GORE EXCLUDER Iliac Branch Endoprosthesis CEB231210ARecalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00733132635290), received between Jun 25, 2018 and Aug 31, 2026 — classified as 4 deaths, 87 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (11 reports).

2 other recalls cover devices cleared under the same FDA submission (P020004); 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 97 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• InjuryApr 28, 2026Detachment of Device or Device Component; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, AN FSA WAS CALLED INTO AN EMERGENT CASE INVOLVING TREATMENT OF SEVERELY CALCIFIED BILATERAL COMMON ILIAC ARTERIES WITH BILATERAL KISSING STENT PLACEMENT USING GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). DURING THE PROCEDURE, AN AORTIC RUPTURE OCCURRED, AND THE PHYSICIAN DETERMINED THAT THE BEST COURSE OF ACTION WAS TO EXTEND THE BILATERAL VBX DEVICES PROXIMALLY USING ADDITIONAL VBX DEVICES AND TO IMPLANT A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (EXCLUDER® DEVICE). THE EXCLUDER® DEVICE WAS ADVANCED THROUGH THE LEFT GROIN SHEATH. THE CONTRALATERAL GATE WAS SUCCESSFULLY DEPLOYED, CANNULATED, AND BRIDGED WITH A VBX STENT. IT WAS LATER CONFIRMED THAT BOTH SIDE OF THE EXCLUDER® DEVICE RECEIVED VBX DEVICES: AN 11 MM VBX WAS PLACED ON THE CONTRALATERAL (RIGHT) SIDE INTO THE RIGHT COMMON ILIAC ARTERY, AND A 11 MM VBX WAS PLACED ON THE IPSILATERAL (LEFT) SIDE ALONG WITH A VIABAHN DEVICE INTO THE LEFT EXTERNAL ILIAC ARTERY. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE REMAINDER OF THE DEVICE BY PULLING THE DEPLOYMENT LINE (GRAY KNOB), THE DISTAL PORTION OF THE IPSILATERAL LIMB FAILED TO DEPLOY AND REMAINED CONSTRAIN

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 25017770 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THIS 68-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTOILIAC ANEURYSM. THE PATIENT WAS TREATED WITH GORE®¿DEVICES INCLUDING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT (IBC) IN THE LEFT COMMON ILIAC ARTERY AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS INTERNAL ILIAC COMPONENT (IIC) IN THE LEFT INTERNAL ILIAC ARTERY. A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS ALSO IMPLANTED. THE SITES WERE ACCESSED PERCUTANEOUSLY ON THE LEFT AND RIGHT. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATIONS AND SUCCESSFULLY DEPLOYED. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED AFTER SUCCESSFUL ACCESS, DELIVERY AND DEPLOYMENT OF THE DEVICES. THERE WERE NO ACCESS-RELATED COMPLICATIONS. THE PATIENT ALSO HAD EMBOLIZATION WITH COILS OF THE INTERNAL ILIAC ARTERY AND LUMBAR ARTERY VESSEL(S) DURING THE INDEX PROCEDURE. THE PATIENT WAS HOME ON (B)(6), 2025. ON (B)(6) 2025, THE PATIENT HAD A CTA THAT SHOWED A MILD THROMBUS WITHIN THE IBC AND IIC. THERE WAS NO LOSS OF PATENCY OF THE GORE® DEVICES NOTED. ON (B)(6) 2026, THE PATIENT HAD A CTA THAT SHOWED LOSS OF PATENCY OF EXC

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 24976799 ↗
• InjuryApr 20, 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 AND BILATERAL ILIAC ARTERY ANEURYSMS USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS ALSO IMPLANTED IN THE BILATERAL ILIAC ARTERIES. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED FOR TYPE IB ENDOLEAKS FROM THE RIGHT INTERNAL ILIAC ARTERY AND THE RIGHT EXTERNAL ILIAC ARTERY, WHICH HAD BEEN FOUND DURING A FOLLOW-UP EXAMINATION. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS IMPLANTED IN THE INTERNAL ILIAC ARTERY AND EXCLUDER ILIAC EXTENDER WAS IMPLANTED IN THE EXTERNAL ILIAC ARTERY TO EXTEND THE TREATMENT AREA. THE ENDOLEAKS DISAPPEARED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 24933816 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE DEVICE). IN ADDITION, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS IMPLANTED IN THE PATIENT'S LEFT RENAL ARTERY TO TREAT OSTIAL RENAL STENOSIS. ON (B)(6) 2026, LATER IN THE EVENING, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE AS A DISSECTION WAS DISCOVERED IN THE PATIENT'S LEFT DISTAL COMMON ILIAC ARTERY, DISTAL TO THE IBE DEVICE. AN ILIAC EXTENDER ENDOPROSTHESIS (PLL161207) WAS IMPLANTED AS EXTENSION TO THE IBE DEVICE TO COVER THE DISSECTION. CAUSE OF THE DISSECTION IS UNKNOWN. THE DISSECTION WAS RESOLVED AND FLUOROSCOPY SHOWED THE PATIENT HAD ADEQUATE BLOOD FLOW THROUGH THE BILATERAL LIMBS AND DOWN THE LEGS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 24904093 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). IBE WAS IMPLANTED IN THE BILATERAL COMMON ILIAC ARTERIES. ON AN UNKNOWN DATE IN 2026, DURING A POSTOPERATIVE FOLLOW-UP EVALUATION, OCCLUSION OF THE ILIAC BRANCH COMPONENT PLACED IN THE LEFT EXTERNAL ILIAC ARTERY WAS IDENTIFIED. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. THROMBECTOMY WAS CONDUCTED NEAR THE BIFURCATION OF THE ILIAC BRANCH COMPONENT, FOLLOWED BY PLACEMENT OF A BARE-METAL STENT IN THE LEFT EXTERNAL ILIAC ARTERY, RESULTING IN IMPROVED ARTERIAL BLOOD FLOW. THE LEFT INTERNAL ILIAC ARTERY WAS ALSO FOUND TO BE THROMBOSED, BUT NO ADDITIONAL INTERVENTION WAS PERFORMED, AND THE PROCEDURE WAS CONCLUDED. BASED ON CLINICAL ASSESSMENT, IT WAS REPORTED THAT THE OCCLUSION MAY HAVE EXTENDED FROM THE LEFT EXTERNAL ILIAC ARTERY INTO THE TRUNK OF THE ILIAC BRANCH COMPONENT, WHICH MAY HAVE SUBSEQUENTLY CONTRIBUTED TO SECONDARY OCCLUSION OF THE LEFT INTERNAL ILIAC ARTERY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24709484 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING LITERATURE WAS REVIEWED. TITLE: A CASE OF INFLAMMATORY AORTIC ANEURYSM AND PSEUDOANEURYSM RELATED TO POST-IMPLANTATION SYNDROME AFTER ENDOVASCULAR AORTIC REPAIR AUTHOR: SEIGO HAPPO, ET AL. SOURCE: JOURNAL OF ABDOMINAL EMERGENCY MEDICINE (1340-2242) VOL. 45, ISSUE NO. 2, PAGES 284 (2025.02) ON JUNE 5, 2024, A 77-YEAR-OLD MAN UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND LEFT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). NO MAJOR ADVERSE EVENTS WERE OBSERVED IN THE EARLY POSTOPERATIVE PERIOD; HOWEVER, THE PATIENT SUBSEQUENTLY DEVELOPED PERSISTENT FEVER. CONTRAST-ENHANCED CT PERFORMED FOUR MONTHS AFTER THE PROCEDURE DEMONSTRATED MARKED INFLAMMATORY CHANGES, INCLUDING SIGNIFICANT AORTIC WALL THICKENING THROUGHOUT THE ENTIRE STENT GRAFT (SG) TREATMENT REGION AND IRREGULAR ATTENUATION OF THE SURROUNDING FAT TISSUE. LABORATORY TESTS SHOWED MILD INFLAMMATION, WITH WHITE BLOOD CELLS 9,500/¿L AND C-REACTIVE PROTEIN 3.46 MG/DL, WHILE PROCALCITONIN LEVELS WERE NOT ELEVATED AND BLOOD CULTURES WERE NEGATIVE. IGE LEVELS WERE ELEVATED AT 2,588 IU/ML. BASED ON THESE FINDINGS, THE CONDITION WAS CO

  Patient problems: Insufficient Information

  MAUDE report 24709220 ↗
• InjuryFeb 6, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE), WITH GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS BEING USED IN THE ILIAC ARTERIES. THE PHYSICIAN INTENTIONALLY DID NOT IMPLANT DEVICES IN THE HGB, SO THAT BLOOD WOULD CONTINUE TO PERFUSE THE ANEURYSM SAC AND PROVIDE BLOOD TO THE SPINAL CORD. THE PATIENT TOLERATED THE PROCEDURE. ON 1 MONTH FOLLOW-UP IMAGING, THE ANEURYSM SAC MEASURED 64MM. ON 6MONTH FOLLOW-UP IMAGING, THE ANEURYSM SAC MEASURED 66MM. ON FOLLOW-UP IMAGING (B)(6) 2025, THE ANEURYSM SAC MEASURED 71MM. NO TREATMENT IS LISTED; BUT THE PHYSICIAN INTENDS TO PERFORM AN ANGIO IN FEBRUARY 2026 TO SEE WHAT COULD BE DONE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 24283465 ↗
• InjuryJan 7, 2026Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT URGENT ENDOVASCULAR TREATMENT FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. ON (B)(6) 2024, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES WERE IMPLANTED IN THE RIGHT ILIAC ARTERY TO PREVENT A DISTAL TYPE I ENDOLEAK. ON AN UNKNOWN DATE (AFTER (B)(6) 2024), THE ANEURYSM ENLARGEMENT WAS OBSERVED. CT IMAGING REVEALED A TYPE II ENDOLEAK FROM THE INFERIOR MESENTERIC ARTERY (IMA) AND THE LUMBAR ARTERY (LA). ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED TO TREAT THE TYPE II ENDOLEAK. THE IMA AND LA WERE EMBOLIZED. DURING EMBOLIZATION OF THE LA, A DISSECTION AT THE ORIGIN OF THE LEFT INTERNAL ILIAC ARTERY OCCURRED DUE TO A NON-GORE GUIDEWIRE. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES WERE IMPLANTED IN THE LEFT ILIAC ARTERY TO TREAT THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23987209 ↗
• MalfunctionDec 22, 2025Material Deformation; Material Deformation

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. WHILE DEPLOYING THE CONTRALATERAL LEG COMPONENT BY PUSHING IT UP IN THE IPSILATERAL SIDE, IT MOVED PROXIMALLY AND WAS PLACED WHERE THE PROXIMAL SIDE OF THE DEVICE WAS EXTENDED APPROXIMATELY 1CM PAST THE FLOW SPLITTER. THERE WAS NO OBSTRUCTION OF BLOOD FLOW IN THE CONTRALATERAL SIDE; HOWEVER, A BARE STENT WAS PLACED FOR PREVENTIVE PURPOSES FROM THE SAME LEVEL. AFTER THE ILIAC BRANCH COMPONENT(IBC) WAS FULLY DEPLOYED, BALLOONING WAS PERFORMED USING THE KISSING BALLOONING TECHNIQUE(KBT). REPORTEDLY, THE IPSILATERAL LEG WAS COMPRESSED BY THE CONTRALATERAL LEG, AND THE LUMEN OF THE IPSILATERAL LEG BECAME NARROWED. ATTEMPTS WERE MADE TO EXPAND THE IPSILATERAL LEG USING KBT, BUT IT WAS UNSUCCESSFUL. THEREFORE, A BARE STENT WAS PLACED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874167 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND A RIGHT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG ENDOPROSTHESIS), GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES. ON (B)(6) 2025, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2025, THE PATIENT WAS URGENTLY TRANSPORTED TO THE HOSPITAL. CT REVEALED A TYPE A DISSECTION (OUTSIDE THE TREATMENT AREA OF THE EXCLUDER DEVICES), COLLAPSE OF THE PROXIMAL PORTION OF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS, AND ALMOST COMPLETE LOSS OF BLOOD FLOW TO THE LOWER LIMBS. ON THE SAME DAY, THE PATIENT UNDERWENT ARTIFICIAL GRAFT REPLACEMENT. THE PHYSICIAN STATED THAT AN ULTRASOUND TAKEN AT DISCHARGE REVEALED NO ENDOLEAKS AND NO FINDINGS SUGGESTIVE OF TYPE A DISSECTION. THE PHYSICIAN ALSO STATED THAT THE TYPE A DISSECTION WAS OBSERVED APPROXIMATELY 2 WEEKS AFTER DISCHARGE, SO IT MIGHT HAVE NEWLY DEVELOPED AFTER DISCHARGE, AND THE PROXIMAL PORTION OF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS MIGHT HAVE COLLAPSED BECAUSE A FALSE LUMEN COMPRESSED IT.

  Patient problems: Stenosis

  MAUDE report 23724204 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). ON AN UNKNOWN DATE IN (B)(6) 2025, THE PATIENT WAS HOSPITALIZED TO UNDERGO CORONARY ARTERY BYPASS GRAFTING (CABG). A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED AN OCCLUSION EXTENDING FROM THE PROXIMAL PORTION OF THE CONTRALATERAL LIMB OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS TO THE LEFT COMMON FEMORAL ARTERY. THE INTERNAL ILIAC ARTERY WAS ALSO OCCLUDED. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION TO TREAT THE OCCLUSION. THROMBECTOMY USING FOGARTY CATHETERS WAS ATTEMPTED. BECAUSE COMPLETE REMOVAL OF THROMBUS WAS NOT ACHIEVED, AN ADDITIONAL STENT GRAFT WAS PLACED AS AN INNER LINING. FURTHERMORE, DUE TO VESSEL ANGULATION NEAR THE FLOW DIVIDER OF THE ILIAC BRANCH COMPONENT (IBE), A BARE-METAL STENT WAS ADDITIONALLY DEPLOYED. BLOOD FLOW IMPROVED BUT FLOW DISTAL TO THE COMMON FEMORAL ARTERY REMAINED REDUCED. THE PROCEDURE WAS CONCLUDED WITH A PLAN FOR FOLLOW-UP OBSERVATION. NO TREATMENT W

  Patient problems: Obstruction/Occlusion

  MAUDE report 23724110 ↗
• InjuryNov 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (2 CONTRALATERAL COMPONENTS), GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG CONFORMABLE), AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (ILIAC BRANCH COMPONENT AND INTERNAL ILIAC COMPONENT) TO TREAT AN ANEURYSM. ON (B)(6) 2025, A GRAFT INFECTION WAS OBSERVED, AND PATIENT UNDERWENT EXPLANT SURGERY IN WHICH ALL THE DEVICES WERE EXPLANTED. IT ALSO UNKNOWN WHICH DEVICE HAD AN INFECTION. IT WAS ALSO REPORTED PATIENT HAS NO KNOWN HISTORY OF PREVIOUS INFECTIONS, AND IT IS UNKNOWN WHAT CAUSED THE INFECTION. NO FURTHER PATIENT INFORMATION IS AVAILABLE, AND DEVICES WERE DISCARDED. THE FIELD SALES ASSOCIATE WAS NOTIFIED ABOUT THIS EXPLANT SURGERY ON (B)(6) 2025.

  Patient problems: Medical device site infection

  MAUDE report 23498265 ↗
• MalfunctionSep 10, 2025Entrapment of Device; Entrapment of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING A UNILATERAL GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). REPORTEDLY, THE DEVICE DEPLOYED ON FIRST STAGE WITH NO ISSUE. HOWEVER, UPON SECOND STAGE DEPLOYMENT, DEVICE DIDN'T APPEAR TO FULLY OPEN, RESTRICTING THE DELIVERY SYSTEM FROM BEING REMOVED FROM THE BODY. THE PHYSICIAN TRIED MULTIPLE ATTEMPTS AND DELIVERY SYSTEM APPEARED TO BE GETTING STUCK WITHIN THE EXTERNAL PORTION OF THE LIMB, AS WELL AS THE OLIVE TIP GETTING CAUGHT ON THE FLOW DIVIDER. AFTER MUCH MANIPULATION, TWISTING AND PUSHING THE DELIVERY SYSTEM UP AND DOWN, IT FINALLY CAME OUT OF THE BODY INTACT. PROCEDURE WAS SUCCESSFUL IN THE END AND THERE WAS NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023045 ↗
• InjuryAug 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). ON (B)(6) 2025, A CT SCAN SHOWED DISCONNECTION OF THE BRIDGING CONTRALATERAL LEG FROM THE ILIAC BRANCH COMPONENT (IBC). THIS WAS DUE TO MIGRATION OF THE CONTRALATERAL LEG BUT NOT DUE TO IBC DEVICE. THERE WAS A TYPE IIIA ENDOLEAK BETWEEN THESE TWO COMPONENTS. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED. ANOTHER BRIDGING CONTRALATERAL LEG WAS ADDITIONALLY IMPLANTED. ALSO, AN AORTIC EXTENDER WAS IMPLANTED TO REINFORCE THE CONNECTION SITE. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: BECAUSE OF HIGHLY ANGULATED BLOOD VESSELS AND LARGE DIAMETER OF THE ANEURYSM, THE OVERLAP LENGTH OF THE CONNECTION WAS SHORT AT THE TIME OF INITIAL PROCEDURE. AN ADDITIONAL AORTIC EXTENDER SHOULD HAVE BEEN PLACED AT THE TIME OF THE INITIAL PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 22836797 ↗
• InjuryAug 12, 2025Difficult to Advance; Difficult to Advance

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). DURING THE INSERTION OF THE IBE, THE GUIDEWIRE BECAME ENTANGLED, MAKING THE INSERTION DIFFICULT. AFTER DEPLOYMENT OF THE IBE, ANGIOGRAPHY REVEALED THAT THE SUPERIOR AND INFERIOR GLUTEAL ARTERIES WERE NOT VISUALIZED. IT WAS CONSIDERED THAT THE THROMBUS HAD EITHER EMBOLIZED TO THE SUPERIOR AND INFERIOR GLUTEAL ARTERIES OR HAD FORMED THERE, RESULTING IN OCCLUSION. THROMBUS ASPIRATION WAS PERFORMED, AND SUBSEQUENT ANGIOGRAPHY CONFIRMED VISUALIZATION OF BOTH ARTERIES. THE PHYSICIAN COMMENTED: ¿IT IS UNCLEAR WHETHER THE THROMBUS WAS DISLODGED DURING THE PROCEDURE OR FORMED DUE TO SOME OTHER CAUSE. THE REASON FOR ITS APPEARANCE IN THAT LOCATION IS UNKNOWN.¿

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22787784 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT WAS IMPLANTED WITH GORE®EXCLUDER®AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT FOR A RIGHT COMMON ILIAC ARTERY ANEURYSM AND A GORE®EXCLUDER®ILIAC BRANCH ENDOPROSTHESIS (CEB) WAS IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY (RCIA) AND EXTENDED INTO THE RIGHT INTERNAL ILIAC ARTERY (RIIA) USING GORE®VIABAHN®VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICE. THE PHYSICIAN THEN EXTENDED COVERAGE OF THE CEB WITH A GORE®EXCLUDER®AAA CONTRALATERAL LEG DEVICE. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD TECHNICAL SUCCESS AND WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS DETERMINED TO HAVE A THROMBOSED RCIA AND REIA (CEB231210A, PLC271000). ON (B)(6) 2025, THE PATIENT UNDERWENT THROMBECTOMY OF THE REIA AND RIGHT COMMON FEMORAL ARTERY (RCFA) BY OPEN FEMORAL ARTERY EXPOSURE. A GORE®VIABAHN®VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS IMPLANTED TO RELINE AND EXTEND COVERAGE DOWN TO THE EXTERNAL AND FEMORAL ARTERY. AN ANGIOGRAM SHOWED BOTH THE INTERNAL AND EXTERNAL ILIAC ARTERIES WERE OPEN AND PATENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22536162 ↗
• InjuryJul 7, 2025Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE ON JUNE 9, 2025, FROM THE IMAGING DATABASE: ON (B)(6) 2025, A 67-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS AN PLANNED PROCEDURE FOR A COMMON ILIAC ARTERY ANEURYSM. THE PATIENT WAS TREATED WITH FIVE GORE® EXCLUDER® ENDOPROSTHESIS DEVICES IN THE INFRARENAL ABDOMINAL AORTA, BILATERAL INTERNAL ILIAC ARTERIES, AND RIGHT EXTERNAL ILIAC ARTERY. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. ON (B)(6) 2025, IT WAS NOTED THE PATIENT HAS AN OCCLUDED RIGHT EXTERNAL ILIAC ARTERY. THERE HAS BEEN NO HOSPITALIZATION OR REINTERVENTION AT THIS TIME. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22413031 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR THE RIGHT COMMON ILIAC ARTERY ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES AND GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESES. A TOTAL OF FIVE STENT GRAFTS WERE IMPLANTED, INCLUDING ONE TRUNK IPSILATERAL LEG, TWO CONTRALATERAL LEGS, ONE ILIAC BRANCH COMPONENT AND ONE INTERNAL ILIAC COMPONENT. IN (B)(6) 2025 (EXACT DATE UNKNOWN), A FOLLOW-UP CT SCAN REVEALED A THROMBOTIC OCCLUSION EXTENDING FROM THE BIFURCATION OF THE TRUNK IPSILATERAL LEG TO THE RIGHT GROIN AREA. ON (B)(6), 2025, A REINTERVENTION WAS PERFORMED INCLUDING A THROMBECTOMY. SUBSEQUENTLY, ONE STENT GRAFT WAS ADDITIONALLY IMPLANTED IN EACH OF THE LEFT AND RIGHT COMMON ILIAC ARTERIES. ANOTHER STENT GRAFT WAS IMPLANTED IN THE RIGHT EXTERNAL ILIAC AS AN EXTENSION, AND THE RIGHT INTERNAL ILIAC WAS INTENTIONALLY COVERED. AFTER EXPANDING THE PTA BALLOON IN THE RIGHT DISTAL AREA, A BARE METAL STENT WAS PLACED NEAR THE RIGHT GROIN. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN¿S COMMENT: ¿THE REASON FOR THE THROMBOTIC OCCLUSION IS UNKNOWN.¿

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22401525 ↗
• InjuryJul 3, 2025Migration; Migration

  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® ILIAC BRANCH ENDOPROSTHESIS (IBE). AFTER DEPLOYING THE ILIAC BRANCH COMPONENT (IBC) IN THE RIGHT COMMON ILIAC ARTERY, THE 12FR SHEATH WAS ADVANCED INTO THE CONTRALATERAL GATE, DURING THE SHEATH INSERTION, THE DEVICE WAS INADVERTENTLY PUSHED DISTALLY, RESULTING IN MIGRATION. ANGIGRAHTY AFTER REPOSITIONING SHOWED A POSSIBLE VESSEL RUPTURE OF THE RIGHT COMMON ILIAC ARTERY. THE VESSEL RUPTURE MAY HAVE OCCURRED WHEN THE DEVICE WAS MIGRATED. THERE WAS NO DECREASE IN BLOOD PRESSURE, SO THE PLANNED STENT GRAFT PLACEMENT WAS CONTINUED. THE VESSEL RUPTURE OF THE RIGHT COMMON ILIAC ARTERY WAS SUCCESSFULLY REPAIRED BY PLACING STENTGRAFTS.

  Patient problems: Perforation of Vessels

  MAUDE report 22401493 ↗
• InjuryJun 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS, THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). TO CONNECT THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS TO THE IBE, THE CONTRALATERAL LEG ENDOPROSTHESIS (PLC) WAS DEPLOYED AND BALLOONED. ON AN UNKNOWN DATE IN 2023, 6 MONTHS POST-OP, NO ISSUES WERE OBSERVED DURING THE FOLLOW-UP EXAMINATION. ON AN UNKNOWN DATE IN 2024, 1 YEAR POST-OP, THE PATIENT DID NOT RETURN FOR THE SCHEDULED FOLLOW-UP. ON (B)(6) 2025, 2 YEARS POST-OP, FOLLOW-UP IMAGING REVEALED A SEPARATION AT THE OVERLAP BETWEEN THE IBE AND THE PLC, RESULTING IN A TYPE IIIA ENDOLEAK, ALONG WITH THROMBOTIC OCCLUSION OF THE IPSILATERAL LEG OF THE IBE AND THE RIGHT EXTERNAL ILIAC ARTERY. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION. AN ATTEMPT WAS MADE TO RECANALIZE THE OCCLUDED RIGHT EXTERNAL ILIAC ARTERY, BUT IT WAS UNSUCCESSFUL. THEREFORE, AN ADDITIONAL STENT GRAFT WAS PLACED FROM THE OVERLAPPING SECTION OF THE EXISTING STENT GRAFT TO THE RIGHT INTERNAL ILIAC ARTERY TO TREAT THE

  Patient problems: Clinical Endoleak; Thrombosis/Thrombus

  MAUDE report 22269597 ↗
• InjuryMay 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THIS PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR TREATMENT FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE RIGHT COMMON ILIAC ARTERY ANEURYSM EXCEEDED 30MM. THE CONTRALATERAL LEG WAS DECIDED TO BE LANDED ON THE RIGHT COMMON ILIAC ARTERY AS AN EMERGENCY TREATMENT. THE PATIENT TOLERATED THE PROCEDURE WITHOUT ENDOLEAK. A STAGED PROCEDURE FOR THE RIGHT ILIAC ARTERY USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS SCHEDULED FOR A LATER DATE. ON (B)(6) 2023, THE STAGED PROCEDURE WAS PERFORMED AS PLANNED USING IBE. SUBSEQUENTLY, A TENDENCY FOR ANEURYSM ENLARGEMENT WAS NOTED. A TYPE II ENDOLEAK, AS WELL AS A DISTAL TYPE I ENDOLEAK FROM THE LEFT SIDE, WAS SUSPECTED. ON (B)(6) 2025, REINTERVENTION WAS PERFORMED. ALTHOUGH NO ENDOLEAKS WERE DETECTED ON INTRAOPERATIVE ANGIOGRAPHY, COIL EMBOLIZATION OF THE LEFT/THIRD LUMBAR ARTERY AND NBCA EMBOLIZATION INTO THE LEFT/FOURTH LUMBAR ARTERY AND ANEURYSM SAC WERE PERFORMED FOR THE SUSPECTED TYPE II ENDOLEAK. IN ADDITION, THREE STENT GRAFTS (IBE AND ILIAC EXTENDER COMPONENT) WERE IMPLANTED IN THE LEFT DISTAL SIDE FOR THE SUSPECTED DISTAL T

  Patient problems: Clinical Endoleak

  MAUDE report 21981906 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020004. One submission often covers many models, so check the product and lot details in each record.

• Z-0996-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)
• Z-0995-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER AAA Endoprosthesis