AT THE END OF THE PROCEDURE IT WAS REPORTED THAT THERE WAS A PERSISTENT TYPE IA ENDOLEAK PRESENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7717627 ↗
• MalfunctionJul 20, 2018Patient-Device Incompatibility; Device Dislodged or Dislocated

  A HELI-FX ENDOANCHORING SYSTEM WAS USED AS AN ACCESSORY DEVICE IN CONJUNCTION WITH NON MDT EXTENSION LIMBS FOR THE ENDOVASCULAR TREATMENT OF A TYPE IA ENDOLEAK IN A PREVIOUSLY IMPLANTED NON-MDT STENT GRAFT. IT WAS NOTED THAT THERE WAS LOCALIZED THROMBUS AT THE SEAL ZONE WITH 50% CIRCUMFERENCE (MAX THICKNESS 17MM) AND LOCALIZED CALCIUM OF 10% (MAX THICKNESS OF 1MM). EIGHT ENDOANCHORS IN TOTAL WERE IMPLANTED; HOWEVER, THE TYPE IA ENDOLEAK WAS STILL PRESENT AT THE END OF THE PROCEDURE. IT WAS REPORTED THAT, APPROXIMATELY 2 MONTHS POST PROCEDURE, DURING A FOLLOW UP CT, TWO ENDOANCHORS WERE OBSERVED TO HAVE DISLODGED FROM THE ENDOGRAFT AND WERE NOT ADEQUATELY PENETRATING THE AORTIC WALL. THIS WAS OBSERVED AGAIN DURING A FOLLOW UP CT APPROXIMATELY 8 MONTHS POST PROCEDURE ALONG WITH A TYPE II ENDOLEAK. NO ACTION WAS TAKEN AS A RESULT OF THESE EVENTS. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Aneurysm; No Consequences Or Impact To Patient

  MAUDE report 7706053 ↗
• MalfunctionJul 10, 2018Leak/Splash; Migration or Expulsion of Device; Device Dislodged or Dislocated

  A HELI-FX ENDOANCHORING SYSTEM WAS USED AS AN ACCESSORY DEVICE WITH A NON-MDT CUFF FOR THE ENDOVASCULAR TREATMENT OF A TYPE IA ENDOLEAK OF A NON-MDT STENT GRAFT ON. IT WAS REPORTED THAT FOUR ENDOANCHORS WERE SUCCESSFULLY IMPLANTED FROM THE AORTIC CUFF TO THE AORTIC NECK. ANEURYSM MAX DIAMETER WAS 66MM AND NECK LENGTH WAS 12MM WITH A PROXIMAL NECK ANGULATION OF 42 DEGREES. IT WAS REPORTED APPROXIMATELY 1 MONTH POST INDEX PROCEDURE, A FOLLOW UP CT SCAN SHOWED THREE ENDOANCHORS NO LONGER ADEQUATELY PENETRATED THE AORTIC WALL. ONE ENDOANCHOR WAS IN THE DILATED AORTA AND TWO WERE IN THE SAC. NO ACTION WAS TAKEN AS A RESULT OF THIS EVENT AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7673978 ↗
• InjuryMay 21, 2018Leak/Splash; Leak/Splash

  A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED THAT 5 DAYS LATER, A NON-MDT CUFF WAS IMPLANTED ALONG WITH 10 ENDOANCHORS TO TREAT A TYPE IA ENDOLEAK. IT WAS REPORTED THAT APPROXIMATELY 3 YEARS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND A TYPE IA ENDOLEAK. THE EVENT HAS BEEN ASSESSED AS RELATED TO THE ENDOGRAFT AND TO THE ANEURYSM. A RE-INTERVENTION WAS CARRIED OUT DURING WHICH ADDITIONAL NON-MDT STENT GRAFTS WERE IMPLANTED. IT WAS REPORTED THAT THE RE-INTERVENTION WAS SUCCESSFUL AND NO ENDOLEAKS WERE IDENTIFIED, ALTHOUGH THE FOLLOWING DAY THE PATIENT EXPERIENCED LEFT-HAND PAIN ASSOCIATED WITH LEFT BRACHIAL ACCESS, AN ULTRASOUND SHOWED A HEMATOMA WHICH WAS REMOVED IN THE OR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Abdominal Pain; Hematoma

  MAUDE report 7530613 ↗
• InjuryFeb 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE 9 HELI-FX ENDOANCHORS WERE IMPLANTED IN A PATIENT FOR THE TREATMENT OF A TYPE IA ENDOLEAK IN ANOTHER MANUFACTURER'S STENT GRAFT SYSTEM USED FOR THE ENDOVASCULAR TREATMENT OF A 6CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PROCEDURE WAS AN OVERALL SUCCESS. HOWEVER, IT WAS REPORTED THAT THE PATIENT DEVELOPED A URINARY TRACT INFECTION THAT WAS ASSESSED BY THE INVESTIGATOR AS PROBABLY RELATED TO THE INDEX PROCEDURE. PATIENT WAS URINATING FREQUENTLY AND HAD LOWER BACK PAIN. THE PATIENT WAS TREATED WITH MEDICATION. IT IS NOTED THAT THE PATIENT SYMPTOMS HAVE RESOLVED AND THAT THE EVENT IS RESOLVED. NO FURTHER CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7291566 ↗
• MalfunctionFeb 21, 2018Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 7.2CM ABDOMINAL AORTIC ANEURYSM WITH APPROX 5MM OF PROXIMAL NECK LENGTH. IT WAS REPORTED THAT AFTER IMPLANTATION OF THE ENDURANT BIFURCATE AND THE PLACEMENT OF 6 HELIFX ENDOANCHORS, BOTH IN GOOD PROXIMAL POSITION, A COMPLETION ANGIOGRAM SHOWED A TYPE IA ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY RELATED AND WAS DUE TO THE SHORT, CONICAL PROXIMAL NECK. IT WAS REPORTED THAT INTERVENTION WAS PERFORMED, DIAGNOSTIC ANGIOGRAM DEMONSTRATED APPROXIMATELY 1MM OF PROXIMAL NECK COULD BE ACHIEVED BY PLACING AN AORTIC CUFF. THE PHYSICIAN MADE THE DECISION TO BALLOON THE PROXIMAL STENT GRAFT SEVERAL TIMES, WITH THE ADDITION OF 8 ENDOANCHORS IMPLANTED AT THE PROXIMAL END OF THE STENT GRAFT. A FOLLOW UP ANGIOGRAM SHOWED A SIGNIFICANT REDUCTION OF THE ENDOLEAK AFTER THE INTERVENTION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING A FOLLOW UP CT, NO ENDOLEAK WAS OBSERVED. NO CLINICAL SEQUELAE WERE REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7285184 ↗
• InjuryFeb 6, 2018Adverse 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 OF AN ABDOMINAL AORTIC ANEURYSM. AN ENDURANT STENT GRAFT SYSTEM WAS ALSO IMPLANTED. SIX ENDOANCHORS WERE DEPLOYED SUCCESSFULLY, FROM THE MAIN BODY TO THE PROXIMAL NECK. IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST THE INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH PNEUMONIA AFTER EXPERIENCING SHORTNESS OF BREATH. THE PATIENT ALSO TESTED POSITIVE FOR E. COLI. THE PATIENT WAS TREATED WITH MEDICATION FOR THE E.COLI AND ANTIBIOTICS FOR THE PNEUMONIA . PER THE PHYSICIAN THE EVENT IS NOT RELATED TO THE DEVICE OR PROCEDURE. THE SPONSOR HAS ASSESSED THE EVENT AS POSSIBLY RELATED TO THE PROCEDURE. THE EVENT IS RESOLVED.

  Patient problems: Pneumonia; Unspecified Infection

  MAUDE report 7244512 ↗
• MalfunctionJan 12, 2018Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A HELI-FX APPLIER AND ENDOANCHORS WERE USED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THREE ENDOANCHORS WERE SUCCESSFULLY IMPLANTED. WHILE TRYING TO LOAD THE FOURTH ENDOANCHOR INTO THE APPLIER FROM THE CASSETTE, THE DEVICE WOULD NOT RETRACT THE ENDOANCHOR FULLY FROM THE CASSETTE. THE EVENT WAS RESOLVED BY OPENING ANOTHER HELI-FX APPLIER. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS MALFUNCTION OF THE DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185136 ↗
• MalfunctionDec 15, 2017Failure to Power Up; Device Operates Differently Than Expected; Failure to Power Up; Device Operates Differently Than Expected

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR TREATMENT. A HELI-FX ENDOANCHOR SYSTEM WAS USED FOR THE TREATMENT OF A PROXIMAL TYPE I ENDOLEAK THAT OCCURRED DURING THE INDEX PROCEDURE. IT WAS REPORTED THAT FIRST TWO ENDOANCHORS WERE CAPTURED AND DEPLOYED WITH NO ISSUE, SCRUB/TECH ATTEMPTED TO CAPTURE ANOTHER ANCHOR BUT WAS UNABLE TO COMPLETE CAPTURE AND ONLY PARTIAL CAPTURE WAS COMPLETED. SCRUB/TECH INSTRUCTED TO DEPLOY THE PARTIALLY LOADED ENDOANCHOR AND DISCARD THE ENDOANCHOR. THE SCRUB/ TECH ATTEMPTED TO LOAD ANOTHER ENDOANCHOR, THE BACKWARD BUTTON WAS PRESSED AND THEN WITH DOWNWARD PRESSURE INTO CASSETTE WITH MOTOR RUNNING ATTEMPTED TO CAPTURE A NEW ANCHOR. DURING CAPTURE OF THIS ENDOANCHOR, THE APPLIER MOTOR STOPPED, THE BACK ARROW WAS FLASHING AND THE BLUE ERROR LIGHT SIGNALING. THE BACK BUTTON WAS HELD/PRESSED WITH NO RESPONSE AND NO MOTOR NOISE NOTED. THE FORWARD BUTTON WAS THEN PRESSED WITH NO RESPONSE. THE BACK AND FORWARD BUTTONS WERE HELD SIMULTANEOUSLY WITH NO RESPONSE. THE PHYSICIAN DECIDED TO FINISH THE CASE WITH THE INITIAL TWO ENDOANCHORS DEPLOYED. THE PHYSICIAN STATED THAT THE EVENT IS DEVICE RELATED. NO CLINICAL SEQUELAE REPORTED, AND THE PAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7121369 ↗
• MalfunctionDec 8, 2017Leak/Splash; Leak/Splash

  HELI-FX ENDOANCHORS WAS SELECTED AS AN ACCESSORY DEVICE FOR THE ENDOVASCULAR TREATMENT OF A PROXIMAL TYPE I ENDOLEAK FROM ANOTHER MANUFACTURER¿S STENT GRAFT. IT WAS REPORTED THAT 4 ENDOANCHORS WERE IMPLANTED IN THE PROXIMAL NECK OF THE MAIN BODY OF THE ENDOGRAFT DUE TO CONCERN FOR LATE FAILURE OF THE DEVICES. HOWEVER, IT WAS REPORTED THAT APPROXIMATELY 40 DAYS POST INDEX PROCEDURE, AN UNIDENTIFIED ENDOLEAK WAS NOTED. IT WAS NOTED THAT ¿DURING PROCEDURE, AFTER PLACEMENT OF ENDOANCHORS, OPERATING SURGEON NOTICED A SMALL UNIDENTIFIED ENDOLEAK¿. NO TREATMENT WAS GIVEN, AND THE PATIENT RECOVERED WITHOUT TREATMENT. IT WAS NOTED THAT THE EVENT WAS NOT RELATED TO THE DEVICE OR PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7099260 ↗
• MalfunctionDec 1, 2017Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 68MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, ON THE FINAL ANGIOGRAM, A PROXIMAL TYPE I ENDOLEAK WAS NOTICED. THE PHYSICIAN BALLOONED AGAIN AND PLACED 9 ENDOANCHORS TO RESOLVE THE LEAK. ANOTHER ANGIO WAS PERFORMED, BUT THE TYPE 1 ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN ELECTED TO STOP THE PROCEDURE. IT WAS REPORTED THAT THE LEFT RENAL ARTERY WAS THE LOWEST RENAL ARTERY AND THE PROXIMAL EDGE OF THE STENT GRAFT WAS AT THAT LEVEL. DUE TO THE ANGLE THAT THE STENT GRAFT WAS IMPLANTED PROXIMALLY, THE RIGHT SIDE OF THE STENT GRAFT HAD LANDED DISTAL TO THE RIGHT RENAL ARTERY, WHICH WAS 5MM MORE PROXIMAL. THE PHYSICIAN DETERMINED THAT BY PLACING A PROXIMAL CUFF, IT WOULD STILL PROBABLY LAND THE EXACT SAME WAY AND SO DECIDED NOT TO PLACE ONE AS THERE WAS NO AVAILABLE LANDING ZONE AT THE LEFT RENAL ARTERY. THE PHYSICIAN HAS NOT DETERMINED WHEN OR IF ANY INTERVENTION WILL BE PERFORMED. IT WAS REPORTED THAT, AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY, DUE TO THE SHORT AND CONICAL PROXIMAL AORTIC NECK MEASURING 29-33 MM IN DIAMETER AND 11MM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7074017 ↗
• InjuryNov 13, 2017Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  A HELI-FX APPLIER WAS USED TO TREAT A TYPE 1A ENDOLEAK FROM ANOTHER MANUFACTURER'S STENT GRAFT. IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY DEPLOYED TWO ENDOANCHORS. AT THIS POINT THE BLUE ERROR LIGHT WAS BLINKING. THE PHYSICIAN HAD PUSHED THE APPLIER INTO THE DEFLECTED GUIDE CATHETER VERY HARD, AND THAT THEY BELIEVED THIS MAY HAVE CAUSED THE ISSUE. LATER ON IN THE PROCEDURE, A BUBBLE WAS NOTED IN THE AORTA, WHICH WAS REMOVED WITH A 2 CATHETER BY THE PHYSICIAN. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS USER ERROR. A NEW APPLIER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Embolism

  MAUDE report 7023893 ↗
• InjuryNov 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HELI-FX APPLIER WAS USED TO TREAT A TYPE 1A ENDOLEAK FROM ANOTHER MANUFACTURER'S STENT GRAFT. IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY DEPLOYED TWO ENDOANCHORS. AT THIS POINT THE BLUE ERROR LIGHT WAS BLINKING. THE PHYSICIAN HAD PUSHED THE APPLIER INTO THE DEFLECTED GUIDE CATHETER VERY HARD, AND THAT THEY BELIEVED THIS MAY HAVE CAUSED THE ISSUE. LATER ON IN THE PROCEDURE, A BUBBLE WAS NOTED IN THE AORTA, WHICH WAS REMOVED WITH A 2 CATHETER BY THE PHYSICIAN. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS USER ERROR. A NEW APPLIER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Embolism

  MAUDE report 7023890 ↗
• InjuryNov 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HELI-FX APPLIER AND ENDOANCHORS WERE USED IN THE PATIENT TO PREVENT LATE FAILURE OF THE ENDURANT STENT GRAFT USED IN THE TREATMENT OF A 46MM AAA. THERE WAS A PROXIMAL NECK ANGULATION OF 10 DEGREES AND A SUPRARENAL NECK ANGULATION OF 10 DEGREES. 30 PERCENT OF THE PROXIMAL AORTIC SEAL ZONE CIRCUMFERENCE HAD LOCALIZED THROMBUS THAT MEASURED 8 MM THICK. THERE WAS NO CALCIUM AT THE SEAL ZONE. IT WAS REPORTED THAT, DURING THE INDEX PROCEDURE, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED AFTER THE ENDURANT STENT GRAFT WAS IMPLANTED. THE PHYSICIAN ELECTED TO IMPLANT 5 ENDOANCHORS IN THE PROXIMAL NECK OF THE MAIN BODY STENT GRAFT. THE ENDOLEAK WAS RESOLVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT POST PROCEDURE, THE PATIENT SUFFERED HYPOTENSION AND THIS WAS DEEMED PROBABLY RELATED TO THE PROCEDURE BUT NOT TO THE DEVICE. THIS RESOLVED ON THE SAME DATE AFTER ADMINISTRATION OF IV FLUIDS. IT WAS REPORTED THAT ON THE NEXT DAY, THE PATIENT SUFFERED CONFUSION. THIS WAS DEEMED TO BE POSSIBLY RELATED TO THE PROCEDURE BUT NOT TO THE DEVICE. THIS RESOLVED ON THE SAME DAY WITHOUT TREATMENT.

  Patient problems: Confusion/ Disorientation; Low Blood Pressure/ Hypotension

  MAUDE report 7016907 ↗
• InjuryOct 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM AND HELI-FX APPLIER AND GUIDE WERE USED FOR THE ENDOVASCULAR TREATMENT OF A 60X120 MM THORACIC AORTIC DISSECTION AND ANEURYSM. THE ILIAC ARTERIES WERE 6.5MM IN DIAMETER BILATERALLY. IT WAS REPORTED THAT THE VALIANT STENT GRAFTS WERE INSERTED ON THE LEFT FEMORAL SITE AND IT IS UNKNOWN WHAT SIDE THE HELI-FX WAS INSERTED. AN ULTRASOUND WAS PERFORMED AS THERE WAS RIGHT GROIN PULSATILE MASS. THE RIGHT GROIN PULSATILE MASS RESOLVED WITHOUT TREATMENT. THE PHYSICIAN REPORTED SITE ACCESS PROBLEMS AND THE PATIENT HAD A RIGHT GROIN PULSATILE MASS. THE PATIENT WAS GIVEN A FOLLOW UP ULTRASOUND SCAN. THE PHYSICIAN REPORTED THAT THE EVENT RESOLVED WITHOUT TREATMENT. THE INVESTIGATOR ASSESSED THE EVENT AS RELATED TO THE INDEX PROCEDURE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Local Reaction

  MAUDE report 6943912 ↗
• InjuryOct 3, 2017Leak/Splash; Leak/Splash

  HELI-FX APTUS ENDOANCHORS WERE IMPLANTED AS ACCESSORY DEVICES FOR THE ENDOVASCULAR TREATMENT OF A TYPE IA ENDOLEAK FROM ANOTHER MANUFACTURER¿S STENT GRAFT . IT WAS REPORTED THAT DURING THE INTERVENTION PROCEDURE, FOUR ENDOANCHORS WERE IMPLANTED, RESOLVING THE ENDOLEAK. APPROXIMATELY SIX MONTHS LATER, A TYPE IA ENDOLEAK WAS OBSERVED. AN INTERVENTION WAS PERFORMED APPROXIMATELY THREE WEEKS LATER. THE PHYSICIAN PERFORMED A SNORKEL TECHNIQUE AND IMPLANTED ANOTHER MANUFACTURER'S AORTIC CUFF; HOWEVER, THE EVENT DID NOT RESOLVE. PER THE INVESTIGATOR, THE CAUSE OF THE EVENT WAS MOST LIKELY RELATED TO THE PATIENT'S ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THE PHYSICIAN.

  Patient problems: Injury

  MAUDE report 6912734 ↗