GORE EXCLUDER Iliac Branch Endoprosthesis HGB161407ARecalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00733132635337), received between Sep 6, 2018 and Jun 21, 2026 — classified as 1 death, 50 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (8 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 65 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ILIAC ARTERY ANEURYSM USING GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESES, AND GORE DRYSEAL FLEX INTRODUCER SHEATHS AS ACCESSORIES. AFTER DEPLOYMENT OF THE ILIAC BRANCH COMPONENT (IBC: CEB231410A) IN THE RIGHT COMMON ILIAC ARTERY, A PULL-THROUGH WAS CREATED FROM THE LEFT SIDE, AND THE INTERNAL ILIAC COMPONENT (IIC: HGB161407A) WAS ADVANCED. THE IBC MIGRATED PROXIMALLY, RESULTING IN INSUFFICIENT TREATMENT LENGTH FOR THE IIC IN THE RIGHT INTERNAL ILIAC ARTERY. AN ADDITIONAL IIC WAS SUBSEQUENTLY PLACED DISTALLY. ANGIOGRAPHY SHOWED SLIGHTLY DECREASED BLOOD FLOW IN THE INFERIOR GLUTEAL ARTERY. DURING THE FINAL ANGIOGRAPHY, DECREASED BLOOD FLOW IN THE RIGHT INTERNAL ILIAC ARTERY WAS OBSERVED. THE PHYSICIAN DECIDED TO ADMINISTER ANTIPLATELET THERAPY, AND THE PATIENT WAS PLACED UNDER OBSERVATION. THE PATIENT TOLERATED THE PROCEDURE. ON (B))6) 2026, THE PATIENT UNDERWENT A CTA FOLLOW-UP. THE CTA REVEALED LOSS OF PATENCY OF THE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS INTERNAL ILIAC COMPONENT (IIC). NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 24963312 ↗
• 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 24933793 ↗
• InjuryFeb 26, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE ON FEBRUARY 4, 2026 FROM THE IMAGING DATABASE AND IMEDIDATA BASE: ON (B)(6), 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A PLANNED ENDOVASCULAR PROCEDURE FOR AN COMMON ILIAC ARTERY ANEURYSM. THIS WAS A REINTERVENTION OF A PRIOR ENDOVASCULAR PROCEDURE. A GORE ENDOVASCULAR DEVICE WAS NOT USED IN THE PRIOR ENDOVASCULAR PROCEDURE. THE PATIENT WAS TREATED WITH THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS IN THE RIGHT COMMON ILIAC ARTERY AND LEFT INTERNAL ILIAC ARTERY. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS PLACED IN THE INFRARENAL ABDOMINAL AORTA AND THE LEFT COMMON ILIAC ARTERY. THE GORE® DEVICES WERE SUCCESSFULLY IMPLANTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT UNDERWENT A CTA, WHICH REVEALED A TYPE II ENDOLEAK. ON (B)(6) 2025, THE PATIENT UNDERWENT A CTA, WHICH REVEALED A TYPE II ENDOLEAK. THE LEAK WAS IDENTIFIED IN THE LEFT HYPOGASTRIC ARTERY, THE SITE OF THE INTERNAL ILIAC COMPONENT AND TREATED WITH A COIL-AND-COVER PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT A CTA, WHICH REVEALED A TYPE II ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 24459864 ↗
• InjuryJan 21, 2026Malposition of Device

  ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9 ABDOMINAL AORTIC ANEURYSM AND RIGHT COMMON ILIAC ARTERY ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PATIENT UNDERWENT RE-INTERVENTION FOR A DISCONNECT/OCCLUSION OF THE IBE DEVICES IN THE RIGHT INTERNAL ILIAC ARTERY (RIIA) FROM THE CEB IN THE RIGHT COMMON ILIAC ARTERY. WE PUT A LIMB EXTENSION INTO THE RIGHT EXTERNAL ILIAC ARTERY AND BYPASSED OVER THE FLOW DIVIDER OF THE IBE DEVICE, INTENTIONALLY COVERING THE RIIA AND LEAVING ONLY FLOW VIA THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24132726 ↗
• InjuryJan 13, 2026Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE ON DECEMBER 22, 2025, FROM A TGR STUDY NOTIFICATION: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A PLANNED ENDOVASCULAR PROCEDURE FOR A COMMON ILIAC ARTERY ANEURYSM. THE PATIENT WAS TREATED WITH THE GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE GORE® DEVICES WERE SUCCESSFULLY IMPLANTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT HAD A CTA. INITIAL FINDINGS NOTED OCCLUSION OF THE RIGHT INTERNAL ILIAC ENDOPROSTHESIS, A TYPE II ENDOLEAK, AND STENT KINKING. NO REINTERVENTION HAS OCCURRED. THE PHYSICIAN CONFIRMED THAT BOTH INTERNAL ILIAC COMPONENTS ON THE RIGHT ARE OCCLUDED, AND THE OCCLUSION WAS ANATOMY-RELATED DUE TO POOR DISTAL OUTFLOW OF THE INTERNAL ILIAC BRANCHES. THE PHYSICIAN ALSO STATED THAT THERE WAS NO KINKING; HOWEVER, MILD NARROWING OF THE BILATERAL EXTERNAL ILIAC ARTERY STENT COMPONENTS WAS OBSERVED.

  Patient problems: Clinical Endoleak; Obstruction/Occlusion

  MAUDE report 24057716 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT FOR 3.7CM BILATERAL COMMON ILIAC ARTERY ANEURYSMS (BL-CIAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) DEVICES AND TWO GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENTS. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6), 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 30MM WITH A MAXIMUM DIAMETER PROXIMAL LANDING ZONE OF 20MM. THE MAXIMUM DIAMETER OF THE RIGHT COMMON ILIAC ARTERY MEASURED 14MM AND THE MAXIMUM DIAMETER OF THE LEFT COMMON ILIAC ARTERY MEASURED 33MM. 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, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED AND DETERMINED: THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 28MM, THE MAXIMUM DIAMETER OF THE RCIA MEASURED 34MM, AND THE MAXIMUM DIAMET

  Patient problems: Aneurysm expansion

  MAUDE report 23854659 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2025, THIS 79-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTOILIAC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG ENDOPROSTHESIS), FOUR GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES (THREE CONTRALATERAL LEG ENDOPROSTHESIS DEVICES AND ONE AORTA EXTENDER ENDOPROSTHESIS), AND TWO GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES. TWO GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES WERE IMPLANTED IN THE LEFT ILIAC ARTERY. THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND TWO CONTRALATERAL LEG ENDOPROSTHESIS DEVICES WERE IMPLANTED IN THE RIGHT EXTERNAL ILIAC ARTERY. THERE WAS SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THE INTENDED LOCATION, AND SUCCESSFUL RETRIEVAL OF THE DELIVERY SYSTEMS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT HAD BILATERAL BUTTOCK CLAUDICATION RELATED TO GORE REGISTRY DEVICE (EXCLUDER ILIAC BRANCH ENDOPROSTHESIS INTERNAL ILIAC COMPONENT (IIC)). THIS EVENT IS ONGOING, BUT NO TREATMENT IS REQUIRED. ON (B)(6) 2025, TH

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23847465 ↗
• MalfunctionDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO GORE THAT A PATIENT WAS TO BE IMPLANTED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE DEVICE) TO TREAT COMMON ILIAC ARTERY ANEURYSM. THE IBE DEVICE WAS DELIVERED TO TARGET LESION AND HAS NOT BEEN DEPLOYED YET. THE DISTAL TIP WAS FOUND BROKEN, AND THE ENDO WAS DISPLACED AND DETACHED. THE PHYSICIAN REMOVED THE DETACHED DISTAL TIP AND ENDO FROM PATIENT. ANOTHER IBE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE AND DIDN'T EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835317 ↗
• InjuryDec 5, 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) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). THE IBES WERE PLACED IN BOTH ILIAC ARTERIES. ON AN UNKNOWN DATE, DILATATION OF THE LEFT INTERNAL ILIAC ARTERY DUE TO ANEURYSMAL CHANGE WAS OBSERVED. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION. THE LEFT INTERNAL ILIAC ARTERY AND ITS BRANCH VESSELS WERE EMBOLIZED, AND TWO ADDITIONAL STENT GRAFTS WERE DEPLOYED EXTENDING TO THE LEFT EXTERNAL ILIAC ARTERY. ATTENDING PHYSICIAN¿S COMMENT: AT THE TIME OF THE INITIAL PROCEDURE, PART OF THE LEFT INTERNAL ILIAC ARTERY WAS ALREADY ANEURYSMAL, SO THIS REINTERVENTION HAD BEEN ANTICIPATED.

  Patient problems: Aneurysm

  MAUDE report 23724169 ↗
• InjuryNov 25, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES AND GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESES. TWO CONTRALATERAL LEGS, ONE ILIAC BRANCH COMPONENT AND ONE INTERNAL ILIAC COMPONENT WERE DEPLOYED WITH A NON-GORE MAIN TRUNK. ON AN UNSPECIFIED DATE, A TYPE I ENDOLEAK WAS OBSERVED AT THE DISTAL END OF THE INTERNAL ILIAC COMPONENT, WHICH HAD BEEN PREVIOUSLY IMPLANTED IN THE RIGHT INTERNAL ILIAC ARTERY. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED. THE RIGHT SUPERIOR AND INFERIOR GLUTEAL ARTERIES WERE COIL-EMBOLIZED, AND AN ADDITIONAL STENT GRAFT WAS PLACED, EXTENDING TO THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 23652721 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM, AND BILATERAL ILIAC AORTIC ANEURYSM TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. IT WAS REPORTED FOLLOW UP IMAGES DATED (B)(6) 2025, SHOWED THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS INTERNAL ILIAC COMPONENT HAD THROMBOSED AND THERE WAS A COMPLETE BLOCKAGE. THE PATIENT WAS NOT SYMPTOMATIC, AND THE EVENT IS ONGOING.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23560618 ↗
• InjuryNov 12, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2025, A REINTERVENTION OF 24-HOUR LYSIS WAS INITIATED, AND BLOOD FLOW WAS RESTORED TO TREAT GRAFT THROMBOSIS. ON (B)(6) 2025 AFTER LYSIS COMPLETED, A SUPRA RENAL FIXATION CUFF WAS IMPLANTED PROXIMAL TO THE IMPLANTED GRAFT. AN ADDITIONAL GRAFT WAS IMPLANTED DISTALLY TO EXTEND THE LIMB ON THE LEFT SIDE. THE PATIENT TOLERATED THE REINTERVENTION (CAPTURED UNDER (B)(4). ON AN UNKNOWN DATE IN (B)(6) 2025, THE PATIENT UNDERWENT CTA IMAGING WHERE CONTRAST WAS SEEN OUTSIDE THE GRAFTS, INDICATING THE PATIENT HAD A TYPE 1B ENDOLEAK IN THE LEFT HYPOGASTRIC ARTERY AND IN THE RIGHT COMMON ILIAC ARTERY. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED TO TREAT THE TYPE 1B ENDOLEAK IN THE LEFT HYPOGASTRIC ARTERY, DISTAL TO THE PREVIOUSLY IMPLANTED GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICE (INTERNAL ILIAC COMPONENT). IN ADDITION, THE TYPE 1B ENDOLEAK WAS TREATED IN THE RIGHT COMMON ILIAC ARTERY, DISTAL TO A PREVIOUSLY IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICE (27 MM CONTRALATERAL LEG ENDOPROSTHESIS). THE PATIENT HAD TWO PREVIOUSLY IMPLANTED 27 MM CONT

  Patient problems: Clinical Endoleak

  MAUDE report 23536146 ↗
• MalfunctionOct 21, 2025Break; Break

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS BEING TREATED FOR A BILATERAL AORTO-ILIAC ANEURYSM USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM. BEFORE DEPLOYMENT, THE WIRE GOT WRAPPED AROUND THE CATHETER, PREVENTING IT FROM ADVANCING. WHEN TRYING TO REMOVE THE DEVICE, THE WIRE BROKE THE PROXIMAL END OF THE DEVICE, WHERE THE DEVICE IS SOLDERED ON TO THE CATHETER. ALL PARTS OF THE DEVICE WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND DISCARDED. IMAGES ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353564 ↗
• 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 22787794 ↗
• MalfunctionAug 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT COMMON ILIAC ARTERY ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE). POST DEPLOYMENT OF THE INTERNAL ILIAC ARTERY COMPONENT WHEN WITHDRAWING THE DELIVERY CATHETER, THE LEADING OLIVE AND A PORTION OF THE INNER LUMEN BROKE AND DETACHED FROM THE DELIVERY CATHETER AND REMAINED IN THE PATIENT. THE PHYSICIAN SNARED THE DETATCHED OLIVE TIP AND LUMEN AND SUCCESSFULLY WITHDREW IT WITHIN THE SHEATH. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786489 ↗
• 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 22401531 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. REPORTEDLY, THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WAS IMPLANTED RIGHT SIDE. THE PROCEDURE WENT WELL WITH ALL DEVICES BEING IMPLANTED WITH NO ISSUES AND PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, THE RIGHT INTERNAL ILIAC ARTERY BECAME ANEURYSM AND A MIGRATION OF THE TRUNK-IPSILATERAL LEG COMPONENT DISTALLY WERE OBSERVED ON THE FOLLOW UP COMPUTED TOMOGRAPHY IMAGING. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS(VBX) WAS ADVANCED AND ATTEMPT WAS MADE TO PRESERVE THE SUPERIOR OR INFERIOR GLUTEAL ARTERY, BUT THE DEVICE COULD ONLY BE ADVANCED TO JUST ABOVE THE BIFURCATION OF THE GLENOID ARTERY DUE TO STRONG TORTUOSITY OF THE RIGHT INTERNAL ILIAC ARTERY, THE VBX DEVICE WAS DEPLOYED AT THAT SITE. SUBSEQUENTLY, AN ATTEMPT TO APPROACH THE SUPERIOR GLUTEAL ARTERY USING A SECOND VBX DEVICE WAS UNSUCCESSFUL, AND THE PLAN WAS TO EMBOLIZE THE RIGHT INTERNAL ILIAC ARTERY AT A LATER DATE. AN ADDITIONAL STENT GRAFT WAS PLACED TO TREAT THE MIGRAT

  Patient problems: Aneurysm

  MAUDE report 21615838 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. REPORTEDLY, THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WAS IMPLANTED RIGHT SIDE. THE PROCEDURE WENT WELL WITH ALL DEVICES BEING IMPLANTED WITH NO ISSUES AND PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, THE RIGHT INTERNAL ILIAC ARTERY BECAME ANEURYSM AND A MIGRATION OF THE TRUNK-IPSILATERAL LEG COMPONENT DISTALLY WERE OBSERVED ON THE FOLLOW UP COMPUTED TOMOGRAPHY IMAGING. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS(VBX) WAS ADVANCED AND ATTEMPT WAS MADE TO PRESERVE THE SUPERIOR OR INFERIOR GLUTEAL ARTERY, BUT THE DEVICE COULD ONLY BE ADVANCED TO JUST ABOVE THE BIFURCATION OF THE GLENOID ARTERY DUE TO STRONG TORTUOSITY OF THE RIGHT INTERNAL ILIAC ARTERY, THE VBX DEVICE WAS DEPLOYED AT THAT SITE. SUBSEQUENTLY, AN ATTEMPT TO APPROACH THE SUPERIOR GLUTEAL ARTERY USING A SECOND VBX DEVICE WAS UNSUCCESSFUL, AND THE PLAN WAS TO EMBOLIZE THE RIGHT INTERNAL ILIAC ARTERY AT A LATER DATE. AN ADDITIONAL STENT GRAFT WAS PLACED TO TREAT THE MIGRAT

  Patient problems: Aneurysm

  MAUDE report 21615644 ↗
• InjuryMar 15, 2025Complete Blockage; Complete Blockage

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND UNILATERAL ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. AN RLT311413 TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED IN THE PATIENT'S AORTA, A CEB231410A ILIAC BRANCH COMPONENT AND HGB161407A INTERNAL ILIAC COMPONENT WERE IMPLANTED IN THE PATIENT'S LEFT ILIAC ARTERY, AND A PLC271000 CONTRALATERAL LEG COMPONENT WAS USED AS A BRIDGING COMPONENT. A PLC231000 CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO EXTEND THE IPSILATERAL LIMB. IMAGING EVALUATION SUGGESTS THAT THE PATIENT'S AORTIC NECK IS APPROXIMATELY 70 DEGREES. ON (B)(6) 2024, POST-IMPLANTATION NON-CONTRAST CT REVEALED THAT THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG COMPONENT APPEARED TO BE COMPRESSED AT THE ANGULATED PORTION OF THE AORTA. ON (B)(6) 2025, THE GORE REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD PRESENTED WITH LEG PAIN. EVALUATION OF POST-IMPLANTATION CTA IMAGING, DATED (B)(6) 2025, REVEALED THAT THE AORTA HAD DISSECTED AND THAT THE ENTIRE DEVICE SYSTEM HAD THROMBOSED AND OCCLUDED. THE DISSECTION REPORTEDLY EXTENDED PROXIMAL TO THE PATIENT'S DESCENDI

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 21613840 ↗
• InjuryMar 13, 2025Material Separation; Improper or Incorrect Procedure or Method; Activation Failure; Material Separation; Improper or Incorrect Procedure or Method; Activation Failure

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A LEFT INTERNAL ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT THE EXTERNAL ILIAC COMPONENT WAS IMPLANTED WITH NO REPORTED ISSUES. THE INTERNAL ILIAC COMPONENT (IIC) WAS ADVANCED WITH NO REPORTED ISSUES AND POSITIONED IN THE INTENDED LOCATION. THE PHYSICIAN BEGAN TO DEPLOY THE IIC AND APPROXIMATELY 2CM OF THE DEVICE WERE DEPLOYED WHEN DEPLOYMENT STOPPED. THE PHYSICIAN CONTINUED TO ATTEMPT TO PULL THE DEPLOYMENT LINE, BUT DEPLOYMENT WAS UNABLE TO BE RESTARTED. THE PHYSICIAN CONTINUED TO PULL WITH NO RESULT, SO THE DECISION WAS MADE TO ATTEMPT TO WITHDRAW THE DEVICE BACK INTO THE INTRODUCER SHEATH FOR REMOVAL. THE DEVICE WAS UNABLE TO BE WITHDRAWN BACK INTO THE SHEATH, AND THE DELIVERY CATHETER BROKE AT THE LEVEL OF THE PARTIALLY DEPLOYED DEVICE. THE PEBAX TUBING WITH PARTIALLY DEPLOYED DEVICE AND ATTACHED LEADING OLIVE TIP ALL REMAINED IN THE INTERNAL ILIAC ARTERY. IT WAS UNKNOWN WHAT CAUSED THE DEPLOYMENT FAILURE AND IT WAS NOTED THAT THE INTRODUCER SHEATH HAD BEEN PULLED BACK FULLY PRIOR TO DEPLOYMENT. THE TRAILING END OF THE DELIVERY CATHETER WAS REMOVED THROUGH THE INTR

  Patient problems: Obstruction/Occlusion

  MAUDE report 21602030 ↗
• InjuryNov 28, 2024Adverse 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) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. IMPAIRED BLOOD FLOW IN THE LEFT INTERNAL ILIAC ARTERY WAS OBSERVED AFTER THE PLACEMENT. A FINAL ANGIOGRAPHY REVEALED A DISSECTION IN THE LEFT INTERNAL ILIAC ARTERY. REPORTEDLY, THE BEGINNING OF THE PATIENT¿S INTERNAL ILIAC ARTERIES WAS ORIGINALLY NARROW, AND THE DISSECTION POSSIBLY OCCURRED DURING THE INSERTION AND PLACEMENT OF THE INTERNAL ILIAC COMPONENT INTO THE LEFT INTERNAL ILIAC ARTERY. HOWEVER, NO FURTHER INTERVENTION WAS PERFORMED FOR THE DISSECTION, AND THE PHYSICIAN DECIDED TO MONITOR THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 20803767 ↗
• InjurySep 9, 2024Malposition of Device; Malposition of Device

  ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE PROCEDURE, WHEN THE PHYSICIAN DEPLOYED AN INTERNAL ILIAC COMPONENT AT THE RIGHT INTERNAL ILIAC ARTERY, THE DEVICE PARTIALLY COVERED THE OSTIUM OF THE RIGHT SUPERIOR GLUTEAL ARTERY. THE BLOOD FLOW OF THE RIGHT SUPERIOR GLUTEAL ARTERY WAS DELAYED; HOWEVER, NO ADDITIONAL TREATMENT WAS REQUIRED TO FIX THE ISSUE. THE PATIENT TOLERATED THE PROCEDURE AND HAD SINCE BEEN MONITORED. ACCORDING TO THE REPORTING PHYSICIAN, THE RIGHT INTERNAL ILIAC ARTERY WAS SHORT IN LENGTH AND HE WAS AWARE OF THE RISK OF COVERING THE RIGHT SUPERIOR GLUTEAL ARTERY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20177542 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). THE IBE WAS IMPLANTED IN THE LEFT SIDE. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, A FOLLOW-UP EXAMINATION SHOWED THROMBOTIC OCCLUSION OF THE INTERNAL ILIAC COMPONENT (LEFT INTERNAL ILIAC ARTERY; IIA) AND ANEURYSM ENLARGEMENT OF THE RIGHT COMMON ILIAC ARTERY. AN ADDITIONAL TREATMENT WAS INDICATED. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. THE RIGHT INTERNAL ILIAC ARTERY WAS COIL-EMBOLIZED AND AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO EXTEND THE TREATMENT AREA INTO THE EXTERNAL ILIAC ARTERY. NO TREATMENT WAS GIVEN FOR THE OCCLUSION OF THE LEFT IIA. THE FINAL ANGIOGRAPHY SHOWED NO ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: REGARDING THE OCCLUSION OF THE LEFT IIA, THE DIAMETER OF THE LEFT IIA WAS ORIGINALLY NARROW, SO THE THROMBOSIS MIGHT HAVE OCCURRED DUE TO THE POOR BLOOD FLOW.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 20082907 ↗
• MalfunctionAug 21, 2024Premature Activation; Premature Activation

  ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AM ABDOMINAL AORTIC ANEURYSM AND A RIGHT COMMON ILIAC ARTERY ANEURYSM UTILIZING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (INTERNAL ILIAC COMPONENT HGB161207A) AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (SERIAL# IS UNKNOWN). DURING THE PROCEDURE, THE DEVICE COULD NOT REACH INTENDED LANDING ZONE, DUE TO TORTUOUS ANATOMY. WHILE REMOVING THE SHEATH AND HGB161207A DEVICE FROM THE BODY, THE HGB161407A DEVICE WAS INADVERTENTLY DEPLOYED IN A 12FR SHEATH. AFTER REMOVING SHEATH FROM THE BODY IN TORTUOUS CIA AND EIA, THE STENT WAS NOTED TO BE FRACTURED IN THE MIDDLE. NO TEAR WAS OBSERVED WITH THE SHEATH. IT WAS ALSO REPORTED THERE WAS DIFFICULTY INITIALLY ADVANCING THE SHEATH. THERE WERE NO PARTS OF SHEATH OR CATHETER LEFT IN THE BODY AND NO HARM TO THE PATIENT WAS OBSERVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER NEW INTERNAL ILIAC COMPONENT AND THE SAME SHEATH. PATIENT TOLERATED THE PROCEDURE. PHYSICIAN BELIEVES THE TEAR IN THE GRAFT WAS CAUSED BY TORTUOUS VESSEL. NO IMAGES OR FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20016625 ↗

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