GORE EXCLUDER Iliac Branch Endoprosthesis HGB161007ARecalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00733132635313), received between Jun 28, 2018 and Sep 29, 2026 — classified as 2 deaths, 73 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (9 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 94 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Obstruction/Occlusion

  MAUDE report 50929002 ↗
• 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 ↗
• InjuryMay 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 ILIAC ARTERY ANEURYSMS USING A NON-GORE STENT GRAFT (ENDURANT) AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. FOLLOWING DEPLOYMENT OF A NON-GORE MAIN TRUNK, AN ILIAC BRANCH COMPONENT (IBC) WAS PLACED IN THE RIGHT COMMON ILIAC, AND AN INTERNAL ILIAN COMPONENT (IIC) WAS PLACED IN THE RIGHT INTERNAL ILIAC. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, COMPRESSION OF THE IIC AND OCCLUSION OF THE RIGHT INTERNAL ILIAC WERE OBSERVED. REINTERVENTION WAS PERFORMED, AND AN ADDITIONAL STENT GRAFT WAS IMPLANTED AT THE STENOTIC SEGMENT OF THE RIGHT EXTERNAL ILIAC. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 25263912 ↗
• InjuryMay 20, 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 ABDOMINAL AND ILIAC ARTERY ANEURYSMS USING THE GORE® EXCLUDER® AAA ENDOPROSTHESES AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. AFTER DEPLOYMENT OF THE ILIAC BRANCH COMPONENT (IBC), COIL EMBOLIZATION OF THE INFERIOR GLUTEAL ARTERY WAS PERFORMED. SUBSEQUENTLY, TWO INTERNAL ILIAC COMPONENTS (IICS) WERE DEPLOYED FROM THE LEFT INTERNAL ILIAC ARTERY TO THE SUPERIOR GLUTEAL ARTERY. A CONTRALATERAL LEG WAS THEN DEPLOYED TO CONNECT THE TRUNK IPSILATERAL LEG WITH THE IBC. THE PATIENT TOLERATED THE PROCEDURE. POSTOPERATIVELY, MILD GLUTEAL CLAUDICATION WAS NOTED, ALTHOUGH CT CONFIRMED PRESERVATION OF BLOOD FLOW IN THE LEFT INTERNAL ILIAC ARTERY. IN (B)(6) 2026, FOLLOW-UP CT DEMONSTRATED COMPLETE OCCLUSION OF THE LEFT INTERNAL ILIAC ARTERY. PERSISTENT SYMPTOMS OF GLUTEAL CLAUDICATION WERE ALSO OBSERVED. THE EVENT IS ONGOING.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 25226454 ↗
• InjuryMay 20, 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 ABDOMINAL AND ILIAC ARTERY ANEURYSMS USING THE GORE® EXCLUDER® AAA ENDOPROSTHESES AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. AFTER DEPLOYMENT OF THE ILIAC BRANCH COMPONENT (IBC), COIL EMBOLIZATION OF THE INFERIOR GLUTEAL ARTERY WAS PERFORMED. SUBSEQUENTLY, TWO INTERNAL ILIAC COMPONENTS (IICS) WERE DEPLOYED FROM THE LEFT INTERNAL ILIAC ARTERY TO THE SUPERIOR GLUTEAL ARTERY. A CONTRALATERAL LEG WAS THEN DEPLOYED TO CONNECT THE TRUNK IPSILATERAL LEG WITH THE IBC. THE PATIENT TOLERATED THE PROCEDURE. POSTOPERATIVELY, MILD GLUTEAL CLAUDICATION WAS NOTED, ALTHOUGH CT CONFIRMED PRESERVATION OF BLOOD FLOW IN THE LEFT INTERNAL ILIAC ARTERY. IN (B)(6) 2026, FOLLOW-UP CT DEMONSTRATED COMPLETE OCCLUSION OF THE LEFT INTERNAL ILIAC ARTERY. PERSISTENT SYMPTOMS OF GLUTEAL CLAUDICATION WERE ALSO OBSERVED. THE EVENT IS ONGOING.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 25226432 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE ON AUGUST 18, 2025, FROM THE MEDIDATA STUDY DATABASE AND IMAGING EMAIL: 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

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 24976855 ↗
• MalfunctionApr 17, 2026Material Separation; Detachment of Device or Device Component; Difficult to Advance

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RIGHT COMMON ILIAC ARTERY ANEURYSM USING A NON-GORE STENT GRAFT (MAIN DEVICE: AFX), GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. THE NON-GORE STENT GRAFT WAS IMPLANTED IN THE ABDOMINAL AORTA. AN 18 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS THEN INSERTED FROM THE RIGHT SIDE, AND THREE AORTIC EXTENDER ENDOPROSTHESES (TWO GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND ONE GORE® EXCLUDER® AAA ENDOPROSTHESIS) WERE IMPLANTED PROXIMALLY. AN ILIAC BRANCH COMPONENT WAS DELIVERED FROM THE RIGHT SIDE AND DEPLOYED. A 14 FR SHEATH WAS INSERTED ALONGSIDE AN 18 FR SHEATH, AND THE IPSILATERAL U TURN TECHNIQUE WAS PERFORMED. ALTHOUGH THE U TURN WAS ACHIEVED, THERE WAS STRONG RESISTANCE AND THE ILIAC BRANCH COMPONENT MIGRATED DISTALLY. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) CONFIRMED THAT THE GATE OF THE ILIAC BRANCH COMPONENT WAS NOT COMPRESSED AT THAT TIME. CANNULATION OF THE INTERNAL ILIAC ARTERY WAS ATTEMPTED USING A RADIFOCUS WIRE AND A KMP CATHETER, AND THE INTERNAL ILIAC ARTERY WAS DILATED USING A PTA BALLOON. THE WIRE WAS THEN E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907601 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A DISTAL TYPE I ENDOLEAK ON THE LEFT SIDE USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. ON MARCH 26, 2026, IT WAS REPORTED THAT A DEVICE INFECTION WAS CONFIRMED, AND A REPLACEMENT TREATMENT IS PLANNED.

  Patient problems: Unspecified Infection

  MAUDE report 24855037 ↗
• MalfunctionFeb 23, 2026Failure to Unfold or Unwrap; Material Twisted/Bent

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND 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 IN THE LEFT COMMON ILIAC ARTERY, INSERTION OF THE INTERNAL ILIAC COMPONENT (IIC) INTO THE LEFT INTERNAL ILIAC ARTERY WAS ATTEMPTED; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL BECAUSE THE STIFF GUIDEWIRE BECAME ENTANGLED WITH THE THROUGH-WIRE. THE IIC WAS REMOVED, AND THE PHYSICIAN ATTEMPTED RECANNULATION, BUT THIS WAS AGAIN UNSUCCESSFUL AS THE THROUGH-WIRE AND THE STIFF GUIDEWIRE CROSSED. ADDITIONAL MANEUVERS, INCLUDING PTA BALLOON DILATION, WERE ALSO ATTEMPTED BUT WERE UNSUCCESSFUL. DURING THESE ATTEMPTS, THE 12FR SHEATH BEGAN TO WITHDRAW, SO THE PHYSICIAN ATTEMPTED TO RETRIEVE THE IIC BACK INTO THE SHEATH; HOWEVER, IT COULD NOT BE REINTRODUCED. THE IIC WAS THEN WITHDRAWN FROM THE PATIENT TOGETHER WITH THE SHEATH. DEFORMATION OF THE SHEATH TIP WAS OBSERVED. IN ADDITION, THE IIC SHOWED LOOSENING OF THE DEPLOYMENT LINE WITH PARTIAL PREMATURE OPENING, AND THE PROXIMAL SHAFT WAS FOUND TO BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24423687 ↗
• MalfunctionFeb 19, 2026Difficult to Remove; Material Separation; Malposition of Device; Material Twisted/Bent

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A LEFT INTERNAL ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. AFTER DEPLOYING THE ILIAC BRANCH COMPONENT(IBC) IN RIGHT ILIAC ARTERY, THE INTERNAL ILIAC COMPONENT(IIC) WAS ADVANCED USING U-TURN TECHNIQUE. DURING ADVANCING THE IIC DEVICE, THE DSF SHEATH BECAME DISLODGED FROM THE RIGHT INTERNAL ILIAC GATE. THE DELIVERY OF THE IIC DEVICE WAS CONTINUED, BUT IT WAS DIFFICULT, AND X-RAY IMAGING CONFIRMED THAT THE ROOT OF THE OLIVE TIP HAD BENT 180 DEGREES. ATTEMPTS WERE MADE TO WITHDRAW THE DEVICE; HOWEVER, THE REMOVAL WAS DIFFICULT. DURING REPEATED PUSH-AND-PULL MANIPULATION OF THE DELIVERY CATHETER, THE STENT GRAFT INITIATED TO DEPLOY WITHIN THE IPSILATERAL LEG OF IBC DEVICE AND SUBSEQUENTLY FULLY DEPLOYED. UPON WITHDRAWING THE DELIVERY CATHETER, IT WAS CONFIRMED THAT THE DISTAL PART OF THE DELIVERY CATHETER WAS SEPARATED. AN ATTEMPT WAS MADE TO RETRIEVE IT FROM THE IPSILATERAL SIDE USING A SNARE CATHETER BUT WAS UNSUCCESSFUL, SO THE CONTRALATERAL SIDE WAS PUNCTURED, AND THE SEPARATED DISTAL PART WAS SUCCESSFULLY RETRIEVED WITH A SNARE CATHETER. THE PROCEDURE THEN CONTINUED USING UP AND OVER TEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385869 ↗
• MalfunctionJan 13, 2026Material Separation

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR BILATERAL ILIAC ARTERY ANEURYSMS USING GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESES, AND GORE DRYSEAL FLEX INTRODUCER SHEATHS AS ACCESSORIES. WHILE DELIVERING THE INTERNAL ILIAC COMPONENT, THE DELIVERY CATHETER AND THE PULL-THROUGH WIRE BECAME ENTANGLED. IT WAS RESOLVED AFTER MULTIPLE ATTEMPTS AT RE-CANNULATION, AND DEPLOYMENT WAS SUCCESSFULLY COMPLETED. UPON REMOVAL OF THE DELIVERY CATHETER, THE LEADING OLIVE WAS FOUND TO HAVE REMAINED INSIDE THE ANEURYSM SAC; HOWEVER, AS THE STIFF WIRE HAD ALREADY BEEN REMOVED, IT WAS LEFT WITHIN THE ANEURYSM SAC. IN ADDITION, A DISSECTION WAS OBSERVED NEAR THE PUNCTURE SITE OF THE RIGHT COMMON FEMORAL ARTERY, WHICH WAS SURGICALLY REPAIRED. IT WAS ALSO REPORTED THAT THERE WAS A RESISTANCE WHILE ADVANCING THE 16FR SHEATH. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24054541 ↗
• InjuryJan 8, 2026Adverse 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 AORTIC ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) DEVICES. POSTOPERATIVE CT IMAGING REVEALED OCCLUSION OF THE INTERNAL ILIAC COMPONENT. THE PATIENT REMAINS ASYMPTOMATIC AND IS UNDER OBSERVATION. THE PHYSICIAN¿S COMMENT: DUE TO THE TORTUOSITY OF THE INTERNAL ILIAC ARTERY, THE DISTAL END OF THE INTERNAL ILIAC COMPONENT MAY HAVE BECOME POSITIONED IN A WAY THAT IT WAS COVERED BY THE VESSEL WALL. ADDING AN ADDITIONAL ILIAC LEG MIGHT HAVE BEEN NEEDED; HOWEVER, INTRAOPERATIVE ANGIOGRAPHY AT THE END OF THE PROCEDURE SHOWED NO BLOOD FLOW ISSUES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24016282 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A RUPTURED LEFT COMMON ILIAC ARTERY ANEURYSM (LCIAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES, A GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICE AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WITHIN THE LEFT INTERNAL ILAC ARTERY (LIIA). AN ADJUNCTIVE PROCEDURE WAS ALSO PERFORMED, WHEREIN THE INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 27 MM WITH A MAXIMUM DIAMETER PROXIMAL LANDING ZONE OF 22 MM. THE MAXIMUM DIAMETER OF THE RIGHT COMMON ILIAC ARTERY MEASURED 37 MM AND THE MAXIMUM DIAMETER OF THE LEFT COMMON ILIAC ARTERY MEASURED 25 MM. 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, AN INTERVENTION WAS

  Patient problems: Clinical Endoleak

  MAUDE report 23751560 ↗
• 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 23724070 ↗
• InjuryDec 4, 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 23723667 ↗
• InjuryNov 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6)2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR COMMON ILIAC ARTERY ANEURYSMS USING GORE EXCLUDER AAA ENDOPROSTHESES AND GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2018, THROMBOSIS OF THE RIGHT EXTERNAL ILIAC ARTERY WAS OBSERVED. A THROMBECTOMY WAS PERFORMED, AND A BARE METAL STENT WAS IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE THROMBOSIS WAS TRIGGERED BY A SEVERE TWIST OBSERVED IN THE ANATOMY-BASED VIEW. NO FURTHER INFORMATION WAS AVAILABLE. ON AN UNKNOWN DATE DURING FOLLOW-UP, THROMBOTIC OCCLUSION OF THE INTERNAL ILIAC COMPONENT (IIC: HGB161007A) WAS OBSERVED. ADDITIONALLY, A TYPE I ENDOLEAK WAS NOTED AT THE DISTAL PORTION OF THE CONTRALATERAL LEG, WHICH HAD BEEN PLACED TOWARD THE LEFT COMMON ILIAC ARTERY. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED. THE LEFT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED, AND AN ADDITIONAL STENT GRAFT WAS PLACED AS AN EXTENSION TO THE LEFT EXTERNAL ILIAC ARTERY. SINCE COLLATERAL CIRCULATION WAS MAINTAINING BLOOD FLOW TO THE RIGHT INTERNAL ILIAC ARTERY, NO SPECIFIC TREATMENT WAS ADMINISTERED FOR THE OCCLUSION OF THE IIC. THE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23565828 ↗
• 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 23560578 ↗
• InjuryNov 12, 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). WHEN DEPLOYING THE IBE ON THE PATIENT¿S LEFT SIDE, THE INTERNAL ILIAC COMPONENT (IIC) REMAINED PATENT; HOWEVER, BLOOD FLOW TO THE DISTAL PORTION OF THE IIC COULD NOT BE CONFIRMED. DURING INSERTION OF A SELECTIVE VASCULAR CATHETER (KMP CATHETER) FOR IIC PLACEMENT, A POSSIBLE DISSECTION OF THE DISTAL IIC WAS CONSIDERED. BLOOD FLOW TO THE DISTAL IIC REMAINED UNCLEAR, AND IT WAS MANAGED WITH OBSERVATION. DURING DEPLOYMENT OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, IT WAS REPORTED THAT THE CONTRALATERAL GATE DID NOT FULLY EXPAND DUE TO THE PATIENT¿S VASCULAR ANATOMY. AFTER DEPLOYING THE IPSILATERAL LEG FIRST, THE GATE OPENED, AND CANNULATION WAS SUCCESSFUL. IN ADDITION, BECAUSE THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS HAD MIGRATED APPROXIMATELY 7 MM DISTALLY, AN AORTIC EXTENDER ENDOPROSTHESIS WAS ADDITIONALLY PLACED PROXIMALLY. DUE TO THE PATIENT¿S ANATOMIC CONSTRAINT, THE ORIGIN OF THE ILIAC BR

  Patient problems: Obstruction/Occlusion

  MAUDE report 23539316 ↗
• MalfunctionSep 11, 2025Fracture; Fracture

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ILIAC ANEURYSM, UTILIZING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. IT WAS REPORTED DURING THE PROCEDURE, UPON TRYING TO REMOVE THE DELIVERY CATHETER, RESISTANCE WAS NOTED AS THE OLIVE TIP CAME BACK INTO THE 12 FR SHEATH. IT WAS ALSO REPORTED THE PHYSICIAN APPLIED SOME FORCE, AND THE OLIVE TIP AND PART OF THE DELIVERY SHAFT SEPARATED. THE OLIVE TIP WAS SUCCESSFULLY RETRIEVED, AND NO ADVERSE EVENTS OCCURRED. THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025741 ↗
• InjuryAug 18, 2025Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TREATED FOR AN AORTO-ILIAC ANEURYSM USING A GORE® EXCLUDER® IIIAC BRANCH ENDOPROSTHESIS (IBE) SYSTEM. A CEB231410 WAS USED AS THE MAIN BODY DUE TO LENGTH CONCERNS, WHILE THE CEB231210 WAS USED IN THE ILIAC ARTERY. ON (B)(6) 2025, A REINTERVENTION OCCURRED BECAUSE THE RIGHT INTERNAL ILIAC COMPONENT HAD THROMBOSED, AND THROMBUS WAS SEEN INSIDE THE ILIAC BRANCH COMPONENT. THE PHYSICIAN USED A CONTRALATERAL LEG TO EXTEND FROM THE FLOW DIVIDER INTO THE EXTERNAL ILIAC, COVERING THE RIGHT INTERNAL ILIAC. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 22829940 ↗
• InjuryAug 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) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. ON AN UNKNOWN DATE, THROMBOTIC OCCLUSION OF THE INTERNAL ILIAC COMPONENT WAS CONFIRMED (DETAILS UNKNOWN). ON (B)(6) 2025, THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND WAS DIAGNOSED WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. ADDITIONALLY, AN PROXIMAL TYPE I ENDOLEAK CAUSED BY VASCULAR DILATION JUST BELOW THE RENAL ARTERIES WAS IDENTIFIED. EMERGENCY REINTERVENTION WAS PERFORMED, INVOLVING THE ADDITIONAL PLACEMENT OF AN AORTIC EXTENDER ENDOPROSTHESIS ON THE PROXIMAL SIDE OF THE PREVIOUSLY IMPLANTED DEVICE, ALONG WITH THE INJECTION OF EMBOLIC MATERIAL (NBCA) INTO THE ANEURYSM SAC. PHYSICIAN¿S COMMENT: SEVEN YEARS HAVE PASSED SINCE THE INITIAL EVAR, AND IT IS CONSIDERED THAT VASCULAR DILATION BELOW THE RENAL ARTERIES IN RELATION TO THE IMPLANTED DEVICE WAS THE CAUSE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22723500 ↗
• InjuryAug 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) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. ON AN UNKNOWN DATE, THROMBOTIC OCCLUSION OF THE INTERNAL ILIAC COMPONENT WAS CONFIRMED (DETAILS UNKNOWN). ON (B)(6) 2025, THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND WAS DIAGNOSED WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. ADDITIONALLY, AN PROXIMAL TYPE I ENDOLEAK CAUSED BY VASCULAR DILATION JUST BELOW THE RENAL ARTERIES WAS IDENTIFIED. EMERGENCY REINTERVENTION WAS PERFORMED, INVOLVING THE ADDITIONAL PLACEMENT OF AN AORTIC EXTENDER ENDOPROSTHESIS ON THE PROXIMAL SIDE OF THE PREVIOUSLY IMPLANTED DEVICE, ALONG WITH THE INJECTION OF EMBOLIC MATERIAL (NBCA) INTO THE ANEURYSM SAC. PHYSICIAN¿S COMMENT: SEVEN YEARS HAVE PASSED SINCE THE INITIAL EVAR, AND IT IS CONSIDERED THAT VASCULAR DILATION BELOW THE RENAL ARTERIES IN RELATION TO THE IMPLANTED DEVICE WAS THE CAUSE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22723488 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR BILATERAL COMMON ILIAC ARTERY ANEURYSMS (CIAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES, AND GORE® EXCLUDER® LLIAC BRANCH ENDOPROSTHESES (IBE) AND GORE® VIABAHN® (VBX) BALLOON EXPANDABLE ENDOPROSTHESIS. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 24MM, WITH A PROXIMAL LANDING ZONE DIAMETER OF 22MM. THE LEFT COMMON ILIAC ARTERY (LCIA) MAXIMUM DIAMETER MEASURED 48MM AND THE RIGHT COMMON ILIAC (RCIA) MEASURED 78MM. THE PATIENT TOLERATED THE PROCEDURE; NO DISCHARGE DATE WAS RECORDED. ON (B)(6) 2025, IT WAS REPORTED THE PATIENT HAD THROMBOSIS OF THE GORE® EXCLUDER® INTERNAL ILIAC BRANCH ENDOPROSTHESIS (HGB161007/(B)(6)) IMPLANTED WITHIN THE RIIA. THE EVENT IS ONGOING AND NO ADDITIONAL TREATMENT FOR THE PATIENT IS SCHEDULED.

  Patient problems: Stenosis

  MAUDE report 22282893 ↗
• InjuryJun 16, 2025Malposition of Device; Malposition of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). THEN IBE WAS PLACED IN THE LEFT SIDE. DURING THIS STEP, INFERIOR GLUTEAL ARTERY WAS UNINTENTIONALLY COVERED BY THE INTERNAL ILIAC COMPONENT. NO INTERVENTION WAS PERFORMED FOR THE UNINTENTIONAL COVERAGE. ALL OTHER DEVICES WERE SUCCESSFULLY IMPLANTED AS PLANNED. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: TO AVOID COVERING THE INFERIOR GLUTEAL ARTERY THE INTERNAL ILIAC COMPONENT WAS DEPLOYED WHILE BEING PULLED UPWARD, BUT THE DISTAL END OF THE DEVICE WAS NOT PULLED SUFFICIENTLY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22216592 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE ON MAY 27, 2025, FROM THE IMAGING DATABASE: ON (B)(6) 2024, THIS 69-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A PLANNED PROCEDURE FOR AN AORTOILIAC ANEURYSM. THE PATIENT WAS TREATED WITH TWO GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES, TWO GORE® EXCLUDER® ENDOPROSTHESIS DEVICES, THREE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES AND A GORE® VIABAHN® ENDOPROSTHESIS. IT IS UNKNOWN WHERE THE GORE® VIABAHN® ENDOPROSTHESIS WAS IMPLANTED EXACTLY. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. THE SITES WERE ACCESSED PERCUTANEOUSLY. THERE WERE THREE ADJUNCTIVE CORRECTIVE PROCEDURES; COIL EMBOLIZATIONS TO THE INFERIOR MESENTERIC ARTERY (IMA), THE LUMBAR ARTERY VESSELS, AND ONE OTHER LOCATION NOT SPECIFIED. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED AFTER SUCCESSFUL ACCESS, DELIVERY AND DEPLOYMENT OF THE DEVICES. HE WAS DISCHARGED HOME ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT UNDERWENT A CTA IN WHICH THE PATIENT HAD AN UNEXPECTED RESULT. THE IMAGE WAS READ AS HAVING ¿THE IIC WITHIN THE RT. IIA IS OCCLUDED.¿ THE REPORTED LOSS OF PATENCY AFFECTS THE RIGHT INTERNAL ILIAC A

  Patient problems: Obstruction/Occlusion

  MAUDE report 22200839 ↗

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