GORE EXCLUDER Iliac Branch EndoprosthesisRecalls & reported problems across all models

We found 6 models of GORE EXCLUDER Iliac Branch Endoprosthesis by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 469 adverse event reports in the FDA's MAUDE database, received between Jun 25, 2018 and Sep 30, 2026 — classified as 13 deaths, 395 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (58 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 Iliac Branch Endoprosthesis problems

GORE EXCLUDER Iliac Branch Endoprosthesis models

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

• GORE EXCLUDER Iliac Branch Endoprosthesis CEB231410A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 deaths117 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis CEB231210A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths97 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis HGB161007A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths94 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis HGB161407A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death65 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis CEB231010A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death49 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis HGB161207A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  47 reports

Recent GORE EXCLUDER Iliac Branch Endoprosthesis adverse event reports

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

• InjurySep 30, 2026Patient-Device Incompatibility

  The following information was reported to Gore:On (b)(6) 2026, this patient underwent an endovascular treatment for pararenal abdominal aortic aneurysm using GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE).GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE), and GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX) were concomitantly implanted.After deploying the second VBX device in the right renal artery, it migrated proximally during ballooning and dislodged from the renal artery to the aneurysmal sac. Therefore, two more VBX devices were implanted to bridge the TAMBE portal to the right renal artery.During the initial procedure, a type II Endo leak and dissection of a branch vessel of the right renal artery were found. They were left for monitoring.After the procedure, it was reported that treatment for the type II Endo leak was performed (details unknown).

  Patient problems: Clinical Endoleak

  MAUDE report 50942709 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Obstruction/Occlusion

  MAUDE report 50929002 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  The following information was reported to Gore:On (b)(6), 2026, angiography revealed that the right internal iliac artery was patent.On (b)(6) 2026, a patient underwent an endovascular procedure to treat an abdominal aortic aneurysm and common iliac artery aneurysms using GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) devices and GORE® DrySeal Flex Introducer Sheath (DSF) devices.Two DSFs were inserted into both femoral arteries, and a pull-through wire was created. The iliac branch component was deployed in the left common iliac artery via a DSF inserted through the right femoral artery, while the internal iliac component was deployed in the left internal iliac artery via a DSF inserted through the left femoral artery.Another iliac branch component was deployed in the right common iliac artery via a DSF inserted through the right femoral artery. After that, angiography revealed that the right internal iliac artery was occluded. The timing of the occlusion was unknown. The iliac branch component did not occlude the right internal iliac artery physically.The right internal iliac artery could not be cannulated due to the occlusion; therefore, the internal iliac gate of the iliac b

  Patient problems: Obstruction/Occlusion

  MAUDE report 50515414 ↗
• InjuryAug 25, 2026Malposition of Device

  The following information was reported to Gore:On (b)(6), 2026, the patient underwent an endovascular treatment for an abdominal aortic aneurysm and a common iliac artery aneurysm using GORE® EXCLUDER® Conformable AAA Endoprosthesis and GORE® EXCLUDER®AAA Endoprosthesis devices. The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) was planned for implantation in the right iliac artery.The trunk¿ipsilateral leg component was first deployed below the renal arteries, followed by placement of the contralateral leg on the right side and the ipsilateral leg on the left side. A pull-through wire access was then established from the right side, and the iliac branch component was deployed in the right iliac artery using the up-and-over technique.During deployment, the bifurcation between the right internal and external iliac arteries was misidentified, resulting in the contralateral gate of the iliac branch component being inadvertently deployed into the right external iliac artery. Even though cannulation of the right internal iliac artery was attempted, the guidewire could not be adequately straightened to achieve access. Consequently, preservation of the right internal iliac artery was

  Patient problems: Obstruction/Occlusion

  MAUDE report 50423772 ↗
• InjuryJun 21, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS PLACED ON THE LEFT SIDE. ON (B)(6) 2026, ANEURYSMAL DILATATION WAS OBSERVED IN THE LEFT INTERNAL ILIAC ARTERY WHERE THE INTERNAL ILIAC COMPONENT HAD BEEN PLACED. A REINTERVENTION WAS PERFORMED, DURING WHICH THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND AN ADDITIONAL STENT GRAFT WAS RELINED WITHIN THE LEFT LEG, EXTENDING INTO THE LEFT EXTERNAL ILIAC ARTERY.

  Patient problems: Aneurysm expansion

  MAUDE report 25572589 ↗
• InjuryJun 18, 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 THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE), AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE CONCOMITANTLY IMPLANTED. ADDITIONALLY, PRIOR TO THIS PROCEDURE, THE PATIENT HAD RECEIVED FIRST STAGE IMPLANTATION WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM ON (B)(6) 2026. ALL THE PLANNED DEVICES WERE IMPLANTED SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE. AFTER THE PROCEDURE, THE PATIENT DEVELOPED SPINAL CORD ISCHEMIA WITHIN 1 DAY. CEREBROSPINAL DRAINAGE WAS INITIATED, AND THE PATIENT WAS UNDER OBSERVATION AT THE TIME OF THIS REPORTING.

  Patient problems: Ischemia

  MAUDE report 25543089 ↗
• MalfunctionJun 17, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT FOR A RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) DEVICES. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 22MM WITH A MAXIMUM DIAMETER PROXIMAL LANDING ZONE OF 19.3MM. THE MAXIMUM DIAMETER OF THE RIGHT COMMON ILIAC ARTERY MEASURED 40MM AND THE MAXIMUM DIAMETER OF THE LEFT COMMON ILIAC ARTERY MEASURED 22MM. 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, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED AND THE SITE REPORTS THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 21MM, THE MAXIMUM DIAMETER OF THE RCIA MEASURED 43MM, AND THE MAXIMUM DIAMETER OF THE LCIA

  Patient problems: Clinical Endoleak

  MAUDE report 25538237 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) IN COMBINATION WITH THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT THE PROCEDURAL PLAN INITIALLY INCLUDED CONSIDERATION OF THORACIC REPAIR ALONE; HOWEVER, THE TREATING TEAM ELECTED TO PROCEED WITH THORACOABDOMINAL REPAIR USING THE TAMBE SYSTEM. CTAG DEVICES WERE IMPLANTED IN THE THORACIC AORTA, FOLLOWED BY DEPLOYMENT OF THE TAMBE AORTIC COMPONENT AND GORE® EXCLUDER® ILIAC BRANCH AND CONTRALATERAL LEG COMPONENTS. SPECIFIC GORE® VIABAHN® VBX IMPLANT DETAILS WERE NOT AVAILABLE AT THE TIME OF REPORTING. THE PROCEDURE REPORTEDLY PROGRESSED WITHOUT TECHNICAL COMPLICATIONS. NEAR THE CONCLUSION OF THE PROCEDURE, AN INTRAOPERATIVE PRESSURE TEST WAS PERFORMED TO SIMULATE THE IMPACT OF LUMBAR ARTERY COVERAGE. NEUROMONITORING WAS ASSESSED DURING THIS PERIOD, AND NO CHANGES WERE OBSERVED. BASED ON THESE NEUROMONITORING FINDINGS, THE PHYSICIAN PROCEEDED WITH COMPLETION OF THE LEFT ILIAC LIMB. IT WAS REPORTED THAT DURING THE PROCEDURE THE PATIENT EXPERIENCED

  Patient problems: Ischemia Stroke; Paresis

  MAUDE report 25449438 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN AORTOILIAC ANEURYSM AND A RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIA)WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6), 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 56MM WITH A MAXIMUM DIAMETER PROXIMAL LANDING ZONE OF 25.4MM. THE MAXIMUM DIAMETER OF THE RICA AND LCIA WERE NOT PROVIDED. SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THEIR INTENDED LOCATION, AND RETRIEVAL OF THE DELIVERY SYSTEM AND TECHNICAL SUCCESS WERE REPORTED. THERE WERE NO CORRECTIVE PROCEDURE(S) OR COMPLICATIONS RELATED TO THE DEVICE OR PROCEDURE. 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 AND WAS REPORTED TO HAVE A TYPE II ENDOLEAK INVOLVING THE INFERIOR MESENTERIC ARTERY (IMA) AND LUMBAR ARTERIES. THERE IS NO LOSS OF PATENCY TO A GORE® DEVICE AND NO DEVICE INTEGRITY EVENTS REPORTED. THIS EVENT IS NOTED TO BE ON GOING AND NO TREATMENT WAS PROVID

  Patient problems: Clinical Endoleak

  MAUDE report 25446774 ↗
• InjuryJun 9, 2026Obstruction of Flow

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN AORTOILIAC ANEURYSM UTILIZING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (ILIAC BRANCH COMPONENT) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) EXTENDING INTO THE EXTERNAL ILIAC ARTERY (REFERENCE (B)(4) FOR THE VBX DEVICE). AT THE PATIENT'S ONE MONTH FOLLOW-UP SCAN, EVERYTHING LOOKED OK; HOWEVER, THERE APPEARED TO BE A NARROWING BELOW THE VBX DEVICE IN THE EXTERNAL ILIAC, SO THE PHYSICIAN ELECTED TO PUT THE PATIENT ON ELIQUIS OUT OF CONCERN OF THROMBOSIS. ON (B)(6) 2026, AT ANOTHER FOLLOW-UP SCAN, THERE WAS THROMBOSIS IN THE VBX DEVICE IN THE EXTERNAL ILIAC TO THE FLOW DIVIDER OF THE ILIAC BRANCH COMPONENT. REPORTEDLY, THE INTERFACE BETWEEN THE ARTERY AND THE VBX DEVICE LOOKED "KINKED"; HOWEVER, THE VBX STENT ITSELF LOOKED OK BESIDES THE THROMBOSIS, AS IT DID NOT LOOK NARROWED. THE PHYSICIAN REPORTED THE CAUSE OF THE THROMBOSIS WAS THE PATIENT'S SMALL, CALCIFIED ARTERIES AND TORTUOSITY; HOWEVER, THE PATIENT'S ARTERY SIZES WERE REPORTEDLY ON LABEL FOR DEVICE SIZE. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE WHERE THE PHYSICIAN WAS PLANNING TO REMOVE THE CLOT AND

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25443612 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR INTERVENTION (DEBRANCHED ILIAC BRANCH AND A COOK AAA ENDOGRAFT PROCEDURE) INVOLVING PLACEMENT OF A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WITHIN THE ILIAC VASCULATURE. THE PATIENT¿S ANATOMY WAS NOTABLE FOR AN ANEURYSMAL GLUTEAL ARTERY BRANCH, AND A PREVIOUSLY EMBOLIZED AND COVERED INTERNAL ILIAC ARTERY. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO ADVANCE THE COOK AAA ENDOGRAFT THROUGH A GORE® DRYSEAL FLEX INTRODUCER SHEATH; HOWEVER, ADVANCEMENT WAS UNSUCCESSFUL DUE TO SMALL VESSEL CALIBER AND SIGNIFICANT ARTERIAL CALCIFICATION. THE DEVICE WAS SUBSEQUENTLY REMOVED, AND THE PROCEDURAL STRATEGY WAS MODIFIED TO PROCEED WITH THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. FOLLOWING SUCCESSFUL PLACEMENT OF THE ILIAC BRANCH COMPONENT (CEB). TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE INTRODUCED NEXT. DURING DEPLOYMENT, THE ROSEN GUIDEWIRE WAS INADVERTENTLY WITHDRAWN EXCESSIVELY, LEAVING AN UNDEPLOYED 8 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WITHOUT ADEQUATE GUIDEWIRE SUPPORT. GORE FSA (FIELS SALES ASSOCIATE) ADVICE WAS PROVIDED TO RE-ADVANCE A NEW ROSEN GUIDEWIRE TO

  Patient problems: Vascular Dissection

  MAUDE report 25382859 ↗
• MalfunctionMay 28, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND BILATERAL COMMON ILIAC ARTERY ANEURYSMS AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICE AND GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. ADDITIONALLY, IT WAS REPORTED ADJUNCTIVE PROCEDURES PERFORMED DURING INDEX PROCEDURE INCLUDED: COIL EMBOLIZATION OF AN INTERNAL/EXTERNAL ILIAC ARTERY (SIDE NOT IDENTIFIED). THE PATIENT TOLERATED THE PROCEDURE. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2026, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 64MM WITH A MAXIMUM DIAMETER PROXIMAL LANDING ZONE OF 28MM. THE MAXIMUM DIAMETER OF THE RIGHT COMMON ILIAC ARTERY (RCIA) MEASURED 47MM. THE MAXIMUM DIAMETER OF THE LEFT COMMON ILIAC ARTERY (LCIA) MEASURED 36MM. SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THEIR INTENDED LOCATION, AND RETRIEVAL OF THE DELIVERY SYSTEM AND TECHNICAL SUCCESS WERE REPORTED. THERE WERE NO CORRECTIVE PROCEDURE(S) OR COMPLICATIONS RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND WAS D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322321 ↗
• MalfunctionMay 28, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND BILATERAL COMMON ILIAC ARTERY ANEURYSMS AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICE AND GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. ADDITIONALLY, IT WAS REPORTED ADJUNCTIVE PROCEDURES PERFORMED DURING INDEX PROCEDURE INCLUDED: COIL EMBOLIZATION OF AN INTERNAL/EXTERNAL ILIAC ARTERY (SIDE NOT IDENTIFIED). THE PATIENT TOLERATED THE PROCEDURE. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2026, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 64MM WITH A MAXIMUM DIAMETER PROXIMAL LANDING ZONE OF 28MM. THE MAXIMUM DIAMETER OF THE RIGHT COMMON ILIAC ARTERY (RCIA) MEASURED 47MM. THE MAXIMUM DIAMETER OF THE LEFT COMMON ILIAC ARTERY (LCIA) MEASURED 36MM. SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THEIR INTENDED LOCATION, AND RETRIEVAL OF THE DELIVERY SYSTEM AND TECHNICAL SUCCESS WERE REPORTED. THERE WERE NO CORRECTIVE PROCEDURE(S) OR COMPLICATIONS RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND WAS D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322140 ↗
• InjuryMay 27, 2026Malposition of Device

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ENDOLEAK ASSOCIATED WITH A PREVIOUSLY IMPLANTED NON-GORE STENT GRAFT USING THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE ILIAC BRANCH COMPONENT (IBC) WAS DEPLOYED FROM THE LEFT COMMON ILIAC TO THE EXTERNAL ILIAC; HOWEVER, THE INTERNAL ILIAC GATE WAS POSITIONED THAT IT COVERED HALF OF THE LEFT EXTERNAL ILIAC. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO REPOSITION THE IBC USING A BALLOON; HOWEVER, THE INTERNAL ILIAC GATE WAS POSITIONED THAT IT COVERED HALF OF THE LEFT INTERNAL ILIAC ARTERY, MAKING CANNULATION IMPOSSIBLE. THE LEFT INTERNAL ILIAC WAS COIL EMBOLIZED, AND AN ADDITIONAL STENT GRAFT WAS PLACED EXTENDING TO THE LEFT EXTERNAL ILIAC. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 25296206 ↗
• InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. AFTER PLACEMENT OF THE INTERNAL ILIAC COMPONENT (IIC) IN THE LEFT INTERNAL ILIAC ARTERY, IT WAS OBSERVED THAT BLOOD FLOW TO THE SUPERIOR AND INFERIOR GLUTEAL ARTERIES WAS NOT GOOD. WHILE ADVANCING AN ADDITIONAL IIC DEVICE FOR PLACEMENT INTO THE INFERIOR GLUTEAL ARTERY, RUPTURE OCCURRED AT THE ORIGIN OF THE INFERIOR GLUTEAL ARTERY. REPORTEDLY, THE OLIVE TIP OF THE IIC DELIVERY CATHETER WAS INSERTED INTO THE INFERIOR GLUTEAL ARTERY AT THE TIME THE RUPTURE OCCURRED. THE INFERIOR GLUTEAL ARTERY WAS EMBOLIZED WITH COIL. THE PROCEDURE WAS COMPLETED AFTER CONFIRMING NO BLOOD FLOW ISSUES IN THE SUPERIOR GLUTEAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT EXCESSIVE FORCE MIGHT HAVE BEEN APPLIED DURING BALLOONING AND DEVICE DELIVERY.

  Patient problems: Perforation of Vessels

  MAUDE report 25267615 ↗

Other W. L. Gore & Associates, Inc. products

• GORE EXCLUDER AAA Endoprosthesis81 models · 1,121 reports
• GORE DRYSEAL FLEX Introducer Sheath29 models · 1,009 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery51 models · 988 reports
• GORE DUALMESH PLUS BIOMATERIAL12 models · 734 reports
• GORE VIABAHN VBX Balloon Expandable Endo111 models · 557 reports · 1 recall
• GORE DUALMESH Biomaterial13 models · 485 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral10 models · 427 reports
• GORE TAG Conformable Thoracic Stent Graft25 models · 325 reports