AFX Endovascular AAA System BA28-90/I20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00818009012630), received between Apr 1, 2016 and Dec 6, 2023 — classified as 1 death, 49 injuries.

The most frequently reported specific device problem is “Leak/Splash” (21 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 50 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2023Material Puncture/Hole; Device-Device Incompatibility; Material Puncture/Hole; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF AN AFX BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN OVATION IX EXTENDER. APPROXIMATELY SIX (6) YEARS AFTER THE INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) OVATION IX ILIAC LIMBS, AN OVATION PRIME FILL POLYMER, AND AN ALTO MAIN BODY. IT WAS REPORTED THAT THE ENDOLEAK WAS RESOLVED POST-PROCEDURE. ADDITIONAL INFORMATION: A CLINICAL EVALUATION REVEALED EVIDENCE INDICATING THE PRESENCE OF A SAC GROWTH MEASURING 6.9 MM. THIS GROWTH WAS IDENTIFIED DURING A REVIEW ANALYSIS OF THE CT (COMPUTED TOMOGRAPHY) SCAN CONDUCTED ON (B)(6) 2023.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18278780 ↗
• InjuryAug 29, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT, AFX LIMB STENT GRAFT, AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY SEVEN (7) YEARS AFTER POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ENDOLEAK TYPE IB, ENDOLEAK TYPE IIIA, AND ENDOLEAK TYPE IIIB. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) OVATION IX EXTENDERS AND AN AFX2 BIFURCATED STENT GRAFT. THE PATIENT REPORTEDLY IS IN STABLE CONDITION POST RE-INTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 17644562 ↗
• InjuryJan 27, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX BIFURCATED STENT GRAFT AND AN AFX LIMB STENT GRAFT IN THE RIGHT COMMON ILIAC (RCI). APPROXIMATELY SIX (6) YEARS POST INITIAL IMPLANT, A TYPE IIIA ENDOLEAK WAS IDENTIFIED AT ROUTINE FOLLOW UP. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF TWO (2) AFX LIMB STENT GRAFT'S IN THE RCI. REPORTED UNDER MFR# 2031527-2021-00137. NOW, APPROXIMATELY A YEAR AND A HALF (1.5) YEARS POST REINTERVENTION, A TYPE IIIA ENDOLEAK WAS IDENTIFIED AT ROUTINE FOLLOW UP. AN ADDITIONAL INTERVENTION HAS NOT YET BEEN SCHEDULED. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN OVATION IX ILIAC LIMB ON (B)(6) 2023.

  Patient problems: Clinical Endoleak

  MAUDE report 16254954 ↗
• InjuryOct 13, 2022Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX BIFURCATED STENT GRAFT, A VELA SUPRARENAL STENT GRAFT, AND TWO (2) LIMB STENT GRAFTS. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE A TYPE 3A ENDOLEAK WAS IDENTIFIED. RE-INTERVENTION WAS COMPLETED SUCCESSFULLY WITH THE IMPLANT OF AN OVATION IX ILIAC LIMB. THE FINAL PATIENT STATUS WAS REPORTED AS BEING STABLE.

  Patient problems: Failure of Implant

  MAUDE report 15600973 ↗
• InjuryMay 26, 2022Material Puncture/Hole; Material Puncture/Hole

  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, A TYPE 3B ENDOLEAK WITH ANEURYSM ENLARGEMENT WAS IDENTIFIED VIA COMPUTERIZED TOMOGRAPHY AT ROUTINE FOLLOW-UP VISIT. REINTERVENTION HAS NOT YET BEEN SCHEDULED. THE PATIENT IS REPORTED TO BE GOOD.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14519283 ↗
• InjuryFeb 22, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE A RUPTURED AORTA WAS IDENTIFIED WITH A TYPE IIIA ENDOLEAK. REINTERVENTION WAS COMPLETED WITH IMPLANT OF A MEDTRONIC (NON-ENDOLOGIX) DEVICE(S). THE PATIENT WAS REPORTED TO BE DOING WELL POST REINTERVENTION.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 13579915 ↗
• InjuryNov 9, 2021Off-Label Use; Insufficient Device Problem Information; Off-Label Use; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A NON-ENDOLOGIX THORACIC CUFF TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA); THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM PER DEVICE IFU. REPORTEDLY, THE INITIAL PROCEDURE WAS DONE EMERGENTLY (OFF-LABEL) AND THE THORACIC CUFF WAS PLACED INSIDE THE AFX BIFURCATED STENT GRAFT TO GAIN SEAL AND STABILIZE THE PATIENT. NOW, APPROXIMATELY 6 YEARS POST INITIAL PROCEDURE, PATIENT PRESENTED WITH ABDOMINAL PAIN AND A TYPE 1A ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICE WITH ANOTHER BIFURCATED STENT GRAFT TO RESOLVE THE REPORTED EVENT. THE INTERVENTION WAS REPORTED AS SUCCESSFUL AND THE PATIENT WAS STABLE AND DISCHARGED THE DAY AFTER THE PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 12780034 ↗
• InjuryApr 26, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 5.5 YEARS POST INITIAL PROCEDURE, IT APPEARS THAT THE PATIENTS AORTIC NECK HAS DILATED CAUSING THE BIFURCATED STENT GRAFT TO MOVE. THE GRAFT IS NO LONGER COVERING THE RENAL ARTERIES. THERE IS NO EVIDENCE OF AN ENDOLEAK. THE PATIENT IS STABLE AND BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 11728447 ↗
• InjuryMar 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A LIMB STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 6 YEARS POST INITIAL IMPLANT DURING A ROUTINE FOLLOW UP, A 3A ENDOLEAK WAS IDENTIFIED. REPORTEDLY, THE PATIENT IS STABLE AND IS PENDING A RE-INTERVENTION. ADDITIONAL INFORMATION: THE PHYSICIAN ELECTED TO IMPLANT TWO (2) ILIAC LIMBS TO RESOLVE THE EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST SECONDARY PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 11499535 ↗
• InjuryMar 7, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, TWO (2) VELA INFRARENAL STENT GRAFT EXTENSIONS, AND TWO (2) LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL IMPLANT, A TYPE 3B ENDOLEAK WITH SAC GROWTH WERE IDENTIFIED. A RE-INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN AFX VELA SUPRARENAL AND AN AFX2 BIFURCATED STENT GRAFT TO TREAT THIS EVENT. THE PATIENT IS CURRENTLY BE MONITORED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11426317 ↗
• InjuryNov 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE AND A HALF (5.5) YEARS LATER DURING A ROUTINE FOLLOW UP, ANEURYSM GROWTH TO 6.3CM WAS IDENTIFIED WITH NO ENDOLEAK PRESENT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN OVATION IX ABDOMINAL AORTIC ANEURYSM STENT ON (B)(6) 2020. THE PATIENT IS REPORTEDLY IN STABLE CONDITION POST SECONDARY ENDOVASCULAR REPAIR. ADDITIONAL INFORMATION: CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST MULTIPLE TYPE II ENDOLEAKS OCCURRED. THE TYPE II ENDOLEAKS WERE DISCOVERED DURING A REVIEW OF THE 62 MONTH POST IMPLANT COMPUTED TOMOGRAPHY (CT) SCAN. AS A TYPE II ENDOLEAK IS ANATOMY-RELATED, THIS EVENT IS NO LONGER REPORTABLE TO THE FDA AS THERE IS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF AN ENDOLOGIX DEVICE.

  Patient problems: Aneurysm

  MAUDE report 10778488 ↗
• InjurySep 12, 2020Insufficient Device Problem Information; Separation Problem; Insufficient Device Problem Information; Separation Problem

  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, A TYPE 3A ENDOLEAK WITH DEVICE SEPARATION WAS IDENTIFIED. RE-INTERVENTION COMPLETED SUCCESSFULLY. THE PHYSICIAN IMPLANTED AN AFX VELA SUPRARENAL SENT GRAFT TO BRIDGE THE SEPARATED DEVICES. THE FINAL PATIENT STATUS WAS REPORTED AS BEING STABLE.

  Patient problems: Failure of Implant

  MAUDE report 10526055 ↗
• InjuryJun 15, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE 5.5 YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW-UP, A TYPE IIIA ENDOLEAK WAS DETECTED VIA A COMPUTERIZED TOMOGRAPHY ANGIOGRAM. RE-INTERVENTION WAS COMPLETED WITH IMPLANT OF AN AFX VELA SUPRARENAL AND AN AFX VELA INFRARENAL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10154716 ↗
• InjuryApr 14, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  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, THE PATIENT PRESENTED WITH A TYPE 3A ENDOLEAK. THE PATIENT WAS REPORTEDLY STABLE.

  Patient problems: Failure of Implant

  MAUDE report 9960914 ↗
• InjuryFeb 12, 2020Insufficient 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 FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK WITH SAC GROWTH WAS IDENTIFIED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY AN OVATION LIMB EXTENSION. PATIENT IS DOING WELL. THE PATIENT WAS RECENTLY IMPLANTED (NON - ENDOLOGIX) COILS IN THE IMA (INFERIOR MESENTERIC ARTERY) DUE TO A TYPE 2 ENDOLEAK (NON- DEVICE RELATED).

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9703518 ↗
• InjuryDec 31, 2019Misconnection; Separation Problem; Misconnection; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A TYPE IIIA ENDOLEAK WITH IMPLANT SEPARATION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A MEDTRONIC (NON-ENDOLOGIX) THORACIC CUFF DEVICE ON (B)(6) 2019, HOWEVER, NOT ENOUGH OVERLAP WAS ACHIEVED. ANOTHER TWO (2) DAYS LATER, THE PATIENT AGAIN PRESENTED EMERGENTLY WITH AN ANEURYSM RUPTURE. THE PHYSICIAN TREATED BY UNKNOWN MEANS BUT SUFFICIENT OVERLAP WAS CONFIRMED AND THE ANEURYSM SUCCESSFULLY SEALED. PATIENT IS REPORTEDLY DOING WELL AND RECOVERING. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH A VELA SUPRARENAL PROXIMAL EXTENSION AND A VELA INFRARENAL PROXIMAL EXTENSION TO SEAL THE ENDOLEAK. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION THREE (3) DAYS POST ENDOVASCULAR PROCEDURE.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 9536945 ↗
• InjuryDec 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A INFRARENAL STENT GRAFT AND A LIMB STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY, THREE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED SAC GROWTH WITH NO IDENTIFIABLE LEAK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO IDENTIFIABLE LEAK BUT THE AAA HAS GROWN SIGNIFICANTLY. THE PATIENT IS DOING WELL. ADDITIONAL INFORMATION: THE PHYSICIAN ELECTED TO RELINED THE ORIGINALLY IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT, AFX SUPRARENAL STENT GRAFT, AND AN OVATION IX EXTENDER LIMB STENT GRAFT TO RESOLVE THIS EVENT. DURING THE REVIEW OF MEDICAL IMAGES / RECORDS, A TYPE 1B ENDOLEAK OF THE RIGHT COMMON ILIAC ARTERY AND A SMALL TYPE 1A ENDOLEAK WERE IDENTIFIED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9508911 ↗
• InjuryOct 14, 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 FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 3B ENDOLEAK WITH SAC GROWTH WAS REPORTED. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED USE NON- ENDOLOGIX STENTS TO RESOLVE THIS EVENT. THE INTERVENTION WAS SUCCESSFUL AND THE PATIENT WAS REPORTED AS STABLE. ADDITIONAL INFORMATION: DURING OUR INVESTIGATION, THE REPORTED TYPE 3B ENDOLEAK WAS REFUTED, RATHER IT WAS A TYPE 1B ENDOLEAK FROM THE LEFT COMMON ILIAC ARTERY.

  Patient problems: Aneurysm

  MAUDE report 9186966 ↗
• InjuryJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND TWO (2) INFRARENAL STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3.5 YEARS POST INITIAL PROCEDURE, A TYPE 2 ENDOLEAK (NON - DEVICE RELATED FAILURE) OF INFERIOR MESENTERIC ARTERY (IMA) WAS REPORTED AND THE PHYSICIAN ELECTED TO COIL THE IMA. NOW, APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK ON THE RIGHT SIDE WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. 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 EXTENDER TO RESOLVE THIS REPORTED EVENT. THE PATIENT WAS REPORTED TO BE DISCHARGED POST INTERVENTION WITH NO ISSUES.

  Patient problems: Failure of Implant

  MAUDE report 8805500 ↗
• InjuryJun 4, 2019Insufficient Device Problem Information; Separation Problem; Insufficient Device Problem Information; Separation Problem

  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, THE PATIENT PRESENTED EMERGENTLY WITH PAIN. A COMPUTERIZED TOMOGRAPHY (CTA) SCAN IDENTIFIED A TYPE 3A ENDOLEAK WITH INSUFFICIENT OVERLAP AND COMPONENT SEPARATION, SAC GROWTH AND RIGHT SIDE ILIAC ANEURYSM. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT A SUPRARENAL STENT GRAFT EXTENSION AND A LIMB STENT GRAFT TO RESOLVE THIS EVENT. THE PATIENT WAS DISCHARGED WITH NO ISSUES NOTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8668832 ↗
• InjuryApr 8, 2019Misconnection; Deformation Due to Compressive Stress; Insufficient Device Problem Information; Misconnection; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE IIIA ENDOLEAK WITH ANEURYSM ENLARGEMENT (4.8CM TO 5.5CM) WERE DETECTED DURING ROUTINE FOLLOW-UP CT. THE PHYSICIAN PLANS TO RELINE AND WILL CONTINUE TO MONITOR THE PATIENT. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8493378 ↗
• InjuryMar 13, 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 FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN; THE SUBSEQUENT CT REVEALED A TYPE IB (RIGHT SIDE) AND TYPE III (A OR B AT THE BIFURCATION) ENDOLEAKS. IN IMMEDIATE RESPONSE, THE RIGHT INTERNAL WAS COILED, AND THE PATIENT WAS REPORTEDLY IN STABLE CONDITION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH A BIFURCATED AFX2, AN OVATION IX EXTENDER, AND OVATION IX ILIAC LIMB DEVICES ON 14 FEB 2019. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8416379 ↗
• InjuryJan 4, 2019Disconnection; Leak/Splash; Misconnection; Device Dislodged or Dislocated; Disconnection; Leak/Splash; Misconnection; Device Dislodged or Dislocated

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A COMPONENT SEPARATION WAS DETECTED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH A MEDTRONIC (NON-ENDOLOGIX) DEVICE ON AN UNKNOWN DATE. THE PATIENT IS REPORTEDLY DOING WELL. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8220439 ↗
• InjuryNov 21, 2018Leak/Splash; Stretched; Leak/Splash; Stretched

  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 IMPLANT, SAC GROWTH HAS BEEN REPORTED WITH NO VISIBLE ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANT WITH ANOTHER BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION. THE PHYSICIAN ALSO PLACED SEVERAL COILS IN THE ANEURYSM SAC. THE PATIENT WAS REPORTED AS STABLE POST SECONDARY PROCEDURE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8097855 ↗
• InjuryNov 9, 2018Leak/Splash; Material Puncture/Hole; Product Quality Problem; Material Integrity Problem; Leak/Splash; Material Puncture/Hole; Product Quality Problem; Material Integrity Problem

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A TYPE IIIB ENDOLEAK WAS DETECTED BY ROUTINE FOLLOW-UP CT. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT WHO IS REPORTED IN STABLE CONDITION. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8057534 ↗

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-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-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• 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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• 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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• 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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL

…and 1 more.