AFX Endovascular AAA System BA28-100/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00818009010049), received between Jan 22, 2016 and Jan 24, 2024 — classified as 4 deaths, 38 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (17 reports).

16 other recalls cover devices cleared under the same FDA submission (P040002); 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 44 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2024Off-Label Use; Detachment of Device or Device Component; Device-Device Incompatibility; Off-Label Use; Detachment of Device or Device Component; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2015. ADDITIONALLY, (3) THREE OVATION IX ILIAC EXTENDERS WERE IMPLANTED ON (B)(6) 2016 FOR AN UNKNOWN REASON. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY NINE (9) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, THE LEFT LEG OF THE BIFURCATED STENT GRAFT WAS FOUND TO HAVE SEPARATED FROM ONE OF THE OVATION IX ILIAC EXTENDERS (CLASSIFIED AS A TYPE 3A ENDOLEAK). THE PHYSICIAN ELECTED TO RELINE THE PREVIOUSLY IMPLANTED STENT GRAFTS WITH AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT, AN OVATION IX ILIAC LIMB AND AN OVATION IX ILIAC EXTENDER ON (B)(6) 2024 TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS STABLE POST-SECONDARY PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18572936 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL PROXIMAL EXTENSION AND FOUR (4) AFX LIMB STENT GRAFT DISTAL EXTENSIONS. ON AN UNKNOWN DATE, THE PATIENT HAD A TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) DEVICE PLACED TO TREAT A DISSECTION. IT WAS ALSO NOTED THAT THE THORACIC AORTA WAS PREVIOUSLY STENTED AT THE SUPRA-CELIAC. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE REGARDING THIS INITIAL REPORT. ADDITIONAL INFORMATION: INTERNAL CLINICAL ASSESSMENT IDENTIFIED THAT THE PATIENT HAS A DOCUMENTED HISTORY OF TYPE B AORTIC DISSECTION WITH MULTIPLE REPAIRS, INCLUDING A (PRE-EXISTING) TEVAR FOR DISSECTION ON (B)(6) 2016, WHICH WAS PRIOR TO THE EVAR WITH ENDOLOGIX DEVICES ON (B)(6) 2016. THEREFORE, A COMPLAINT IS NOT WARRANTED SINCE THERE IS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE. THIS EVENT IS NO LONGER REPORTABLE.

  Patient problems: Vascular Dissection

  MAUDE report 17599960 ↗
• InjuryJan 18, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST-INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WAS IDENTIFIED. RE-INTERVENTION WAS PERFORMED AND THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL AFX VELA INFRARENAL. THE FINAL PATIENT STATUS WAS REPORTED AS BEING GOOD POST-INTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 16200306 ↗
• InjuryJan 3, 2023Material Puncture/Hole; Unintended Movement; Material Puncture/Hole; Unintended Movement

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN EXPANDING ANEURYSM, LIMB MOVEMENT, AND AN ENDOLEAK (INDETERMINATE ORIGIN). THE PATIENT'S CURRENT STATUS IS STABLE AND THE PHYSICIAN PLANS TO DO A RE-INTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak; Failure of Implant

  MAUDE report 16092147 ↗
• InjuryJul 27, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT, GORE EXCLUDER LEG STENT (NON-ENDOLOGIX), AND A NON-ENDOLOGIX S.M.A.R.T STENT (NON-ENDOLOGIX). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, AN ENDOLEAK OF INDETERMINATE ORIGIN AND AN ANEURYSM ENLARGEMENT WERE REPORTED. THE PATIENT IS BEING MONITORED AS FUTURE TREATMENT PLANS ARE BEING DISCUSSED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15114126 ↗
• InjuryMar 18, 2022Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL AND AN AFX VELA SUPRARENAL (MOST PROXIMAL) EXTENSION. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IIIB ENDOLEAK AND ASYMPTOMATIC. IT IS UNKNOWN IF THE PHYSICIAN PLANS TO RE-INTERVENE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13807630 ↗
• InjurySep 13, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW UP, A TYPE 3B ENDOLEAK WAS IDENTIFIED ON THE PROXIMAL EXTENSION AND THE PATIENT WAS TREATED WITH TWO (2) INFRARENAL STENT GRAFT EXTENSIONS AND ANOTHER SUPRARENAL STENT GRAFT EXTENSION TO TREAT THE ENDOLEAK. THIS EVENT WAS REPORTED UNDER MDR#2031527-2020-00342. NOW, APPROXIMATELY EIGHT (8) MONTHS POST INTERVENTION THE PATIENT HAS BEEN IDENTIFIED WITH A POSSIBLE TYPE 3B ENDOLEAK. A RE-INTERVENTION IS PLANNED BUT HAS NOT BEEN SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 12464624 ↗
• InjurySep 2, 2021Patient-Device Incompatibility; Device-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Device-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX BIFURCATED STENT GRAFT, A VELA SUPRARENAL STENT GRAFT, AND THREE (3) LIMB STENT GRAFTS. APPROXIMATELY SIX (6) YEARS AFTER THE INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WAS IDENTIFIED DURING A ROUTINE FOLLOW-UP. THE PHYSICIAN DOES NOT PLAN ON DOING A RE-INTERVENTION AT THIS TIME SINCE THE PATIENT IS CURRENTLY UNDERGOING CANCER TREATMENT. THE PATIENT WILL CONTINUE TO BE MONITORED. ADDITIONAL INFORMATION: DURING THE CLINICAL ASSESSMENT, THERE WAS EVIDENCE TO REASONABLY SUGGEST ON (B)(6) 2015, A SECONDARY ENDOVASCULAR PROCEDURE WAS COMPLETED FOR A RIGHT ILIAC ANEURYSM REPAIR. AN AFX LIMB EXTENSION, A SNORKEL STENT (NON- ENDOLOGIX) AND TWO OTHER NON - ENDOLOGIX STENTS (VIABAHN AND ICAST) WERE IMPLANTED WITHIN THE RIGHT INTERNAL ILIAC ARTERY. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. IT IS UNCLEAR IF THIS EVENT FROM 2015 IS RELATED TO THE ENDOLOGIX DEVICE. THIS EVENT OF 2015 WILL BE INVESTIGATED SEPARATELY AND A SEPARATE MDR WILL BE FILED IF REQUIRED OR NEEDED. THE REPORTED TYPE 3A ENDOLEAK WAS INCORRECTLY REP

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12414997 ↗
• InjuryJul 12, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH ANEURYSM ENLARGEMENT (UNKNOWN DIAMETER) AND A POTENTIAL TYPE IIIB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN AFX2 BIFURCATED STENT GRAFT ON (B)(6) 2021.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12150640 ↗
• InjuryApr 27, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ANEURYSM ENLARGEMENT (5.7MM TO 7.5MM) AND A SUSPECT TYPE IIIB ENDOLEAK. THE PATIENT IS REPORTEDLY IN GOOD CONDITION, AND A RE-INTERVENTION IS CURRENTLY SCHEDULED. ADDITIONAL INFORMATION: REVIEW OF ANGIOGRAM DATED 30APR2021 FOUND NO ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ALTO MAIN BODY STENT GRAFT AND THREE (3) OVATION IX ILIAC LIMBS TO TREAT THE ANEURYSM ENLARGEMENT. THE PATIENT WAS REPORTED AS DOING WELL POST SECONDARY PROCEDURE. A COMPLAINT IS NOT WARRANTED SINCE THERE IS NO ALLEGED DEFICIENCY RELATED TO IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11734993 ↗
• DeathJan 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, STENOSIS WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Stenosis

  MAUDE report 11216507 ↗
• DeathDec 7, 2020Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY EMERGENTLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE PATIENT PRESENTED EMERGENT WITH GROIN, BELLY AND BACK PAIN. A RUPTURED ANEURYSM DUE TO A SEPARATION OF THE DEVICES (TYPE 3A ENDOLEAK) WAS IDENTIFIED BY A COMPUTERIZED TOMOGRAPHY (CT) SCAN. IT WAS REPORTED THAT THE PATIENT CODED WHILE IN TRANSIT AND WAS WITHOUT A PULSE FOR AN EXTENDED AMOUNT OF TIME BUT THE TEAM WAS ABLE TO REVIVE HIM WITH COMPRESSIONS AND EPINEPHRINE. THE PHYSICIAN WAS ELECTED TO IMPLANT A VELA SUPRARENAL AORTIC EXTENSION AND THE FINAL ANGIOGRAM LOOKED SUCCESSFUL. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO COMPLICATIONS FROM OPENING THE ABDOMEN ONE DAY POST RE-INTERVENTION TO TREAT COMPARTMENT SYNDROME.

  Patient problems: Death; Rupture

  MAUDE report 10960000 ↗
• InjuryApr 13, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND (2) VELA SUPRARENAL STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 4.5 YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP A TYPE 1A ENDOLEAK WAS IDENTIFIED. PATIENT IS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 9955497 ↗
• DeathApr 3, 2020Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4.5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED AAA TO THE EMERGENCY ROOM (ER). A TYPE 3A ENDOLEAK WITH SAC GROWTH WAS IDENTIFIED. THE PHYSICIAN ELECTED TO PERFORM AN OPEN REPAIR AND THE DEVICES WERE EXPLANTED. THE PATIENT WAS REPORTED TO NOT BE IN GOOD HEALTH POST INTERVENTION AND EXPIRED DUE TO POST SURGERY COMPLICATIONS.

  Patient problems: Aneurysm; Death; Rupture

  MAUDE report 9924059 ↗
• InjuryFeb 25, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IIIB ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH A GORE (NON-ENDOLOGIX) EXCLUDER. THE PATIENT WAS REPORTEDLY IN GOOD CONDITION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: CLINICAL INVESTIGATION IDENTIFIED EVIDENCE TO REASONABLY SUGGEST SAC GROWTH OF 9MM AND A CONTAINED RUPTURE HAD OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE FINAL PATIENT STATUS WAS DISCHARGED HOME ON THE FIRST POSTOPERATIVE DAY FOLLOWING A SECONDARY ENDOVASCULAR PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant; Rupture

  MAUDE report 9751727 ↗
• InjuryFeb 11, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND A LIMB STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 3B ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH OVATION IX ABDOMINAL STENT GRAFT SYSTEM. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9696063 ↗
• DeathNov 15, 2019Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 3B ENDOLEAK WITH SAC GROWTH WAS IDENTIFIED WHILE THE PATIENT WAS BEING TREATED FOR A BOWEL OBSTRUCTION. THE PATIENT WAS REPORTED AS STABLE AND AN INTERVENTION HAS BEEN SCHEDULED. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DUE TO COMPLICATIONS FROM HER SMALL BOWEL INSTRUCTION SURGERY.

  Patient problems: Aneurysm; Death

  MAUDE report 9329097 ↗
• InjuryAug 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3.5 YEARS POST INITIAL PROCEDURE, (EXACT DATE WAS NOT REPORTED) AN ENDOLEAK OF INDETERMINATE ORIGIN (POSSIBLE TYPE 1, 2 AND /OR 3A). AN INTERVENTION HAS BEEN SCHEDULED AND THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 8898238 ↗
• InjuryAug 8, 2019Collapse; Material Puncture/Hole; Collapse; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THERE (3) YEARS POST INITIAL PROCEDURE, (EXACT DATE WAS NOT PROVIDED) A TYPE 3B ENDOLEAK WITH SAC GROWTH WAS IDENTIFIED. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL STENT GRAFT EXTENSION AND TWO (2) OVATION IX ILIAC LIMBS TO RESOLVE THIS REPORTED EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST INTERVENTION. ADDITIONALLY, CLINICAL ASSESSMENT DETERMINED THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE 2 ENDOLEAK OF THE LUMBAR (NON DEVICE RELATED FAILURE) AND DISTAL STENT BUCKLING OF THE BIFURCATED STENT GRAFT.

  Patient problems: Aneurysm; Patient Problem/Medical Problem

  MAUDE report 8874466 ↗
• InjuryJun 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE (THE EXACT DATE WAS NOT PROVIDE), A TYPE 1A ENDOLEAK WAS IDENTIFIED. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT A SUPRARENAL STENT GRAFT EXTENSION TO RESOLVE THIS LEAK. THE INTERVENTION WAS SUCCESSFUL AND THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 8668831 ↗
• InjuryMay 3, 2019Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT CONFIRMING THAT THE PATIENT WAS INITIALLY TREATED ON AN EMERGENT BASIS (OFF-LABEL USE) DUE TO A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8579359 ↗
• InjuryJan 31, 2019Material Puncture/Hole; Product Quality Problem; Material Integrity Problem; Material Puncture/Hole; Product Quality Problem; Material Integrity Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A FABRIC TEAR (TYPE IIIB ENDOLEAK) AND ANEURYSM GROWTH WERE DETECTED PER ROUTINE FOLLOW-UP CT. THE PHYSICIAN PLANS TO RE-INTERVENE IN (B)(6) 2019. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8292603 ↗
• InjuryOct 23, 2018Leak/Splash; Off-Label Use; Leak/Splash; Off-Label Use

  THE PATIENT WAS READMITTED TO THE HOSPITAL THREE (3) YEARS POST OP FOR ABDOMINAL PAIN AND HAS GI ISSUES/ILEAUS AND INFECTION. THE CTA SHOWED AAA SIZE ( 11CM ) AND EVIDENCE OF A POTENTIAL TYPE IA/IB AND TYPE II ENDOLEAK. AS OF THE DATE OF THIS REPORT THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THERE ARE NO PLANS FOR A RE-INTERVENTION. REFERENCE MDR 2031527-2016-00120 FOR PREVIOUSLY REPORTED TYPE IA ENDOLEAK AND RE-INTERVENTION AND MDR 2031527-2017-00256 FOR PREVIOUSLY REPORTED TYPE IB ENDOLEAK AND RE-INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 7997897 ↗
• InjuryJul 24, 2018Unintended Movement; Unintended Movement

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A COMPONENT SEPARATION AND ANEURYSM SAC ENLARGEMENT PER FOLLOW-UP CT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EXPLANTING THE AFX STENT, AND THE PROCEDURE CONCLUDED WITHOUT INCIDENT. THE PATIENT IS DOING WELL AND IS EXPECTED TO MAKE A FULL RECOVERY. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7713825 ↗
• InjuryJun 13, 2018Leak/Splash; Leak/Splash

  ENDOLOGIX WAS MADE AWARE OF PATIENT WITH AN UNDETERMINED ENDOLEAK WITH SAC GROWTH ON (B)(6) 2018. THE SAC GROWTH WAS DISCOVERED ON (B)(6) 2018 DURING A ROUTINE PATIENT FOLLOW UP. HOWEVER ON (B)(6) 2018, IT WAS CONFIRMED BY THE REP THAT THE PATIENT HAD A TYPE 2 ENDOLEAK WITH A POSSIBLE TYPE 1A, ALONG WITH SAC GROWTH. ON (B)(6) 2018 A SECONDARY PROCEDURE WAS PERFORMED. PHYSICIAN DID A AORTIC PROXIMAL EXTENSION PLACEMENT. THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT, A SUPRARENAL EXTENSION AND TWO (2) LIMB EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM BACK ON (B)(6) 2015. NO FURTHER INFORMATION PROVIDED ON PATIENT CONDITION POST OP.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7599130 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040002. One submission often covers many models, so check the product and lot details in each record.

• Z-1048-2017 · Jan 4, 2017 · Terminated
  AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C
• Z-1049-2017 · Jan 4, 2017 · Terminated
  AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 B
• Z-1037-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1038-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (A
• Z-1054-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• Z-1047-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoili
• Z-1039-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• Z-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• Z-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• Z-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• Z-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL

…and 1 more.