GORE EXCLUDER Conf AAA Endo - Trunk-IpsilateralRecalls & reported problems across all models

We found 10 models of GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 427 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2021 and Sep 28, 2026 — classified as 16 deaths, 318 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (71 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral problems

GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT281412

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths101 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT261412

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths87 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT231412

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths82 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT321414

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths65 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT361414

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths54 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT201412

  System, Endovascular Graft, Aortic Aneurysm Treatment
  24 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT201212

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death6 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT261212

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death4 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT231212

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT281212

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report

Recent GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  The following information was reported to Gore:On (b)(6) 2025, the patient underwent an endovascular treatment for an abdominal aortic aneurysm using GORE® EXCLUDER® Conformable AAA Endoprosthesis and GORE® EXCLUDER®AAA Endoprosthesis devices. The patient was on dialysis. Therefore, the Trunk-Ipsilateral Leg Component was deployed distal to the superior mesenteric artery (SMA). No Endo leak was observed on completion angiography, and the procedure was completed. On an unknown date, during postoperative follow-up imaging, enlargement of the aneurysm sac was observed. A proximal Type I Endo leak and/or Type II Endo leaks were suspected. On (b)(6) 2026, reintervention was performed to address the suspected proximal type I Endo leak. Intraoperative angiography did not demonstrate a definitive proximal Type I Endo leak; however, an additional stent graft was deployed at the proximal side as a preventive measure. Angiography confirmed a Type II Endo leak originating from lumbar arteries. No treatment was performed for the Type II Endo leak, and the procedure was completed.

  Patient problems: Aneurysm expansion

  MAUDE report 50911130 ↗
• InjurySep 28, 2026Patient-Device Incompatibility

  The following publication was reviewed: Title: Treatment of Patients with Severely Angulated Proximal Aortic Necks Using the GORE EXCLUDER Conformable AAA Endoprosthesis.Source: The 56th Annual Meeting of the Japanese Society for Cardiovascular Surgery, O61-6.It was reported the outcomes of four patients with severely angulated proximal aortic necks of 90 degrees or greater who underwent endovascular aneurysm repair at the one institution between April 2023 and July 2025. The GORE EXCLUDER Conformable AAA Endoprosthesis was used in all patients.¿Case 2¿A 75-year-old man with a medical history of cerebral infarction, myocardial infarction treated with percutaneous coronary intervention, rectal cancer surgery, and emphysema. The patient underwent EVAR because the abdominal aortic aneurysm measured more than 50 mm in diameter and showed progressive enlargement. The proximal aortic neck angle was 97 degrees, and the neck length was 25 mm.The main device was angulated to conform to the infrarenal aortic angulation and was subsequently deployed. Intraoperative angiography showed no abnormal findings.A Type II endoleak was identified postoperatively. Transcatheter arterial embolization wa

  Patient problems: Clinical Endoleak

  MAUDE report 50911106 ↗
• MalfunctionSep 14, 2026Difficult or Delayed Activation; Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50761371 ↗
• InjuryAug 25, 2026Malposition of Device; Material Deformation

  The following information was reported to Gore:On (b)(6) 2026, a patient underwent an endovascular procedure to treat an abdominal aortic aneurysm using a GORE® EXCLUDER® Conformable AAA Endoprosthesis device.When guidewire insertion into the contralateral gate of the trunk-ipsilateral leg was attempted, it was difficult. The left leg of the trunk-ipsilateral leg near the flow divider was found to be compressed.The physician attempted to apply tension to the pull-through guidewire to press the device against the vessel at the compressed area; however, the guidewire could not advance through the compressed area.Then the physician removed the clear knob and deployed the ipsilateral leg, and attempted to access the contralateral gate from the proximal side; however, the guidewire still could not advance. Also, a 0.014-inch guidewire was used to gain access, but it also could not advance. The physician attempted ballooning of the ipsilateral leg and used a micro guidewire from distal; however, all attempts failed to advance the guidewire into the contralateral gate.The physician decided to abandon the procedure considering the fluoroscopy time and radiation dose.The procedure was compl

  Patient problems: Obstruction/Occlusion

  MAUDE report 50424279 ↗
• InjuryAug 12, 2026Device Endoleak

  The following was reported to Gore:On (b)(6) 2025 the patient underwent endovascular treatment as a planned endovascular procedure for an abdominal aortic aneurysm. The patient was treated with a GORE® EXCLUDER® Conformable Endoprosthesis, and GORE® EXCLUDER® AAA Endoprosthesis. The GORE® devices were successfully implanted.On (b)(6) 2026 the patient underwent a reintervention procedure to treat a Type 1A endoleak. Endoanchors were placed to resolve the endoleak.

  Patient problems: Clinical Endoleak

  MAUDE report 50222447 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  On June 2, 2026, this patient underwent endovascular treatment for an Aortoiliac aneurysm (AAA) and was implanted with GORE® EXCLUDER® Conformable AAA ENDOPROSTHESIS devices. Additionally, during the index procedure the patient¿s right common iliac artery was coil embolized. Pre-procedure computed tomography angiography (CTA) performed on March 25, 2026, determined the maximum diameter of the abdominal aorta measured 59mm, with a maximum diameter proximal landing zone of 24mm. The maximum diameter of the right common iliac artery (RCIA) measured 37.7mm and the maximum diameter of the left common iliac artery (LCIA) measured 32mm. Successful access, delivery, and accurate deployment of the devices to their intended location, and retrieval of the delivery system was reported. There were no corrective procedure(s) or complications related to the device, procedure, or withdrawal of the delivery system. The patient tolerated the procedure and was discharged to home (self-care) on (b)(6) 2026. On(b)(6), 2026, the patient experienced ongoing buttock claudication related to the treatment/procedure.On an unknown date in (b)(6)2026, a type II endoleak was determined and reported to be due to

  Patient problems: Reduced Blood Flow

  MAUDE report 50168633 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  The following notifications were received by Gore Imaging Services (GIS):On (b)(6), 2025, this patient underwent endovascular treatment for an Aortoiliac aneurysm (AAA) and bilateral common iliac artery aneurysms (BCIAA) and was implanted with GORE® EXCLUDER® AAA ENDOPROSTHESIS devices and GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) devices. Successful access, delivery, and accurate deployment of the devices to their intended location, and retrieval of the delivery system was reported. There were no corrective procedure(s) or complications related to the device, procedure, or withdrawal of the delivery system. The patient tolerated the procedure and was discharged to home (self-care) on (b)(6), 2025. On (b)(6), 2025, the patient underwent follow-up CTA. The site reports the maximum diameter of the abdominal aorta measures 49mm, the maximum diameter of the (RCIA) measures 25mm, and the maximum diameter of the (LCIA) was not provided. The site reports no endoleak, adverse events or device deficiencies and no loss of patency of the aorto-iliac device. Gore Imaging Services (GIS) review of the CTA reports device compression / infolding of the EXCLUDER Conformable AAA Endoprosthes

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50166089 ↗
• InjuryJul 30, 2026Material Deformation

  The following information was reported to Gore:On (b)(6)2026, a patient underwent an endovascular procedure to treat abdominal aortic and iliac artery aneurysms using a GORE® EXCLUDER® Conformable AAA Endoprosthesis device, GORE® EXCLUDER® AAA Endoprosthesis System devices, and GORE® EXCLUDER® Iliac Branch Endoprosthesis devices.On (b)(6)2026, a follow-up angiography revealed that the left leg of the trunk-ipsilateral component near the flow splitter area was compressed. A stent was deployed inside the left leg of the trunk-ipsilateral component. The compression was resolved.The patient tolerated the procedure.

  Patient problems: Insufficient Information

  MAUDE report 50078063 ↗
• InjuryJul 27, 2026Device Endoleak

  The following was reported:On (b)(6) 2026, the patient underwent endovascular treatment as a planned endovascular procedure for an abdominal aortic aneurysm.The patient was treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis, GORE® EXCLUDER® AAA Endoprostheses. The GORE® devices were successfully implanted. The patient was discharged on (b)(6) 2026.On (b)(6), 2026, the patient underwent a CTA.GIS noted that the patient had a Type II Endoleak.The clinical site reported that the patient had a Type IA Endoleak.The physician stated that a reintervention procedure is scheduled for (b)(6) 2026.

  Patient problems: Clinical Endoleak

  MAUDE report 50046115 ↗
• InjuryJun 19, 2026Patient-Device Incompatibility; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG ENDOPROSTHESIS) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS HAD MIGRATED DISTALLY, RESULTING IN A PROXIMAL TYPE I ENDOLEAK. ON (B)(6), 2026, A REINTERVENTION WAS PERFORMED. A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTA EXTENDER) WAS IMPLANTED PROXIMALLY. THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. THE MIGRATION MIGHT HAVE BEEN AVOIDED IF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS HAD BEEN DEPLOYED IN BETTER CONFORMITY WITH THE PATIENT¿S ANATOMY. THE PATIENT¿S PROXIMAL NECK WAS REPORTED TO BE ANGULATED.

  Patient problems: Clinical Endoleak

  MAUDE report 25557710 ↗
• MalfunctionJun 11, 2026Material Deformation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE IN (B)(6) 2026, AT THE ONE-MONTH FOLLOW-UP EXAMINATION, COMPRESSION OF THE IPSILATERAL LEG OF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS WAS OBSERVED AT THE ANGULATED PORTION BELOW THE PROXIMAL NECK. THE ABI WAS REPORTED TO BE LESS THAN 1.0. THE PATIENT WAS ASYMPTOMATIC. REINTERVENTION WITH IMPLANTATION OF A BARE STENT IN THE STENOTIC AREA IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467229 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2026, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH DETERMINED SLIGHT ANEURYSM SAC ENLARGEMENT WITH A PERSISTENT TYPE II ENDOLEAK RELATED TO THE L3/L4 LUMBAR ARTERIES. ON (B)(6), 2026, THE PATIENT UNDERWENT REINTERVENTION FOR THE TYPE II ENDOLEAK AND ENDOANCHORS WERE PLACED. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 25446962 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. AFTER DEPLOYMENT OF THE PROXIMAL PART OF THE TRUNK-IPSILATERAL LEG COMPONENT, ANGIOGRAPHY FOR REPOSITIONING REVEALED OCCLUSION OF THE LEFT RENAL ARTERY. THE LEFT RENAL ARTERY WAS SELECTIVELY CATHETERIZED AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS PLACED FOLLOWING DEPLOYMENT OF ALL THE PLANNED DEVICES. ADEQUATE BLOOD FLOW IN THE LEFT RENAL ARTERY WAS CONFIRMED. THE PROCEDURE WAS CONCLUDED WITHOUT ANY OTHER PROBLEMS. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE LEFT RENAL ARTERY WAS VISUALIZED ON THE INITIAL ANGIOGRAPHY; HOWEVER, IT WAS FOUND TO BE OCCLUDED ON ANGIOGRAPHY AFTER DEPLOYMENT OF THE PROXIMAL PORTION OF THE TRUNK-IPSILATERAL LEG. IN ADDITION TO PRE-EXISTING STENOSIS OF THE LEFT RENAL ARTERY, THE AORTIC NECK WAS HIGHLY SHAGGY, AND IT IS CONSIDERED THAT PLAQUE SHIFT OR THROMBUS DISLODGEMENT DURING DEPLOYMENT MAY HAVE CAUSED THE OCCLUSION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 25439508 ↗
• InjuryJun 5, 2026Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE IIIB ENDOLEAK FROM PREVIOUSLY IMPLANTED NON-GORE STENT GRAFTS (AFX AND BARE METAL STENT) IN THE ABDOMINAL AORTA EXTENDING TO BOTH COMMON ILIAC ARTERIES. GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG ENDOPROSTHESIS) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG ENDOPROSTHESIS DEVICES) WERE IMPLANTED TO TREAT THE TYPE IIIB ENDOLEAK BY RELINING THE PREVIOUSLY IMPLANTED NON-GORE DEVICES. THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS WAS IMPLANTED FROM AROUND THE MIDDLE OF THE PROXIMAL BARE STENT OF THE NON-GORE STENT GRAFT INTO THE ABDOMINAL AORTA. THE CONTRALATERAL LEG ENDOPROSTHESIS DEVICES WERE IMPLANTED INTO BOTH COMMON ILIAC ARTERIES TO SLIGHTLY EXTEND THE INITIALLY IMPLANTED NON-GORE DEVICES. ON AN UNKNOWN DATE, A TYPE II ENDOLEAK WAS OBSERVED. ON (B)(6) 2026, COIL EMBOLIZATION WAS PERFORMED TO TREAT THE TYPE II ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 25404403 ↗
• InjuryJun 5, 2026Migration

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, WITH THE GORE® DRYSEAL FLEX INTRODUCER SHEATHS AS ACCESSORIES. AFTER DEPLOYMENT OF THE TRUNK IPSILATERAL LEG JUST BELOW THE LEFT RENAL ARTERY, THE PHYSICIAN ATTEMPTED TO ADVANCE A 14FR SHEATH. RESISTANCE WAS ENCOUNTERED NEAR THE CONTRALATERAL GATE. SUBSEQUENT ANGIOGRAPHY CONFIRMED COVERAGE OF THE LEFT RENAL ARTERY CAUSED BY THE PROXIMAL END OF THE TRUNK IPSILATERAL LEG. AS GUIDEWIRE INSERTION INTO THE LEFT RENAL ARTERY WAS DEEMED IMPOSSIBLE, NO FURTHER INTERVENTION WAS PERFORMED. AN ADDITIONAL STENT GRAFT WAS PLACED IN THE RIGHT RENAL ARTERY, AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 25403855 ↗

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