AFX Introducer System S17-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00818009011381), received between May 24, 2016 and Jun 4, 2025 — classified as 2 deaths, 16 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K120212); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. PREVIOUSLY A BARE (NON-ENDOLOGIX) STENT HAD BEEN IMPLANTED ON THE RIGHT CIA ABOUT 20 YEARS AGO, AND IT SLIGHTLY STUCK OUT TO THE AORTIC BIFURCATION. THE AFX INTRODUCER SHEATH WAS INSERTED THROUGH RIGHT ACCESS, HOWEVER, IT WAS NOT ABLE TO BE ADVANCED BECAUSE IT GOT CAUGHT IN THE BARE (NON-ENDOLOGIX) STENT. AN ATTEMPT WAS MADE AGAIN BY REPLACING THE SHEATH WITH A DRYSEAL (NON-ENDOLOGIX) BUT IT WAS UNSUCCESSFUL. THE AFX INTRODUCER SHEATH WAS ABLE TO BE ADVANCED THROUGH LEFT ACCESS ALTHOUGH IT GOT CAUGHT IN THE BARE (NON-ENDOLOGIX) STENT, HOWEVER THE AFX2 MAIN BODY WAS IMPLANTED. AFTERWARDS, WHEN THE SHEATH WAS REMOVED, THE RA MARKER OF THE AFX INTRODUCER SHEATH WAS LEFT BETWEEN THE IPSILATERAL LEG AND BLOOD VESSEL. SINCE IT WAS STUCK, THE PROCEDURE CONTINUED. A NEW AFX SHEATH WAS USED TO IMPLANT THE AFX VELA SUPRARENAL. AFTER OVERALL TOUCH-UP, IT WAS CONFIRMED THERE WERE NO ENDOLEAKS, AND THE PROCEDURE WAS COMPLETED. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22143142 ↗
• InjuryApr 30, 2025Off-Label Use; Failure to Advance; Off-Label Use; Failure to Advance

  THE PATIENT WAS BEING TREATED FOR AN AORTIC ILIAC OCCLUSIVE DISEASE (AIOD) ON (B)(6) 2025. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE ABSENCE OF AN ABDOMINAL AORTIC ANEURYSM (AAA). THE SURGEON TRIED PUTTING IN AN AFX INTRODUCER SHEATH IN PREPARATION TO IMPLANT AN AFX BIFURCATED STENT GRAFT BUT WAS UNABLE TO ADVANCE THE AFX INTRODUCER SHEATH THROUGH THE VESSEL DUE TO NARROWING FROM CALCIFICATIONS. THE SURGEON DECIDED TO TRY IMPLANTING TWO OVATION IX EXTENDERS INSTEAD BY DOING THE COVERED ENDOVASCULAR RECONSTRUCTION OF AORTIC BIFURCATION (CERAB) TECHNIQUE, HOWEVER, WHEN THE SURGEON PUT IN THE TWO KISSING STENTS AND STARTED BALLOONING THEY RUPTURED THE DISTAL AORTA. THE PATIENT HAD EXTENSIVE BILATERAL CALCIFICATIONS THAT RUPTURED DURING THE BALLOONING PROCESS. THE PATIENT EXPIRED DURING THE PROCEDURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 21936030 ↗
• InjuryFeb 18, 2025Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  THE PATIENT WAS BEING TREATED TO REPAIR A SIGNIFICANTLY CALCIFIED ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025. THE AFX INTRODUCER SHEATH WAS INSERTED THROUGH THE LEFT ACCESS VIA THE CUT-DOWN METHOD. THE AFX2 BIFURCATED STENT GRAFT (BSG) WAS IMPLANTED ACCORDING TO PLAN. AN ATTEMPT TO ADVANCE THE AFX INTRODUCER SHEATH TO IMPLANT THE AFX VELA SUPRARENAL WAS MADE; HOWEVER, THE AFX INTRODUCER SHEATH WOULD NOT ADVANCE BECAUSE THE LEGS OF THE AFX2 BSG WERE NOT DEPLOYED COMPLETELY DUE TO CALCIFICATION. BALLOONING WAS PERFORMED TO EXPAND THE AFX2 BSG LEGS, BUT THE AFX INTRODUCER SHEATH WOULD STILL NOT ADVANCE. THEREFORE, THE AFX INTRODUCER SHEATH WAS ADVANCED WHILE THE BALLOON WAS BEING DEFLATED. THE AFX VELA SUPRARENAL WAS DEPLOYED WITHOUT ISSUE; HOWEVER, WHEN WITHDRAWING THE TIP OF THE DELIVERY SYSTEM, THE AFX VELA SUPRARENAL MOVED DISTALLY SLIGHTLY. CONSEQUENTLY, THE AFX INTRODUCER SHEATH WAS REMOVED FROM THE PATIENT AND A GORE (NON-ENDOLOGIX) DRYSEAL SHEATH WAS INSERTED THROUGH THE SAME ACCESS SITE AND ADVANCED INSIDE THE AFX2 BSG WITHOUT PROBLEMS, AND A MEDTRONIC (NON-ENDOLOGIX) ENDURANT CUFF WAS IMPLANTED. WHEN CLOSING THE ACCESS SITE AFTER THE REMOVAL OF THE GORE (NON-ENDOLOGIX) D

  Patient problems: Foreign Body In Patient

  MAUDE report 21404821 ↗
• InjuryJan 22, 2025Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. THE AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED FIRST BUT THE DISTAL END OF THE LEFT LEG OF THE BIFURCATED STENT GRAFT COULD NOT BE DEPLOYED COMPLETELY DUE TO THE BLOOD FLOW AND CALCIFICATION OF THE LEFT COMMON ILIAC ARTERY. THE DEPLOYMENT SITUATION DID NOT CHANGE AFTER TOUCH-UP WAS PERFORMED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE SHEATH PROXIMALLY IN ORDER TO IMPLANT THE VELA SUPRARENAL, BUT IT WOULD NOT ADVANCE DUE TO INTERFERENCE WITH THE DISTAL END OF THE LEFT LEG OF THE BIFURCATED STENT GRAFT. THE SHEATH WAS ABLE TO BE ADVANCED FURTHER WHILE BEING ROTATED. THE ANGIOGRAPHY SHOWED S-SHAPED AORTIC NECK TORTUOSITY AND THE INSUFFICIENT SEALING AND FIXATION OF THE BIFURCATED STENT GRAFT IN THE NECK. THE VELA SUPRARENAL DISTALLY MIGRATED APPROXIMATELY 5 TO 10MM. THE ANGIOGRAPHY SHOWED A TYPE IIIA ENDOLEAK, SO THE PHYSICIAN ELECTED TO ADD A VELA INFRARENAL. DURING THE ATTEMPT TO ADVANCE THE SHEATH, IT WAS CAUGHT ON THE DISTAL END OF THE LEFT LEG OF THE BIFURCATED STENT GRAFT. THE SHEATH COULD BE ADVANCED FURTHER WHILE BEING ROTATED. AFTER THE VELA IN

  Patient problems: Foreign Body In Patient

  MAUDE report 21214011 ↗
• InjurySep 14, 2022Failure to Advance; Failure to Advance

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THE INITIAL IMPLANT PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE AFX INTRODUCER SYSTEM IN PREPARATION FOR IMPLANT OF AN AFX PROXIMAL EXTENSION. DURING THIS PROCEDURE, THERE WAS ABNORMAL BLOOD LOSS (1300CC) TO THE PATIENT AS WELL AS AN ACCESS SITE COMPLICATION IN THE RIGHT FEMORAL ARTERY. IN RESPONSE TO THE BLOOD LOSS, THE PHYSICIAN PROVIDED FOUR (4) UNITS OF PRBCS (PACKED RED BLOOD CELLS), AND THE PATIENT WAS TRANSFERRED TO ICU (INTENSIVE CARE UNIT) IN STABLE CONDITION. THIS EVENT WAS DISCOVERED DURING CLINICAL ASSESSMENT TO RELATED PATIENT ID 58056 (REFERENCE MFR. REPORT # 3008011247-2022-00082). IT IS UNKNOWN IF THE AFFECTED DEVICE IS AVAILABLE FOR RETURN/EVALUATION.

  Patient problems: Exsanguination; Failure of Implant

  MAUDE report 15422661 ↗
• InjuryJan 20, 2021Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  DURING THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT TO TREAT ILIAC ARTERY ANEURYSMS ON BOTH SIDES, DAMAGE TO THE ACCESS VESSEL WAS IDENTIFIED. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO THE ABSENCE OF A ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT TWO NON-ENDOLOGIX (GORE EXCLUDER) STENT GRAFTS WERE IMPLANTED ON BOTH SIDES COVERING THE EXTERNAL AND COMMON ILIAC ARTERIES PRIOR TO THE AFX2 BIFURCATED STENT GRAFT BEING IMPLANTED. THIS INITIAL PROCEDURE IS ALSO OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. THE AFX INTRODUCER SYSTEM WAS INSERTED INTO THE RIGHT ACCESS VESSEL ALONG WITH THE AFX2 BIFURCATED STENT GRAFT DELIVERY SYSTEM. WHEN THE DOCTOR ATTEMPTED TO RETRACT THE INNER CORE, IT WOULD NOT RETRACT FROM A CERTAIN POINT AND DAMAGE TO THE ACCESS VESSEL WAS SUSPECTED. THE ENTIRE ASSEMBLY OF THE AFX2 DELIVERY SYSTEM AND INTRODUCER SYSTEM WERE REMOVED. THE INTRODUCER SHEATH WAS FOUND TO HAVE ACCORDION-LIKE DEFORMATION FOR 10 CM FROM THE SHEATH TIP. THE DAMAGED VESSEL WAS SURGICALLY REPLACED WITH A VASCULAR GRAFT. THE PROCEDURE WAS THEN COMPLETED.

  Patient problems: Perforation of Vessels

  MAUDE report 11205456 ↗
• InjuryDec 1, 2020Use of Device Problem; Patient-Device Incompatibility; Detachment of Device or Device Component; Use of Device Problem; Patient-Device Incompatibility; Detachment of Device or Device Component

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. DURING THE INITIAL IMPLANT PROCEDURE AND FOLLOWING DEPLOYMENT OF THE VELA INFRARENAL PROXIMAL EXTENSION, THE PHYSICIAN OBSERVED THE DISTAL RADIOPAQUE MARKER TO THE 17FR INTRODUCER SHEATH WAS ABSENT. CONTRAST WAS INJECTED THROUGH THE SHEATH AND X-RAY SCREENING LOCATED THE DETACHED RADIOPAQUE MARKER TO BE WITHIN THE MAIN BODY STENT GRAFT. THE PHYSICIAN ELECTED TO CONCLUDE THE PROCEDURE AND DID NOT ATTEMPT TO REMOVE THE DETACHED MARKER. THE PATIENT IS REPORTEDLY DOING WELL ONE DAY POST-OPERATIVE. NOTE: PATIENT HAD A PRE-EXISTING AORTIC DISSECTION AND OCCLUDED RIGHT COMMON ILIAC ARTERY (CAUTIONARY PRODUCT USE).

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 10928443 ↗
• DeathNov 25, 2020Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Insufficient Device Problem Information

  DURING THE TWO (2) ATTEMPTS OF PLACEMENT OF THE AFX SHEATH, DISSECTION/PERFORATION OF THE EXTERNAL ILIAC IN THE REGION CLOSE TO ACCESS/PER-CLOSE DEVICE HAD OCCURRED. THE BIFURCATED STENT GRAFT WAS NOT IMPLANTED. THE PHYSICIAN ATTEMPTED TO REPAIR THE TEAR BY CUTTING DOWN TO SITE IN ILIAC; HOWEVER THE PATIENT EXPIRED. THE PHYSICIAN STATED THAT THE SHEATH DID NOT CAUSE THIS EVENT HOWEVER MEDICAL RECORDS/IMAGES WILL BE REQUESTED TO DETERMINE THE EXACT CAUSE OF THIS EVENT.

  Patient problems: Death

  MAUDE report 10900945 ↗
• InjurySep 12, 2020Retraction Problem; Insufficient Device Problem Information; Retraction Problem; Insufficient Device Problem Information

  THE PHYSICIAN WAS IMPLANTING AN AFX2 BIFURCATED STENT GRAFT TO TREAT THE PATIENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THE PROCEDURE ONCE THE SHEATH WAS ADVANCED, THE CONTROL CORD WAS PULLED BUT BECAME STUCK ON THE LEFT LIMB OF THE BIFURCATED STENT GRAFT AND A LOOP IN THE CORD WAS FORMED. THE DELIVERY SYSTEM WAS UNABLE TO BE RETRACTED AND AN OPEN REPAIR WAS PERFORMED. THE PHYSICIAN HAD TO CUT THE CONTROL CORD TO REMOVE THE DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ISSUES REPORTED WITH THE PATIENT'S CONDITION POST PROCEDURE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10526047 ↗
• MalfunctionFeb 6, 2020Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX STENT GRAFTS. DURING THIS PROCEDURE, IT WAS DISCOVERED THAT THE RADIOPAQUE MARKER FROM THE INTRODUCER SYSTEM HAS BECOME DETACHED AND WAS STILL INSIDE OF THE PATIENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE RADIOPAQUE MARKER BUT WAS UNSUCCESSFUL. THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE. CURRENTLY NO PATIENT HARM HAS BEEN REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 9678722 ↗
• DeathNov 7, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  DURING THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT, IT WAS REPORTED THAT DURING THE RETRACTION OF THE DELIVERY SYSTEM (AFX INTRODUCER SYSTEM II) THE PHYSICIAN FELT RESISTANCE. THE PHYSICIAN ATTEMPTED TO ROTATE THE INNER CORE AND RETRACT THE NOSE CONE AT THE SAME TIME TO RETRACT THE DELIVERY SYSTEM HOWEVER THE NOSE CONE SEPARATED FROM THE INNER CORE AND THE INNER CORE CAME OUT SEPARATELY. ATTEMPTS WERE MADE TO RETRIEVE THE NOSE CONE BUT WERE UNSUCCESSFUL. AS THE NOSE CONE WAS STILL INSIDE OF THE PATIENT, THE PHYSICIAN PERFORMED A SURGICAL CUT DOWN PROCEDURE TO RETRIEVE THE DEVICE. THE NOSE CONE WAS RETRIEVED SUCCESSFULLY, AND A SUPRARENAL STENT GRAFT WAS IMPLANTED AT THE CONTRALATERAL PERCUTANEOUS ACCESS SITE. THE CASE WAS SUCCESSFULLY COMPLETED, AND THE PATIENT WAS REPORTED AS STABLE. ADDITIONAL INFORMATION: A CLINICAL ASSESSMENT OF THE DISCHARGE SUMMARY AND MEDICAL RECORDS PROVIDED, DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST THAT THE POST-OPERATIVE COURSE IN THIS PATIENT WITH MULTIPLE CO-MORBIDITIES INCLUDED GASTROINTESTINAL BLEEDING FROM GASTRIC AND DUODENAL ULCERS, POST-OPERATIVE ILEUS AND RESPIRATORY FAILURE ULTIMATELY LEAD TO THE PATIENT DEATH.

  Patient problems: Death; High Blood Pressure/ Hypertension; No Code Available

  MAUDE report 9292417 ↗
• InjuryJul 19, 2019Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  DURING AN ENDOVASCULAR ANEURYSM SEALING (EVAS) PROCEDURE FOR THE PATIENT WITH Y-GRAFT (NON- ENDOLOGIX) REPLACEMENT HISTORY. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF- LABEL). THERE WAS DIFFICULTY DURING SHEATH INSERTION DUE TO ACCESS VESSEL TORTUOSITY (LEFT) AS WELL AS IMPLANTED Y-GRAFT (NON- ENDOLOGIX). THE BIFURCATED STENT GRAFT DEPLOYED AS INTENDED BUT THE LIMBS WERE SLIGHTLY CROSSED INSIDE THE Y-GRAFT. IT WAS ALSO DIFFICULTY TO RETRACT THE DELIVERY SYSTEM TIP, THEREFORE A SMALLER SHEATH WAS INSERTED FROM THE SAME SIDE WITH MORE PROXIMAL AREA AND ANGIOPLASTY (PTA) WAS PERFORMED SEVERAL TIMES. AS A DAMAGE WAS OBSERVED ON AFX SHEATH (ACCORDION-LIKE), A NEW SHEATH WAS INSERTED FOR THE IMPLANTATION OF THE SUPRARENAL STENT GRAFT EXTENSION THAT WAS IMPLANTED FROM THE RIGHT ACCESS. THE LEFT ACCESS VESSEL WAS DAMAGED AROUND EXTERNAL ILIAC ARTERY (EIA), IT WAS SUTURED AND REPAIRED. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Perforation of Vessels

  MAUDE report 8809111 ↗
• InjuryNov 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INITIAL PROCEDURE, AN INCIDENT OCCURRED DURING AN AIOD + AORTIC ULCERATION CASE. DURING DELIVERY OF THE BIFURCATED STENT, THE SHEATH CAME BACK AND WOULDN'T TRACK ANY FURTHER. THE PHYSICIAN ADVANCED THE DEVICE AND SHEATH TOGETHER. THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING AND ORIENTING THE AFX BIFURCATION. THE AFX BIFURCATION WAS POSITIONED THEN DEPLOYED AS EXPECTED. UPON REMOVAL OF THE DEVICE THE PHYSICIAN FELT THE SHEATH CONCERTINA AND ELECTED TO REMOVE THE STENT AND SHEATH TOGETHER. UPON REMOVING THE DEVICE, DAMAGE OF THE SHEATH WAS OBSERVED WITH WHAT APPEARED TO BE A PORTION OF THE INTIMA REMOVED AS WELL. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Perforation of Vessels

  MAUDE report 8087568 ↗
• InjurySep 6, 2018Break; Material Fragmentation; Break; Material Fragmentation

  DURING AN INITIAL PROCEDURE THE MARKER BAND ON THE S17-45 SHEATH SHEARED OFF WHILE REMOVING THE SHEATH. THE ISSUE WAS NOT FOUND UNTIL AFTER THE VESSEL WAS CLOSED AT THE END OF THE PROCEDURE. IT WAS VISUALIZED UNDER FLUOROSCOPY BUT COULD NOT DETERMINE IF IT WAS IN THE VESSEL OR IN THE SUBCUTANEOUS LAYER. THE PHYSICIAN DECIDED TO CUT DOWN IN THE PATIENTS RIGHT GROIN TO EXPLORE. THE MARKER BAND WAS FOUND TO PARTIALLY BE IN AND OUT OF THE VESSEL. THE PHYSICIAN REMOVED THE MARKER BAND SUCCESSFULLY. THE PATIENT IS DOING WELL POST OPERATIVELY. THERE HAS BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant; Vascular Dissection

  MAUDE report 7853579 ↗
• InjurySep 1, 2017Entrapment of Device; Kinked; Difficult to Remove; Patient-Device Incompatibility; Entrapment of Device; Kinked; Difficult to Remove; Patient-Device Incompatibility

  DURING THE INITIAL IMPLANT OF AFX DEVICES; A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION, THE PHYSICIAN HAD DIFFICULTY WITHDRAWING THE INNER CORE OF THE SUPRARENAL DELIVERY SYSTEM FROM THE INTRODUCER SHEATH. THE PHYSICIAN ELECTED TO REMOVE THE ENTIRE DELIVERY SYSTEM, THE SUPRARENAL INNER CORE AND THE INTRODUCER SHEATH, FROM THE PATIENT. IN REMOVING THE DELIVERY SYSTEM THE ACCESS SITE SUTURES WERE PULLED OUT. THE PHYSICIAN IMPLANTED A NON-ENDOLOGIX DEVICE TO RESOLVE THE ISSUE. FOLLOWING THE REMOVAL OF THE INTRODUCER SHEATH FROM THE PATIENT IT WAS NOTED THE TIP OF THE SHEATH WAS DAMAGED. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS REPORTED AS DOING WELL. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Perforation of Vessels

  MAUDE report 6840506 ↗
• InjuryJul 6, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING THE INITIAL IMPLANT PROCEDURE OF A BIFURCATED STENT THE PATIENT HAD AN INTRAOPERATIVE RIGHT ILIAC RUPTURE. THE TREATMENT OF THE RUPTURED ILIAC WAS NOT INITIALLY REPORTED TO ENDOLOGIX, IT IS UNKNOWN IF ANY ADDITIONAL NON-ENDOLOGIX STENTS WERE IMPLANTED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION POST PROCEDURE. TO DATE THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 6689324 ↗
• InjuryApr 5, 2017Partial Blockage; Hole In Material; Leak/Splash; Patient-Device Incompatibility; Partial Blockage; Hole In Material; Leak/Splash; Patient-Device Incompatibility

  IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE WITH TWO BIFURCATED DEVICES AND A SUPRARENAL AORTIC EXTENSION. FOLLOWING THE IMPLANT PROCEDURE THE PHYSICIAN IDENTIFIED A DISSECTION AND STENOSIS OF THE LEFT COMMON FEMORAL ARTERY (LCFA) WHICH NEEDED SURGICAL REPAIR. THE INTIMAL FLAP WAS OBSERVED COVERING THE SUPERFICIAL FEMORAL ARTERY (SFA) AS WELL AS THE PROFUNDA CAUSING THE STENOSIS. THE PHYSICIAN COMPLETED AN ENDARTERECTOMY WITH CORMATRIX PATCH CLOSURE TO RESOLVE THE ISSUE. THE PATIENT IS REPORTED AS WELL FOLLOWING THE PROCEDURE.

  Patient problems: Blood Loss; Intimal Dissection; Ischemia; Stenosis

  MAUDE report 6461903 ↗
• MalfunctionNov 7, 2016Device Markings/Labelling Problem; Packaging Problem; Device Markings/Labelling Problem; Packaging Problem

  A INTRODUCER DEVICE USED IN A PROCEDURE WAS DISCOVERED TO HAVE THE INCORRECT LABEL ON THE PACKING. THE SERIAL NUMBER FROM THE DEVICE IN THE PACKAGE DID NOT MATCH THE SERIAL NUMBER ON THE OUTSIDE OF THE PACKAGE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6082077 ↗
• MalfunctionNov 7, 2016Device Markings/Labelling Problem; Packaging Problem; Device Markings/Labelling Problem; Packaging Problem

  AN INTRODUCER DEVICE INSPECTED BY THE CUSTOMER WAS DISCOVERED TO HAVE THE INCORRECT LABEL ON THE PACKAGING. THE LOT/ SERIAL NUMBER FROM THE DEVICE IN THE PACKAGE DID NOT MATCH THE LOT/ SERIAL NUMBER ON THE OUTSIDE OF THE PACKAGE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6081523 ↗
• InjuryNov 2, 2016Material Fragmentation; Delamination; Device Operates Differently Than Expected; Material Fragmentation; Delamination; Device Operates Differently Than Expected

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND AN INFRARENAL AORTIC EXTENSION ON (B)(6) 2016. AFTER THE COMPLETION OF THE INITIAL IMPLANT WHEN THE PHYSICIAN WAS WITHDRAWING THE DELIVERY SYSTEM THERE WAS PLASTIC THREAD SEEN COMING FROM THE INCISION SIGHT. THE PHYSICIAN REMOVED THE PLASTIC THREAD FROM THE INCISION SIGHT AND DID NOT OBSERVE ANY ADDITIONAL MATERIAL IN THE INCISION SIGHT FOLLOWING THE PROCEDURE. THE PATIENT WAS STABLE POST PROCEDURE.

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

  MAUDE report 6074301 ↗
• MalfunctionOct 12, 2016Material Fragmentation; Delamination; Device Operates Differently Than Expected; Material Fragmentation; Delamination; Device Operates Differently Than Expected

  ON (B)(6) 2016 AT THE COMPLETION OF THE INITIAL IMPLANT OF AFX DEVICES, A LONG PLASTIC STRING WAS OBSERVED COMING FROM THE INTRODUCER DEVICE WHEN REMOVED FROM THE GROIN AREA OF THE PATIENT. THE IMPLANT PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6022662 ↗
• InjuryAug 18, 2016Material Fragmentation; Defective Component; Delamination; Device Operates Differently Than Expected; Material Fragmentation; Defective Component; Delamination; Device Operates Differently Than Expected

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT, AND A NON ENDOLOGIX PROXIMAL EXTENSION ON (B)(6) 2016. AT THE COMPLETION OF THE INITIAL PROCEDURE, DURING THE CLOSURE OF THE ACCESS SITE A PLASTIC FRAGMENT WAS DISCOVERED COMING FROM THE ACCESS VESSEL. THE PLASTIC FRAGMENT WAS REMOVED BY HAND IN ONE INTACT PIECE. THERE WAS NO KNOWN IMPACT TO THE PATIENT. THE PATIENT IS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5887466 ↗
• MalfunctionMay 24, 2016Material Fragmentation; Defective Component; Delamination; Device Operates Differently Than Expected; Material Fragmentation; Defective Component; Delamination; Device Operates Differently Than Expected

  DURING THE INITIAL IMPLANT PROCEDURE WHEN THE PHYSICIAN REMOVED THE INTRODUCER DELIVERY SYSTEM FROM THE PATIENT, A PLASTIC THREADLIKE MATERIAL WAS SEEN COMING FROM THE TIP OF THE INTRODUCER OUT OF THE PATIENT LEG. NO OTHER MATERIAL WAS OBSERVED. THE PHYSICIAN COMPLETED THE PROCEDURE AND THE PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5677376 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120212. One submission often covers many models, so check the product and lot details in each record.

• Z-1436-2013 · May 13, 2013 · Terminated
  Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitat