APTUS Heli-FXRecalls & reported problems across all models

We found 2 models of APTUS Heli-FX by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Mar 17, 2017 and Mar 15, 2022 — classified as 10 deaths, 29 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (20 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported APTUS Heli-FX problems

APTUS Heli-FX models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• APTUS Heli-FX® SA-85

  Endovascular suturing system
  8 deaths50 reports
• APTUS Heli-FX® SG-64

  Endovascular suturing system
  2 deaths3 reports

Recent APTUS Heli-FX adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryMay 21, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT 4 HELI-FX ENDOANCHORS WERE IMPLANTED IN THE 79.2MM DIAMETER ANEURYSM DUE TO NECK DILATATION APPROXIMATELY 5 YEARS LATER. AN ENDURANT II LIMB EXTENSION WAS ALSO IMPLANTED DURING THE SAME PROCEDURE. APPROXIMATELY 16 MONTHS POST IMPLANTATION OF THE ENDOANCHORS, IT WAS NOTED THAT A TYPE IA ENDOLEAK WAS OBSERVED. AS PER THE INVESTIGATOR, THE EVENT WAS POSSIBLY RELATED TO THE ENDOGRAFT. APPROXIMATELY 17 MONTHS POST IMPLANTATION OF THE ENDOANCHORS, INTERVENTION TO TREAT THE TYPE IA ENDOLEAK AND ANEURYSM EXPANSION WAS CARRIED OUT, DURING THE PROCEDURE BALLOONING WAS PERFORMED BUT THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AND THE EVENT WAS NOT RESOLVED. A FURTHER RE-INTERVENTION WAS CARRIED OUT APPROXIMATELY 1 WEEK LATER. DURING THIS PROCEDURE, AN AORTIC CUFF WAS IMPLANTED ALONG WITH ADDITIONAL ENDOANCHORS AND A NON MDT STENT. THE PROCEDURE WAS SUCCESSFUL AND THE EVENT WAS RESOLVED, NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7530040 ↗
• DeathApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HELI-FX APPLIER AND ENDOANCHORS AND ENDURANT AORTIC CUFF WERE USED IN THE ENDOVASCULAR TREATMENT OF THE PATIENT. THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 54.4MM. IT WAS REPORTED THAT THE PATIENT HAD AN ANEURX MAIN BODY AND ANEURX ILIAC EXTENSION CUFFS IMPLANTED APPROXIMATELY 14.5 YEARS BEFORE. THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 54.4MM. IT WAS REPORTED THAT DURING THE INTERVENTION, 4 ENDOANCHORS WERE IMPLANTED IN THE MAIN BODY AT THE PROXIMAL NECK. IT WAS NOTED THAT THE PATIENT EXPIRED APPROXIMATELY 2 YEARS POST INTERVENTION FROM AN UNKNOWN CAUSE. RELATIONSHIP BETWEEN THE PATIENT DEATH AND THE STUDY DEVICE OR PROCEDURE WAS NOT REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death

  MAUDE report 7435558 ↗

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