AFX2 Bifurcated Endograft System BEA22-60/I13-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00818009015068), received between Jul 1, 2016 and Dec 9, 2025 — classified as 5 deaths, 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (9 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Difficult or Delayed Activation; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Difficult or Delayed Activation; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  THE PATIENT WAS BEING IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE MID AND DISTAL AORTA AND COMMON ILIAC ARTERIES HAD CALCIUM AND STENOSIS. PRIOR TO THE STENT GRAFT IMPLANT THE ARTERIES WERE PREDILATED WITHOUT DIFFICULTY. AN AFX SHEATH WAS POSITIONED IN THE AORTA WITHOUT DIFFICULTY. THE CONTRALATERAL LIMB WAS SNARED WITHOUT DIFFICULTY. THE AFX2 DEVICE REQUIRED VERY LITTLE MANIPULATION FOR ORIENTATION ON THE BIFURCATION AND WAS ADVANCED WITHOUT DIFFICULTY AND POSITIONED AT THE BIFURCATION WITH VERY LITTLE MANIPULATION AND ORIENTATION. THE IPSILATERAL LIMB WAS RECAPTURED IN THE AFX SHEATH AND SET ON THE BIFURCATION. THE CONTROL CORD KNOB WAS FREE BUT WOULD NOT RETRACT AND APPEARED TO BE CONNECTED TO THE GRAFT AND WOULD NOT COME OUT. WHEN THE PHYSICIAN RETRACTED CONTROL CORD THE PROXIMAL END OF THE BIFURCATED STENT GRAFT FOLDED OVER AND THE CORD REMAINED STUCK. THE MIDDLE CORE WAS RETRACTED AND THE NOSE CONE CAME DOWN APPEARING TO OPEN THE MAIN BODY VERY LITTLE BUT STOPPED AND WOULD NOT RETRACT. THE CONTRALATERAL LIMB COVER WAS REMOVED AND THE CONTRALATERAL LIMB AND MAIN BODY WAS DILATED, AND SUPPORTED IN ATTEMPT TO COMPLETE CONTROL CO

  Patient problems: Foreign Body In Patient

  MAUDE report 23756934 ↗
• InjuryFeb 7, 2025Off-Label Use; Obstruction of Flow; Off-Label Use; Obstruction of Flow

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL EXTENSION, AND TWO OVATION ILIAC LIMBS FOR THE TREATMENT OF THROMBOSIS ON (B)(6) 2021. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) SINCE THERE IS NO ABDOMINAL AORTIC ANEURYSM PRESENT. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH PAIN ON (B)(6) 2025. THE COMPUTED TOMOGRAPHY (CT) REVEALED THAT THERE IS THROMBOSIS IN AORTA EXTENDING BILATERALLY DISTALLY THROUGH THE ILIAC LIMBS. THE PHYSICIAN ELECTED TO RELINE THE ENTIRE STENT GRAFT SYSTEM, WITH AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) OVATION ILIAC LIMBS. THE INTERVENTION WAS SUCCESSFUL. THE PATIENT IS DOING WELL.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 21339602 ↗
• InjuryDec 26, 2024Off-Label Use; Obstruction of Flow; Off-Label Use; Obstruction of Flow

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN OVATION IX ILIAC LIMB TO TREAT OCCLUSIVE DISEASE ON (B)(6) 2020. THIS INITIAL PROCEDURE WAS OUTSIDE THE INDICATIONS FOR USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX SYSTEM, AS SPECIFIED IN THE IFU. APPROXIMATELY FOUR (4) YEARS AFTER THE INITIAL PROCEDURE, IT WAS REPORTED THAT THE PATIENT SUFFERED FROM COMPLETE OCCLUSION OF THE AFX2 GRAFT. ON (B)(6) 2024, THE PATIENT UNDERWENT A REINTERVENTION. THE THROMBUS WAS REMOVED THROUGH A PROCESS CALLED THROMBECTOMY, AND AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED OVER THE EXISTING, ORIGINAL AFX2 BIFURCATED STENT GRAFT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21020008 ↗
• DeathFeb 2, 2024Off-Label Use; Activation Failure; Off-Label Use; Activation Failure

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. DURING THIS INITIAL PROCEDURE THE YELLOW CORD FAILED TO RELEASE. THIS DEVICE WAS NOT IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT¿S AORTA AND ILIAC ARTERY RUPTURED. THE PROCEDURE WAS COMPLETED BY IMPLANT OF ANOTHER AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL AORTIC EXTENSION. THE DELIVERY SYSTEM IS NOT AVAILABLE FOR RETURN AS WAS RETAINED BY THE HOSPITAL.

  Patient problems: Ruptured Aneurysm

  MAUDE report 18632089 ↗
• InjuryJul 11, 2023Off-Label Use; Obstruction of Flow; Off-Label Use; Obstruction of Flow

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) HOURS AFTER POST INITIAL PROCEDURE THE PHYSICIAN INDICATED THAT THE GRAFT HAD BECOME OCCLUDED. TO ADDRESS THIS ISSUE THE PHYSICIAN IMPLANTED TWO (2) OVATION IX EXTENDER(S) AND TWO GORE (NON-ENDOLOGIX DEVICE) VBX STENT GRAFTS TO SUPPORT THE LIMBS, EXTENDING THEM BEYOND THEIR ORIGINAL POSITIONS. THE GRAFTS ARE CURRENTLY FUNCTIONING WELL, AND THE PATIENT'S CONDITION IS REPORTED AS STABLE.

  Patient problems: Failure of Implant; Ischemia; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 17302554 ↗
• InjuryJan 9, 2023Off-Label Use; Insufficient Device Problem Information; Off-Label Use; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN OVATION IX EXTENDER. THIS CASE IS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL) DUE THE USE OF AFX WITH OVATION DEVICES. FOUR (4) DAYS POST INDEX PROCEDURE ((B)(6) 2017), LEFT ILIAC OCCLUSION FROM A NON-ENDOLOGIX DEVICE CLOSURE FAILURE. A LEFT ILIAC ENDARTERECTOMY WAS PERFORMED. THIS WILL NOT BE CAPTURED AS THIS EVENT IS NON-ENDOLOGIX DEVICE RELATED. APPROXIMATELY THREE DAYS (3) DAYS POST-SECONDARY NON-ENDOLOGIX PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION (ELEVATED TROPONIN, WITH RESULTANT HEART CATHETERIZATION (PROCEDURE RELATED HARM)). ON (B)(6) 2017, A CORONARY ARTERY BYPASS GRAFT WAS PLACED. THE PATIENT STATUS WAS NOT REPORTED. ADDITIONALLY, ON AN UNKNOWN DATE, FOR AN UNKNOWN REASON A FEMORAL-FEMORAL BYPASS GRAFT WAS PERFORMED. THE PATIENT STATUS WAS NOT REPORTED. NOTE: THIS EVENT WAS DISCOVERED DURING THE CLINICAL ANALYSIS REPORTED UNDER MFR# 2031527-2022-00257. AFTER THE INITIAL REPORT, THE CLINICAL EVALUATION ALSO SHOWS REASONABLE EVIDENCE TO SUGGEST DETERMINED THERE WAS A LEFT ILIAC OCCLUSION WITHIN THE STENT AT THE TIME OF THE FEM-FE

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 16122168 ↗
• InjuryDec 8, 2022Off-Label Use; Off-Label Use

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT FOR TREATMENT OF OCCLUSIVE DISEASE. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF THE DEVICE WITHOUT THE PRESENCE OF AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS NOTED THAT DURING THE PROCEDURE AND POST OPERATIVELY THE WIRE WENT INTO A DISSECTION PLANE. TWO (2) DAYS POST OPERATIVELY THE PATIENT PRESENTED BACK TO HOSPITAL STABLE WITH BACK PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A DISSECTION EXTENDING TO THORACIC AORTA. THE PATIENT WAS THEN BROUGHT TO THE OPERATING ROOM (OR) FOUR (4) DAYS LATER AND TREATED WITH AN 25-75 AFX INFRARENAL AORTIC EXTENSION WHICH WAS EXTENDED TO THE LEVEL OF THE RENAL ARTERIES AS WELL AS GORE/COOK (NON-ENDOLOGIX) THORACIC STENTS TO SEAL DISSECTION. THE PATIENT WAS REPORTED TO HAVE LEFT THE OR IN STABLE CONDITION.

  Patient problems: Pain; Vascular Dissection

  MAUDE report 15947065 ↗
• InjuryNov 3, 2022Use of Device Problem; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Use of Device Problem; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN OVATION IX EXTENDER. THIS CASE IS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL) DUE THE USE OF AFX WITH OVATION DEVICES. APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED WITH A LEFT COMMON ILIAC OCCLUSION. REPORTEDLY, THIS IS NOT RELATED TO THE AFX2 BIFURCATED STENT GRAFT; HOWEVER, THERE WAS POOR OUTFLOW. REINTERVENTION HAS BEEN SCHEDULED. THE PATENT IS REPORTED TO BE GOOD.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15722684 ↗
• InjuryAug 11, 2022Use of Device Problem; Obstruction of Flow; Device-Device Incompatibility; Use of Device Problem; Obstruction of Flow; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY TREATED FOR AN AORTOILIAC OCCLUSIVE DISEASE (AIOD) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL, AND AN OVATION IX EXTENDER. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE ABSENCE OF AN ABDOMINAL AORTIC ANEURYSM (AAA) AND DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. REPORTEDLY, THE PATIENT CONTINUED SMOKING AND DID NOT SHOW UP FOR FOLLOW-UP APPOINTMENTS. APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED WITH GANGRENOUS FOOT. IT WAS THEN IDENTIFIED THAT THERE WAS THROMBUS IN THE AFX2 BIFURCATED STENT GRAFT. REINTERVENTION PLANS AND PATIENT STATUS ARE UNKNOWN AS THE PATIENT REPORTEDLY LEFT THE HOSPITAL AGAINST MEDICAL ADVICE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15214328 ↗
• DeathJul 7, 2021Complete Blockage; Malposition of Device; Unintended Movement; Complete Blockage; Malposition of Device; Unintended Movement

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (2) TWO DAYS POST-PROCEDURE THE PATIENT WAS SUBMITTED TO THE (ER) EMERGENCY ROOM WITH PAIN. IT WAS DISCOVERED THAT THE GRAFT WAS COMPLETELY OCCLUDED. A RE-INTERVENTION WAS PERFORMED AND THE PHYSICIAN ELECTED TO IMPLANT AN AFX VELA SUPRARENAL. IT WAS REPORTED THAT THE PATIENT HAD A GOOD FEMORAL PULSE. IT WAS THEN DISCOVERED AFTER THE ANGIOGRAM THAT THE GRAFT HAD JUMPED DURING DEPLOYMENT DUE TO THE TIGHT DISTAL AORTA AND THE VELA SUPRARENAL WAS NOW COVERING BOTH RENALS. A SURGICAL CONVERSION WAS DONE TO EXPLANT THE BIFURCATED STENT GRAFT AND VELA SUPRARENAL. THE PHYSICIAN THEN PERFORMED AN AORTOBIFEM BYPASS. FOLLOWING THE RE-INTERVENTION, THE PATIENT WAS BEING MONITORED BUT THEN PASSED AWAY. THE REASON FOR THE PATIENT EXPIRING IS UNDETERMINED AT THIS TIME.

  Patient problems: Failure of Implant; Ischemia; Pain

  MAUDE report 12132334 ↗
• InjuryDec 16, 2020Complete Blockage; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Complete Blockage; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA), AND THROMBOEMBOLISM OF DISTAL AORTA AND ILIAC. APPROXIMATELY 5 MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH RIGHT LEG PAIN AND A COMPUTED TOMOGRAPHIC ANGIOGRAM (CTA) REVEALED AN OCCLUDED RIGHT LIMB. THE PHYSICIAN SUCCESSFULLY REVASCULARIZED THE LIMB AND PLACED TWO OVATION LIMB EXTENSIONS TO TREAT THIS EVENT. THE PATIENT IS REPORTEDLY STABLE AND DISCHARGED HOME.

  Patient problems: Occlusion; Pain

  MAUDE report 11021224 ↗
• InjuryAug 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS BEING TREATED FOR ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. IT WAS NOTED THAT THE DISTAL AORTA WAS NARROW AND CALCIFIED. APPROXIMATELY, ONE (1) YEAR POST INITIAL PROCEDURE, IT WAS IDENTIFIED THAT THERE WAS A SMALL FLOW LUMEN AND THROMBUS HAD FORMED IN THE GRAFT. RE-INTERVENTION WAS COMPLETED WITH IMPLANT OF AN OVATION IX ILIAC LIMB. FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Thrombosis

  MAUDE report 10366016 ↗
• DeathApr 1, 2020Partial Blockage; Improper or Incorrect Procedure or Method; Partial Blockage; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN OCCLUSIVE DISEASE IN THE DISTAL AORTA AND THROMBUS LINING THE AORTA FROM THE BIFURCATION TO THE MID AORTA. THIS CASE IS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL) DUE THE DEVICE BEING USED TO TREATMENT NOT APPROVED PER THE IFU. IT WAS ALSO REPORTED THAT PHYSICIAN HAD TO PERFORM A CUT DOWN DURING THE INITIAL PROCEDURE DUE TO EMBOLIZATION. APPROXIMATELY 16 DAYS POST INITIAL PROCEDURE, THE PATIENT WAS PRESENT IN THE EMERGENCY ROOM (ER) DUE TO AN OCCLUDED AORTA. IT WAS REPORTED THAT THE PATIENT WAS NOT TAKING THE ANTIPLATELET THERAPY AND THROMBOSED THE GRAFT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH A MANUAL THROMBECTOMY AND IMPLANT TWO (2) NON- ENDOLOGIX (GORE) LIMB EXTENSIONS TO RE-LINE THE AORTA. THE RE-INTERVENTION WAS SUCCESSFUL HOWEVER THE PATIENT WAS STILL IN POOR HEALTH. THE PATIENT EXPIRED ON THE FOLLOWING DAY.

  Patient problems: Death; Occlusion; Thrombosis

  MAUDE report 9914406 ↗
• InjuryNov 7, 2019Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 1.5 YEARS POST-OP, OCCLUSION WAS IDENTIFIED IN THE LEFT COMMON ILIAC ARTERY LOCATED DISTAL TO THE STENT GRAFT. THE PHYSICIAN ELECTED TO IMPLANT THREE (3) OVATION IX STENT GRAFT EXTENDERS. THE PATIENT WAS REPORTED AS DOING GREAT.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 9293777 ↗
• InjuryOct 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (1) MONTH POST INITIAL PROCEDURE AT THE 1 MONTH FOLLOW UP CT PATIENT PRESENTED WITH WHAT APPEARED TO BE A TYPE 3A ENDOLEAK. PHYSICIAN ELECTED TO TREAT WITH A INFRARENAL STENT TO RESOLVE THE LEAK. REPORTEDLY, INTERVENTION WENT WELL AND PATIENT IS DOING GREAT.

  Patient problems: Failure of Implant

  MAUDE report 9253858 ↗
• InjuryAug 19, 2019Improper 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

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH THROMBOSED AFX GRAFT, FROM INFRA-RENAL AORTA TO COMMON FEMORAL ARTERIES. BILATERAL OPEN THROMBECTOMIES WERE PERFORMED AND AN OVATION ILIAC EXTENSION WAS PLACED IN THE AFX GRAFT BODY TO TRAP THE RESIDUAL CLOT. THROMBOSIS FROM UNKNOWN ORIGIN AND NO MECHANICAL OR ANATOMICAL REASON FOR CLOTTING WAS REPORTED. THE PATIENT IS DOING GREAT AND WAS DISCHARGED ON (B)(6)2019. ADDITIONAL INFORMATION: PRE-EXISTING SEVERE OCCLUSIVE ARTERIAL DISEASE WAS IDENTIFIED THEREFORE THIS IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL).

  Patient problems: Thrombosis

  MAUDE report 8907067 ↗
• InjuryApr 10, 2019Off-Label Use; Malposition of Device; Off-Label Use; Malposition of Device

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) OVATION IX EXTENDERS TO TREAT AORTOILIAC OCCLUSIVE DISEASE (AIOD). THIS CASE IS OUTSIDE THE INDICATIONS OF USE (OFF -LABEL). DURING THIS INITIAL PROCEDURE AN ANGIOGRAM WAS PERFORMED AND THE GRAFT WAS FOUND TO BE COVERING THE RENAL ARTERIES. ATTEMPTS WERE MADE TO PULL THE GRAFT DISTALLY WITHOUT SUCCESS. THE PHYSICIAN DECIDED TO EXPLANT THE DEVICES. THE DEVICE WAS EXPLANTED WITHOUT COMPLICATION AND THE PATIENT IS REPORTED TO BE RECOVERING WELL.

  Patient problems: Failure of Implant

  MAUDE report 8500394 ↗
• InjuryJan 17, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT WITHIN PRE-EXISTING NON- ENDOLOGIX (COOK TUBE) CUFF THAT WAS LEAKING (1A ENDOLEAK). APPROXIMATELY TWO (2) MONTHS POST INITIAL PROCEDURE, ANOTHER TYPE 1A ENDOLEAK WITH SAC GROWTH WAS IDENTIFIED. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT A SUPRARENAL STENT GRAFT EXTENSION (CUFF) TO RESOLVE THIS ENDOLEAK. THE PROCEDURE WAS REPORTED TO BE SUCCESSFUL. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8259509 ↗
• InjuryJan 10, 2019Obstruction of Flow; Obstruction of Flow

  AN AFX BIFURCATED WAS INITIALLY IMPLANTED. THE PATIENT PRESENTED THREE (3) MONTHS POST-OP WITH A GRAFT OCCLUSION (NON-SPECIFIC). AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED. IT IS UNKNOWN IF A RE-INTERVENTION HAS BEEN PLANNED OR COMPLETED AT THIS TIME.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 8236256 ↗
• InjuryNov 21, 2018Partial Blockage; Partial Blockage

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL IMPLANT,AN AFX OCCLUSION AND PULMONARY EMBOLISM (PE) WERE DETECTED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY AN AORTOBIFEM ON AN UNKNOWN DATE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Occlusion; Pulmonary Embolism

  MAUDE report 8097859 ↗
• InjuryJul 3, 2018Partial Blockage; Occlusion Within Device; Partial Blockage; Occlusion Within Device

  ENDOLOGIX WAS INFORMED THAT A REVISION WAS PERFORMED ON AN AFX GRAFT PLACED IN 2017 FOR AN OCCLUDED LIMB. PATIENT PRESENTED THIS WEEK WITH A TOTALLY OCCLUDED LEFT COMMON ILIAC THAT EXTENDED INTO HER LEFT EXTERNAL ILIAC. SHE WAS TREATED WITH EKOS TO REMOVE THE CLOT THEN A SELF EXPANDING STENT WAS PLACED IN HER LEFT EXTERNAL ILIAC ARTERY. IT IS NOT CLEAR AS TO WHETHER THE GRAFT CAUSED THE OCCLUSION OR IF THE CULPRIT WAS DISTAL DISEASE. THE PATIENT IS DOING WELL AND AS OF THE DATE OF THIS REPORT, NO ADDITIONAL PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7658742 ↗
• InjuryMay 11, 2018Occlusion Within Device; Improper or Incorrect Procedure or Method; Occlusion Within Device; Improper or Incorrect Procedure or Method

  ENDOLOGIX WAS MADE AWARE OF A PATIENT THAT HAD A SURGICAL CONVERSION (EXPLANT) PERFORMED ON (B)(6) 2018 DUE TO THROMBOSIS FROM THE LIMBS OF THE DEVICE. PATIENT WAS TREATED OFF IFU FOR AORTIC OCCLUSIVE DISEASE. PATIENT'S INITIAL IMPLANT WAS DONE ON (B)(6) 2017 BY DR. (B)(6) AT (B)(6) MEDICAL CENTER.

  Patient problems: Occlusion; Thrombosis

  MAUDE report 7507028 ↗
• InjuryApr 19, 2018Partial Blockage; Off-Label Use; Partial Blockage; Off-Label Use

  ON (B)(6) 2016, THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT. ON (B)(6) 2017, A SECONDARY PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON. DURING THE SECONDARY PROCEDURE A AFX VELA INFRARENAL WAS IMPLANTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Occlusion

  MAUDE report 7444341 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT. ON (B)(6) 2017, A SECONDARY PROCEDURE WAS PERFORMED TO RELINE THE AFX2 BIFURCATED STENT GRAFT FOR AN UNKNOWN REASON. DURING THE SECONDARY PROCEDURE THE PATIENT WAS IMPLANTED WITH AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT AND AFX VELA INFRARENAL. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 7443808 ↗
• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A PATIENT WHO, A FEW MONTHS AGO ((B)(6) 2017), WAS PLACED WITH AN AFX DEVICE TO TREAT FOR AIOD (AORTO ILIAC OCCLUSIVE DISEASE). REP REPORTED THAT THE PHYSICIAN AT THE TIME DID NOT WANT TO GO ALL THE WAY UP THE AORTA DUE TO A LARGE CHUNK OF CALCIUM. PHYSICIAN THOUGHT PUTTING THE GRAFTON BELOW WOULD ALLEVIATE THE PATIENT'S SYMPTOMS, BUT THE PATIENT SYMPTOMS WERE ONLY HALF BETTER. PHYSICIAN IS ELECTING ADD ANOTHER DEVICE UP TOP TO COVER THE CALCIUM AND OPEN THE AORTA AGAIN. THIS IS NOT A DEVICE FAILURE BUT A PHYSICIAN PREFERENCE IN BOTH THE PRIMARY CASE LANDING LOW AND THE SECONDARY CASE WHICH WILL BE DONE NEXT WEEK PUTTING ANOTHER PIECE HIGHER (OFF LABEL PROCEDURE). REP NOTED THAT HE WENT OVER THE CASE WITH THE PHYSICIAN YESTERDAY AT (B)(6) HOSPITAL IN (B)(6). PATIENT IS CURRENTLY STABLE AND THE SECONDARY PROCEDURE IS SCHEDULED FOR (B)(6) 2018.

  Patient problems: Occlusion

  MAUDE report 7429497 ↗

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-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-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-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• Z-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL

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