AFX2 Bifurcated Endograft System BEA28-80/I20-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00818009014412), received between Aug 4, 2016 and Aug 11, 2025 — classified as 1 death, 42 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 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 43 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Off-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 AFX2 BIFURCATED STENT GRAFT AN AFX VELA SUPRARENAL, AN AFX VELA INFRARENAL, AND TWO OVATION IX ILIAC LIMBS. DURING A ROUTINE FOLLOW UP ON (B)(6) 2025, A TYPE IIIB ENDOLEAK WAS IDENTIFIED. REINTERVENTION WAS PERFORMED ON (B)(6) 2025 WIT THE IMPLANT OF AN ALTO ABDOMINAL STENT SYSTEM, AN ADDITIONAL OVATION IX ILIAC LIMB, AND TWO OVATION IX LIMB EXTENSIONS. THE LEAK WAS RESOLVED AND THE PATIENT IS DOING WELL. NOTE: THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22770034 ↗
• InjuryJul 30, 2025Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2023 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AFX VELA SUPRARENAL, AFX VELA INFRARENAL, AND AN OVATION IX EXTENDER. ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2025 IDENTIFIED A POSSIBLE TEAR AT THE BIFURCATION AREA OF THE MAIN BODY (TYPE IIIB ENDOLEAK). REPORTEDLY, THERE IS ALSO THE POSSIBILITY OF A TYPE IB ENDOLEAK AS WELL SINCE THE LEAK COULD BE COMING FROM THE LEFT LIMB. REINTERVENTION WAS COMPLETED ON (B)(6) 2025. THE SURGEON ELECTED TO RE-LINE THE GRAFT BY IMPLANTING AN AFX VELA SUPRARENAL, AFX VELA INFRARENAL AND OVATION IX EXTENDER. PATIENT STATUS WAS REPORTED AS DOING WELL POST SECONDARY PROCEDURE. THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED.

  Patient problems: Clinical Endoleak

  MAUDE report 22667685 ↗
• InjuryJun 30, 2025Unintended Movement; Unintended Movement

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2018. APPROXIMATELY SEVEN (7) YEARS AFTER THE INITIAL PROCEDURE, A COMPONENT SEPARATION WAS REPORTED, RESULTING IN A TYPE IIIA ENDOLEAK. REINTERVENTION WAS COMPLETED ON 26 JUNE 2025 WITH THE IMPLANT OF TWO AFX VELA INFRARENAL.

  Patient problems: Clinical Endoleak

  MAUDE report 22359615 ↗
• InjuryMar 7, 2025Collapse; Off-Label Use; Lack of Effect; Collapse; Off-Label Use; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN OVATION IX ILIAC LIMB TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE, DURING FOLLOW UP A TYPE 1A ENDOLEAK AND A TYPE 1B ENDOLEAK (FROM THE LEFT COMMON ILIAC ARTERY) WERE IDENTIFIED. 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. THE PHYSICIAN ELECTED TO IMPLANT AN INFRARENAL AORTIC EXTENSION AND AN OVATION IX ILIAC LIMB TO RESOLVE THIS EVENT. THE FINAL PATIENT STATUS WAS REPORTED AS DISCHARGED HOME AND RECOVERING.

  Patient problems: Clinical Endoleak

  MAUDE report 21546459 ↗
• InjuryDec 26, 2024Off-Label Use; Obstruction of Flow; Off-Label Use; Obstruction of Flow

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) MONTHS POST PROCEDURE, DURING A ROUTINE FOLLOW UP, LEFT ILIAC LIMB OCCLUSION WAS IDENTIFIED. ON (B)(6) 2024 A RCIA EXPRESS (NON-ENDOLOGIX) STENT WAS IMPLANTED. PATIENT STATUS IS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21021738 ↗
• InjuryJun 7, 2024Off-Label Use; Off-Label Use

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL AORTIC EXTENSION, TWO EXCLUDER (NON-ENDOLOGIX) ILIAC LIMBS THAT WERE IMPLANTED BILATERALLY, AND THE LEFT INTERNAL ILIAC ARTERY (IIA) WAS OCCLUDED WITH COILS FOR TREATMENT OF A COMMON ILIAC ARTERY ANEURYSM (CIAA). IT WAS NOTED THAT THE RIGHT (IIA) HAD BEEN OCCLUDED PRIOR TO THE ENDOVASCULAR AORTIC REPAIR (EVAR). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE TREATMENT OF AN CIAA AND THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE AN INDETERMINATE TYPE ENDOLEAK AND RIGHT CIAA ENLARGEMENT MEASURING APPROXIMATELY 40MM. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19488971 ↗
• InjuryMay 16, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, DURING ROUTINE FOLLOW-UP A POSSIBLE TYPE 3B ENDOLEAK WAS DISCOVERED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST SECONDARY PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 19329092 ↗
• InjuryMar 8, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2019, WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. IT WAS REPORTED ON (B)(6) 2024, THAT ROUTINE FOLLOW-UP COMPUTED TOMOGRAPHY SCAN IDENTIFIED ANEURYSM ENLARGEMENT AND A POSSIBLE TYPE IB ENDOLEAK. REINTERVENTION IS SCHEDULED FOR (B)(6) 2024. THE PATIENT IS STABLE. REINTERVENTION WAS COMPLETED ON (B)(6) 2024 WITH THE IMPLANT OF AN AFX LIMB STENT GRAFT AND AN OVATION IX EXTENDER. REPORTEDLY, THE POSSIBLE TYPE IB ENDOLEAK WAS NOT SEEN AT REINTERVENTION; HOWEVER, THE PHYSICIAN ELECTED TO EXTEND THE LIMB. THE PATIENT WAS FINE POST-REINTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18867896 ↗
• InjuryAug 28, 2023Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS BEING TREATED FOR AN ILIAC ARTERY ANEURYSMS ON (B)(6) 2023. AFTER OCCLUDING THE LEFT INTERNAL ILIAC ARTERY, A GORE (NON-ENDOLOGIX) CONTRALATERAL LEG ENDOPROSTHESIS (CLE) WAS IMPLANTED ON THE LEFT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. FROM THE RIGHT ACCESS THE AFX2 BIFURCATED STENT GRAFT (BSG) DELIVERY SYSTEM WAS INSERTED AND THE AFX2 BIFURCATED STENT GRAFT WAS DEPLOYED. A GORE ILIAC BRANCH ENDOPROSTHESIS (IBE) STENT GRAFT WAS THEN IMPLANTED ON THE RIGHT SUPERIOR GLUTEAL ARTERY, AND THREE GORE INTERNAL ILIAC COMPONENT (IIC) LEGS WERE ADDED. AFTER BALLOON TOUCH-UP, TYPE IIIA ENDOLEAK WAS CONFIRMED BETWEEN IBE LEG JUNCTIONS; THEREFORE, TWO MORE GORE IIC LEGS WERE ADDED. BALLOON TOUCH-UP WAS PERFORMED AGAIN. THE FINAL ANGIOGRAPHY IDENTIFIED A TYPE IIIB ENDOLEAK AROUND THE AFX2 BSG BIFURCATION. A GORE IPSILATERAL LEG ENDOPROSTHESIS (ILE) AND A GORE CLE WERE ADDED INSIDE THE AFX2 BSG, AND ONE MORE CLE WAS ADDED. BALLOON TOUCH-UP WAS PERFORMED. HOWEVER, TYPE IIIB ENDOLEAK WAS STILL OBSERVED. REPORTEDLY, IT IS POSSIBLE THAT THE LEAK FROM THE IBE JUNCTIONS WAS FLOWING TO AFX2 BSG TYPE IIIB ENDOLEAK AREA. A TYPE IA ENDOLEAK WAS ALSO CONFIRMED; THEREFORE, A GORE LC

  Patient problems: Clinical Endoleak

  MAUDE report 17638471 ↗
• InjuryMay 24, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT ON AN UNKNOWN DATE. THE PATIENT LATER PRESENTED WITH EXPANDING COMMON ILIAC ANEURYSMS (UNKNOWN DISTANCE), AND THE STENT GRAFT APPEARS TO BE INTACT WITH NO ISSUES. THE PATIENT WILL CONTINUE TO BE MONITORED, AND IS REPORTEDLY IN STABLE CONDITION.

  Patient problems: Aneurysm

  MAUDE report 16994445 ↗
• InjuryFeb 21, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX AND HALF (6.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED STABLE WITH A TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE THE ORIGINALLY IMPLANTED STENT GRAFTS WITH A MEDTRONIC (NON-ENDOLOGIX) STENT GRAFT TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST THIS SECONDARY PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 16414678 ↗
• InjuryJan 28, 2023Migration or Expulsion of Device; Material Puncture/Hole; Lack of Effect; Migration or Expulsion of Device; Material Puncture/Hole; Lack of Effect

  ON (B)(6) 2016, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. ON (B)(6) 2023, ANEURYSM ENLARGEMENT WITH DISTAL MOVEMENT OF THE AFX2 BIFURCATED STENT GRAFT OF APPROXIMATELY 1-2CM WAS IDENTIFIED AT ROUTINE FOLLOW-UP. SUCCESSFUL REINTERVENTION WAS COMPLETED ON (B)(6) 2023, WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. PATIENT WAS DISCHARGED ONE DAY POST-REINTERVENTION..

  Patient problems: Aneurysm

  MAUDE report 16261625 ↗
• InjuryDec 8, 2022Material Puncture/Hole; Improper or Incorrect Procedure or Method; Material Puncture/Hole; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL PROXIMAL EXTENSION, AND AN AFX LIMB STENT GRAFT DISTAL EXTENSION. APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A POTENTIAL TYPE IIIB ENDOLEAK AS DETECTED PER CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) OVATION IX DISTAL EXTENDERS ON (B)(6) 2022. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Aneurysm; Clinical Endoleak; Failure of Implant

  MAUDE report 15945980 ↗
• InjuryAug 31, 2022Off-Label Use; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL AND AN OVATION IX ILIAC LIMB. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX2 SYSTEM PER THE IFU. REPORTEDLY, AT THE INITIAL PROCEDURE, THE PATIENT HAD A RIGHT COMMON ILIAC ANEURYSM AND THE PHYSICIAN ELECTED TO LAND ON TH LEFT IN ORDER TO SPARE THE LEFT INTERNAL. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, ROUTINE FOLLOW-UP IDENTIFIED A TYPE IB ENDOLEAK IN THE LEFT COMMON ILIAC ARTERY WITH THE ANEURYSM AT 25MM. REINTERVENTION HAS BEEN SCHEDULED. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Failure of Implant

  MAUDE report 15328839 ↗
• InjuryAug 25, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND AN OVATION EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4 YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW UP A TYPE 3A ENDOLEAK WAS IDENTIFIED. PATIENT IS PENDING A FOLLOW UP ANGIOGRAM AND THE PHYSICIAN IS PLANNING A RE-INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 15296028 ↗
• InjuryJul 21, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 5 YEARS POST INITIAL PROCEDURE, A TYPE 3B ENDOLEAK AND A TYPE 1B ENDOLEAK WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICE WITH ANOTHER BIFURCATED STENT GRAFT, AN INFRARENAL STENT AND A LIMB STENT GRAFT EXTENSION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 15080180 ↗
• InjuryApr 5, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AN AFX INFRARENAL AORTIC EXTENSION. APPROXIMATELY NINE (9) YEARS POST INITIAL PROCEDURE, MIGRATION OF THE PROXIMAL STENT GRAFT (12MM), A TYPE IIIB ENDOLEAK OF THE DISTAL BIFURCATED STENT GRAFT AND SAC GROWTH WERE IDENTIFIED. THE PHYSICIAN ELECTED TO RE-LINE THE ORIGINALLY IMPLANTED STENT GRAFTS WITH AN AFX2 BIFURCATED STENT GRAFT. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MRN 2031527-2022-00012.DURING THE RE- INTERVENTION OF THE PREVIOUSLY REPORTED EVENT, THERE WAS INTRAOPERATIVE KINKING OF THE RIGHT ILIAC LIMB OF THE AFX2 BIFURCATED STENT GRAFT AND AN INTRAOPERATIVE TYPE 3A ENDOLEAK THAT WERE NOT RESOLVED THAT WERE IDENTIFIED. THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 14018076 ↗
• InjuryFeb 18, 2022Off-Label Use; Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, A SUPRARENAL AORTIC EXTENSION, AN OVATION IX EXTENDER AND AN OVATION IX ILIAC LIMB 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 IFU. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP A JUNCTIONAL ENDOLEAK (CLASSIFIED AS A TYPE 3A ENDOLEAK) WAS IDENTIFIED ON THE RIGHT ILIAC LIMB EXTENSION. THE PATIENT IS STABLE AND CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Failure of Implant

  MAUDE report 13561021 ↗
• InjuryAug 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT (BSG), AFX VELA SUPRARENAL, AND TWO (2) OVATION IX EXTENDERS. THE OVATION IX EXTENDERS WERE PLACED BILATERALLY DUE TO TORTUOUS ILIAC'S TO GET MORE COVERAGE. THE PHYSICIAN BALLOONED THE OVERLAP WITH THE Q50X BALLOON OF THE AFX2 BSG AND THE OVATION IX EXTENDER ON THE LEFT SIDE CAUSING A DISSECTION IN THE LEFT COMMON ILIAC LEADING TO PATIENT BLOOD LOSS AND PRESSURE DROP. A CODA BALLOON (NON-ENDOLOGIX) ADVANCED ON THE RIGHT SIDE INTO AFX2 BSG TO OCCLUDE THE AORTA AND STABILIZE PATIENT PRESSURE. THEN A GORE VBX BALLOON MOUNTED STENT 11X79 MM (NON-ENDOLOGIX) WAS IMPLANTED FROM THE GRAFT BIFURCATION PAST ENDOLOGIX LIMB EXTENSION TO JUST ABOVE THE LEFT INTERNAL ARTERY SUCCESSFULLY SEALING THE DISSECTION. THE FINAL ANGIOGRAPHY RUN DEMONSTRATED THAT THE GRAFT WAS SEALED. THE PATIENT WAS REPORTED TO BE DOING WELL. NOTE: PER THE SIZING SHEET - THIS IS AN OFF-LABEL CASE. THE PROXIMAL NECK IS OFF-LABEL DUE TO THE 12 MM SEAL ZONE HOWEVER THERE IS PROBABLY A 14 MM PROXIMAL SEAL WITH 28 VELA. ADDITIONAL CLARIFICATION PER CLINICAL ASSESSMENT: THE REPORTED INTRAOPERATIVE DISSECTION WAS REFUTED

  Patient problems: Low Blood Pressure/ Hypotension; Rupture; Vascular Dissection

  MAUDE report 12320886 ↗
• InjuryJul 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY (1) ONE-MONTH POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE 1B ENDOLEAK COMING FROM THE LEFT LIMB. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING (2) TWO OVATION IX EXTENDERS. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL AND IS IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 12140755 ↗
• InjuryJun 25, 2021Off-Label Use; Patient-Device Incompatibility; Insufficient Device Problem Information; Off-Label Use; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IB ENDOLEAK AND ANEURYSM SAC GROWTH (UNKNOWN DIAMETER) IN THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) OVATION IX EXTENDERS ON (B)(6) 2021. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL AND THE ENDOLEAK WAS SUCCESSFULLY RESOLVED.

  Patient problems: Failure of Implant

  MAUDE report 12068031 ↗
• InjuryMay 17, 2021Partial Blockage; Partial Blockage

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 1 MONTH POST INITIAL IMPLANT A COMPUTED TOMOGRAPHY SCAN IDENTIFIED STENT THROMBOSIS OF THE LEFT LIMB WITH 100% OCCLUSION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH A THROMBECTOMY / THROMBOLYSIS ANGIOJET AND PTA/STENT (10 X 60 MM) NON-ENDOLOGIX.

  Patient problems: Failure of Implant

  MAUDE report 11832007 ↗
• DeathNov 24, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 8 MONTHS POST INITIAL PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH FLANK PAIN AND A 3A ENDOLEAK WAS IDENTIFIED. RE-INTERVENTION WAS COMPLETED. THE PATIENT WAS RELINED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION WITH EXCELLENT RESULTS. NO RESIDUAL ENDOLEAKS. PATIENT IS DOING WELL POST RE-INTERVENTION.

  Patient problems: Death; Failure of Implant; Respiratory Failure; Rupture

  MAUDE report 10897174 ↗
• InjuryOct 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS LATER, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED ENLARGEMENT OF THE RIGHT COMMON ILIAC ARTERY ANEURYSM, AND A POSSIBLE TYPE 1B ENDOLEAK ON THE DISTAL END OF THE RIGHT LIMB. A REINTERVENTION IS PLANNED AND THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10752249 ↗
• InjurySep 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND TWO SUPRARENAL STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WAS IDENTIFIED BY A COMPUTED TOMOGRAPHY (CT) SCAN. THE PATIENT CURRENTLY STABLE AND AN INTERVENTION IS BEING PLANNED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10526049 ↗

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-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• Z-0589-06 · 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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL

…and 1 more.